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Central California Alliance for Health

Pharmacy Prior Authorization Criteria

March 2020

Notice of Nondiscrimination and Accessibility

Discrimination is Against the Law Central California Alliance for Health (the Alliance) complies with Federal civil rights and nondiscrimination laws to make sure all members have access to its programs and services. This means that the Alliance does not exclude or treat members differently because of race, color, national origin, age, disability, or sex.

The Alliance provides services, at no cost, to help members communicate with us. • Members with a disability can ask for: ○ A trained sign language interpreter, and ○ Written information in large print, audio, easy to use electronic formats and other formats.

• Members whose primary language is not English can ask for: ○ A trained language interpreter, and ○ Information written in a language they can understand.

If you need these services, contact the Alliance Member Services Department at 1-800-700-3874 or if you believe that the Alliance did not provide these services or treated you differently because of race, color, national origin, age, disability, or sex, you can file a grievance in any of these ways:

Phone: 1-800-700-3874 ext. 5816 Website: https://www.ccah-alliance.org/Complaints.html Fax: 1-831-430-5579 Email: [email protected] Mail: Grievance Department 1600 Green Hills Road, Suite 101 Scotts Valley, CA 95066

If you need help filing a grievance, our Member Service Representatives and Grievance Coordinators can help you. Contact the Alliance Member Services Department at 1-800-700-3874 or Grievance Department at 1-800-700-3874, ext. 5816. For the Hearing or Speech Assistance Line, call 1-800-735-2929 (TTY: Dial 7-1-1).

You can also file a complaint with the U.S. Department of Health and Human Services, Office for Civil Rights in any of these ways:

Phone: 1-800-368-1019 (TTY: Dial 1-800-537-7697) Website: https://ocrportal.hhs.gov/ocr/portal/lobby.jsf Email: [email protected] Mail: U.S. Department of Health and Human Services, Office for Civil Rights 200 Independence Avenue, SW Room 509F, HHH Building Washington, D.C. 20201 Forms: https://www.hhs.gov/ocr/complaints/index.html

November 4, 2016

LANGUAGE ASSISTANCESI

LANGUAGE ASSISTANCE CONTINUED

Alliance Contact Information

Address

Santa Cruz County Main Office Monterey County Office Merced County Office 1600 Green Hills Road, 950 East Blanco Road, 530 West 16th Street, Suite 101 Suite 101 Suite B Scotts Valley, CA 95066-4981 Salinas, CA 93901-3400 Merced, CA 95340-4710 (831) 430-5500 (831) 755-6000 (209) 381-5300 Hours: M-F, 8am-5pm Hours: M-F, 8am-5pm Hours: M-F, 8am-5pm

Phone Directory

Automated System (831) 430-5501

Authorizations – Pharmacy (831) 430-5507

Authorizations – Non-Pharmacy (831) 430-5506

Status Requests for Non-Pharmacy (831) 430-5511

Care Management (831) 430-5512

Claims Inquiries (831) 430-5503

EDI Support Line (831) 430-5510

Health Education (831) 430-5580

Member Services (831) 430-5505

Provider Services (831) 430-5504

Department Fax Numbers

Administration (831) 430-5852

Claims (831) 430-5858

Finance (831) 430-5853

Health Services PA and RAFs (831) 430-5850

Member Services (831) 430-5856

Pharmacy Authorizations (831) 430-5851

Provider Services (831) 430-5857

Forward

Central California Alliance for Health (The Alliance), with direction from the Pharmacy & Therapeutics (P&T) Committee, has developed this formulary to be used by Alliance providers and members. The Medi-Cal List of Contract Drugs has not been in use by the Alliance since January 1, 1997.

The P&T committee will continue to update and revise this formulary based on quality of care considerations and sound pharmacoeconomic principles. The Alliance’s contract with the State of California requires mandatory generic substitution whenever an equivalent product is available. By Alliance policy, the only drugs not requiring mandatory generic substitution are Coumadin, Dilantin, and Lanoxin. However, clinicians may prescribe a Brand Name drug with a “do not substitute” order when there is clinical justification for doing so. In the latter case, a Prior Authorization must be submitted to the Alliance for consideration prior to dispensing the medication to an Alliance member.

The Formulary is a list of medication available to Central California Alliance for Health members under their pharmacy benefit. All drugs are listed by their generics names and the most common proprietary (branded) name. In situations where an FDA- approved generic equivalent is available, brand names are listed for reference purposes only, and do no denote coverage for the brand.

The same formulary is used for all Alliance members including Whole Child Members with California Children’s Service eligibility.

Over-the-counter (OTC) medications are not a covered benefit for Knox-Keene line of business (LOB) including Medi-Cal Access Program, and IHSS except for loratadine, cetirizine, fexofenadine, ketotifen, prenatal vitamins, nicotine patches and gum, OTC contraceptives and diabetic supplies.

Formulary Terms 5-Day Emergency Fills Emergency authorizations for Prior Authorizations outside of Central California Alliances’ normal business hours may be requested from MedImpact at (800) 788-2949. MedImpact may authorize up to a 5 day supply of medication, pending further authorization by Central California Alliance for Health.

Central California Alliance for Health will also authorize a retroactive Prior Authorization allowing the pharmacy to dispense up to a 5 day supply of a non-formulary drug in an emergency situation. Central California Alliance for Health does not require that the situation meet any legal (i.e., pharmacy law) definition of “emergency” -- it is the judgment of the dispensing pharmacist that determines the need for emergency authorization in order to avoid pain, suffering, severe emotional distress, or worsening of any medical condition that could result in the need for emergency medical treatment.

Brand Name Unless otherwise stated, the brand names shown in the formulary guide are non-formulary when an equivalent generic is approved by the FDA. Brand names used in this formulary guide are representative only, for ease of drug recognition by providers. Generic products must be dispensed whenever possible, as required by the Formulary Utilization Management Initiative (refer to State’s Medi-Cal program).

Carve-Out Drugs (Excluded Drugs) The following drugs are covered by State Medi-Cal:

1. All antiretroviral drugs except Retrovir (zidovudine), and Videx (didanosine). 2. All antipsychotics, antimania, MAO inhibitors and antiparkinson anticholinergic drugs used for side effects. 3. Drugs to treat ED and opioid detoxification. 4. All blood factors and coagulation factors. 5. Certain drugs for the treatment of Hepatitis B.

These are prescription services that are not included in the Alliances’ scope of coverage, but are covered (or covered with Prior Authorization) by the State Medi-Cal Fee-For-Service program. These drugs remain a potential benefit for eligible Alliance members through State Medi-Cal, but the Alliance is not financially responsible and all claims for these drugs (including secondary copays) must be reimbursed through the State Medi-Cal program.

These drugs are non-formulary but, with the exception of ED drugs, are covered by the Alliance for the Medi-Cal Access program and IHSS.

Please contact State Medi-Cal at 1-800-541-555 or go to https://learn.medi-cal.ca.gov/Resources/eTARNewsTips.aspx

Formulary Terms (Continued) Code 1 Restriction Code 1 medications are formulary, but their use is limited to a specific medical condition, failure/intolerance to 1st line therapy, member’s place of residence, or other stipulated restriction(s). Although Code 1 restricted drugs do not require a Prior Authorization when the Code 1 restriction is met, pharmacy providers must maintain documentation that the drug is being dispensed according to the Code 1 restriction. Any other use of the drug is considered non- formulary and requires a Prior Authorization. To facilitate filling of a Code 1 prescription, prescribers should write the member’s diagnosis, and any other Code 1 criteria if met, on the prescription.

Dollar Amount Limit Central California Alliance for Health has an online adjudication limit of $1,000 for any single claim, for most drugs. Claims submitted for more than $1,000 will require a Prior Authorization, even if on formulary. Compound prescription claims using formulary ingredients have a $100 limit, with a Prior Authorization required on claims that exceed $100.

Dual Eligible Members A dual eligible member is a Medi-Cal member who is also eligible for Medicare, whether or not they are actually enrolled in Medicare. Medi-Cal is always secondary to Medicare, thus if patient is eligible for Medicare, Medicare must be billed prior to billing Central California Alliance for Health. Dual eligible individuals are required to join a Medicare plan, and there is a process by which CMS auto-enrolls members into Medicare upon becoming eligible. However, if a member is not yet enrolled in Medicare, but is eligible for Medicare, there is a process by which pharmacies can enroll patients in Part D at Point-of-Sale (LINET program, administered by Humana). Medications that are excluded from the members Medicare plan may be submitted directly to Central California Alliance for Health. Please note that medication that are excluded from the Members Medicare may also be exempt from Medi-Cal &/or Central California Alliance for Health’s benefits. Medications that are non-formulary on member’s Part D (but not excluded) must go through the Prior Authorization procedures with the Part D plan rather than Central California Alliance for Health. Pharmacies may submit a Prior Authorization to Central California Alliance for Health for consideration of Part B copays; Central California Alliance for Health is federally prohibited from paying any Part D copays or deductibles. eCOB Electronic coordination of benefits (eCOB). The ability to transmit & adjudicate electronically (online) the portion of the primary insurance claim that is the patient’s responsibility, to the secondary insurance. If the medication is non-formulary or non-preferred with the primary insurance, a prior auth. should be sought with the primary before submitting a PRIOR AUTHORIZATION to Central California Alliance for Health. Per CMS Federal regulations, Central California Alliance for Health is not responsible for any Part D copays, deductibles or “donut hole” (gap) amounts.

Formulary Terms (Continued) Excluded Drugs Medications that have been excluded from Part D by Federal CMS regulation and are typically not a covered benefit by Medicare D plans. Excluded Drugs include: drugs covered exclusively by Part A or B, OTCs, Rx vitamin & mineral supplements (except niacin & fluoride products), cough & cold agents, fertility agents, agents for weight gain/loss (except megestrol), agents for cosmetic use. Drugs which are excluded from PART D coverage per CMS may be eligible for coverage through the member’s secondary Medi-Cal (Central California Alliance for Health) coverage, depending on the drugs’ Central California Alliance for Health formulary status (e.g., some drugs which are excluded from CMS for Part D are also excluded from Central California Alliance for Health coverage).

Formulary Note that additional restrictions may apply to formulary medications. A formulary agent may be subject to dollar limit, age, quantity, or other limitations which necessitate a PA despite formulary status.

Medical Supplies The pharmacy department will review authorization requests for blood glucose meters, test strips, lancets, syringes, needles and sharps containers. All other requests for medical supplies will need to be sent to the Utilization Management department. The fax number for the Utilization Management department is (831) 430-5850.

Prior Authorization A prior authorization request form for Central California Alliance for Health services.

To facilitate prompt determination of a Prior Authorization (PA), and to minimize the need for communication between the prescriber, the pharmacy, and Central California Alliance for Health staff, prescribers are encouraged to include the following information, as appropriate:  Diagnosis: Prior Authorization must have an accurate diagnosis (preferably with specific ICD-10) provided by the physician. The diagnosis info must be specific for the patient & drug in question. Dispensing pharmacy staff is asked NOT to complete this section on the Prior Authorization without checking with the prescriber, as many drugs have multiple indications & the diagnosis should never be assumed based on a common use. An incorrect diagnosis may cause further delay of the review process.  Other Formulary Medications tried and nature of the failure.  Clinical Justification for the use of a non-formulary drug, including relevant lab results and medical history.

Prior Authorizations submitted to Central California Alliance for Health without the above information may be denied due to insufficient information for clinical review. If denied due to insufficient information, the request may be resubmitted with a new completed Prior Authorization form & the required information at any time, since the new submission is treated as a new Prior Authorization.

Formulary Terms (Continued) Over the Counter Medications (OTC’s) Over-the-counter (OTC) medications are not a covered benefit for Knox-Keene line of business (LOB) including Medi-Cal Access Program, and IHSS except for loratadine, cetirizine, fexofenadine, ketotifen, prenatal vitamins, nicotine patches and gum, OTC contraceptives and diabetic supplies.

A prescription is required for both formulary OTC claims and non-formulary OTC requests.

Quantity Limit A drug may be limited to a maximum daily, monthly, yearly or lifetime usage.

Secondary Insurance When a Member has more than one medical &/or prescription insurance, one is assigned as the primary and the other is secondary—meaning reimbursement for services is the responsibility of the primary insurance first. The secondary is billed only after the primary. A secondary insurance may utilize its own formulary restrictions. State funded programs are always secondary to any private or federal insurance plans—i.e., they are the payers of last resort. All reimbursement issues should be resolved with the primary insurance before submitting a Prior Authorization to Central California Alliance for Health – this includes using the allowed day’s supply, using the primary’s formulary preferred agents, obtaining prior auth. from the primary for non- preferred or non-formulary items, etc.

If the Member’s commercial insurance does not cover a medication, a Prior Authorization must be submitted to the commercial primary insurance first. If the Prior Authorization is denied an appeal must be submitted and denied prior to submitting a request directly to Central California Alliance for Health with a copy of both denials from the primary insurance.

If the Member has a commercial primary insurance, Central California Alliance for Health will pay for the remaining copay balance due. Central California Alliance for Health requires verbal or written notification of the amount that the primary insurance paid.

Step Therapy Online approval without a Prior Authorization requires prior treatment with prerequisite drug therapy. Member must have had a previous trial of one or more designated 1st line agent(s) paid by MedImpact within a designated time frame in order for claim to adjudicate without a Prior Authorization. Prior Authorizations submitted for STEP agents are needed when there is no qualifying claim in the claim history look-back period; in the event that a Prior Authorization is needed for a STEP item, additional criteria may have been established by P & T, over & above what is equal to the electronic step edit.

Carve-Out Drugs The following drugs are carved out from the Alliance formulary for AIDS and Hep B indications. They are to be billed to State Medi-Cal via EDS, not the Alliance. Some of the medications may require a TREATMENT AUTHORIZATION REQUEST (TAR) submitted to State Medi-Cal and approved prior to dispensing. Consult your State EDS manual for further information.

All of these are non-formulary for the Medi-Cal Access program and IHSS and require a Prior Authorization to be submitted to the Alliance. Please note that medications in bold lettering are new additions to the carve-out list.

AIDS Drugs ( and Hep B )Drugs TAR Required (Y/N) Abacavir/Lamivudine N Abacavir Sulfate N Abacavir Sulfate/Dolutegravir/Lamivudine (Triumeq) N Atazanavir Sulfate N Atazanavir/Cobicistat (Evotaz) N Bictegravir/Emtricitabine/Tenofovir Alafenamide (Biktarvy) N Cobicistat (Tybost) N Darunavir Ethanolate N Darunavir/Cobicistat (Prezcobix) N Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (Symtuza) N Delavirdine Mesylate N Dolutegravir (Tivicay) N Dolutegravir/ Lamivudine (Dovato) N Dolutegravir/ Rilpivirine (Juluca) N Doravine (Pifeltro) N Doravirine/ Lamivudine/ Tenofovir disoproxil fumarate (Delstrigo) N Efavirenz N Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate ( Atripla) N Efavirenz/Lamivudine/Tenofovir Disoproxil Fumarate ( Symfi LO) N Efavirenz/Lamivudine/Tenofovir Disoproxil Fumarate ( Symfi ) N Elvitegravir (Vitekta) N Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Disoproxil Fumarate (Stribild) N Elvitegravir/Cobicistat/Emtricitabine/Tenofovir alafenamide (Genvoya) N Emtricitabine/Rilpivirine/Tenofovir Alafenamide (Odefsey) N

AIDS Drugs ( and Hep B )Drugs Continued TAR Required (Y/N) Emtricitabine/Rilpivirine/ Tenofovir Disoproxil Fumarate (Complera) N Emtricitabine/Tenofovir Alafenamide ( Descovy) N Emtricitabine N Enfuvirtide Y Etravirine N Fosamprenavir Calcium N Ibalizumab-uiyk ( Trogarzo ) N Indinavir Sulfate N Lamivudine N Lamivudine/ Tenofovir disoproxil fumarate ( Cimduo) N Lopinavir/Ritonavir N Maraviroc N Nelfinavir Mesylate N Nevirapine N Raltegravir Potassium N Rilpivirine Hydrochloride N Ritonavir N Saquinavir N Saquinavir Mesylate N Stavudine N Tenofovir Alafenamide (Vemlidy) N Tenofovir Disoproxil-Emtricitabine N Tenofovir Disoproxil Fumarate N Tipranavir N Zidovudine/Lamivudine N Zidovudine/Lamivudine/ Abacavir Sulfate N

Carve-Out Drugs The following drugs are carved out from the Alliance formulary for Mental Health indications. They are to be billed to State Medi-Cal via EDS, not the Alliance. Some of the medications may require a TREATMENT AUTHORIZATION REQUEST (TAR) submitted to State Medi-Cal and approved prior to dispensing. Consult your State EDS manual for further information.

All of these are non-formulary for the Medi-Cal Access program and IHSS and require a Prior Authorization to be submitted to the Alliance. Please note that medications in bold lettering are new additions to the carve-out list.

Psychiatric Drugs TAR Requirement (Y/N) Amantadine HCl N Amantadine HCl ER Y Aripiprazole Y(Age 0-17) Aripiprazole lauroxil (Aristada Initio) Y Asenapine (Saphris) Y(Age 0-17) Benztropine Mesylate N Brexpiprazole Y Cariprazine Y Chlorpromazine HCl Y(Age 0-17) Clozapine Y(Age 0-17) Fluphenazine Decanoate Y Fluphenazine HCl Y(Age 0-17) Haloperidol Y(Age 0-17) Haloperidol Decanoate Y(Age 0-17) Haloperidol Lactate Y(Age 0-17) Iloperidone (Fanapt) Y(Age 0-17) Isocarboxazid Y Lithium Carbonate N Lithium Citrate N Loxapine Succinate Y(Age 0-17) Lurasidone Hydrochloride Y(Age 0-17) Molindone HCl Y(Age 0-17) Olanzapine Y(Age 0-17) Olanzapine Fluoxetine HCl Y Olanzapine Pamoate Monohydrate (Zyprexa Relprevv) Y

Psychiatric Drugs Continued TAR Requirement (Y/N) Paliperidone (Invega) Y Paliperidone Palmitate (Invega Sustenna) Y Paliperidone Palmitate (Invega Trinza) Y Perphenazine Y(Age 0-17) Phenelzine Sulfate Y Pimavanserin (Nuplazid) Y Pimozide Y Quetiapine Y(Age 0-17) Risperidone Y(Age 0-17) Risperidone ER injectable suspension (Perseris) Y Risperidone Microspheres Y Selegiline (transdermal only) Y Thioridazine HCl Y(Age 0-17) Thiothixene Y(Age 0-17) Thiothixene HCl Y(Age 0-17) Tranylcypromine Sulfate Y Trifluoperazine HCl Y(Age 0-17) Trihexyphenidyl N Ziprasidone HCl Y(Age 0-17) Ziprasidone Mesylate Y

Carve-Out Drugs

The following drugs are carved out from the Alliance formulary for Opioid Detoxification indication. They are to be billed to State Medi-Cal via EDS, not the Alliance. Some of the medications may require a TREATMENT AUTHORIZATION REQUEST (TAR) submitted to State Medi-Cal and approved prior to dispensing. Consult your State EDS manual for further information.

All of these are non-formulary for the Medi-Cal Access program and IHSS and require a Prior Authorization to be submitted to the Alliance. Please note that medications in bold lettering are new additions to the carve-out list.

Alcohol, Heroin Detoxification and Dependency Treatment Drugs TAR Requirement (Y/N) Acamprosate Calcium N Buprenorphine HCl ( Does not require a TAR, except for the drugs below) N Buprenorphine Extended-Release Inj (Sublocade) N Buprenorphine HCl (Belbuca) * Y Buprenorphine Implant (Probuphine) Y Buprenorphine/Naloxone HCl N Naloxone HCl N Naltrexone (oral) N Naltrexone Microsphere Injectable Suspension (Vivitrol) N Lofexidine Hydrochloride (Lucemyra) Y Disulfiram (Antabuse) N

Carve-Out Drugs The following drugs are carved out from the Alliance formulary for Blood and Coagulation Factors. They are to be billed to State Medi-Cal via EDS, not the Alliance. Some of the medications may require a TREATMENT AUTHORIZATION REQUEST (TAR) submitted to State Medi-Cal prior to dispensing. Consult your State EDS manual for further information.

All of these are non-formulary for the Medi-Cal Access program and IHSS and require a Prior Authorization to be submitted to the Alliance. Please note that medications in bold lettering are new additions to the carve-out list.

Blood and Coagulation Factors Antihemophilic factor VIII/von Willebrand factor complex (human) Anti-inhibitor Coagulation factor X (human) Emicizumab (Hemlibra) Factor VIIa (antihemophilic factor, recombinant) Factor VIII (antihemophilic factor, human) Factor VIII (antihemophilic factor, recombinant) Factor VIII (antihemophilic factor, recombinant) (Afstyla), per IU Factor VIII (antihemophilic factor, recombinant) (Novoeight) Factor VIII (antihemophilic factor, recombinant) (Nuwiq), per IU Factor VIII (antihemophilic factor, recombinant) PEGylated, per IU Factor IX (antihemophilic factor, purified, nonrecombinant) Factor IX (antihemophilic factor, recombinant) Factor IX (antihemophilic factor, recombinant) (Rixubis) Factor IX, albumin , (recombinant), (Idelvion) per IU Factor IX complex Factor X (human), per IU Factor XIII (antihemophilic factor, human) Factor XIII A-Subunit (recombinant) Hemophilia clotting factor, not otherwise classified Injection, factor VIII (antihemophilic factor, recombinant) (Obizur) Injection, factor VIII, fc fusion protein (recombinant) Injection Factor IX, (antihemophilic factor, recombinant), glycopegylated, (Rebinyn), 1 IU Injection, factor IX fusion protein (recombinant) Von Willebrand factor (recombinant) (Vonvendi), per IU Von Willebrand factor complex (human), Wilate Von Willebrand factor complex (Humate-P)

Nutritional Supplements The Alliance covers oral nutritional supplements and enteral formulas for Medi-Cal eligible members when medically necessary.

A prior authorization will need to be submitted via the Alliance Portal or by fax to the Alliance Pharmacy Department at (831)430-5851.

Please include the following when submitting a Prior Authorization:  Copy of prescribing provider’s prescription  Completed Prior Authorization request form  Recent chart notes that address medical justification as to why the member is unable to meet his/her nutritional needs with standard or fortified foods  Growth charts for pediatric members or relevant weight history for adult members

Conditions that may necessitate oral nutritional supplements or enteral formulas include, but are not limited to:  Increased metabolic needs  Cow’s milk allergy/intolerance to standard formulas in infancy  Preterm birth  Cancer with significant weight loss  Decubitus ulcers  ESRD on HD or PD  Severe swallowing or chewing difficulty  Conditions impairing digestion and absorption  Failure to Thrive  Underweight status or unintended weight loss defined by the Medi-Cal guidelines

The Alliance will not authorize oral nutrition supplements when used for convenience or preference of the member or provider.

All requests will be reviewed for medical necessity by the Alliance’s Registered Dietitian (RD).

For a list of covered products, please see the Medi-Cal Enteral Formulary, available here.

The Alliance’s Enteral Nutrition policy can be accessed here.

Date: September 2017 GTC: ALLERGY: 1Z Brand Name: Generic Name: Dymista 137 mcg azelastine/ 50 mcg fluticasonenasal spray

Criteria: **Diagnosis** of allergic rhinitis AND tried and failure of formulary alternatives Fluticasone 50mcg nasal spray AND Azelastine 137 mcg nasal spray used concurrently

Quantity Limits:

Date: GTC: ALLERGY: 1Z Brand Name: Generic Name: Optivar azelastine opthalmic drops

Criteria: **Diagnosis** of allergic conjunctivitis AND has inadequate response, intolerable side effect, or contraindication to ketotifen ophthalmic drops (OTC)

Quantity Limits: 1 bottle/rx

Date: September 2016 GTC: ALLERGY: 1Z Brand Name: Generic Name: Qnsal, Qnasl Children, Beconase AQ beclomethasone dipropionate HFA aerosol, beclomethasone dipropionate nasal spray

Criteria: **Diagnosis** of allergic rhinitis AND has inadequate response, intolerable side effect, or contraindication to both fluticasone nasal spray AND Nasacort OTC

Quantity Limits:

Date: September 2016 GTC: ALLERGY: 1Z Brand Name: Generic Name: Rhinocort Aqua budesonide nasal spray (rx)

Criteria: Use Rhinocort Allergy 32MCG Spray (OTC)

Quantity Limits:

Date: July 2018 GTC: ALLERGY: 1Z Brand Name: Generic Name: Zyrtec Capsule cetirizine capsule

Criteria: **Diagnosis** of upper respiratory allergies AND trial and failure of cetirizine tablets

Quantity Limits:

Date: September 2017 GTC: ALLERGY: 1Z Brand Name: Generic Name: Zyrtec Chewable Tablets cetirizine chew tablet

Criteria: **Diagnosis** of upper respiratory allergies AND trial and failure of cetirizine rapdis OR loratadine rapdis AND trial and failure of loratidine solution OR cetirizine solution

Quantity Limits:

Date: September 2016 GTC: ALLERGY: 1Z Brand Name: Generic Name: Omnaris ciclesonide nasal spray, ciclesonide HFA aerosol Zetonna

Criteria: **Diagnosis** of allergic rhinitis AND patient has inadequate response, intolerable side effect or contraindication to both fluticasone nasal spray AND Nasacort OTC

Quantity Limits:

Date: September 2017 GTC: ALLERGY: 1Z Brand Name: Generic Name: Clarinex desloratadine tablets

Criteria: **Diagnosis** of upper respiratory allergies AND trial and failure of Loratadine, Cetirizine and Levocetirizine*

Quantity Limits:

Date: September 2017 GTC: ALLERGY: 1Z Brand Name: Generic Name: Xyzal levocetirizine tablets

Criteria: **Diagnosis** of upper respiratory allergies AND trial and failure of loratadine or cetirizine

Quantity Limits:

Date: July 2018 GTC: ALLERGY: 1Z Brand Name: Generic Name: Claritin Capsules loratadine capsule

Criteria: **Diagnosis** of upper respiratory allergies AND trial and failure of loratadine tablets

Quantity Limits:

Date: GTC: ALLERGY: 1Z Brand Name: Generic Name: Nasacort AQ triamcinolone nasal spray (rx)

Criteria: Use Nasacort Allergy 24HR Spray (OTC)

Quantity Limits:

Date: August 2019 GTC: ALLERGY: 1Z Brand Name: Generic Name: Xhance fluticasone propionate nasal spray (exhalation delivery system)

Criteria: **Diagnosis** of nasal polyps AND Trial and failure of at least 3 formulary nasal steroids (such as Rhinocort, Flonase, Nasacort OTC, or flunisolide)

Quantity Limits:

Date: GTC: ALLERGY: 1Z Brand Name: Generic Name: Patanase olopatadine nasal spray

Criteria: **Diagnosis** of allergic rhinitis AND has inadequate response, intolerable side effect, or contraindication to formulary alternative azelastine nasal spray.

Quantity Limits: 1 bottle/month

Date: July 2018 GTC: ALLERGY: 1Z Brand Name: Generic Name: Nasonex mometasone nasal spray

Criteria: If patient has inadequate response, intolerable side effect or contraindication to generic fluticasone nasal spray, Nasacort OTC or Budesonide

Quantity Limits:

Date: March 2018 GTC: ANTI- NEOPLASTICS: 0F Brand Name: Generic Name: Rituxan

Criteria: **Diagnosis** of AND has been evaluated by a rheumatologist AND has inadequate response, intolerable side effect, or contraindication to one DMARD (such as , hydroxychloroquine, leflunomide, or sulfasalazine) OR Has severe active rheumatoid arthritis

Quantity Limits: IV: 1000mg on days 1 and 15. May retreat every 24 weeks.

Date: October 2018 GTC: ANTI- NEOPLASTICS: 0F Brand Name: Generic Name: FDA-Approved Oncology Drugs FDA-approved oncology drugs

Criteria: **Diagnosis** of cancer AND prescribed by hematologist/oncologist AND use FDA-approved indications and Medi-Cal guidelines and/or in regimens consistent with NCCN Guidelines

FDA-approved Oncology Drugs: abiraterone acetate, ado- emtansine, dimaleate, aldesleukin, amifostine (Ethyol), asparaginase (Erwinaze), bendamustine, , Bexarotene, bleomycin sulfate, bortezomib, , busulfan, cabazitaxel, capecitabine, carboplatin, carfilzomib, carmustine (BiCNU), , , cisplatin, cladribine, , cyclophosphamide, cytarabine, dabrafenib, mesylate, dacarbazine, , daunorubicin HCL, , docetaxel, doxorubicin HCL, enzalutamide, epirubicin HCL, eribulin mesylate, HCL, estramustine phosphate sodium, etoposide, , exemestane, floxuridine, fulvestrant, gemcitabine HCL, goserelin acetate, hydroxyurea, idelalisib, ifosfamide, ifosfamide/ mesna, mesylate, (Besponsa), , irinotecan HCL, ixabepilone, , ditosylate, letrozole, leuprolide acetate, lomustine, mechlorethamine HCL, megestrol acetate, melphalan, mitomycin, mitotane, mitoxantrone HCL, HCL, nivolum@ab, , , olaparib, oxaliplatin, paclitaxel, paclitaxel nanoparticle albumin bound (nabpaclitaxel-Abraxane), , panobinostat, , HCL, pegaspargase, pemetrexed disodium, pentostatin, , plicamycin, porfimer sodium, , , rituximab, tosylate, streptozocin, malate, tamoxifen citrate, temozolomide, teniposide, thiotepa, topotecan HCL, dimethyl sulfoxide, trastuzumab, tretinoin, , vinblastine sulfate, , vorinostat, ziv-

Quantity Limits:

Date: 3/1/20 GTC: ANTI- NEOPLASTICS: 0F Brand Name: Generic Name: Jakafi Criteria: Prescribed by or in consultation with a hematologist, oncologist, or bone marrow transplant specialist

AND

One of the following:

1. Primary myelofibrosis (PMF), Post-polycythemia vera myelofibrosis, or Post-essential thrombocythemia myelofibrosis for treatment of ONE of the following: a. Symptomatic low-risk myelofibrosis (MF) [as defined by IPSS] b. Symptomatic intermediate risk 1 (INT-1) MF c. INT-2 MF or high-risk MF if not a transplant candidate and platelets > 50K d. MF-accelerated phase or MF-blast phase/acute myeloid for the improvement of splenomegaly and other disease-related symptoms AND age 18+

OR

2. Polycythemia vera (PV) for patients with failure, contraindication or intolerance to hydroxyurea and alfa- AND age 18+ AND patient is symptomatic low-risk PV with potential indications for cytoreductive therapy, or they are high-risk PV

OR

3. Acute Graft-Versus-Host Disease (must meet all): 1. Diagnosis of steroid-refractory Grade II – IV aGVHD; 2. Age ≥ 12 years; 3. Member has a history of bone marrow/stem cell transplant; 4. Failure of a systemic corticosteroid (e.g., prednisone, methylprednisolone) at up to therapeutic doses, unless contraindicated or clinically significant adverse effects are experienced; 5. Dose does not exceed 20 mg per day. Quantity Limits:

Date: January 2019 GTC: ANTIEMESIS/ANTIVERTIGO: 0Q Brand Name: Generic Name: Bonjesta ER doxylamine succinate/vitamin B6

Criteria: and vomiting due to pregnancy AND an adequate trial of 2 weeks of OTC doxylamine and pyridoxine

Quantity Limits:

Date: June 2016 GTC: ANTIEMESIS/ANTIVERTIGO: 0Q Brand Name: Generic Name: Diclegis doxylamine/pyridoxine

Criteria: Nausea and vomiting due to pregnancy AND an adequate trial of 2 weeks of OTC doxylamine AND pyridoxine

Quantity Limits: Max 30 tablets per dispensing and max of 4 dispensings in a 12 month period

Date: GTC: ANTIEMESIS/ANTIVERTIGO: 0Q Brand Name: Generic Name: Marinol dronabinol

Criteria: **Diagnosis** of anorexia associated with weight loss in patients with AIDS

Quantity Limits: 2 tablets/day Max: 20mg/day

Date: August 2019 (modified) GTC: ANTIEMESIS/ANTIVERTIGO: 0Q Brand Name: Generic Name: Sancuso granisetron 3.1mg/24 hour patch

Criteria: Member receiving moderately or highly emetogenic ORAL for up to 5 consecutive days AND - has had an inadequate response or intolerance to generic ondansetron and generic granisetron tablets OR - patient unable to tolerate oral dosage forms

Member receiving moderately or highly emetogenic PARENTERAL chemotherapy for up to 5 consecutive days AND - has had an inadequate response or intolerance to granisetron (tablet or injectable) AND ondansetron AND Aloxi

Quantity Limits: 1 patch per cycle

Date: September 2017 GTC: ANTIEMESIS/ANTIVERTIGO: 0Q Brand Name: Generic Name: Akynzeo netupitant/apalonosetron 300-0.5mg capsule

Criteria: Prevention of nausea and vomiting in patients receiving highly emetogenic chemotherapy AND tried and failed or intolerant to at least one oral 5-HT3 antagonists (generic granisetron, generic ondansetron, Aloxi, Anzemet) AND tried and failed or intolerant to Emend

Quantity Limits: QL: 1 Capsule per cycle

Date: September 2017 GTC: ANTIEMESIS/ANTIVERTIGO: 0Q Brand Name: Generic Name: Zuplenz ondansetron 4mg film

Criteria: Prevention of nausea and vomiting in patients receiving moderately and/or highly emetogenic chemotherapy OR Prevention of nausea and vomiting associated with radiotherapy in patients receiving total body irradiation, single high-dose fraction to abdomen, or daily fractions to the abdomen AND tried and failed or intolerant to at least one oral 5-HT3 antagonists: generic granisetron, generic ondansetron, Aloxi, Anzemet AND tried and failed or intolerant to Emend

Quantity Limits: 10 films per cycle

Date: August 2019 (modified) GTC: ANTIEMESIS/ANTIVERTIGO: 0Q Brand Name: Generic Name: Aloxi palonosetron

Criteria: Prevention of nausea and vomiting due to moderately or highly emetogenic PARENTERAL chemotherapy

Quantity Limits: Up to 0.25mg/5ml per cycle

Date: GTC: ANTIEMESIS/ANTIVERTIGO: 0Q Brand Name: Generic Name: Transderm-Scop scopolamine patch

Criteria: Prevention of nausea/ vomiting

-Tried and failed Meclizine OR Dimenhydrinate AND 1 of the following (ondansetron, prochlorperazine, or metoclopramide)

OR

Prevention of chemotherapy-induced nausea/ vomiting

Quantity Limits: 3 patches/ Rx For chemotherapy-induced, quantity sufficient to last through treatment 1 fill per request EXCEPT 12 fills for chemotherapy induced

Date: September 2016 GTC: ASTHMA: 1X Brand Name: Generic Name: Proventil HFA albuterol

Criteria: **Diagnosis** of bronchospasm, asthma, COPD AND has inadequate response, intolerable side effect, or contraindication to Ventolin HFA, ProAir HFA, or ProAir Respiclick

Quantity Limits:

Date: September 2017 GTC: ASTHMA: 1X Brand Name: Generic Name: Proventil albuterol sulfate tablets

Criteria: **Diagnosis** of bronchospasm, asthma AND has inadequate response, intolerable side effect, or contraindication to Albuterol syrup AND Albuterol sulfate ER 12hrs Tablets

Quantity Limits:

Date: September 2017 GTC: ASTHMA: 1X Brand Name: Generic Name: Vospire albuterol sulfate tablets ER 12 HR

Criteria: **Diagnosis** of bronchospasm, asthma AND has inadequate response, intolerable side effect, or contraindication to Albuterol syrup

Quantity Limits:

Date: August 2019 (modified) GTC: ASTHMA: 1X Brand Name: Generic Name: Brovana Nebulization arformoterol

Criteria: **Diagnosis** of COPD AND has inadequate response or intolerable side effect to formulary Striverdi AND Serevent* OR **Diagnosis** of asthma AND symptoms are inadequately controlled on long-term maintenance treatment which includes an inhaled corticosteroid (ICS) AND has inadequate response or intolerable side effect to Striverdi AND Serevent* OR Member unable to use inhaler *Prior authorization required

Quantity Limits: Date: June 2018 GTC: ASTHMA: 1X Brand Name: Generic Name: Symbicort budesonide/formoterol

Criteria: **Diagnosis** of Asthma AND has inadequate response, intolerable side effect or contraindication to formulary alternative fluticasone/salmeterol (AirDuo) in ≥12 years of age OR **Diagnosis** of Asthma AND has inadequate response, intolerable side effect or contraindication to preferred alternative generic Advair (Fluticasone/Salmeterol and Wixela Inhub) in <12 years of age OR **Diagnosis** of COPD AND has inadequate response, intolerable side effect or contraindication to preferred alternative generic Advair (Fluticasone/Salmeterol (AG for Advair Diskus) and Wixela Inhub (ANDA for Advair Diskus)

Quantity Limits: Date: July 2018 GTC: ASTHMA: 1X Brand Name: Generic Name: Alvesco ciclesonide

Criteria: **Diagnosis** of asthma AND has inadequate response, intolerable side effect, or contraindication to 2 formulary alternatives such as QVAR, Pulmicort, Arnuity, Flovent, ArmonAir, Asmanex

Quantity Limits: Date: July 2018 GTC: ASTHMA: 1X Brand Name: Generic Name: Breo Ellipta fluticasone furoate/vilanterol

Criteria: **Diagnosis** of Asthma AND has inadequate response, intolerable side effect or contraindication to formulary alternative fluticasone/salmeterol (AirDuo) in ≥12 years of age OR **Diagnosis** of Asthma AND has inadequate response, intolerable side effect or contraindication to preferred alternative generic Advair (Fluticasone/Salmeterol and Wixela Inhub) in <12 years of age OR **Diagnosis** of COPD AND has inadequate response, intolerable side effect or contraindication to preferred alternative generic Advair (Fluticasone/Salmeterol (AG for Advair Diskus) and Wixela Inhub (ANDA for Advair Diskus)

Quantity Limits: Date: June 2018 GTC: ASTHMA: 1X Brand Name: Generic Name: Airduo Respiclick (Brand Only) fluticasone/salmeterol

Criteria: **Diagnosis** of asthma AND has inadequate response or intolerable side effects to generic AirDuo.

Quantity Limits: Date: July 2018 GTC: ASTHMA: 1X Brand Name: Generic Name: Advair HFA fluticasone/salmeterol

Criteria: **Diagnosis** of asthma AND has inadequate response, intolerable side effect or contraindication to formulary alternative fluticasone/salmeterol (AirDuo) in ≥12 years of age OR **Diagnosis** of asthma AND has inadequate response, intolerable side effect or contraindication to preferred alternative Symbicort <12 years of age

Quantity Limits: Date: June 2018 GTC: ASTHMA: 1X Brand Name: Generic Name: Trelegy Ellipta fluticasone/umeclidinium/vilanterol

Criteria: **Diagnosis** of severe COPD AND had been stabilized on a triple therapy with ICS inhaler, LABA inhaler and LAMA inhaler OR **Diagnosis** of severe COPD AND has been stabilized on dual therapy (LAMA/LABA, LAMA/ICS, LABA/ICS) AND now requiring the third inhaler (LAMA, LABA, or ICS) AND prescribed by a pulmonologist

Quantity Limits: Date: August 2019 (modified) GTC: ASTHMA: 1X Brand Name: Generic Name: Perforomist, Nebulization formoterol

Criteria: **Diagnosis** of COPD AND has inadequate response or intolerable side effect to formulary Striverdi AND Serevent* OR **Diagnosis** of asthma AND symptoms are inadequately controlled on long-term maintenance treatment which includes an inhaled corticosteroid (ICS) AND has inadequate response or intolerable side effect to Striverdi AND Serevent* OR Member unable to use inhaler *Prior authorization required

Quantity Limits: Date: July 2018 GTC: ASTHMA: 1X Brand Name: Generic Name: Lonhala Magnair Vials glycopyrrolate 25 mcg/1ml vial

Criteria: **Diagnosis** of COPD, including chronic bronchitis and/or emphysema AND Has inadequate response or intolerable side effect to ipratropium solution (Atrovent) or ipratropium/albuterol solution (Duoneb) AND Has inadequate response or intolerable side effect to Seebri Neohaler* (OR is unable to use an inhaler) AND Has inadequate response or intolerable side effect to one other long acting anticholingeric medication such as: Tudorza, Spiriva, Incruse, Utibron, Anoro Ellipta, Bevespi, Stiolto (OR is unable to use an inhaler)

Quantity Limits: 60 mL per fill. 1 vial (25 mcg) inhaled twice daily May approve x 3 Can only be used w/ proprietary nebulizer (unlike Yupelri, which can be used w/ any jet nebuilzer) Note: Seebri Neohaler contains the same active ingredient as Lonhala (glycopyrrolate)

Date: July 2018 GTC: ASTHMA: 1X Brand Name: Generic Name: Seebri Neohaler glycopyrrolate

Criteria: **Diagnosis** of COPD AND has inadequate response, intolerable side effect or contraindication to preferred alternative Atrovent HFA or Incruse Ellipta

Quantity Limits:

Date: September 2017 GTC: ASTHMA: 1X Brand Name: Generic Name: Arcapta Neohaler indacaterol

Criteria: **Diagnosis** of COPD AND has inadequate response or intolerable side effect to formulary Striverdi OR **Diagnosis** of asthma AND symptoms are inadequately controlled on long-term maintenance treatment which includes an inhaled corticosteroid (ICS) AND has inadequate response or intolerable side effect to Striverdi

Quantity Limits: Date: September 2016 GTC: ASTHMA: 1X Brand Name: Generic Name: Xopenex Solution levalbuterol

Criteria: **Diagnosis** of bronchospasm, asthma, COPD AND has inadequate response, intolerable side effect, or contraindication to albuterol nebulized solution

Quantity Limits: Date: August 2019 GTC: ASTHMA: 1X Brand Name: Generic Name: Nucala mepolizumab

Criteria: Patient has a **Diagnosis** of severe asthma with an eosinophilic phenotype and meets ALL of the following criteria: • The patient is 12 years of age or older • The patient has a documented blood eosinophil level of at least 300 cells/mcL within the past 6 months • The patient is currently adherent to a maximally tolerated dose of an inhaled corticosteroid plus at least one other maintenance medication (e.g., a long-acting inhaled beta2-agonist, a long-acting muscarinic antagonist, leukotriene receptor antagonist, theophylline, or oral corticosteroid) • The patient has experienced at least 2 or more asthma exacerbations within the past 12 months (exacerbation is defined as an asthma-related event requiring hospitalization, emergency room visit, or systemic corticosteroid burst lasting at least 3 days) • Nucala will be used as add-on maintenance treatment • The patient is not concurrently treated with Xolair, Dupixent, or another anti-IL-5 asthma biologic (e.g., Cinqair, Fasenra) • Nucala is prescribed by or given in consultation with a physician specializing in pulmonary medicine or allergy medicine

Quantity Limits:

Date: September 2017 GTC: ASTHMA: 1X Brand Name: Generic Name: Metaproterenol Sulfate Tablets metaproterenol sulfate tablets

Criteria: **Diagnosis** of bronchospasm, asthma AND has inadequate response, intolerable side effect, or contraindication to albuterol syrup

Quantity Limits: Date: July 2018 GTC: ASTHMA: 1X Brand Name: Generic Name: Dulera mometasone/formoterol

Criteria: **Diagnosis** of Asthma AND has inadequate response, intolerable side effect or contraindication to formulary alternative fluticasone/salmeterol (AirDuo) in ≥12 years of age OR **Diagnosis** of Asthma AND has inadequate response, intolerable side effect or contraindication to preferred alternative generic Advair (Fluticasone/Salmeterol and Wixela Inhub) in <12 years of age OR **Diagnosis** of COPD AND has inadequate response, intolerable side effect or contraindication to preferred alternative generic Advair (Fluticasone/Salmeterol (AG for Advair Diskus) and Wixela Inhub (ANDA for Advair Diskus)

Quantity Limits:

Date: September 2016 GTC: ASTHMA: 1X Brand Name: Generic Name: Singulair montelukast oral granules

Criteria: Montelukast oral granules are formulary for patients < 2yo. If > 2yo, approve if **Diagnosis** of asthma, allergic rhinitis AND has inadequate response or intolerable side effect to formulary montelukast chewables or montelukast tablets

Quantity Limits: Date: October 2018 GTC: ASTHMA: 1X Brand Name: Generic Name: Xolair omalizumab 150mg subcutaneous vial

Criteria: **Diagnosis** of moderate to severe persistent asthma in patients 6 years to 11 years: • Positive skin test or in vitro reactivity to a perennial aeroallergen • Symptoms are inadequately controlled with max doses of inhaled corticosteroids • Pre-treatment serum IgE level between 30 and 1300 IU/ml **Diagnosis** of moderate to severe persistent asthma in patients 12 years and older: • Positive skin test or in vitro reactivity to a perennial aeroallergen • Symptoms are inadequately controlled with max doses of inhaled corticosteroids • Pre-treatment serum IgE level between 30 and 700 IU/ml **Diagnosis** of chronic idiopathic urticaria (CIU) in patients 12 years and older: • Must have the presence of urticaria (hives) on most days of the week, for a duration of longer than six (6) weeks AND Trial and failure of the following: • At least two (2) H1 antihistamines (loratadine, cetirizine, fexofenadine) • H1 antihistamine in combination with H2 (ranitidine, famotidine) OR • H1 antihistamine in combination with Leukotriene modifier (Singulair)

Quantity Limits: Date: August 2019 (modified) GTC: ASTHMA: 1X Brand Name: Generic Name: Cinqair reslizumab 100mg/10ml vial

Criteria: Patient has a **Diagnosis** of severe asthma with an eosinophilic phenotype and meets ALL of the following criteria: • The patient is 18 years of age or older • The patient has a documented blood eosinophil level of at least 300 cells/mcL within the past 6 months • The patient is currently adherent to a maximally tolerated dose of an inhaled corticosteroid plus at least one other maintenance medication (e.g., a long-acting inhaled beta2-agonist, a long-acting muscarinic antagonist, leukotriene receptor antagonist, theophylline, or oral corticosteroid) • The patient has experienced at least 2 or more asthma exacerbations within the past 12 months (exacerbation is defined as an asthma-related event requiring hospitalization, emergency room visit, or systemic corticosteroid burst lasting at least 3 days) • Cinqair will be used as add-on maintenance treatment • The patient is not concurrently treated with Xolair, Dupixent, or another anti-IL-5 asthma biologic (e.g., Nucala, Fasenra) • Cinqair is prescribed by or given in consultation with a physician specializing in pulmonary medicine or allergy medicine

Quantity Limits: Date: August 2019 GTC: ASTHMA: 1X Brand Name: Generic Name: Fasenra reslizumab 100mg/10ml vial

Criteria: Patient has a **Diagnosis** of severe eosinophilic asthma and meets ALL of the following criteria: • The patient is 12 years of age or older • The patient has a documented blood eosinophil level of at least 300 cells/mcL or more within the past 6 months • The patient is currently adherent to a maximally tolerated dose of an inhaled corticosteroid AND at least one other maintenance medication (e.g., a long-acting inhaled beta2-agonist, long-acting muscarinic antagonist, leukotriene receptor antagonist, theophylline, or oral corticosteroid) • The patient has experienced at least 2 or more asthma exacerbations within the past 12 months (exacerbation is defined as an asthma-related event requiring hospitalization, emergency room visit, or systemic corticosteroid burst lasting at least 3 or more days) • Fasenra will be used as add-on maintenance treatment • The patient is NOT being concurrently treated with Xolair, Dupixent, or another anti-IL5 asthma biologic (e.g. Nucala, Cinqair) • Fasenra is prescribed by or given in consultation with a physician specializing in pulmonary medicine or allergy medicine

Quantity Limits: Date: September 2017 GTC: ASTHMA: 1X Brand Name: Generic Name: Daliresp roflumilast

Criteria: **Diagnosis** of COPD AND has inadequate response or intolerable side effect to trial of two (2) formulary alternatives among: generic Airduo, Symbicort , Breo Ellipta , Dulera and Atrovent , Spiriva, and Stirverdi

Quantity Limits: Date: August 2019 (modified) GTC: ASTHMA: 1X Brand Name: Generic Name: Serevent salmeterol

Criteria: **Diagnosis** of COPD AND has inadequate response or intolerable side effect to formulary Striverdi OR **Diagnosis** of asthma AND symptoms are inadequately controlled on long-term maintenance treatment which includes an inhaled corticosteroid (ICS)

Quantity Limits: Date: September 2017 GTC: ASTHMA: 1X Brand Name: Generic Name: Terbutaline Sulfate Tablets terbutaline sulfate tablets

Criteria: **Diagnosis** of bronchospasm, asthma AND has inadequate response, intolerable side effect, or contraindication to albuterol syrup AND albuterol sulfate ER 12hrs tablets

Quantity Limits: Date: September 2017 GTC: ASTHMA: 1X Brand Name: Generic Name: Theo-24 theophylline 24 HR ER capsules

Criteria: **Diagnosis** of asthma or COPD AND tried/failed Theophylline ER 12H tablets OR Theophylline ER 24 hours tablets

Quantity Limits: Date: July 2018 GTC: ASTHMA: 1X Brand Name: Generic Name: Spiriva Respimat tiotropium

Criteria: **Diagnosis** of COPD AND has inadequate response, intolerable side effect or contraindication to preferred alternative Atrovent HFA or Incruse Ellipta (May approve for asthma)

Quantity Limits: Date: September 2016 GTC: ASTHMA: 1X Brand Name: Generic Name: Accolate zafirlukast

Criteria: **Diagnosis** of asthma AND has inadequate response, intolerable side effect, or inability to use formulary montelukast chewables or tablets

Quantity Limits: Date: August 2019 GTC: ASTHMA: 1X Brand Name: Generic Name: Yupelri revefenacin vial for nebulization

Criteria: **Diagnosis** of COPD, including chronic bronchitis and/or emphysema AND Has inadequate response or intolerable side effect to ipratropium solution (Atrovent) or ipratropium/albuterol solution (Duoneb) AND Has inadequate response or intolerable side effect to two (2) long acting anticholingeric medications such as Tudorza, Spiriva, Incruse, Utibron, Anoro Ellipta, Bevespi, Stiolto (OR is unable to use an inhaler)

Quantity Limits: Date: August 2019 GTC: ASTHMA: 1X Brand Name: Generic Name: Zyflo zileuton ER

Criteria: **Diagnosis** of asthma AND Age 12 years or older AND Trial and failure of montelukast (or another leukotriene receptor antagonist)

Quantity Limits: Date: GTC: AUTONOMIC NERVOUS SYSTEM DISORDERS: 2D Brand Name: Generic Name: Razadyne, Razadyne ER galantamine oral tablet, galantamine oral solution, extended-release capsule

Criteria: **Diagnosis** of Alzheimer's dementia AND Mini Mental State Examination (MMSE) score <23 OR an equivalent score on another screening test AND trial and failure of donepezil or medical justification why they cannot be used.

Razadyne oral solution or ER capsule requires: T/F of Razadyne tablets or medical justification why tablets cannot be used.

Quantity Limits: IR: 2 tablets/day Soln: 6mL/day ER: 1 capsule/day Date: November 2019 GTC: AUTONOMIC NERVOUS SYSTEM DISORDERS: 2D Brand Name: Generic Name: Namenda (oral solution), Namenda XR memantine oral tablet, memantine oral solution, extended-release capsule

Criteria: Trial and failure of Namenda tablets or medical justification why tablets cannot be used.

Quantity Limits: Soln: 10mL/day ER: 1 capsule/day

Date: September 2017 GTC: AUTONOMIC NERVOUS SYSTEM DISORDERS: 2D Brand Name: Generic Name: Namzaric memantine/donepezil 1-10/14/10 mg, 7-10mg, 14-10mg, 21-10mg, 28-10mg

Criteria: **Diagnosis** of moderate to severe Alzheimer disease AND documentation from the member Rx profile or clinician progress notes that the member has had a previous trial of generic memantine and generic donepezil (administered as separate agents) in the last 180 days AND medical justification why the member cannot continue the generics as separate agents

Quantity Limits: 1 capsule per day Date: GTC: AUTONOMIC NERVOUS SYSTEM DISORDERS: 2D Brand Name: Generic Name: Exelon rivastigmine oral capsule, rivastigmine oral solution, transdermal patch

Criteria: **Diagnosis** of mild-moderate Alzheimer's dementia or mild-moderate dementia associated with Parkinson’s disease AND Mini Mental State Examination (MMSE) score <23 OR an equivalent score on another screening test For Alzheimer’s dementia AND T/F of donepezil or medical justification why they cannot be used

Exelon patch or oral solution requires: T/F of Exelon capsules or medical justification why capsules cannot be used

Quantity Limits: 2 capsules/day Up to 6 mL/day 1 patch/day

Date: October 2018 GTC: BEHAVIORAL HEALTH - ANTIDEPRESSANTS: 0N Brand Name: Generic Name: Aplenzin ER bupropion HBR ER tablet

Criteria: **Diagnosis** of depression or Seasonal Affective Disorder (SAD) AND has inadequate response, intolerable side effect, or contraindication to 2 formulary antidepressants such as: fluoxetine, paroxetine, sertraline, citalopram, escitalopram , venlafaxine, duloxetine AND trial of bupropion IR, bupropion SR or bupropion XL at a dose of 300mg per day for SAD or 450mg for depression AND submission of medical records documenting: • details of failure/intolerance to bupropion formulation tried AND • which attempts were taken to resolve these

Quantity Limits: 1 tablet/day Date: October 2018 GTC: BEHAVIORAL HEALTH - ANTIDEPRESSANTS: 0N Brand Name: Generic Name: Forfivo XL bupropion HCL 450mg oral tablet

Criteria: **Diagnosis** of depression AND has inadequate response, intolerable side effect, or contraindication to 2 formulary antidepressants such as: fluoxetine, paroxetine, sertraline, citalopram, escitalopram, venlafaxine, duloxetine AND trial of bupropion IR, bupropion SR, or bupropion XL at a dose of 450mg per day AND submission of medical records documenting: • details of failure/intolerance to bupropion formulation tried AND • which attempts were taken to resolve these

Quantity Limits: 1 tablet/day Date: October 2018 GTC: BEHAVIORAL HEALTH - ANTIDEPRESSANTS: 0N Brand Name: Generic Name: Anafranil clomipramine HCL oral capsule

Criteria: **Diagnosis** of obsessive-compulsive disorder AND has inadequate response, intolerable side effect, or contraindication to 3 formulary antidepressants such as: fluoxetine, sertraline, citalopram, escitalopram, paroxetine, duloxetine, venlafaxine, bupropion AND submission of medical records documenting: • details of failure/intolerance to each drug AND • which attempts were taken to resolve these

Quantity Limits: Date: October 2018 GTC: BEHAVIORAL HEALTH - ANTIDEPRESSANTS: 0N Brand Name: Generic Name: Luvox CR fluvoxamine maleate CR capsule

Criteria: Has inadequate response, intolerable side effect, or contraindication to 2 formulary antidepressants such as: fluoxetine, paroxetine, sertraline, citalopram, escitalopram, venlafaxine, duloxetine AND trial of fluvoxamine immediate-release (IR) formulation AND submission of medical records documenting: • details of failure/intolerance to fluvoxamine IR AND • which attempts were taken to resolve these

Quantity Limits: 2 capsules/day Max: 300mg/day

Date: October 2018 GTC: BEHAVIORAL HEALTH - ANTIDEPRESSANTS: 0N Brand Name: Generic Name: Tofranil-PM imipramine pamoate oral capsule

Criteria: Has inadequate response, intolerable side effect, or contraindication to 2 formulary tricyclic antidepressants (TCA) such as: amitriptyline, nortriptyline AND trial of imipramine HCl tablet AND submission of medical records documenting: • details of failure/intolerance to imipramine HCl tablet • which attempts were taken to resolve these

Quantity Limits: Date: October 2018 GTC: BEHAVIORAL HEALTH - ANTIDEPRESSANTS: 0N Brand Name: Generic Name: Fetzima ER, Fetzima 20-40 Titration Pack levomilnacipran HCL SA 24h capsule, levomilnacipran HCL 20-40mg SA 24HR dosepack

Criteria: **Diagnosis** of major depression AND has inadequate response, intolerable side effect, or contraindication to 4 formulary antidepressants such as: fluoxetine, sertraline, citalopram, escitalopram, paroxetine, duloxetine, venlafaxine, bupropion AND submission of medical records documenting: • details of failure/intolerance to each drug AND • which attempts were taken to resolve these

Quantity Limits: 1 capsule/day Dose Pack: 1x authorization for titration

Date: October 2018 GTC: BEHAVIORAL HEALTH - ANTIDEPRESSANTS: 0N Brand Name: Generic Name: Paxil CR paroxetine HCL ER tablet

Criteria: **Diagnosis** of depression AND has inadequate response, intolerable side effect, or contraindication to 2 formulary antidepressants such as: fluoxetine, sertraline, citalopram, escitalopram, venlafaxine, duloxetine AND trial of paroxetine HCl immediate-release (IR) formulation AND submission of medical records documenting: • details of failure/intolerance to paroxetine HCl IR AND • which attempts were taken to resolve these

Quantity Limits: 1 tablet/day

Date: October 2018 GTC: BEHAVIORAL HEALTH - ANTIDEPRESSANTS: 0N Brand Name: Generic Name: Pexeva paroxetine mesylate oral tablet

Criteria: **Diagnosis** of depression AND has inadequate response, intolerable side effect, or contraindication to 2 formulary antidepressants such as: fluoxetine, sertraline, citalopram, escitalopram, venlafaxine, duloxetine AND trial of paroxetine HCl immediate-release (IR) formulation AND trial of paroxetine HCl ER formulation* AND submission of medical records documenting: • details of failure/intolerance to paroxetine HCl IR and paroxetine ER AND • which attempts were taken to resolve these

*Prior Authorization Required

Quantity Limits: 1 tablet/day Date: October 2018 GTC: BEHAVIORAL HEALTH - ANTIDEPRESSANTS: 0N Brand Name: Generic Name: Brisdelle paroxetine mesylate 7.5mg oral capsule

Criteria: **Diagnosis** of moderate to severe vasomotor symptoms associated with menopause AND has inadequate response, intolerable side effect, or contraindication to 2 formulary alternatives such as: fluoxetine, sertraline, citalopram, escitalopram, venlafaxine, gabapentin, clonidine AND trial of paroxetine HCl immediate-release (IR) formulation AND submission of medical records documenting: • details of failure/intolerance to paroxetine HCl IR AND • which attempts were taken to resolve these

Quantity Limits: Date: September 2016 GTC: BEHAVIORAL HEALTH - ANTIDEPRESSANTS: 0N Brand Name: Generic Name: Venlafaxine ER Tablet venlafaxine extended-release oral tablet

Criteria: **Diagnosis** of depression AND has inadequate response, intolerable side effect, or contradiction to formulary Venlafaxine ER capsules

For 225mg ER tablet: Has inadequate response, intolerable side effect, or contradiction to formulary Venlafaxine ER 150mg capsule with Venlafaxine ER 75mg capsule, to achieve same 225mg/day dosage

Quantity Limits:

Date: October 2018 GTC: BEHAVIORAL HEALTH - ANTIDEPRESSANTS: 0N Brand Name: Generic Name: Viibryd, Viibryd 10-20 Starter Pack vilazodone HCL oral tablet, vilazodone HCL 10-20mg oral tablet dosepack

Criteria: **Diagnosis** of major depression AND has inadequate response, intolerable side effect, or contraindication to 3 formulary antidepressants such as: fluoxetine, sertraline, citalopram, escitalopram, paroxetine, duloxetine, venlafaxine, bupropion AND submission of medical records documenting: • details of failure/intolerance to each drug AND • which attempts were taken to resolve these

Quantity Limits: 1 tablet/day Starter Kit: 1x authorization for titration

Date: October 2018 GTC: BEHAVIORAL HEALTH - ANTIDEPRESSANTS: 0N Brand Name: Generic Name: Trintellix vortioxetine HBR oral tablet

Criteria: **Diagnosis** of major depression AND has inadequate response, intolerable side effect, or contraindication to 4 formulary antidepressants such as: fluoxetine, sertraline, citalopram, escitalopram, paroxetine, duloxetine, venlafaxine, bupropion AND submission of medical records documenting: • details of failure/intolerance to each drug AND • which attempts were taken to resolve these

Quantity Limits: 1 tablet/day

Date: December 2016 GTC: BEHAVIORAL HEALTH - OTHER: 2L Brand Name: Generic Name: Xanax alprazolam immediate-release tablet

Criteria: **Diagnosis** of anxiety or panic disorder AND has inadequate response, intolerable side effect, or contraindication to the formulary alternatives clonazepam and lorazepam AND member is not currently taking any opiate medications (such as hydrocodone/APAP, Tylenol w/codeine, oxycodone/APAP, morphine sulfate ER, etc.) AND member is not concurrently taking carisoprodol

Quantity Limits: 3 tablets/day

Date: September 2017 GTC: BEHAVIORAL HEALTH - OTHER: 2L Brand Name: Generic Name: Dyanavel XR amphetamine oral solution 2.5mg/ml

Criteria: **Diagnosis** is Attention Deficit Hyperactivity Disorder (ADHD) AND has inadequate response, intolerable side effect, or contraindication to 2 formulary ADHD stimulant medications (1 from each class such as a methylphenidate product AND a mixed amphetamine product) OR Patient has swallowing difficulties AND has inadequate response, intolerable side effect or contraindication to 1 formulary medications that can be sprinkled on soft food (Generic Ritalin LA, Metadate CD and Adderall XR) AND oral solution (methylphenidate) AND supporting documentation that member is unable to swallow solid oral dosage forms of medication (ex. tablets, capsules)

Quantity Limits:

Date: October 2018 GTC: BEHAVIORAL HEALTH - OTHER: 2L Brand Name: Generic Name: Nuvigil armodafinil oral tablet

Criteria: **Diagnosis** of narcolepsy or Shift Work Sleep Disorders or **Diagnosis** of obstructive sleep apnea AND submission of chart notes and relevant test results (such as sleep study) AND inadequate response, intolerable side effect, or contraindication to modafinil AND details of failure/intolerance to modafinil AND which attempts were taken to resolve these

Quantity Limits: 1 tablet/day

Date: September 2016 GTC: BEHAVIORAL HEALTH - OTHER: 2L Brand Name: Generic Name: Kapvay clonidine extended-release oral tablet

Criteria: **Diagnosis** of Attention Deficit Hyperactivity Disorder(ADHD) or Attention Deficit Disorder (ADD) AND has inadequate response, intolerable side effect, or contraindication to 1 formulary non-stimulant medication (guanfacine IR dosed twice daily OR clonidine IR dosed twice daily OR guanfacine ER dosed once daily)

Quantity Limits: 1 tablet/day

Date: September 2017 GTC: BEHAVIORAL HEALTH - OTHER: 2L Brand Name: Generic Name: Adzenys XR-ODT dextroamphetamin/amphetamine 3.1, 6.3, 9.4, 12.5, 15.7 and 18.8mg tablet

Criteria: **Diagnosis** is Attention Deficit Hyperactivity Disorder(ADHD) AND has inadequate response, intolerable side effect, or contraindication to 2 formulary ADHD stimulant medications (1 from each class such as a methylphenidate product AND a mixed amphetamine product) OR Patient has swallowing difficulties AND has inadequate response, intolerable side effect or contraindication to 1 formulary medications that can be sprinkled on soft food (Generic Ritalin LA, Metadate CD and Adderall XR) AND oral solution (methylphenidate)

Quantity Limits: Date: October 2018 GTC: BEHAVIORAL HEALTH - OTHER: 2L Brand Name: Generic Name: Silenor doxepin HCL oral tablet

Criteria: Potential causes of sleep disturbances have been addressed (e.g., inappropriate sleep hygiene and sleep environment issues or treatable medical/psychological causes of chronic insomnia) AND inadequate response, intolerable side effect, or contraindication to 3 formulary agents such as: diphenhydramine, trazodone, zolpidem IR, eszopiclone, zaleplon AND • details of failure/intolerance to each agent AND • which attempts were taken to resolve these

Quantity Limits: 1 tablet/day Date: October 2018 GTC: BEHAVIORAL HEALTH - OTHER: 2L Brand Name: Generic Name: Vyvanse Oral Capsule, Vyvanse Chewable Tablet lisdexamfetamine oral capsule, lisdexamfetamine chewable tablet

Criteria: **Diagnosis** of Attention Deficit Hyperactivity Disorder(ADHD) or Attention Deficit Disorder (ADD) AND must be greater than 6 years of age AND has inadequate response, intolerable side effect, or contraindication to 2 formulary ADHD stimulant medications (1 product from the methylphenidate class AND 1 from the amphetamine class) OR If there is concern about substance abuse, a trial and failure of a non-stimulant alternative

**Diagnosis** of Binge Eating Disorder AND prescribed by psychiatrist AND has inadequate response, intolerable side effect, or contraindication to 2 formulary agents such as SSRIs (fluoxetine, sertraline, citalopram, escitalopram, paroxetine), topiramate, OR zonisamide

Quantity Limits: 1 capsule/day, 1 chew tab/day Date: October 2018 GTC: BEHAVIORAL HEALTH - OTHER: 2L Brand Name: Generic Name: Cotempla XR-ODT Tablet methylphenidate extended-release orally disintegrating tablet

Criteria: **Diagnosis** of Attention Deficit Hyperactivity Disorder (ADHD) AND must be greater than 6 years of age AND failure/inability to swallow methylphenidate tablet or capsule AND trial of methylphenidate solution (5mg/5ml or 10mg/5ml) OR formulation that can be sprinkled on soft food (such as generic Ritalin LA, Metadate CD)

Quantity Limits: 1 tablet/day Date: October 2018 GTC: BEHAVIORAL HEALTH - OTHER: 2L Brand Name: Generic Name: Quillichew ER Chewable Tablet methylphenidate HCL chewable er tab

Criteria: **Diagnosis** of Attention Deficit Hyperactivity Disorder (ADHD) AND must be greater than 6 years of age AND failure/inability to swallow methylphenidate tablet or capsule AND trial of methylphenidate solution (5mg/5ml or 10mg/5ml) OR formulation that can be sprinkled on soft food (such as generic Ritalin LA, Metadate CD)

Quantity Limits: 1 chewable tablet/day Date: October 2018 GTC: BEHAVIORAL HEALTH - OTHER: 2L Brand Name: Generic Name: Quillivant XR Suspension methylphenidate hydrochloride oral suspension, extended release

Criteria: **Diagnosis** of Attention Deficit Hyperactivity Disorder (ADHD) AND must be greater than 6 years of age AND failure/inability to swallow methylphenidate tablet or capsule AND trial of methylphenidate solution (5mg/5ml or 10mg/5ml) OR formulation that can be sprinkled on soft food (such as generic Ritalin LA, Metadate CD)

Quantity Limits: Date: October 2018 GTC: BEHAVIORAL HEALTH - OTHER: 2L Brand Name: Generic Name: Daytrana methylphenidate transdermal patch

Criteria: **Diagnosis** of Attention Deficit Hyperactivity Disorder (ADHD) AND must be greater than 6 years of age AND failure/inability to swallow methylphenidate tablet or capsule AND trial of methylphenidate solution (5mg/5ml or 10mg/5ml) OR formulation that can be sprinkled on soft food (such as generic Ritalin LA, Metadate CD)

Quantity Limits: 1 patch/day Date: July 2018 GTC: BEHAVIORAL HEALTH - OTHER: 2L Brand Name: Generic Name: Nuplazid pimavanserin

Criteria: **Diagnosis** of Parkinson’s disease psychosis AND patient has the presence of hallucinations or delusions (which may include illusions or a false sense of presence) on a recurrent or continuous basis for at least 1 month AND must not have dementia-related psychosis AND must have tried to discontinue or reduce the dose of any medication(s) that may cause or contribute to hallucinations and delusions or provide clinical rationale indicating why dose reduction OR discontinuation of applicable medications would not be appropriate AND Must be prescribed by or in consultation with a neurologist, psychiatrist, or geriatrician

Quantity Limits: 2 tablets/day Date: October 2018 GTC: BEHAVIORAL HEALTH - OTHER: 2L Brand Name: Generic Name: Rozerem ramelteon 8mg oral tablet

Criteria: Potential causes of sleep disturbances have been addressed (e.g., inappropriate sleep hygiene and sleep environment issues or treatable medical/psychological causes of chronic insomnia) AND inadequate response, intolerable side effect, or contraindication to 3 formulary agents such as diphenhydramine, trazodone, zolpidem IR, eszopiclone, zaleplon AND • details of failure/intolerance to each agent AND • which attempts were taken to resolve these

Quantity Limits: 1 tablet/day Date: September 2017 GTC: BEHAVIORAL HEALTH - OTHER: 2L Brand Name: Generic Name: Xyrem sodium oxybate 500 mg/ml

Criteria: Cataplexy associated with Narcolepsy (all below criteria must be met) • Patient must be older than 16 (safety and effectiveness not established in children under 16) • Patient must have a documented **Diagnosis** of narcolepsy • Patient must have cataplexy requiring treatment • Patient has tried three (3) of the following: modafinil, Nuvigil*, a tricyclic antidepressant (TCA) [e.g., amitriptyline, imipramine HCL tablet], a selective serotonin reuptake inhibitor (SSRI) [e.g., fluoxetine, sertraline, paroxetine], or venlafaxine • Xyrem is being prescribed by a neurologist or sleep specialist physican Excessive Daytime Sleepiness associated with Narcolepsy (all below criteria must be met) • Patient must be older than 16. (Safety and effectiveness not established in children under 16.) • Patient must have a documented **Diagnosis** of narcolepsy • Patient must have excessive daytime sleepiness as defined by Epworth Sleepiness Scale (ESS) score greater than or equal to 10. • Patient must have had an intolerance to, or treatment failure of an adequate trial of 3 of the following: amphetamine based stimulant, methylphenidate based stimulant, Provigil® (modafanil) or Nuvigil* (armodafanil) • Xyrem is being prescribed by a neurologist or sleep specialist physician * Prior Authorization Required

Quantity Limits: A quantity limit of 540ml per month will apply.

Date: October 2018 GTC: BEHAVIORAL HEALTH - OTHER: 2L Brand Name: Generic Name: Belsomra suvorexant oral tablet

Criteria: Potential causes of sleep disturbances have been addressed (e.g. inappropriate sleep hygiene and sleep environment issues or treatable medical/psychological causes of chronic insomnia) AND inadequate response, intolerable side effect, or contraindication to 3 formulary agents such as diphenhydramine, trazodone, zolpidem IR, eszopiclone, zaleplon AND details of failure/intolerance to each agent AND which attempts were taken to resolve these

Quantity Limits: 1 tablet/day

Date: November 2019 GTC: BEHAVIORAL HEALTH - OTHER: 2L Brand Name: Edluar Generic Name: Zolpidem tartrate 5 mg sublingual tab, Zolpidem tartrate 10 mg sublingual tab Criteria: Potential causes of sleep disturbances have been addressed (e.g., inappropriate sleep hygiene and sleep environment issues or treatable medical/psychological causes of chronic insomnia) AND Inadequate response, intolerable side effect, or contraindication to 3 formulary agents (such as zolpidem IR, trazodone, eszopiclone, zaleplon, diphenhydramine) AND Details of failure/intolerance to each agent AND which attempts were taken to resolve these

Quantity Limits: 1 capsule per day

Date: October 2018 GTC: BEHAVIORAL HEALTH - OTHER: 2L Brand Name: Generic Name: Intermezzo zolpidem tartrate 1.75mg sublingual tab, zolpidem tartrate 3.5mg sublingual tab

Criteria: Potential causes of sleep disturbances have been addressed (e.g., inappropriate sleep hygiene and sleep environment issues or treatable medical/psychological causes of chronic insomnia) AND inadequate response, intolerable side effect, or contraindication to 3 formulary agents such as diphenhydramine, trazodone, zolpidem IR, eszopiclone, zaleplon AND details of failure/intolerance to each agent AND which attempts were taken to resolve these

Quantity Limits: 1 tablet/day Date: December 2016 GTC: CARDIOVASCULAR DISEASE - ARRHYTHMIA: 0H Brand Name: Generic Name: Multaq dronedarone

Criteria: **Diagnosis** of paroxysmal or persistent atrial fibrillation AND has contraindication or inadequate response to amiodarone

Quantity Limits: 2/day Date: October 2018 GTC: CARDIOVASCULAR DISEASE - ARRHYTHMIA: 0H Brand Name: Generic Name: Rythmol SR propafenone HCL ER (12h) 225mg, 325mg, 425mg capsule

Criteria: **Diagnosis** of paroxysmal atrial fibrillation/flutter associated with disabling symptoms in patients without structural heart disease AND has contraindication or inadequate response to propafenone immediate release tablets

Quantity Limits: 2/day

Date: November 2019 GTC: CARDIOVASCULAR DISEASE - VASODILATION: 0I Brand Name: Generic Name: Nitrolingual Nitroglycerin spray

Criteria: For the treatment of angina AND  Inadequate response or intolerable side effects to sublingual nitroglycerin tablets

Quantity Limits: 1 bottle/Rx

Date: November 2019 GTC: CARDIOVASCULAR DISEASE - VASODILATION: 0I Brand Name: Generic Name: Nitromist Nitroglycerin aerosol spray

Criteria: For the treatment of angina AND  Inadequate response or intolerable side effects to sublingual nitroglycerin tablets AND  generic nitroglycerin spray (Nitrolingual)*

*Prior authorization required

Quantity Limits: 1 bottle/RX

Date: December 2017 GTC: CARDIOVASCULAR DISEASE - HYPERTENSION: 0G Brand Name: Generic Name: Tekturna aliskiren hemifumarate oral tablet 150mg, 300mg

Criteria: **Diagnosis** of hypertension AND has inadequate response, intolerable side effect, or contraindication to 2 formulary ARBs or ACE-I with or without hydrochlorothiazide as separate agents

Quantity Limits: Date: GTC: CARDIOVASCULAR DISEASE - HYPERTENSION: 0G Brand Name: Generic Name: Letairis ambrisentan

Criteria: **Diagnosis** of Pulmonary Arterial Hypertension (PAH) with NYHA-WHO Functional Class II or greater AND has been evaluated by a cardiologist or pulmonologist AND is being used in adjunct with OR has inadequate response, intolerable side effect, or contraindication to PDE-5 inhibitors (sildenafil OR tadalafil*)

*Prior Authorization Required

Quantity Limits: 1 tablet/day Date: GTC: CARDIOVASCULAR DISEASE - HYPERTENSION: 0G Brand Name: Generic Name: Azor, Tribenzor amlodipine besylate, olmesartan medoxomil oral tablet 5mg-20mg, 5mg-40mg, 10mg-20mg, 10mg-40mg and olmesartan medoxomil, amlodipine besylate, hydrochlorothiazide oral tablet 20mg-5mg-12.5mg, 40mg-5mg-12.5mg, 40mg-5mg-25mg, 40mg-10mg-12.5mg, 40mg-10mg-25mg

Criteria: **Diagnosis** of Hypertension AND has inadequate response, intolerable side effect, or contraindication to 2 formulary alternatives such as: • Amlodipine/valsartan (with or without hydrochlorothiazide as separate agent) • Amlodipine as a separate agent with losartan, irbesartan, telmisartan , losartan HCT, valsartan HCT, irbesartan HCT

Quantity Limits: Date: December 2017 GTC: CARDIOVASCULAR DISEASE - HYPERTENSION: 0G Brand Name: Generic Name: Exforge HCT amlodipine besylate, valsartan, hydrochlorothiazide oral tablet 5-160-12.5, 5-160-25, 10-160-12.5, 10-160-25, 10-320- 25

Criteria: **Diagnosis** of Hypertension AND has inadequate response, intolerable side effect, or contraindication to 2 formulary alternatives such as: • Amlodipine/valsartan (with or without hydrochlorothiazide as separate agent) • Amlodipine as a separate agent with losartan, irbesartan, telmisartan , losartan HCT, valsartan HCT, irbesartan HCT

Quantity Limits:

Date: November 2019 GTC: CARDIOVASCULAR DISEASE - HYPERTENSION: 0G Brand Name: Generic Name: Micardis HCT Telmisartan/ hydrochlorothiazide

Criteria: **Diagnosis** of hypertension AND  Trial and failure of 2 formulary alternatives such as losartan, irbesartan, valsartan, telmisartan , losartan HCT, valsartan HCT, irbesartan HCT AND  Must be currently on either telmisartan or HCTZ

Quantity Limits: 1 capsule per day

Date: November 2019 GTC: CARDIOVASCULAR DISEASE - HYPERTENSION: 0G Brand Name: Generic Name: Verelan PM Verapamil ER PM

Criteria: **Diagnosis** of hypertension AND Medical justification why member cannot take formulary verapamil immediate-release and extended-release (generic Verelan 24hr, Calan SR)

Quantity Limits: 1 capsule per day

Date: November 2019 GTC: CARDIOVASCULAR DISEASE - HYPERTENSION: 0G Brand Name: Generic Name: Dyrenium Triamterene

Criteria: For the treatment of peripheral edema states or hypokalemia AND  Medical justification why member cannot take spironolactone and amiloride

Quantity Limits: 2 capsule per day

Date: November 2019 GTC: CARDIOVASCULAR DISEASE - HYPERTENSION: 0G Brand Name: Generic Name: Orenitram ER Treprostinil diolamine tablet

Criteria: **Diagnosis** of Pulmonary Arterial Hypertension (PAH) with NYHA-WHO Functional Class III or greater AND Has been evaluated by a cardiologist or pulmonologist AND Is being used in adjunct with OR has inadequate response, intolerable side effect, or contraindication to BOTH:  PDE-5 inhibitor such as sildenafil* OR tadalafil* AND  Endothelin receptor antagonist such as ambrisentan* (Letairis), macitentan* (Opsumit), bosentan* (Tracleer)

*Prior Authorization Required

Quantity Limits: 3 tabs/day

Date: November 2019 GTC: CARDIOVASCULAR DISEASE - HYPERTENSION: 0G Brand Name: Generic Name: Remodulin Treprostinil sodium vial

Criteria: **Diagnosis** of Pulmonary Arterial Hypertension (PAH) with NYHA-WHO Functional Class III or greater AND Has been evaluated by a cardiologist or pulmonologist AND Is being used in adjunct with OR has inadequate response, intolerable side effect, or contraindication to BOTH:  PDE-5 inhibitor such as sildenafil* OR tadalafil* AND  Endothelin receptor antagonist such as ambrisentan* (Letairis), macitentan* (Opsumit), bosentan* (Tracleer)

*Prior Authorization Required Quantity Limits:

Date: GTC: CARDIOVASCULAR DISEASE - HYPERTENSION: 0G Brand Name: Generic Name: Adcirca tadalafil

Criteria: **Diagnosis** of Pulmonary Arterial Hypertension (PAH) AND has been evaluated by a cardiologist or pulmonologist AND has inadequate response, intolerable side effect, or contraindication to sildenafil

Quantity Limits: 2 tablets/day

Date: GTC: CARDIOVASCULAR DISEASE - HYPERTENSION: 0G Brand Name: Generic Name: Revatio sildenafil

Criteria: **Diagnosis** of Pulmonary Arterial Hypertension (PAH) AND has been evaluated by a cardiologist or pulmonologist

Quantity Limits: 5mg OR 20mg 3 tablets/day OR 2 mL/day

Date: December 2017 GTC: CARDIOVASCULAR DISEASE - HYPERTENSION: 0G Brand Name: Generic Name: Edarbi, Edarbyclor azilsartan medoxomil oral tablet 40mg, 80mg and azilsartan medoxomil, chlorthalidone oral tablet 40mg-12.5mg, 40mg-25mg

Criteria: **Diagnosis** of hypertension AND has inadequate response, intolerable side effect, or contraindication to 2 formulary alternatives such as: losartan, irbesartan, valsartan, telmisartan with or without chlorthalidone as separate agents

Quantity Limits:

Date: GTC: CARDIOVASCULAR DISEASE - HYPERTENSION: 0G Brand Name: Generic Name: Tracleer bosentan

Criteria: **Diagnosis** of Pulmonary Arterial Hypertension (PAH) with NYHA-WHO Functional Class II or greater AND has been evaluated by a cardiologist or pulmonologist AND is being used in adjunct with OR has inadequate response, intolerable side effect, or contraindication to PDE-5 inhibitors (sildenafil OR tadalafil*)

*Prior Authorization Required

Quantity Limits: Initial dosage: 62.5 mg BID x 4 weeks ≥ 40 kg: up to 125mg BID <40 kg: 62.5 mg BID Date: December 2017 GTC: CARDIOVASCULAR DISEASE - HYPERTENSION: 0G Brand Name: Generic Name: Atacand, Atacand HCT candesartan cilexetil oral tablet 4mg, 8mg, 16mg, 32mg and candesartan cilexetil, hydrochlorothiazide oral tablet 16mg-12.5mg, 32mg-12.5mg, 32mg-25mg

Criteria: **Diagnosis** of hypertension AND has inadequate response, intolerable side effect, or contraindication to 2 formulary alternatives such as: losartan, irbesartan, valsartan, telmisartan , losartan HCT, valsartan HCT, irbesartan HCT

Quantity Limits: Date: December 2017 GTC: CARDIOVASCULAR DISEASE - HYPERTENSION: 0G Brand Name: Generic Name: Inspra eplerenone oral tablet 25mg, eplerenone oral tablet 50mg

Criteria: **Diagnosis** of HTN or CHF AND has inadequate response, intolerable side effect, or contraindication to spironolactone

Quantity Limits: Date: December 2017 GTC: CARDIOVASCULAR DISEASE - HYPERTENSION: 0G Brand Name: Generic Name: Teveten eprosartan mesylate oral tablet 400mg, eprosartan mesylate oral tablet 600mg

Criteria: **Diagnosis** of hypertension AND has inadequate response, intolerable side effect, or contraindication to 2 formulary alternatives such as: losartan, irbesartan, valsartan, telmisartan

Quantity Limits: Date: GTC: CARDIOVASCULAR DISEASE - HYPERTENSION: 0G Brand Name: Generic Name: Ventavis inhaled iloprost

Criteria: **Diagnosis** of Pulmonary Arterial Hypertension (PAH) with NYHA-WHO Functional Class III or greater AND has been evaluated by a cardiologist or pulmonologist AND is being used in adjunct with OR has inadequate response, intolerable side effect, or contraindication to an ERA (ambrisentan, bosentan, or macitentan)*

*Prior Authorization Required

Quantity Limits: Max dose = 45 mcg/day (5 mcg 9 times per day) Date: GTC: CARDIOVASCULAR DISEASE - HYPERTENSION: 0G Brand Name: Generic Name: Tyvaso inhaled treprostinil

Criteria: **Diagnosis** of Pulmonary Arterial Hypertension (PAH) with NYHA-WHO Functional Class III or greater AND has been evaluated by a cardiologist or pulmonologist AND is being used in adjunct with OR has inadequate response, intolerable side effect, or contraindication to an ERA (ambrisentan, bosentan, or macitentan)*

*Prior Authorization Required

Quantity Limits: Tyvaso inhalation Starter Kit (NDC 66302-0206-01) Tyvaso Inhalation Refill Kit (NDC= 66302-0206- Date: GTC: CARDIOVASCULAR DISEASE - HYPERTENSION: 0G Brand Name: Generic Name: Bidil isosorbide dinitrate/hydralazine

Criteria: **Diagnosis** of Heart Failure AND has inadequate response, intolerable side effect, or contraindication to isosorbide and hydralazine as separate agents

Quantity Limits: 6 tablets/day Date: GTC: CARDIOVASCULAR DISEASE - HYPERTENSION: 0G Brand Name: Generic Name: Flolan IV epoprostenol

Criteria: **Diagnosis** of Pulmonary Arterial Hypertension (PAH) with NYHA-WHO Functional Class III or greater AND has been evaluated by a cardiologist or pulmonologist AND is being used in adjunct with OR has inadequate response, intolerable side effect, or contraindication to an ERA (ambrisentan, bosentan, or macitentan)*

*Prior Authorization Required

Quantity Limits: Date: GTC: CARDIOVASCULAR DISEASE - HYPERTENSION: 0G Brand Name: Generic Name: Veletri IV epoprostenol

Criteria: **Diagnosis** of Pulmonary Arterial Hypertension (PAH) with NYHA-WHO Functional Class III or greater AND has been evaluated by a cardiologist or pulmonologist AND is being used in adjunct with OR has inadequate response, intolerable side effect, or contraindication to an ERA (ambrisentan, bosentan, or macitentan)*

*Prior Authorization Required

Quantity Limits: Date: GTC: CARDIOVASCULAR DISEASE - HYPERTENSION: 0G Brand Name: Generic Name: Opsumit macitentan

Criteria: **Diagnosis** of Pulmonary Arterial Hypertension (PAH) with NYHA-WHO Functional Class II or greater AND has been evaluated by a cardiologist or pulmonologist AND is being used in adjunct with OR has inadequate response, intolerable side effect, or contraindication to PDE-5 inhibitors (sildenafil OR tadalafil*)

*Prior Authorization Required

Quantity Limits: 1 tablet/day Date: GTC: CARDIOVASCULAR DISEASE - HYPERTENSION: 0G Brand Name: Generic Name: Bystolic nebivolol

Criteria: **Diagnosis** of hypertension AND has inadequate response, intolerable side effect, or contraindication to 2 formulary beta-blockers

Quantity Limits: 1 tablet/day Date: December 2017 GTC: CARDIOVASCULAR DISEASE - HYPERTENSION: 0G Brand Name: Generic Name: Benicar, Benicar HCT olmesartan medoxomil oral tablet 5mg, 20mg, 40mg and olmesartan medoxomil, hydrochlorothiazide oral tablet 20mg-12.5mg, 40mg-12.5mg, 40mg-25mg

Criteria: **Diagnosis** of hypertension AND has inadequate response, intolerable side effect, or contraindication to 2 formulary alternatives such as: losartan, irbesartan, valsartan, telmisartan , losartan HCT, valsartan HCT, irbesartan HCT

Quantity Limits: Date: GTC: CARDIOVASCULAR DISEASE - HYPERTENSION: 0G Brand Name: Generic Name: Adempas riociguat

Criteria: **Diagnosis** of Pulmonary Arterial Hypertension (PAH) with NYHA-WHO Functional Class III or greater AND has been evaluated by a cardiologist or pulmonologist AND is being used in adjunct with OR has inadequate response, intolerable side effect, or contraindication to an ERA (ambrisentan, bosentan, or macitentan)*

*Prior Authorization Required

Quantity Limits: 3 tablets/day Date: October 2018 GTC: CARDIOVASCULAR DISEASE - HYPERTENSION: 0G Brand Name: Generic Name: Uptravi selexipag oral tablet 200mcg, 400mcg, 600mcg, 800mcg, 1000mcg, 1200mcg, 1400mcg, and 1600mcg

Criteria: **Diagnosis** of pulmonary arterial hypertension (PAH) WHO group 1 AND prescribed by a pulmonologist or cardiologist AND documented use of at least two (2) medications that belong to any of the following pharmacologic classes: • A PDE-5 inhibitor such as sildenafil (revatio) or tadalafil (Adcirca) • A guanylate cyclase stimulator such as riociguat (Adempas) • An endothelin receptor antagonist such as ambrisentan (Letairis), macitentan (Opsumit), bosentan (Tracleer)

Quantity Limits: 2 tablets/day Date: December 2017 GTC: CARDIOVASCULAR DISEASE - HYPERTENSION: 0G Brand Name: Generic Name: Aldactazide 50-50 spironolactone, hydrochlorothiazide oral tablet 50mg-50mg

Criteria: **Diagnosis** of hypertension or Edema AND has inadequate response, intolerable side effect, or contraindication to spironolactone HCTZ 25-25 at equivalent dose

Quantity Limits: Date: December 2017 GTC: CARDIOVASCULAR DISEASE - HYPERTENSION: 0G Brand Name: Generic Name: Twynsta telmisartan, amlodipine besylate oral tablet 40mg-5mg, 40mg-10mg, 80mg-5mg, 80mg-10mg

Criteria: **Diagnosis** of Hypertension AND has inadequate response, intolerable side effect, or contraindication to 2 formulary alternatives such as: • Amlodipine/valsartan (with or without hydrochlorothiazide as separate agent) • Amlodipine as a separate agent with losartan, irbesartan, telmisartan , losartan HCT, valsartan HCT, irbesartan HCT

Quantity Limits: Date: GTC: CARDIOVASCULAR DISEASE - LIPID IRREGULARITY: 0J Brand Name: Generic Name: Welchol colesevelam

Criteria: **Diagnosis** of hypercholesterolemia AND has inadequate response, intolerable side effect or contraindication to 2 formulary statins including: simvastatin, atorvastatin, pravastatin, or lovastatin AND formulary fenofibrates including generic Lofibra, Tricor, or Lopid AND has inadequate response, intolerable side effect or contraindication to niacin and bulk cholestyramine

Quantity Limits:

Date: November 2019 GTC: CARDIOVASCULAR DISEASE - LIPID IRREGULARITY: 0J Brand Name: Generic Name: Trilipix Fenofibric acid 45mg, 135mg capsule

Criteria: **Diagnosis** of hypertriglyceridemia, hypercholesterolemia, OR mixed hyperlipidemia AND Medical justification why member cannot take formulary fenofibrates (generic Lofibra, Tricor)

Quantity Limits: 1 capsule per day

Date: November 2019 GTC: CARDIOVASCULAR DISEASE - LIPID IRREGULARITY: 0J Brand Name: Generic Name: Fenoglide Fenofibrate 40mg, 120mg capsule

Criteria: **Diagnosis** of hypertriglyceridemia, hypercholesterolemia, OR mixed hyperlipidemia AND Medical justification why member cannot take formulary fenofibrates (generic Lofibra, Tricor)

Quantity Limits: 1 capsule per day

Date: November 2019 GTC: CARDIOVASCULAR DISEASE - LIPID IRREGULARITY: 0J Brand Name: Generic Name: Triglide Fenofibrate 50mg, 160mg tablet

Criteria: **Diagnosis** of hypertriglyceridemia, hypercholesterolemia, OR mixed hyperlipidemia AND Medical justification why member cannot take formulary fenofibrates (generic Lofibra, Tricor)

Quantity Limits: 1 tablet per day

Date: November 2019 GTC: CARDIOVASCULAR DISEASE - LIPID IRREGULARITY: 0J Brand Name: Generic Name: Lipofen Fenofibrate 50mg, 150mg capsule

Criteria: Diagnosis of hypertriglyceridemia, hypercholesterolemia, OR mixed hyperlipidemia AND  Medical justification why member cannot take formulary fenofibrates (generic Lofibra, Tricor)

Quantity Limits: 1 capsule per day

Date: November 2019 GTC: CARDIOVASCULAR DISEASE - LIPID IRREGULARITY: 0J Brand Name: Generic Name: Antara Fenofibrate (micronized) 30mg, 43mg, 90mg, 130mg capsule

Criteria: **Diagnosis** of hypertriglyceridemia, hypercholesterolemia, OR mixed hyperlipidemia AND Medical justification why member cannot take formulary fenofibrates (generic Lofibra, Tricor)

Quantity Limits: 1 capsule per day

Date: December 2017 GTC: CARDIOVASCULAR DISEASE - LIPID IRREGULARITY: 0J Brand Name: Generic Name: Vytorin ezetimibe, simvastatin oral tablet 10mg-10mg, 10mg-20mg, 10mg-40mg, 10mg-80mg

Criteria: **Diagnosis** of hypercholesterolemia AND has inadequate response, intolerable side effect, or contraindication to formulary ezetimibe and simvastatin taken as separate agents

Quantity Limits:

Date: December 2016 GTC: CARDIOVASCULAR DISEASE - LIPID IRREGULARITY: 0J Brand Name: Generic Name: Fibricor fenofibric acid

Criteria: Trial of all formulary fenofibrates including generic Lofibra, Tricor, and Lopid

Quantity Limits: 1/day Date: December 2017 GTC: CARDIOVASCULAR DISEASE - LIPID IRREGULARITY: 0J Brand Name: Generic Name: Lescol fluvastatin sodium oral capsule Lescol XL 20mg, 40mg fluvastatin sodium oral tablet, extended release 80mg Criteria: **Diagnosis** of hypercholesterolemia, hyperlipidemia, hypertriglyceridemia AND has contraindication or inadequate response to 2 formulary alternatives such as: • rosuvastatin • atorvastatin • lovastatin • pravastatin • simvastatin

Quantity Limits: 1/day

Date: GTC: CARDIOVASCULAR DISEASE - LIPID IRREGULARITY: 0J Brand Name: Generic Name: Vascepa icosapent ethyl

Criteria: **Diagnosis** of hypertriglyceridemia AND has inadequate response, intolerable side effect or contraindication to niacin AND has inadequate response, intolerable side effect or contraindication to one formulary fenofibrates (generic Lofibra, Tricor, or Lopid) AND a preferred omega-3 acid ethyl esters

Quantity Limits: Up to 4/day

Date: December 2017 GTC: CARDIOVASCULAR DISEASE - LIPID IRREGULARITY: 0J Brand Name: Generic Name: Altoprev lovastatin ER tablet 20mg, 40mg, 60mg

Criteria: **Diagnosis** of hypercholesterolemia, hyperlipidemia, hypertriglyceridemia AND has contraindication or inadequate response to 2 formulary alternatives such as: rosuvastatin, atorvastatin, lovastatin, pravastatin, simvastatin

Quantity Limits: 1/day Date: GTC: CARDIOVASCULAR DISEASE - LIPID IRREGULARITY: 0J Brand Name: Generic Name: Advicor niacin/lovastatin

Criteria: **Diagnosis** of hypercholesterolemia or mixed dyslipidemia AND medical justification why formulary niacin ER 24hr and lovastatin cannot be used together as separate agents

Quantity Limits: 2/day Date: GTC: CARDIOVASCULAR DISEASE - LIPID IRREGULARITY: 0J Brand Name: Generic Name: Simcor niacin/simvastatin

Criteria: **Diagnosis** of hypercholesterolemia or hypertriglyceridemia AND medical justification why formulary niacin ER 24hr and simvastatin cannot be used together as separate agents

Quantity Limits: Max 2/day Date: December 2017 GTC: CARDIOVASCULAR DISEASE - LIPID IRREGULARITY: 0J Brand Name: Generic Name: Livalo pitavastatin oral tablet 1mg, 2mg, 4mg

Criteria: **Diagnosis** of hypercholesterolemia, hyperlipidemia, hypertriglyceridemia AND has contraindication or inadequate response to 2 formulary alternatives such as: • rosuvastatin • atorvastatin • lovastatin • pravastatin • simvastatin

Quantity Limits: 1/day Date: October 2018 GTC: CARDIOVASCULAR DISEASE - LIPID IRREGULARITY: 0J Brand Name: Generic Name: Repatha Syringe, Repatha Sureclick, Repatha Pushtronex evolocumab 140mg/ml prefilled syringe, evolocumab 140mg/ml autoinjector, evolocumab 420mg/3.5ml prefilled cartridge

Criteria: **Diagnosis** of Heterozygous familial hypercholesterolemia (HeFH): **Diagnosis** confirmed by one of the following: 1. Simon Broome diagnostic criteria for HeFH (definite) [example:genetic testing consistent with HeFH] 2. Dutch Lipid Network criteria for HeFH with a score of at least 6 AND • Prescribed by a Cardiologist, Endocrinologist or Lipidologist AND • LDL-C level: greater than 70mg/dL (LDL level measured within past 6 months) while patient was on maximal drug treatment and dietary therapy for at least 8 weeks AND • concurrent drug regimen (applicable to all approvable indications) that meets one of the following in combination with ezetimibe for 8 weeks: • high intensity statin (i.e., atorvastatin 40-80 mg, rosuvastatin 20-40 mg daily) • maximally tolerated dose of any statin, given that the patient cannot tolerate a high-intensity statin • complete statin intolerance: severe and intolerable adverse effects (e.g., CK increase to 10 time upper limit of normal, LFTs increase to 3 times upper limit of normal, rhabdomyolysis, severe muscle weakness leading to temporary disability, fall, or inability to use a major muscle group) occurring with trials of at least 2 separate statins and improvement with discontinuation • absolute statin contraindication (e.g., active, decompensated disease, nursing female, pregnancy or plans to become pregnant, hypersensitivity reaction) OR

**Diagnosis** of Homozygous familial hypercholesterolemia (HoFH): **Diagnosis** confirmed by one of the following: 1. Simon Broome criteria (definite) [example:genetic testing consistent with HoFH], Dutch Lipid Network criteria (score ≥8) 2. Clinical **Diagnosis** (untreated LDL-C concentration > 500mg/dL together with either • xanthoma before 10 years of age OR • evidence of HoFH in both parents) AND • prescribed by a Cardiologist, Endocrinologist or Lipidologist AND • LDL-C level: greater than 70mg/dL (LDL level measured within past 6 months) while patient was on maximal drug treatment and dietary therapy for at least 8 weeks AND • concurrent drug regimen (applicable to all approvable indications): Meets one of the following in combination with ezetimibe for 8 weeks: • high intensity statin (i.e., atorvastatin 40-80 mg, rosuvastatin 20-40 mg daily) • maximally tolerated dose of any statin, given that the patient cannot tolerate a high-intensity statin • complete statin intolerance: severe and intolerable adverse effects (e.g., CK increase to 10 time upper limit of normal, LFTs increase to 3 times upper limit of normal, rhabdomyolysis, severe muscle weakness leading to temporary disability, fall, or inability to use a major muscle group) occurring with trials of at least 2 separate statins and improvement with discontinuation • absolute statin contraindication (e.g., active, decompensated liver disease, nursing female, pregnancy or plans to become pregnant, hypersensitivity reaction) OR

History of ASCVD: **Diagnosis** supported by hospital admission, imaging study, or surgical procedure. - Examples of atherosclerotic cardiovascular disease include history of myocardial infarction or other acute coronary syndrome, coronary or other revascularization procedure, transient ischemic attack, or ischemic stroke, atherosclerotic peripheral arterial disease, or documented atherosclerotic disease such as coronary atherosclerosis, renal atherosclerosis, aortic aneurysm secondary to atherosclerosis, or carotid plaque with 50% or more stenosis AND • prescribed by a Cardiologist, Endocrinologist or Lipidologist AND • LDL-C level: greater than 70mg/dL (LDL level measured within past 6 months) while patient was on maximal drug treatment and dietary therapy for at least 8 weeks • concurrent drug regimen (applicable to all approvable indications): Meets one of the following in combination with ezetimibe for 8 weeks: • high intensity statin (i.e., atorvastatin 40-80 mg, rosuvastatin 20-40 mg daily) • maximally tolerated dose of any statin, given that the patient cannot tolerate a high-intensity statin • complete statin intolerance: severe and intolerable adverse effects (e.g., CK increase to 10 time upper limit of normal, LFTs increase to 3 times upper limit of normal, rhabdomyolysis, severe muscle weakness leading to temporary disability, fall, or inability to use a major muscle group) occurring with trials of at least 2 separate statins and improvement with discontinuation • absolute statin contraindication (e.g., active, decompensated liver disease, nursing female, pregnancy or plans to become pregnant, hypersensitivity reaction)

Renewal Criteria: • Achieve/maintain LDL-C reduction ≥30% (ASCVD, HeFH) or a reduction (HoFH) from baseline • Concurrent use with maximally tolerated statin therapy

Quantity Limits: 140 mg per 2 weeks (ASCVD, HeFH) 420mg per 4 weeks (HoFH)

Date: October 2018 GTC: CARDIOVASCULAR DISEASE - LIPID IRREGULARITY: 0J Brand Name: Generic Name: Praluent Pen alirocumab prefilled autoinjector 75mg/ml and 150mg/ml

Criteria: **Diagnosis** of Heterozygous familial hypercholesterolemia (HeFH): **Diagnosis** confirmed by one of the following: 1. Simon Broome diagnostic criteria for HeFH (definite) [example:genetic testing consistent with HeFH] 2. Dutch Lipid Network criteria for HeFH with a score of at least 6 AND • prescribed by a Cardiologist, Endocrinologist or Lipidologist AND • LDL-C level: greater than 70mg/dL (LDL level measured within past 6 months) while patient was on maximal drug treatment and dietary therapy for at least 8 weeks AND • concurrent drug regimen (applicable to all approvable indications) that meets one of the following in combination with ezetimibe for 8 weeks: • high intensity statin (i.e., atorvastatin 40-80 mg, rosuvastatin 20-40 mg daily) • maximally tolerated dose of any statin, given that the patient cannot tolerate a high-intensity statin • complete statin intolerance: severe and intolerable adverse effects (e.g., CK increase to 10 time upper limit of normal, LFTs increase to 3 times upper limit of normal, rhabdomyolysis, severe muscle weakness leading to temporary disability, fall, or inability to use a major muscle group) occurring with trials of at least 2 separate statins and improvement with discontinuation • absolute statin contraindication (e.g., active, decompensated liver disease, nursing female, pregnancy or plans to become pregnant, hypersensitivity reaction) OR

History of ASCVD: **Diagnosis** supported by hospital admission, imaging study, or surgical procedure. - Examples of atherosclerotic cardiovascular disease include history of myocardial infarction or other acute coronary syndrome, coronary or other revascularization procedure, transient ischemic attack, or ischemic stroke, atherosclerotic peripheral arterial disease, or documented atherosclerotic disease such as coronary atherosclerosis, renal atherosclerosis, aortic aneurysm secondary to atherosclerosis, or carotid plaque with 50% or more stenosis AND prescribed by a Cardiologist, Endocrinologist or Lipidologist AND LDL-C level: greater than 70mg/dL (LDL level measured within past 6 months) while patient was on maximal drug treatment and dietary therapy for at least 8 weeks concurrent drug regimen (applicable to all approvable indications) that meets one of the following in combination with ezetimibe for 8 weeks: • high intensity statin (i.e., atorvastatin 40-80 mg, rosuvastatin 20-40 mg daily) • maximally tolerated dose of any statin, given that the patient cannot tolerate a high-intensity statin • complete statin intolerance: severe and intolerable adverse effects (e.g., CK increase to 10 time upper limit of normal, LFTs increase to 3 times upper limit of normal, rhabdomyolysis, severe muscle weakness leading to temporary disability, fall, or inability to use a major muscle group) occurring with trials of at least 2 separate statins and improvement with discontinuation • absolute statin contraindication (e.g., active, decompensated liver disease, nursing female, pregnancy or plans to become pregnant, hypersensitivity reaction)

Renewal: • Achieve/maintain LDL-C reduction ≥30% (ASCVD, HeFH) or a reduction (HoFH) from baseline • Concurrent use with maximally tolerated statin therapy

Quantity Limits: 75mg subcutaneously every 2 weeks or 300mg every 4 weeks Max: 150mg every 2 weeks Date: July 2018 GTC: COLD AND COUGH: 2A Brand Name: Generic Name: Zonatuss benzonatate 150mg

Criteria: Respiratory **Diagnosis** requiring a cough suppresant AND trial and failure of benzonatate 100mg and 200mg

Quantity Limits: Date: September 2017 GTC: COLD AND COUGH: 2A Brand Name: Generic Name: Mucinex ER guaifenesin ER 12HR

Criteria: Respiratory **Diagnosis** requiring an expectorant AND trial and failure of Guaifenesin regular tablets AND Guaifenesin liquid

Quantity Limits: Date: July 2018 GTC: COLD AND COUGH: 2A Brand Name: Generic Name: Robitussin AC guaifenesin with codeine liquid

Criteria: Limited to use in adults 18 years or older. Use in children is no longer indicated or recommended.

Quantity Limits: 240ml per 30 day supply

Date: September 2017 GTC: COLD AND COUGH: 2A Brand Name: Generic Name: Phenylephrine/ Promethazine Syrup phenylephrine/promethazine syrup

Criteria: Respiratory **Diagnosis** requiring antihistamine/decongestant combination AND trial and failure of 2 of the following: • phenylephrine/brompheniramine solution • phenylephrine/diphenhydramine liquid • pseudoephedrine/brompheniramine liquid

Quantity Limits: Date: March 2017 GTC: CONTRACEPTION/OXYTOCICS: 1W Brand Name: Generic Name: Nuvaring etonorgestrel/ethinyl estradiol vaginal ring

Criteria: Has inadequate response, intolerable side effect, or contraindication to formulary oral contraceptive OR Patient has known adherence/compliance issues

Quantity Limits: Date: March 2018 GTC: DENTAL AND ORAL AGENTS: 2G Brand Name: Generic Name: Evoxac cevimeline

Criteria: **Diagnosis** of xerostomia (dry mouth) AND has inadequate response, intolerable side effect, or contraindication to pilocarpine tablets

Quantity Limits:

Date: March 2020 GTC: MISCELLANEOUS AGENTS: 2G Brand Name: Generic Name: Qbrexza Glycopyrronium 2.4% towelette Criteria:

Diagnosis of severe primary axillary hyperhidrosis with ALL of the following: 1. Resting sweat production of 50 mg per axilla measured over 5 minutes at room temperature documented in chart notes AND 2. Documentation of Hyperhidrosis Disease Severity Scale (HDSS) rating of 3 or 4 must be submitted with chart notes AND 3. Member is 9 -17 years of age OR a. Member is at least 18 years old AND has tried and failed Botox* for 30 days AND 4. Medication must be prescribed by or in consultation with a dermatologist AND 5. Prescribing physician has documented the members hyperhidrosis is causing social anxiety, depression, or similar mental health related issues that impact daily life AND 6. Member has tried and failed to respond to treatment with Drysol 20% for at least 1 month with: a. Documentation of attempts to resolve side effects

*Requires prior authorization

Re-authorization • Chart notes with documentation of positive response

Quantity Limits: 30/Rx for 3 fills per authorization

Date: GTC: DERMATOLOGY - ACNE: 0U Brand Name: Generic Name: Differin adapalene cream

Criteria: **Diagnosis** of acne AND patient has inadequate response, intolerable side effect or contraindication to formulary alternatives BPO, topical clindamycin, tretinoin cream AND adapalene 0.1% gel.

Quantity Limits: Date: GTC: DERMATOLOGY - ACNE: 0U Brand Name: Generic Name: Epiduo adapalene/benzoyl peroxide

Criteria: **Diagnosis** of acne AND has inadequate response, intolerable side effect, or contraindication to topical clindamycin, tretinoin cream, adapalene 0.1% gel, AND BPO

Quantity Limits: Date: May 2019 GTC: DERMATOLOGY - ACNE: 0U Brand Name: Generic Name: Azelex 20% Cream azelaic acid

Criteria: **Diagnosis** of Acne AND has inadequate response, intolerable side effect, or contraindication to formulary tretinoin, adapalene 0.1% gel, Benzoyl peroxide, and topical clindamycin AND details of failure/intolerance to above alternatives AND which attempts were taken to resolve these

Quantity Limits: Date: May 2019 GTC: DERMATOLOGY - ACNE: 0U Brand Name: Generic Name: Finacea 15% Foam azelaic acid

Criteria: **Diagnosis** of Rosacea AND patient has inadequate response, intolerable side effect or contraindication to topical metronidazole 0.75% gel AND Azelaic Acid 15% gel*

* Requires Prior Authorization

Quantity Limits: Date: June 2018 GTC: DERMATOLOGY - ACNE: 0U Brand Name: Generic Name: Finacea azelaic acid 15% gel

Criteria: **Diagnosis** of Rosacea AND patient has inadequate response, intolerable side effect or contraindication to topical metronidazole 0.75% gel/cream

* Requires Prior Authorization

Quantity Limits: Date: GTC: DERMATOLOGY - ACNE: 0U Brand Name: Generic Name: Azelex azelaic acid 20% cream

Criteria: **Diagnosis** of Acne AND inadequate response, intolerable side effect, or contraindication to formulary tretinoin, adapalene 0.1% gel, Benzoyl peroxide, and topical clindamycin AND details of failure/intolerance to above alternatives AND which attempts were taken to resolve these

Quantity Limits: Date: August 2019 GTC: DERMATOLOGY - ACNE: 0U Brand Name: Generic Name: Acanya benzoyl peroxide 2.5% + clindamycin 1% gel

Criteria: **Diagnosis** of acne AND Patient has inadequate response, intolerable side effect OR contraindication to formulary alternatives as single ingredients BPO, topical clindamycin, tretinoin cream, AND adapalene 0.1% gel (as-separate agents)

Quantity Limits: Date: GTC: DERMATOLOGY - ACNE: 0U Brand Name: Generic Name: Benzaclin benzoyl peroxide 5% + clindamycin 1% gel

Criteria: **Diagnosis** of acne AND patient has inadequate response, intolerable side effect or contraindication to formulary alternatives as single ingredients BPO, topical clindamycin, tretinoin cream, AND adapalene 0.1% gel

Quantity Limits: Date: GTC: DERMATOLOGY - ACNE: 0U Brand Name: Generic Name: Duac benzoyl peroxide 5% + clindamycin 1.2% gel Neuac

Criteria: **Diagnosis** of acne AND patient has inadequate response, intolerable side effect or contraindication to formulary alternatives as single ingredients BPO, topical clindamycin, tretinoin cream, AND adapalene 0.1% gel

Quantity Limits: Date: GTC: DERMATOLOGY - ACNE: 0U Brand Name: Generic Name: Benzamycin benzoyl peroxide 5% + erythromycin 3% gel

Criteria: **Diagnosis** of acne AND patient has inadequate response, intolerable side effect or contraindication to formulary alternatives as single ingredients BPO, topical clindamycin, tretinoin cream, AND adapalene 0.1% gel

Quantity Limits: Date: June 2018 GTC: DERMATOLOGY - ACNE: 0U Brand Name: Generic Name: Mirvaso brimonidine

Criteria: **Diagnosis** of Rosacea AND patient has inadequate response, intolerable side effect or contraindication to formulary alternative metronidazole 0.75% gel AND Finacea (azelaic acid 15% gel or foam)

Quantity Limits: Date: June 2018 GTC: DERMATOLOGY - ACNE: 0U Brand Name: Generic Name: Aczone dapsone

Criteria: **Diagnosis** of acne AND has inadequate response, intolerable side effect, or contraindication to topical clindamycin, tretinoin cream, adapalene 0.1% gel, AND BPO

Quantity Limits: Date: June 2017 GTC: DERMATOLOGY - ACNE: 0U Brand Name: Generic Name: Absorica isotretinoin

Criteria: **Diagnosis** of acne AND patient has inadequate response, intolerable side effect or contraindication topical tretinoin cream, benzoyl peroxide, topical clindamycin, AND oral antibiotics AND inadequate response or intolerable side effect to any other oral isotretinoin product (e.g., Claravis, Zenatane, Myorisan) OR

**Diagnosis** of cystic or nodular acne AND inadequate response or intolerable side effect to any other oral isotretinoin product (e.g., Claravis, Zenatane, Myorisan)

Quantity Limits: Date: May 2019 GTC: DERMATOLOGY - ACNE: 0U Brand Name: Generic Name: Accutane, Amnesteem, Claravis, Myorisan, Sotret, Zenatane, isotretinoin Isotretinoin

Criteria: **Diagnosis** of Acne AND patient has inadequate response, intolerable side effect or contraindication topical tretinoin cream, benzoyl peroxide, topical clindamycin, AND oral antibiotics OR

**Diagnosis** of cystic or nodular acne

Quantity Limits:

Approvable x 6 months Date: May 2019 GTC: DERMATOLOGY - ACNE: 0U Brand Name: Generic Name: Amnesteem, Claravis, Myorisan, Zenatane isotretinoin

Criteria: **Diagnosis** of Acne AND patient has inadequate response, intolerable side effect or contraindication topical tretinoin cream, benzoyl peroxide, topical clindamycin, AND oral antibiotics

OR

**Diagnosis** of cystic or nodular acne

Quantity Limits:

Approvable x 6 months Date: June 2018 GTC: DERMATOLOGY - ACNE: 0U Brand Name: Generic Name: Soolantra ivermectin

Criteria: **Diagnosis** of rosacea AND patient has inadequate response, intolerable side effect or contraindication to formulary alternative metronidazole 0.75% gel AND Finacea (azelaic acid 15% gel or foam)

OR

**Diagnosis** of head lice AND has inadequate response, intolerable side effect, or contraindication to permethrin (Nix) AND pyrethrins plus piperonyl butoxide (Rid)

Quantity Limits: Date: May 2019 GTC: DERMATOLOGY - ACNE: 0U Brand Name: Generic Name: Noritate 1% Cream metronidazole

Criteria: **Diagnosis** of Rosacea AND : - Has inadequate response(to at least 8 weeks of therapy), intolerable side effect, or contraindication to formulary metronidazole, azelaic acid 15% gel* AND Soolantra* AND - details of failure/intolerance to each of the above alternatives AND which attempts were taken to resolve these

*Prior authorization required

Quantity Limits: Date: March 2018 GTC: DERMATOLOGY - ACNE: 0U Brand Name: Non-Formulary Topical Corticosteroid Generic Name: non-formulary topical corticosteroid

Criteria: Diagnosis of atopic dermatitis, pruritus, psoriasis, etc. AND trial and failure of two formulary equipotent or higher potency corticosteroids

Super High Betamethasone dipropionate, augmented 0.05% Potency (Group (Diprolene AF) ointment 1): Clobetasol Propionate 0.05 % (Temovate) ointment Halobetasol Propionate 0.05 % ointment (Ultravate)

Clobetasol Propionate 0.05 % (Temovate) cream Clobetasol Propionate 0.05 % (Temovate-E) emmolient cream Fluocinonide 0.1% cream Halobetasol Propionate 0.05 % cream (Ultravate)

Betamethasone dipropionate, augmented 0.05% (Diprolene AF) lotion Clobetasol Propionate 0.05 % (Clobex) lotion Halobetasol Propionate 0.05 % (Ultravate) lotion

Clobetasol Propionate 0.05 % (temovate, Cormax) solution Clobetasol Propionate 0.05 % gel (Temovate) Clobetasol Propionate 0.05 % Foam (Olux) Clobetasol Propionate 0.05 % emmolient foam (Olux-E)

Clobetasol Propionate 0.05 % spray (Clobex) Cordran 4MCG/SQ CM (Flurandrenolide) tape

Super High Betamethasone dipropionate 0.05% (Diprosone) ointment Potency (Group Desoximetasone 0.25% (Topicort) ointment 2): Fluocinonide 0.05 % (Lidex) ointment Halcinonide 0.1% (Halog) ointment

Amcinonide 0.1% cream Betamethasone dipropionate augmented 0.05% (Diprolene AF) cream Desoximetasone 0.25% (Topicort) cream Fluocinonide 0.05 % (Lidex) cream anhydrous Halcinonide 0.1% (Halog) cream

Fluocinonide 0.05 % (Lidex) solution

Amcinonide 0.1% lotion Desoximetasone 0.05% (Topicort) gel Fluocinonide 0.05 % (Lidex) gel

High Potency Amcinonide 0.1% ointment (Group 3): Betamethasone Valerate 0.1 % (Valisone) ointment Fluticasone Propionate 0.005 % (Cultivate) ointment Mometasone Furoate 0.1 % (Elocon) ointment Triamcinolone Acetonide 0.5 % (Kenalog) ointment Betamethasone dipropionate 0.05% (Diprosone) cream Desoximetasone 0.05% (Topicort LP) cream Diflorasone 0.05% (Florone) cream Fluocinonide-E 0.05 % (Lidex-E) cream Triamcinolone Acetonide 0.5 % (Triderm, Aristocort HP) cream

Betamethasone Valerate 0.12% (Luqix) Foam

Medium Potency Fluocinolone Acetonide 0.025 % (Synalar) ointment (Group 4): Flurandrenolide 0.05% (Cordran) ointment Hydrocortisone valerate 0.2% (Westcort) ointment Triamcinolone Acetonide 0.1 % (Kenalog) ointment

Clocortolone pivalate 0.1% cream Mometasone Furoate 0.1 % (Elocon) cream Triamcinolone Acetonide 0.1 % (Kenalog) cream

Mometasone Furoate 0.1 % (Elocon) solution

Sernivo 0.05% (Betamethasone dipropionate) Spray Triamcinolone Acetonide 0.2mg/2 second (Kenalog) spray

Lower-Mid Desonide 0.05 % (DesOwen) ointment Potency (Group Hydrocortisone Butyrate 0.1 %(Locoid) ointment 5): Prednicarbate 0.1 % (Dermatop) ointment Triamcinolone Acetonide 0.025 % (Kenalog) ointment

Betamethasone Valerate 0.1% (Beta-Val, Valisone) cream Fluocinolone Acetonide 0.025 % (Synalar) cream Flurandrenolide 0.05 % (Cordran) cream Fluticasone Propionate 0.05 % (Cutivate) cream Hydrocortisone Butyrate 0.1 % (Locoid, locoid lipocream) cream Hydrocortisone probutate 0.1% (Pandel) cream Hydrocortisone Valerate 0.2 % (Westcort) cream Prednicarbate 0.1 % (Dermatop) cream, emolient

Betamethasone dipropionate 0.05% (Diprosone) lotion Fluradrenolide 0.05 % (Cordran) lotion Fluticasone Propionate 0.05 % (Cutivate) lotion Hydrocortisone Butyrate 0.1 % (Locoid) lotion, spray, solution Triamcinolone Acetonide 0.1 % (Kenalog) lotion

Desonide 0.05 % (Desonate) gel

Low Potency Alclometasone Dipropionate 0.05 % (Aclovate) ointment (Group 6): Alclometasone Dipropionate 0.05% (Aclovate) cream Desonide 0.05% (DesOwen) cream Fluocinolone Acetonide 0.01% (Synalar) cream Triamcinolone Acetonide 0.025 % (Kenalog, Aristocort) cream

Betamethasone Valerate 0.1% (Beta-Val, Valisone) lotion Desonide 0.05 %(DesOwen) lotion Triamcinolone Acetonide 0.025 % (Kenalog) lotion

Fluocinolone Acetonide 0.01 % solution (Synalar) Fluocinolone Acetonide 0.01% (Derma-smooth/FS scalp) scalp oil Fluocinolone Acetonide 0.01% (Derma-smooth/FS body) body oil

Capex (fluocinolone) 0.01% shampoo Desonide 0.05 % (Verdeso) foam

Least Potency Hydrocortisone OTC ointment, cream, solution, lotion, (Group 7): foam Hydrocortisone OTC spray

Quantity Limits: Notes: 6 fills for 1 year Formulary =Black font Non-formulary = brown font

Date: May 2019 GTC: DERMATOLOGY - ACNE: 0U Brand Name: Generic Name: Retin A Micro tretinoin microspheres gel

Criteria: **Diagnosis** of Acne AND inadequate response, intolerable side effect, or contraindication to formulary tretinoin, adapalene 0.1% gel, Benzoyl peroxide, AND topical clindamycin

Quantity Limits: Date: May 2019 GTC: DERMATOLOGY - ACNE: 0U Brand Name: Generic Name: Renova, Refissa tretinoin/emollient base 0.02%, tretinoin/emollient base cream 0.05%

Criteria: Renova and Refissa® (tretinoin emollient creams) are indicated as an adjunctive agent for use in the mitigation of fine wrinkles, mottled hyperpigmentation, and tactile roughness of facial skin in patients who do not achieve such palliation using comprehensive skin care and sun avoidance programs alone = NOT A COVERED BENEFIT

Quantity Limits: Date: GTC: DERMATOLOGY - ANTIINFECTIVE: 0S Brand Name: Generic Name: Zovirax Cream and Ointment acyclovir

Criteria: For acyclovir 5% cream **Diagnosis** of recurrent Herpes Labialis AND has inadequate response, intolerable side effect, or contraindication to oral acyclovir AND oral valacyclovir

For acyclovir 5% ointment **Diagnosis** of Genital Herpes, and Virus AND has inadequate response, intolerable side effect, or contraindication to acyclovir AND oral valacyclovir

Quantity Limits: 1 tube (up to 30g) per fill Date: GTC: DERMATOLOGY - ANTIINFECTIVE: 0S Brand Name: Generic Name: Xerese acyclovir/hydrocortisone

Criteria: **Diagnosis** of recurrent Herpes Labialis AND has inadequate response, intolerable side effect, or contraindication to oral acyclovir with hydrocortisone 1% cream AND oral valacyclovir with hydrocortisone 1% cream AND has inadequate response, intolerable side effect, or contraindication to concurrent use of acyclovir 5% cream* AND formulary hydrocortisone 1% cream

*Prior Authorization required

Quantity Limits: 1 tube (5g) per fill Date: May 2019 GTC: DERMATOLOGY - ANTIINFECTIVE: 0S Brand Name: Generic Name: Ulesfia benzyl alcohol

Criteria: **Diagnosis** of head lice AND inadequate response, intolerable side effect, or contraindication to 2 treatments course with permethrin (Nix) OR Pyrethrins plus piperonyl butoxide (Rid)

Quantity Limits: 1 bottle (227mL) per fill 2 fills per treatment Date: June 2018 GTC: DERMATOLOGY - ANTIINFECTIVE: 0S Brand Name: Generic Name: Eurax crotamiton

Criteria: **Diagnosis** of scabies AND has inadequate response, intolerable side effect, or contraindication to permethrin cream

Quantity Limits: Date: GTC: DERMATOLOGY - ANTIINFECTIVE: 0S Brand Name: Generic Name: Jublia efinaconazole

Criteria: **Diagnosis** of onychomycosis AND has inadequate response, intolerable side effect, or contraindication to formulary topical ciclopirox AND has inadequate response, intolerable side effect, or contraindication to two (2) formulary oral agents such as oral terbinafine, , or fluconazole

Quantity Limits: 1 bottle (up to 8mL) per fill Date: GTC: DERMATOLOGY - ANTIINFECTIVE: 0S Brand Name: Generic Name: Extina foam

Criteria: **Diagnosis** of seborrheic dermatitis AND has inadequate response, intolerable side effect, or contraindication to ketoconazole shampoo

Quantity Limits: 1 bottle (up to 100g) per fill Date: GTC: DERMATOLOGY - ANTIINFECTIVE: 0S Brand Name: Generic Name: Xolegel ketoconazole gel

Criteria: **Diagnosis** of seborrheic dermatitis AND has inadequate response, intolerable side effect, or contraindication to ketoconazole shampoo

Quantity Limits: 1 tube (45g) per fill 2 fills per treatment Date: GTC: DERMATOLOGY - ANTIINFECTIVE: 0S Brand Name: Generic Name: Lindane lindane

Criteria: Lindane 1% lotion **Diagnosis** of scabies AND has inadequate response to two (2) application of formulary permethrin 5% cream each about a week apart AND two (2) application of topical crotamiton each 24hr apart OR Intolerable side effect, of contraindication to permethrin or crotamiton

Lindane 1% shampoo **Diagnosis** of head lice AND has inadequate response, intolerable side effect, or contraindication to permethrin (Nix) AND pyrethrins plus piperonyl butoxide (Rid)

Quantity Limits: 1 bottle (60mL) per fill 1 fill per request Date: GTC: DERMATOLOGY - ANTIINFECTIVE: 0S Brand Name: Generic Name: Luzu luliconazole

Criteria: **Diagnosis** of tinea pedis (athlete’s foot), tinea cruris (jock itch), or tinea corporis (ringworm) AND has inadequate response, intolerable side effect, or contraindication to at least three (3) of formulary topical antifungal agents such as: clotrimazole, econazole cream, ketoconazole, miconazole, terbinafine, or tolnaftate

Quantity Limits: 1 tube (60g) per fill Date: August 2019 (modified) GTC: DERMATOLOGY - ANTIINFECTIVE: 0S Brand Name: Generic Name: Ovide malathion

Criteria: **Diagnosis** of head lice AND Has inadequate response, intolerable side effect, or contraindication to 2 treatments course with permethrin (Nix) OR Pyrethrins plus piperonyl butoxide (Rid)

Quantity Limits: Date: GTC: DERMATOLOGY - ANTIINFECTIVE: 0S Brand Name: Generic Name: Naftin naftifine gel & cream

Criteria: **Diagnosis** of tinea pedis (athlete’s foot), tinea cruris (jock itch), or tinea corporis (ringworm) AND has inadequate response, intolerable side effect, or contraindication to at least three (3) of formulary topical antifungal agents such as: clotrimazole, econazole cream, ketoconazole, miconazole, terbinafine, or tolnaftate

Quantity Limits: 1 tube (up to 90g) per fill Date: GTC: DERMATOLOGY - ANTIINFECTIVE: 0S Brand Name: Generic Name: Oxistat oxiconazole cream, oxiconazole lotion

Criteria: **Diagnosis** of tinea pedis (athlete’s foot), tinea cruris (jock itch), or tinea corporis (ringworm) AND has inadequate response, intolerable side effect, or contraindication to at least three (3) of formulary topical antifungal agents such as clotrimazole, econazole cream, ketoconazole, miconazole, terbinafine, or tolnaftate

Quantity Limits: 1 tube (up to 90g) per fill Date: GTC: DERMATOLOGY - ANTIINFECTIVE: 0S Brand Name: Generic Name: Denavir penciclovir

Criteria: **Diagnosis** of herpes labialis AND has inadequate response, intolerable side effect, or contraindication to oral acyclovir AND oral valacyclovir

Quantity Limits: 1 tube (5g) per fill Date: GTC: DERMATOLOGY - ANTIINFECTIVE: 0S Brand Name: Generic Name: Altabax retapamulin

Criteria: **Diagnosis** of impetigo AND has inadequate response, intolerable side effect, or contraindication to mupirocin ointment

Quantity Limits: 1 tube (up to 30g) per fill Date: GTC: DERMATOLOGY - ANTIINFECTIVE: 0S Brand Name: Generic Name: Ertaczo sertaconazole

Criteria: **Diagnosis** of tinea pedis (athlete’s foot) AND has inadequate response, intolerable side effect, or contraindication to at least three (3) of formulary topical antifungal agents such as: clotrimazole, econazole cream, ketoconazole, miconazole, terbinafine, or tolnaftate

Quantity Limits: 1 tube (60g) per fill Date: GTC: DERMATOLOGY - ANTIINFECTIVE: 0S Brand Name: Generic Name: Veregen sinecatechins

Criteria: **Diagnosis** of genital warts or perianal warts AND has inadequate response, intolerable side effect, or contraindication to formulary podofilox solution or imiquimod cream

Quantity Limits: 1 tube (30g) per fill Date: GTC: DERMATOLOGY - ANTIINFECTIVE: 0S Brand Name: Generic Name: Kerydin tavaborole

Criteria: **Diagnosis** of onychomycosis AND has inadequate response, intolerable side effect, or contraindication to formulary topical ciclopirox AND has inadequate response, intolerable side effect, or contraindication to two (2) formulary oral agents such as: oral terbinafine, itraconazole, or fluconazole

Quantity Limits: 1 bottle (up to 10mL) per fill Date: May 2019 GTC: DERMATOLOGY - ANTIINFECTIVE: OS Brand Name: Generic Name: Loprox 1% Shampoo ciclopirox

Criteria: **Diagnosis** of seborrheic dermatitis of the scalp AND inadequate response, intolerable side effect, or contraindication to formulary preferred ketoconazole shampoo

Quantity Limits: Date: May 2019 GTC: DERMATOLOGY - ANTIINFECTIVE: OS Brand Name: Generic Name: Clindagel 1% Daily Gel clindamycin phosphate

Criteria: **Diagnosis** of Acne AND inadequate response, intolerable side effect, or contraindication to 3 formulary preferred Clindamycin formulations such as: - Clindamycin phosphate 1% gel (generic for Cleocin-T) - Clindamycin phosphate 1% lotion - Clindamycin phosphate 1% solution - Clindamycin phosphate 1% swab AND details of failure/intolerance to above alternatives AND which attempts were taken to resolve these

Quantity Limits: Date: May 2019 GTC: DERMATOLOGY - ANTIINFECTIVE: OS Brand Name: Generic Name: Sklice 0.5% Lotion ivermectin lotion

Criteria: **Diagnosis** of head lice AND Has inadequate response, intolerable side effect, or contraindication to 2 treatments course with permethrin (Nix) OR Pyrethrins plus piperonyl butoxide (Rid)

Quantity Limits: Date: May 2019 GTC: DERMATOLOGY - ANTIINFECTIVE: OS Brand Name: Generic Name: Natroba spinosad

Criteria: **Diagnosis** of head lice AND Has inadequate response, intolerable side effect, or contraindication to 2 treatments course with permethrin (Nix) OR Pyrethrins plus piperonyl butoxide (Rid)

Quantity Limits: Date: June 2018 GTC: DERMATOLOGY - ANTIINFLAMMATORY: 0R Brand Name: Generic Name: Eucrisa crisaborole

Criteria: **Diagnosis** of mild to moderate atopic dermatitis AND has inadequate response, intolerable side effect or contraindication to Protopic or Elidel AND one of the following: • has inadequate response, intolerable side effect, or contraindication to 2 formulary topical steroids • condition affects sensitive body areas (e.g. genitals, face)

Quantity Limits: 1 tube = 60 g Date: GTC: DERMATOLOGY - ANTIINFLAMMATORY: 0R Brand Name: Generic Name: Flector Patch diclofenac epolamine 1.3% (12HR) transdermal patch

Criteria: **Diagnosis** of acute pain AND has inadequate response, intolerable side effect, or contraindication to 3 formulary oral NSAIDs such as: ibuprofen, naproxen, meloxicam, diclofenac, sulindac, nabumetone, or etodolac, AND has inadequate response, intolerable side effect or contraindication to generic Voltaren 1% topical gel

Quantity Limits: 2 patches/day Date: GTC: DERMATOLOGY - ANTIINFLAMMATORY: 0R Brand Name: Generic Name: Pennsaid Solution diclofenac sodium 2% pump

Criteria: **Diagnosis** of pain or arthritis AND has inadequate response, intolerable side effect, or contraindication to 3 formulary oral NSAIDs such as: ibuprofen, naproxen, meloxicam, diclofenac, sulindac, nabumetone or etodolac AND has inadequate response, intolerable side effect or contraindication to generic Voltaren 1% topical gel

Quantity Limits: 2 bottles/fill Date: June 2018 GTC: DERMATOLOGY - ANTIPURITIC DRUGS: 0T Brand Name: Generic Name: Prudoxin, Zonalon doxepin cream

Criteria: **Diagnosis** of moderate pruritus in adults with atopic dermatitis AND has inadequate response, intolerable side effect or contraindication 1 topical antihistamine (diphenhydramine) AND has inadequate response, intolerable side effect, or contraindication to 2 formulary high potency topical steroids

**Diagnosis** of lichen simplex chronicus AND has inadequate response, intolerable side effect, or contraindication to 2 formulary high potency topical steroids

Quantity Limits: 1 tube = 45g Date: GTC: DERMATOLOGY - PSORIASIS/ECZEMA: 0V Brand Name: Generic Name: Panretin alitretinoin

Criteria: **Diagnosis** of cutaneous lesions in patients with AIDS-related Kaposi’s sarcoma

Quantity Limits: Date: May 2019 GTC: DERMATOLOGY - PSORIASIS/ECZEMA: 0V Brand Name: Generic Name: Siliq brodalumab

Criteria: **Diagnosis** of moderate to severe plaque psoriasis AND : - Psoriasis affects > 10% BSA or causes significant functional disability (Palms, soles, genitalia, severe scalp psoriasis) AND - Has inadequate response, intolerable side effect, or contraindication to phototherapy (if available) AND - Has inadequate response, intolerable side effect, or contraindication to acitretin or another DMARD (Sulfasalazine, Methotrexate, Leflunomide, Hydroxychloroquine, Cyclosporine) AND trial and failure of TALTZ

Quantity Limits: PsO: Induction: 210mg at week 0, 1, 2. Maintenance: 210 every 2 weeks

Date: Feb 2020 GTC: Brand Name: Generic Name: Skyrizi Risankizumab Criteria: **Diagnosis** of moderate to severe plaque psoriasis AND psoriasis affects > 10% BSA OR Causes significant functional disability (palms, soles, genitalia, severe scalp psoriasis) AND has inadequate response, intolerable side effect, or contraindication to phototherapy if available) AND has inadequate response, intolerable side effect, or contraindication to acitretin or another DMARD

Quantity Limits:

Date: GTC: DERMATOLOGY - PSORIASIS/ECZEMA: 0V Brand Name: Generic Name: Dovonex calcipotriene topical cream, topical ointment, topical solution Calcitrene

Criteria: **Diagnosis** of plaque psoriasis AND inadequate response, intolerable side effect or contraindication to 2 formulary topical steroids, coal tar, or UV therapy OR medical justification why they cannot be used.

For large areas (>3% BSA) please consider systemic therapy such as methotrexate, acitretin*, or cyclosporine*.

*Prior Authorization Required

Quantity Limits: Date: June 2017 GTC: DERMATOLOGY - PSORIASIS/ECZEMA: 0V Brand Name: Generic Name: Santyl collagenase clostridium histolyticum 250 unit/gram topical ointment

Criteria: • Necessity for debridement of chronic dermal ulcers or severely burned areas • Documentation of the size and location of the wound • Prescribed by a specialist (surgeon, podiatrist, burn/wound care facility) • Other methods of debridement have been tried on the wound or the recipient has contraindications or intolerance to other methods of debridement

Quantity Limits: Approve a 14-day supply per fill with a max duration of 6 weeks. Date: June 2018 GTC: DERMATOLOGY - PSORIASIS/ECZEMA: 0V Brand Name: Generic Name: Solaraze diclofenac sodium 3% gel

Criteria: **Diagnosis** of Actinic Keratoses

Quantity Limits: 1 tube (100g) Date: August 2019 (modified) GTC: DERMATOLOGY - PSORIASIS/ECZEMA: 0V Brand Name: Generic Name: Dupixent dupilumab

Criteria: **Diagnosis** of moderate atopic dermatitis AND Trial and failure of 2 formulary corticosteroids AND Protopic AND Eucrisa OR

**Diagnosis** of severe atopic dermatitis AND Trial and failure of a 2 formulary corticosteroids AND Protopic OR

Patient has a **Diagnosis** of moderate to severe asthma with an eosinophilic phenotype and meets ALL of the following criteria: • The patient has a documented blood eosinophil level of at least 150 cells/mcL within the past 6 months

OR

**Diagnosis** of moderate-severe oral corticosteroid-dependent asthma • The patient is 12 years of age or older • The patient is currently adherent on a maximally tolerated inhaled corticosteroid plus at least one other maintenance medication (e.g., long-acting inhaled beta2-agonist, long-acting muscarinic antagonist, leukotriene receptor antagonist, theophylline) • The patient has experienced at least 2 asthma exacerbations within the past 12 months (exacerbation is defined as an asthma-related event requiring hospitalization, emergency room visit, or systemic corticosteroid burst lasting at least 3 days) • Dupixent will be used as an add-on maintenance treatment • The patient is not being concurrently treated with Xolair or an anti-IL5 asthma biologic (e.g., Nucala, Cinqair, Fasenra) • Dupixent is prescribed by or given in consultation with a physician specializing in pulmonary or allergy medicine

Quantity Limits: Date: March 2018 GTC: DERMATOLOGY - PSORIASIS/ECZEMA: 0V Brand Name: Generic Name: Tremfya guselkumab

Criteria: **Diagnosis** of moderate to severe plaque psoriasis AND psoriasis affects > 10% BSA OR causes significant functional disability (palms, soles, genitalia, severe scalp psoriasis) AND has inadequate response, intolerable side effect, or contraindication to phototherapy if available) AND has inadequate response, intolerable side effect, or contraindication to acitretin or another DMARD

Quantity Limits: PsO: Induction: 100mg SQ at Wk: 0 Wk: 4 Maintenance: 100mg every 8 weeks

Date: June 2018 GTC: DERMATOLOGY - PSORIASIS/ECZEMA: 0V Brand Name: Generic Name: Pramosone Foam And Lotion hydrocortisone/pramoxine

Criteria: **Diagnosis** of anorectal inflammation (may include dermatisis, psoriasis, pruritus, swelling associated with hemorrhoids, proctitis, cryptitis, anal fisusres, postoperative pain and pruritus ani) AND has inadequate response, intolerable side effect, or contraindication to hydrocortisone/pramoxine cream

Quantity Limits: Date: March 2018 GTC: DERMATOLOGY - PSORIASIS/ECZEMA: 0V Brand Name: Generic Name: Taltz ixekizumab syringe, autoinjector

Criteria: **Diagnosis** of moderate to severe plaque psoriasis AND psoriasis affects > 10% BSA OR causes significant functional disability (palms, soles, genitalia, severe scalp psoriasis) AND has inadequate response, intolerable side effect, or contraindication to phototherapy if available) AND has inadequate response, intolerable side effect, or contraindication to acitretin or another DMARD

**Diagnosis** of psoriatic arthritis AND has been evaluated by a rheumatologist/dermatologist AND has inadequate response, intolerable side effect, or contraindication to one DMARD (such as methotrexate , hydroxychloroquine, leflunomide, or sulfasalazine ) or apremilast OR Severe active psoriatic arthritis (axial disease – sacroiliitis or spondylitis)

Quantity Limits: PsO: Induction: 160mg x1, then 80mg every 2 weeks for 3 months. Maintenance: 80mg every 4 weeks. PsA with coexisting PsO: Induction:160mg x 1 Maintenance: 80mg every 4 weeks Date: September 2016 GTC: DERMATOLOGY - PSORIASIS/ECZEMA: 0V Brand Name: Generic Name: Elidel pimecrolimus cream

Criteria: **Diagnosis** of moderate to severe atopic dermatitis or vitiligo AND has inadequate response, intolerable side effect or contraindication to Protopic AND one of the following: • has inadequate response, intolerable side effect, or contraindication to 2 formulary topical steroids • condition affects sensitive body areas (e.g. genitals, face)

Quantity Limits: Initial approval: Approval x 3. Reauthorization: Re-asses by reviewing chart notes and progress notes. May approve x 6 again for 1 year total Date: May 2019 GTC: DERMATOLOGY - PSORIASIS/ECZEMA: 0V Brand Name: Generic Name: Cosentyx secukinumab syringe and pen injector

Criteria: **Diagnosis** of moderate to severe plaque psoriasis AND - Psoriasis affects > 10% BSA or causes significant functional disability (Palms, soles, genitalia, severe scalp psoriasis) AND - Has inadequate response, intolerable side effect, or contraindication to phototherapy (if available) AND - Has inadequate response, intolerable side effect, or contraindication to acitretin or another DMARD (Sulfasalazine, Methotrexate, Leflunomide , Hydroxychloroquine, Cyclosporine) AND - Trial and failure of TALTZ

**Diagnosis** of psoriatic arthritis AND - Has been evaluated by a rheumatologist/dermatologist AND - Has inadequate response, intolerable side effect, or contraindication to one DMARD (such as methotrexate , hydroxychloroquine, leflunomide, or sulfasalazine ) or apremilast* AND - Trial and failure of TALTZ OR Severe active psoriatic arthritis (axial disease – sacroiliitis or spondylitis) AND trial and failure of TALTZ

*Prior Authorization Required

Quantity Limits: Date: September 2016 GTC: DERMATOLOGY - PSORIASIS/ECZEMA: 0V Brand Name: Generic Name: Protopic tacrolimus ointment

Criteria: **Diagnosis** of moderate to severe atopic dermatitis or vitiligo AND has inadequate response, intolerable side effect, or contraindication to 2 formulary topical steroids OR Condition affects sensitive body areas (e.g. genitals, face)

Quantity Limits: Initial approval: Approval x 3. Reauthorization: Re-asses by reviewing chart notes and progress notes. May approve x 6 again for 1 year total. Date: GTC: DERMATOLOGY - PSORIASIS/ECZEMA: 0V Brand Name: Generic Name: Tazorac tazarotene topical cream, topical gel

Criteria: Tazorac 0.05% cream/gel

**Diagnosis** of psoriasis AND patient has inadequate response, intolerable side effect or contraindication to 2 formulary topical steroids, coal tar, or UV therapy OR For large areas (>3% BSA) Please consider systemic therapy such as methotrexate, acitretin*, or cyclosporine*.

Tazorac 0.1% cream/gel

**Diagnosis** of Acne AND patient has inadequate response, intolerable side effect or contraindication to formulary alternatives BPO, topical clindamycin AND tretinoin cream.

*Prior Authorization Required

Quantity Limits: Date: June 2018 GTC: DIABETES: 1E Brand Name: Generic Name: Invokana canagliflozin 100, 300mg tablets

Criteria: **Diagnosis** of type 2 diabetes AND HbA1c >6.5% after inadequate response, intolerable side effect, or contraindication to metformin with compliance of at least 3 months AND a trial and failure of preferred alternative Steglatro with compliance for additional 3 months OR HbA1c >6.5% after inadequate response, intolerable side effect, or contraindication to metformin with compliance of at least 3 months AND documentation of established Cardiovascular disease such as coronary artery disease (CAD) , angina, myocardial infarction, stroke, heart failure, cardiomyopathy, arrhythmia, peripheral artery disease, thromboembolic disease, and venous thrombosis, chronic kidney disease of stage 3 or greater HbA1c >7.5% and patient was co-prescribed metformin AND documentation of established Cardiovascular disease such as coronary artery disease (CAD) , angina, myocardial infarction, stroke, heart failure, cardiomyopathy, arrhythmia, peripheral artery disease, thromboembolic disease, and venous thrombosis, chronic kidney disease of stage 3 or greater

*Prior Authorization Required

Quantity Limits: Date: June 2018 GTC: DIABETES: 1E Brand Name: Generic Name: Qtern dapagliflozin/saxagliptin 10‐5mg tablets

Criteria: **Diagnosis** of type 2 diabetes AND compliance to metformin therapy AND inadequate response, intolerable side effect, or contraindication to Steglatro AND alogliptin with compliance of at least 3 month each

*Prior Authorization Required

Quantity Limits: Date: May 2019 GTC: DIABETES: 1E Brand Name: Generic Name: Novolog aspart 100 unit/ml, 10ml vial, 3ml x 5 flexpen

Criteria: **Diagnosis** of Type 1 or Type 2 diabetes AND inadequate response, intolerable side effect to Admelog vial or Admelog Solostar

Quantity Limits: Date: June 2018 GTC: DIABETES: 1E Brand Name: Generic Name: Regranex becaplermin

Criteria: Prescribed by wound specialist AND prescribed as treatment of lower extremity diabetic ulcers that extend into the subcutaneous tissue or beyond AND have an adequate blood supply AND wound is free of infection OR infection has been controlled by systemic antibiotics AND prescribed as an adjunct to good ulcer care practices including initial sharp debridement, pressure relief, and infection control.

Quantity Limits: Limit of 15gm per fill x 3 fills Date: June 2018 GTC: DIABETES: 1E Brand Name: Generic Name: Invokamet canagliflozin-metformin 50‐500mg, 50‐1000mg, 150‐500mg, 150‐1000mg

Criteria: **Diagnosis** of type 2 diabetes AND

HbA1c >6.5% after inadequate response, intolerable side effect, or contraindication to metformin with compliance of at least 3 months AND a trial and failure of preferred alternative Steglatro with compliance for additional 3 months AND trial of metformin and canaglifolozin* administered as separate agents AND medical justification why the member cannot continue taking these as separate agents

HbA1c >6.5% after inadequate response, intolerable side effect, or contraindication to metformin with compliance of at least 3 months AND documentation of established Cardiovascular disease such as coronary artery disease (CAD) , angina, myocardial infarction, stroke, heart failure, cardiomyopathy, arrhythmia, peripheral artery disease, thromboembolic disease, and venous thrombosis, chronic kidney disease of stage 3 or greater AND trial of metformin and canaglifolozin* administered as separate agents AND medical justification why the member cannot continue taking these as separate agents

HbA1c >7.5% and patient was co-prescribed metformin AND documentation of established Cardiovascular disease such as coronary artery disease (CAD) , angina, myocardial infarction, stroke, heart failure, cardiomyopathy, arrhythmia, peripheral artery disease, thromboembolic disease, and venous thrombosis, chronic kidney disease of stage 3 or greater AND trial of metformin and canaglifolozin* administered as separate agents AND medical justification why the member cannot continue taking these as separate agents

*Prior Authorization Required

Quantity Limits: Date: June 2018 GTC: DIABETES: 1E Brand Name: Generic Name: Invokamet XR canagliflozin-metformin ER 50‐500mg, 50‐1000mg, 150‐500mg, 150‐1000mg

Criteria: **Diagnosis** of type 2 diabetes AND

HbA1c >6.5% after inadequate response, intolerable side effect, or contraindication to metformin with compliance of at least 3 months AND a trial and failure of preferred alternative Steglatro with compliance for additional 3 months AND trial of metformin and canaglifolozin* administered as separate agents AND medical justification why the member cannot continue taking these as separate agents

OR

HbA1c >6.5% after inadequate response, intolerable side effect, or contraindication to metformin with compliance of at least 3 months AND documentation of established Cardiovascular disease such as coronary artery disease (CAD) , angina, myocardial infarction, stroke, heart failure, cardiomyopathy, arrhythmia, peripheral artery disease, thromboembolic disease, and venous thrombosis, chronic kidney disease of stage 3 or greater AND trial of metformin and canaglifolozin* administered as separate agents AND medical justification why the member cannot continue taking these as separate agents

OR

HbA1c >7.5% and patient was co-prescribed metformin AND documentation of established Cardiovascular disease such as coronary artery disease (CAD) , angina, myocardial infarction, stroke, heart failure, cardiomyopathy, arrhythmia, peripheral artery disease, thromboembolic disease, and venous thrombosis, chronic kidney disease of stage 3 or greater AND trial of metformin and canaglifolozin* administered as separate agents AND medical justification why the member cannot continue taking these as separate agents

*Prior Authorization Required

Quantity Limits: Date: May 2019 GTC: DIABETES: 1E Brand Name: Generic Name: Farxiga dapagliflozin 5mg, 10mg tablets

Criteria: **Diagnosis** of type 2 diabetes AND

HbA1c >6.5% after inadequate response, intolerable side effect, or contraindication to metformin with compliance of at least 3 months AND a trial and failure of preferred alternative Steglatro with compliance for additional 3 months

OR

HbA1c >6.5% after inadequate response, intolerable side effect, or contraindication to metformin with compliance of at least 3 months AND documentation of established Cardiovascular disease such as coronary artery disease (CAD) , angina, myocardial infarction, stroke, heart failure, cardiomyopathy, arrhythmia, peripheral artery disease, thromboembolic disease, and venous thrombosis, chronic kidney disease of stage 3 or greater

OR

HbA1c >7.5% and patient was co-prescribed metformin AND documentation of established Cardiovascular disease such as coronary artery disease (CAD) , angina, myocardial infarction, stroke, heart failure, cardiomyopathy, arrhythmia, peripheral artery disease, thromboembolic disease, and venous thrombosis, chronic kidney disease of stage 3 or greater

*Prior Authorization Required

Quantity Limits: 1 tablet/day Date: June 2018 GTC: DIABETES: 1E Brand Name: Generic Name: Xigduo XR dapagliflozin-metformin ER 5‐500mg, 5‐1000mg, 10‐500mg, 10‐1000mg

Criteria: **Diagnosis** of type 2 diabetes AND

HbA1c >6.5% AND compliance to metformin therapy AND inadequate response, intolerable side effect, or contraindication to Steglatro with compliance of at least 3 month AND trial of metformin and dapaglifolozin* administered as separate agents AND medical justification why the member cannot continue taking these as separate agents

*Prior Authorization Required

Quantity Limits: Date: June 2018 GTC: DIABETES: 1E Brand Name: Generic Name: Xultophy degludec 100 units/1 ml/liraglutide 3.6 mg/1 ml

Criteria: **Diagnosis** of type 2 diabetes mellitus AND A1C >9% AND documentation of established Cardiovascular disease such as coronary artery disease (CAD) , angina, myocardial infarction, stroke, heart failure, cardiomyopathy, arrhythmia, peripheral artery disease, thromboembolic disease, and venous thrombosis, chronic kidney disease of stage 3 or greater OR patient tried and failed triple therapy (which included either Basaglar or Trulicity* with compliance for at least 3 months AND Soliqua for additional 3 months

*Prior Authorization Required

Quantity Limits: Date: GTC: DIABETES: 1E Brand Name: Generic Name: Diabetic Test Strips diabetic test strips

Criteria: Approve Non-formulary test strip if: - Patient is on a specific insulin pump and it will only operate with a certain brand of test strip - Formulary test strips are limited to 100 strips/month unless: - Patient is using insulin or - Patient is diagnosed with gestational diabetes

Quantity Limits: Date: June 2018 GTC: DIABETES: 1E Brand Name: Generic Name: Trulicity dulaglutide single dose pen 0.75mg/0.5ml, 1.5mg/0.5ml

Criteria: **Diagnosis** of type 2 diabetes AND

HbA1c >6.5% after inadequate response, intolerable side effect, or contraindication to metformin with compliance of at least 3 months

OR

HbA1c >7.5% AND patient was co-prescribed metformin

Quantity Limits: Each pen is 0.5ml 4 pens/ month = 2ml/ month Date: June 2018 GTC: DIABETES: 1E Brand Name: Generic Name: Jardiance empagliflozin 10mg, 25mg tablets

Criteria: **Diagnosis** of type 2 diabetes AND

HbA1c >6.5% after inadequate response, intolerable side effect, or contraindication to metformin or has tried metformin with compliance of at least 3 months AND a trial and failure of preferred alternative Steglatro with compliance for additional 3 months

OR

HbA1c >6.5% after inadequate response, intolerable side effect, or contraindication to metformin or has tried metformin with compliance of at least 3 months AND documentation of established Cardiovascular disease such as coronary artery disease (CAD) , angina, myocardial infarction, stroke, heart failure, cardiomyopathy, arrhythmia, peripheral artery disease, thromboembolic disease, and venous thrombosis, chronic kidney disease of stage 3 or greater

OR

HbA1c >7.5% and patient was co-prescribed metformin AND documentation of established Cardiovascular disease such as coronary artery disease (CAD) , angina, myocardial infarction, stroke, heart failure, cardiomyopathy, arrhythmia, peripheral artery disease, thromboembolic disease, and venous thrombosis, chronic kidney disease of stage 3 or greater

*Prior Authorization Required

Quantity Limits: Date: June 2018 GTC: DIABETES: 1E Brand Name: Generic Name: Glyxambi empagliflozin/linagliptin 10‐5mg, 25‐5mg tablets

Criteria: **Diagnosis** of type 2 diabetes AND

HbA1c >6.5% Has had an inadequate response, intolerable side effect, or contraindication to metformin or has tried metformin with compliance of at least 3 months AND a trial and failure of preferred alternative Steglatro AND alogliptin with compliance of three (3) months each

OR

HbA1c>7.5% and patient was co-prescribed metformin AND documentation of established cardiovascular disease such as coronary artery disease (CAD) , angina, myocardial infarction, stroke, heart failure, cardiomyopathy, arrhythmia, peripheral artery disease, thromboembolic disease, and venous thrombosis, chronic kidney disease of stage 3 or greater

Quantity Limits: Date: June 2018 GTC: DIABETES: 1E Brand Name: Generic Name: Synjardy empagliflozin/metformin 5‐500mg, 12.5‐500mg, 12.5‐1000mg, 5‐1000mg

Criteria: **Diagnosis** of type 2 diabetes AND

HbA1c >6.5% Has had an inadequate response, intolerable side effect, or contraindication to metformin Or has tried metformin with compliance of at least 3 months AND a trial and failure of preferred alternative Steglatro with compliance for additional three (3 )months AND trial of metformin and empaglifolozin* administered as separate agents AND medical justification why the member cannot continue taking these as separate agents OR HbA1c >6.5% Has had an inadequate response, intolerable side effect, or contraindication to metformin Or has tried metformin with compliance of at least 3 months AND documentation of established Cardiovascular disease such as coronary artery disease (CAD) , angina, myocardial infarction, stroke, heart failure, cardiomyopathy, arrhythmia, peripheral artery disease, thromboembolic disease, and venous thrombosis, chronic kidney disease of stage 3 or greater AND trial of metformin AND empaglifolozin* administered as separate agents AND medical justification why the member cannot continue taking these as separate agents OR HbA1c >7.5% and patient was co-prescribed metformin AND documentation of established Cardiovascular disease such as coronary artery disease (CAD) , angina, myocardial infarction, stroke, heart failure, cardiomyopathy, arrhythmia, peripheral artery disease, thromboembolic disease, and venous thrombosis, chronic kidney disease of stage 3 or greater AND trial of metformin AND empaglifolozin* administered as separate agents AND medical justification why the member cannot continue taking these as separate agents

*Prior Authorization Required

Quantity Limits: Date: June 2018 GTC: DIABETES: 1E Brand Name: Generic Name: Synjardy XR empagliflozin/metformin ER 5‐1000mg, 10‐1000mg, 12.5‐1000mg, 25‐1000mg

Criteria: **Diagnosis** of type 2 diabetes AND

HbA1c >6.5% after inadequate response, intolerable side effect, or contraindication to metformin with compliance of at least 3 months AND a trial and failure of preferred alternative Steglatro with compliance for additional 3 months AND trial of metformin AND empaglifolozin* administered as separate agents AND medical justification why the member cannot continue taking these as separate agents

OR

HbA1c >6.5% after inadequate response, intolerable side effect, or contraindication to metformin with compliance of at least 3 months AND documentation of established Cardiovascular disease such as coronary artery disease (CAD) , angina, myocardial infarction, stroke, heart failure, cardiomyopathy, arrhythmia, peripheral artery disease, thromboembolic disease, and venous thrombosis, chronic kidney disease of stage 3 or greater AND trial of metformin AND empaglifolozin* administered as separate agents AND medical justification why the member cannot continue taking these as separate agents

OR

HbA1c >7.5% and patient was co-prescribed metformin AND documentation of established Cardiovascular disease such as coronary artery disease (CAD) , angina, myocardial infarction, stroke, heart failure, cardiomyopathy, arrhythmia, peripheral artery disease, thromboembolic disease, and venous thrombosis, chronic kidney disease of stage 3 or greater AND trial of metformin AND empaglifolozin* administered as separate agents AND medical justification why the member cannot continue taking these as separate agents

*Prior Authorization Required

Quantity Limits: Date: June 2018 GTC: DIABETES: 1E Brand Name: Generic Name: Segluromet ertugliflozin/metformin 2.5-500mg, 2.5-1000mg, 7.5-500mg, 7.5-1000mg

Criteria: **Diagnosis** of diabetes mellitus type 2 AND trial of metformin AND Steglatro administered as separate agents AND medical justification why the member cannot continue taking these as separate agents

*Prior Authorization Required

Quantity Limits: Date: June 2018 GTC: DIABETES: 1E Brand Name: Generic Name: Steglujan ertugliflozin+sitagliptin5-100mg, 15-100mg

Criteria: **Diagnosis** of type 2 diabetes AND - Compliance to metformin therapy AND - Inadequate response, intolerable side effect, or contraindication to Steglatro AND alogliptin -with compliance of at least three (3) month each

*Prior Authorization Required

Quantity Limits: Date: June 2018 GTC: DIABETES: 1E Brand Name: Generic Name: Byetta exenatide 5mcg/dose (1.2ml pen), 10mcg/dose (2.4ml pen), 60 doses per pen

Criteria: **Diagnosis** of type 2 diabetes AND

HbA1c >6.5% AND compliance to metformin therapy AND inadequate response, intolerable side effect, or contraindication to Trulicity* with compliance of at least 3 month

*Prior Authorization Required

Quantity Limits: Date: June 2018 GTC: DIABETES: 1E Brand Name: Generic Name: Bydureon exenatide microspheres 2mg single dose pen or vial

Criteria: **Diagnosis** of type 2 diabetes AND

HbA1c >6.5% AND compliance to metformin therapy AND inadequate response, intolerable side effect, or contraindication to Trulicity* with compliance of at least 3 month

*Prior Authorization Required

Quantity Limits: 4 vials per month Date: June 2018 GTC: DIABETES: 1E Brand Name: Generic Name: Soliqua glargine 100 units/1 ml/lixisenatide 33 mcg / 1 ml 3ml x 5 pens

Criteria: **Diagnosis** of type 2 diabetes mellitus AND A1C >9 OR Patient tried and failed triple therapy (which included either basaglar or Trulicity* with compliance for at least 3 months)

*Prior Authorization Required

Quantity Limits: Date: June 2018 GTC: DIABETES: 1E Brand Name: Generic Name: Lantus Vials glargine 10ml vials

Criteria: **Diagnosis** of uncontrolled diabetes (HbA1C>7%) AND has inadequate response, intolerable side effect, or contraindication Basaglar Kwikpen

Quantity Limits: Date: June 2018 GTC: DIABETES: 1E Brand Name: Generic Name: Glipizide-Metformin glipizide-metformin

Criteria: **Diagnosis** of diabetes mellitus type 2 AND trial of formulary alternative glyburide-metformin AND trial of glipizide AND metformin administered as separate agents AND medical justification why the member cannot continue glipizide AND metformin as separate agents

Quantity Limits: Date: June 2018 GTC: DIABETES: 1E Brand Name: Generic Name: Apidra glulisine 100 units/ml 10ml vial, 3ml x5 solostar pen

Criteria: **Diagnosis** of Type 1 or Type 2 diabetes AND inadequate response, intolerable side effect to Admelog vial or Admelog Solostar

Quantity Limits: Date: June 2019 GTC: DIABETES: 1E Brand Name: Generic Name: Fiasp insulin aspart (niacinamide) vial, flextouch

Criteria: **Diagnosis** of Type 1 or Type 2 diabetes AND inadequate response, intolerable side effect to Admelog vial or Admelog Solostar

Quantity Limits: Date: May 2019 GTC: DIABETES: 1E Brand Name: Generic Name: Novolog Cartridge insulin aspart 3ml cartridge

Criteria: **Diagnosis** of type 1 or type 2 diabetes AND -Medical justification why Admelog cannot be used AND -To be used with refillable pens

Quantity Limits: Date: June 2017 GTC: DIABETES: 1E Brand Name: Generic Name: Tresiba Flextouch insulin degludec pen

Criteria: **Diagnosis** of uncontrolled diabetes (HbA1C>7%) AND has inadequate response, intolerable side effect, or contraindication Basaglar Kwikpen

Quantity Limits: Date: June 2017 GTC: DIABETES: 1E Brand Name: Generic Name: Levemir Vials insulin detemir vials, insulin detemir pens Levemir Flexpen

Criteria: **Diagnosis** of uncontrolled diabetes (HbA1C>7%) AND has inadequate response, intolerable side effect, or contraindication Basaglar Kwikpen

Quantity Limits: Date: June 2017 GTC: DIABETES: 1E Brand Name: Generic Name: Lantus Solostar insulin glargine pen

Criteria: **Diagnosis** of uncontrolled diabetes (HbA1C>7%) AND has inadequate response, intolerable side effect, or contraindication Basaglar Kwikpen

Quantity Limits: Date: June 2017 GTC: DIABETES: 1E Brand Name: Generic Name: Toujeo Solostar insulin glargine pen

Criteria: **Diagnosis** of uncontrolled diabetes (HbA1C>7%) AND has inadequate response, intolerable side effect, or contraindication Basaglar Kwikpen

Quantity Limits: Date: August 2019 GTC: DIABETES: 1E Brand Name: Generic Name: Afrezza Insulin inhalation powder

Criteria: **Diagnosis** of type 1 or type 2 diabetes with A1C ≥7% -Members 18 years of age or older -No underlying lung disease (e.g. asthma, COPD) -Non-smoker or has stopped smoking ≥ 6 months prior -FEV1 ≥ 70% of expected normal within the last 60 days

***All of the above AND 1 of the following:

**Diagnosis** of type 1 diabetes -Currently on long-acting insulin AND -Inadequate response to Admelog vial or Admelog Solostar with compliance of at least 3 months AND -Medical justification why Admelog cannot be continued

**Diagnosis** of type 2 diabetes -Inadequate response to Admelog vial or Admelog Solostar with compliance of at least 3 months AND -Medical justification why Admelog cannot be continued AND -Inadequate response to 2 additional antihyperglycemic medications (including metformin if no contraindication) with compliance of at least 3 months OR If needle phobia meeting DSM-5 diagnostic criteria (requires prescriber attestation): inadequate response to ≥ 3 oral antihyperglycemic medications with compliance of at least 3 months

Re-authorization criteria (for each request):

-Documentation of positive response to therapy (e.g. A1C) -Pulmonary function test after 6 months, then annually (discontinue if decline of ≥ 20% in FEV1) -Member continues to not smoke, and not have chronic lung disease -Type 1 diabetes: continues on basal insulin

Quantity Limits: Initial approval 6 months Re-authorization 12 months Date: March 2018 GTC: DIABETES: 1E Brand Name: Generic Name: Humalog Kwikpen, Jr. Kwikpen insulin lispro

Criteria: **Diagnosis** of Type 1 or Type 2 diabetes AND inadequate response, intolerable side effect to Admelog vial or Admelog Solostar

Quantity Limits: Date: June 2019 GTC: DIABETES: 1E Brand Name: Generic Name: Humapen Luxura HD insulin lispro

Criteria: **Diagnosis** of type 1 or type 2 diabetes AND -Medical justification why Admelog cannot be used OR -Requires half unit dosing

Quantity Limits: 1 pen/ year Date: June 2019 GTC: DIABETES: 1E Brand Name: Generic Name: Humalog Cartridge insulin lispro 3ml cartridge

Criteria: **Diagnosis** of type 1 or type 2 diabetes -Medical justification why Admelog cannot be used AND -To be used with refillable pens, or Disetronic D-TRON and D-TRON plus pumps

Quantity Limits: Date: June 2018 GTC: DIABETES: 1E Brand Name: Generic Name: Tradjenta linagliptin 5 mg tablet

Criteria: **Diagnosis** of type 2 diabetes AND compliance to metformin therapy AND inadequate response, intolerable side effect, or contraindication to alogliptin or alogliptin/metformin* or alogliptin/pioglitazone* with compliance of at least 3 month

*Prior Authorization Required

Quantity Limits: Date: June 2018 GTC: DIABETES: 1E Brand Name: Generic Name: Jentadueto linagliptin/metformin 2.5-500mg, 2.5-850mg, 2.5-1000mg

Criteria: **Diagnosis** of type 2 Diabetes AND compliance to metformin therapy AND inadequate response, intolerable side effect, or contraindication to alogliptin or alogliptin/metformin* or alogliptin/pioglitazone* with compliance of at least 3 month AND trial of metformin AND linagliptin* administered as separate agents AND medical justification why the member cannot continue taking these as separate agents

*Prior Authorization Required

Quantity Limits: 2 tabs/day Date: June 2018 GTC: DIABETES: 1E Brand Name: Generic Name: Jentadueto XR linagliptin/metformin er 2.5-1000mg, 5-1000mg

Criteria: **Diagnosis** of type 2 Diabetes AND compliance to metformin therapy AND inadequate response, intolerable side effect, or contraindication to alogliptin or alogliptin/metformin* or alogliptin/pioglitazone* with compliance of at least 3 month AND trial of metformin AND linagliptin* administered as separate agents AND medical justification why the member cannot continue taking these as separate agents

*Prior Authorization Required

Quantity Limits: Date: June 2018 GTC: DIABETES: 1E Brand Name: Generic Name: Victoza liraglutide pen (18mg/3ml) 2 or 3 pack

Criteria: **Diagnosis** of type 2 diabetes AND

HbA1c >6.5% after inadequate response, intolerable side effect, or contraindication to metformin with compliance of at least 3 months AND a trial and failure of preferred alternative Trulicity* with compliance for additional 3 month

OR

HbA1c >6.5% after inadequate response, intolerable side effect, or contraindication to metformin with compliance of at least 3 months AND established Cardiovascular disease such as coronary artery disease (CAD) , angina, myocardial infarction, stroke, heart failure, cardiomyopathy, arrhythmia, peripheral artery disease, thromboembolic disease, venous thrombosis, chronic kidney disease of stage 3 or greater

OR

HbA1c >7.5% and patient was co-prescribed metformin AND documentation of established Cardiovascular disease such as coronary artery disease (CAD) , angina, myocardial infarction, stroke, heart failure, cardiomyopathy, arrhythmia, peripheral artery disease, thromboembolic disease, venous thrombosis, chronic kidney disease of stage 3 or greater

*Prior Authorization Required

Approve for kids 10 years to 17 years

Trulicity is not recommended for use in patients younger than 18 years.

Quantity Limits: Date: May 2019 GTC: DIABETES: 1E Brand Name: Generic Name: Humalog lispro 100 unit/ml 10ml vial

Criteria: **Diagnosis** of Type 1 or Type 2 diabetes AND inadequate response, intolerable side effect to Admelog vial or Admelog Solostar

Quantity Limits: Date: June 2018 GTC: DIABETES: 1E Brand Name: Generic Name: Adlyxin lixisenatide starter pack (10mcg/dose 3ml pen & 20mcg/dose 3ml pen), maintenance pack (two 20mcg/dose 3ml pens)

Criteria: **Diagnosis** of type 2 diabetes AND

HbA1c >6.5% AND compliance to metformin therapy AND inadequate response, intolerable side effect, or contraindication to Trulicity* with compliance of at least 3 month

*Prior Authorization Required

Quantity Limits: Date: June 2018 GTC: DIABETES: 1E Brand Name: Generic Name: Glumetza metformin ER (mod) 24 hour tablet 500mg, 1000mg

Criteria: **Diagnosis** of diabetes mellitus type 2 AND prescribed by an Endocrinologist AND patient has tried at least 12 weeks of metformin ER (generic: Glucophage XR) AND patient has tried at least 12 weeks of metformin ER OSM (generic: Fortamet) AND submission of medical records (e.g. chart notes, laboratory values) documenting intolerance to generic Glucophage XR AND generic Fortamet which were unable to be resolved with attempts to minimize the adverse effects (such as slower dose titration, dose reduction) AND FDA MedWatch report has been completed AND submitted to report the adverse event with metformin ER (generic: Glucophage XR)

Quantity Limits: Date: June 2018 GTC: DIABETES: 1E Brand Name: Generic Name: Fortamet metformin ER OSM 24 hour tablet 500mg, 1000mg

Criteria: **Diagnosis** of diabetes mellitus type 2 AND patient has tried at least 12 weeks of metformin ER (generic: Glucophage XR) AND submission of medical records (e.g. chart notes, laboratory values) documenting intolerance to metformin ER (generic: Glucophage XR) which is unable to be resolved with attempts to minimize the adverse effects (such as slower dose titration, dose reduction) AND FDA MedWatch report has been completed and submitted to report the adverse event with metformin ER (generic: Glucophage XR)

Quantity Limits: Date: June 2017 GTC: DIABETES: 1E Brand Name: Generic Name: Riomet metformin HCL solution

Criteria: Documentation that the member is unable to swallow or has difficulty swallowing tablets containing metformin. Review of the member’s prescription claims history must show other liquid formulations

Quantity Limits: Date: June 2017 GTC: DIABETES: 1E Brand Name: Generic Name: Korlym mifepristone tablet

Criteria: Initial Authorization: Korlym will be approved based on ALL of the following criteria:

**Diagnosis** of endogenous Cushing’s syndrome (i.e., hypercortisolism is not a result of chronic administration of high dose glucocorticoids) AND One of the following: **Diagnosis** of type 2 diabetes mellitus **Diagnosis** of glucose intolerance AND one of the following: Patient has failed surgery Patient is not a candidate for surgery AND patient must have failed or been intolerant to therapy with at least 2 formulary oral and injectable agents for type 2 diabetes mellitus AND must be prescribed by endocrinologist

Authorization will be issued for 6 months.

Reauthorization: Korlym reauthorization will be approved based on the following criterion: Documentation of one of the following: Patient has improved glucose intolerance while on Korlym therapy Patient has stable glucose intolerance while on Korlym

Quantity Limits: Date: June 2018 GTC: DIABETES: 1E Brand Name: Generic Name: Glyset miglitol

Criteria: **Diagnosis** of diabetes mellitus type 2 AND has inadequate response, intolerable side effect, or contraindication to formulary alternative acarbose

Quantity Limits: Date: June 2018 GTC: DIABETES: 1E Brand Name: Generic Name: Starlix nateglinide 60mg, 120 mg tablet

Criteria: **Diagnosis** of diabetes mellitus type 2 AND has inadequate response, intolerable side effect, or contraindication to formulary alternative Repaglinide

Quantity Limits: Date: June 2019 GTC: DIABETES: 1E Brand Name: Generic Name: Novopen Echo novopen echo

Criteria: **Diagnosis** of type 1 or type 2 diabetes AND medical justification why Admelog cannot be used OR Requires half unit dosing

Quantity Limits: 1 pen/ year Date: June 2019 GTC: DIABETES: 1E Brand Name: Generic Name: Duetact pioglitazone/ glimepiride

Criteria: **Diagnosis** of diabetes mellitus type 2 AND trial of pioglitazone and glimepiride administered as separate agents AND medical justification why patient cannot continue pioglitazone AND glimepiride as separate agents

Quantity Limits: 2 tablets/ day Date: June 2019 GTC: DIABETES: 1E Brand Name: Generic Name: Actoplus Met XR pioglitazone/metformin ER

Criteria: **Diagnosis** of diabetes mellitus type 2 AND trial of pioglitazone AND metformin administered as separate agents AND medical justification why patient cannot continue pioglitazone AND metformin as separate agents AND medical justification why patient cannot continue short-acting formulation

Quantity Limits: 2 tablets/ day Date: June 2018 GTC: DIABETES: 1E Brand Name: Generic Name: Actoplus Met pioglitazone-metformin

Criteria: **Diagnosis** of diabetes mellitus type 2 AND trial of pioglitazone AND metformin administered as separate agents AND medical justification why patient cannot continue pioglitazone AND metformin as separate agents

Quantity Limits: Date: June 2018 GTC: DIABETES: 1E Brand Name: Generic Name: Symlinpen pramlintide

Criteria: For the treatment of type 1 diabetes mellitus and type 2 diabetes mellitus who use mealtime insulin therapy AND failed to achieve desired glucose control despite optimal insulin therapy

Quantity Limits: Date: June 2019 GTC: DIABETES: 1E Brand Name: Generic Name: Avandia rosiglitazone

Criteria: **Diagnosis** of diabetes mellitus type 2 AND compliance to metformin therapy AND inadequate response, intolerable side effect, or contraindication to pioglitazone with compliance of at least 3 months

Quantity Limits: 1 tablet/ day Date: June 2018 GTC: DIABETES: 1E Brand Name: Generic Name: Onglyza saxagliptin 2.5, 5 mg tablets

Criteria: **Diagnosis** of type 2 diabetes AND compliance to metformin therapy AND inadequate response, intolerable side effect, or contraindication to alogliptin or alogliptin/metformin* or alogliptin/pioglitazone* with compliance of at least 3 month

*Prior Authorization Required

Quantity Limits: Date: June 2018 GTC: DIABETES: 1E Brand Name: Generic Name: Kombiglyze XR saxagliptin/metformin ER 2.5-500mg, 2.5-1000mg, 5-1000mg

Criteria: **Diagnosis** of type 2 Diabetes AND compliance to metformin therapy AND inadequate response, intolerable side effect, or contraindication to in or alogliptin/metformin* or alogliptin/pioglitazone* with compliance of at least 3 month AND trial of metformin AND saxagliptin* administered as separate agents AND medical justification why the member cannot continue taking these as separate agents

*Prior Authorization Required

Quantity Limits: Date: May 2019 GTC: DIABETES: 1E Brand Name: Generic Name: Ozempic semaglutide pens: 0.25 or 0.5 mg/ dose (2mg/1.5ml), 1 mg per dose (2mg/1.5ml)

Criteria: **Diagnosis** of type 2 diabetes AND

HbA1c >6.5% AND compliance to metformin therapy AND inadequate response, intolerable side effect, or contraindication to Trulicity* with compliance of at least 3 month

*Prior Authorization Required

Quantity Limits: Date: June 2018 GTC: DIABETES: 1E Brand Name: Generic Name: Januvia sitagliptin 25, 50, 100 mg tablets

Criteria: **Diagnosis** of type 2 diabetes AND compliance to metformin therapy AND inadequate response, intolerable side effect, or contraindication to alogliptin or alogliptin/metformin* or alogliptin/pioglitazone* with compliance of at least 3 month

*Prior Authorization Required

Quantity Limits: Date: June 2018 GTC: DIABETES: 1E Brand Name: Generic Name: Janumet sitagliptin/metformin 50-500mg, 50-1000mg

Criteria: **Diagnosis** of type 2 Diabetes AND compliance to metformin therapy AND inadequate response, intolerable side effect, or contraindication to alogliptin or alogliptin/metformin* or alogliptin/pioglitazone* with compliance of at least 3 month AND trial of metformin AND sitagliptin* administered as separate agents AND medical justification why the member cannot continue taking these as separate agents *Prior Authorization Required

Quantity Limits: Date: June 2018 GTC: DIABETES: 1E Brand Name: Generic Name: Janumet XR sitagliptin/metformin ER 50-500mg, 50-1000mg, 100-1000mg

Criteria: **Diagnosis** of type 2 Diabetes AND compliance to metformin therapy AND inadequate response, intolerable side effect, or contraindication to alogliptin or alogliptin/metformin* or alogliptin/pioglitazone* with compliance of at least 3 month AND trial of metformin AND sitagliptin* administered as separate agents AND medical justification why the member cannot continue taking these as separate agents

*Prior Authorization Required

Quantity Limits: Date: May 2019 GTC: EAR - GENERAL DISORDERS: 0Z Brand Name: Generic Name: Otovel ciprofloxacin 0.3%-fluocinolone 0.025% ear drops

Criteria: **Diagnosis** of acute otitis media with tympanostomy tubes (AOMT) AND patient is at least 6 months old

Quantity Limits: Date: May 2019 GTC: EAR - GENERAL DISORDERS: 0Z Brand Name: Generic Name: Otiprio ciprofloxacin 6% intratympanic suspension

Criteria: **Diagnosis** of bilateral otitis media with effusion undergoing tympanostomy tube placement AND patient is at least 6 months old

OR

**Diagnosis** of acute otitis externa AND patient is at least 6 months old AND has inadequate response, intolerable side effect, or contraindication to ciprofloxacin 0.2% drops

Quantity Limits: Date: June 2018 GTC: EAR - GENERAL DISORDERS: 0Z Brand Name: Generic Name: Dermotic Oil fluocinolone oil

Criteria: **Diagnosis** of chronic eczematous otitis externa

Quantity Limits: 1 bottle/Rx Date: May 2019 GTC: EAR - GENERAL DISORDERS: 0Z Brand Name: Generic Name: Coly-Mycin S neomycin/colistin/hydrocortisone/thonzonium ear drops

Criteria: Has inadequate response, intolerable side effect, or contraindication to neomycin/polymyxin B/HC drops

Quantity Limits: Date: August 2019 (modified) GTC: ELECTROLYTE REGULATION: 1S Brand Name: Generic Name: Auryxia ferric citrate

Criteria: Management of hyperphosphatemia in CKD members on dialysis • Inadequate response, intolerable side effect, or contraindication to Sevelamer carbonate*

*Requires Prior authorization

Treatment of iron-deficiency anemia in CKD members • Inadequate response, intolerable side effect, or contraindication to oral iron tablets (> 3 months) AND Medical justification why formulary oral iron tablets cannot be used with vitamin C

Quantity Limits: Up to 12 tablets/day Date: August 2019 (modified) GTC: ELECTROLYTE REGULATION: 1S Brand Name: Generic Name: Fosrenol lanthanum carbonate chewable tablet, oral powder packet

Criteria: Management of hyperphosphatemia in CKD Stage 5AND Inadequate response, intolerable side effect, or contraindication to Sevelamer carbonate*

*Requires Prior authorization

Quantity Limits: Date: July 2018 GTC: ELECTROLYTE REGULATION: 1S Brand Name: Generic Name: Veltassa patiromer

Criteria: **Diagnosis** of hyperkalemia AND prescribed by appropriate specialist (nephrology, cardiology) AND 1 of the following: - Trial of sodium polystyrene sulfonate (SPS) - Has risk of developing constipation or impaction (e.g. chronic opioid use, underlying bowel disease) - Has risk for sodium or fluid overload (e.g. CHF)

Quantity Limits: 1 packet/ day 30 packets/ Rx Date: September 2016 GTC: ELECTROLYTE REGULATION: 1S Brand Name: Generic Name: Renvela sevelamer carbonate oral tablet, oral powder packet

Criteria: CKD stage 5 members who are unresponsive to calcium based phosphate binder therapy (formulary calcium acetate or calcium carbonate) in amounts exceeding 1,500mg total elemental calcium content. 1,500mg is provided by: - PhosLo 9/day OR - Tums E-X 750mg 5/day OR - When calcium based phosphorus binder are contraindicated

Quantity Limits: Date: September 2016 GTC: ELECTROLYTE REGULATION: 1S Brand Name: Generic Name: Renagel sevelamer HCL oral tablet

Criteria: CKD stage 5 members who are unresponsive to calcium based phosphate binder therapy (formulary calcium acetate or calcium carbonate) in amounts exceeding 1,500mg total elemental calcium content. 1,500mg is provided by: - PhosLo 9/day OR - Tums E-X 750mg 5/day OR - When calcium based phosphorus binder are contraindicated AND trial and failure of Renvela (sevelamer carbonate*) tablets

*Prior Authorization Required

Quantity Limits: Date: September 2017 GTC: ELECTROLYTE REGULATION: 1S Brand Name: Generic Name: Velphoro sucroferric oxyhydroxide 500mg chewable tablet

Criteria: **Diagnosis** of hyperphosphatemia in patients with chronic kidney disease receiving dialysis AND trial and failure of calcium based phosphate binder (PhosLo, Tums) x 3 months. AND trial and failure of Renvela (sevelamer carbonate*)

*Reuires Prior Authorization

Quantity Limits:

Date: Feb 2020 GTC: ENDOCRINE DISORDER – FERTILITY 1H Brand Name: Generic Name: Cialis 5mg Tadalafil 5mg

Criteria: **Diagnosis** of symptomatic benign prostatic hyperplasia (BPH) –AND– Prescribed by urologist –AND-- History of failure, intolerance, or contraindication to both of the following: 1. Alpha Blockers: tamsulosin, afluzosin, doxazosin, or terazosin AND 2. 5-alpha reductase inhibitors: finasteride or dutasteride

Quantity Limits: 1 tab/day

Date: October 2018 GTC: ENDOCRINE DISORDER – OTHER: 1I Brand Name: Generic Name: Tymlos abaloparatide

Criteria: ALL of the following are present: - Age 18 years or older - Female with postmenopausal osteoporosis, as indicated by 1 or more of the following - Femoral neck, spine, or total hip bone mineral density T-score minus 2.5 or less - Hip or vertebral fragility (ie, low-trauma) fracture in patient older than 50 years - T-score between −1.0 and −2.5 at the femoral neck or spine and a 10-yr probability of a hip fracture of ≥3% or a 10-yr probability of a major osteoporosis-related fracture of ≥20% - Failure of, inability to tolerate, or contraindication to oral bisphosphonates, IV bisphosphonates*, and Prolia*

*Prior Authorization Required

Quantity Limits: 80mcg subcutaneously once daily Date: October 2018 GTC: ENDOCRINE DISORDER – OTHER: 1I Brand Name: Generic Name: Miacalcin Injection calcitonin injection

Criteria: Patient using medication for one of the following: - Hypercalcemia with trial and failure of Zometa* - Paget’s disease with trial and failure of Reclast* AND disease is symptomatic (bone pain, hearing loss, bone deformities, fractures, arthritis) OR patient is at risk of complications from Paget’s disease (such as osteoarthritis, heart failure, kidney stones, fractures)

*Prior Authorization Required

Quantity Limits: Hypercalcemia: 4 units/kg q12hr (may increase to max of 8 units/kg q6hr) Paget’s disease: 100 units daily (lower maint doses like 50 units 3x/wk may be sufficient)

Date: December 2017 GTC: ENDOCRINE DISORDER – OTHER: 1I Brand Name: Generic Name: Sensipar cinacalcet

Criteria: **Diagnosis** of Primary hyperparathyroidism in adults who are unable to undergo parathyroidectomy and calcium levels are greater than 10.4 mg/dL OR Secondary hyperparathyroidism in adult CKD patients on dialysis and calcium level is greater than 8.4 and current intact parathyroid hormone levels are greater than 300 pg/ml3 and they have tried/failed one phosphate binder OR Hypercalcemia in adults with parathyroid cancer and current serum calcium levels are greater than 10mg/dL

Quantity Limits: 1 tablet/day Date: October 2018 GTC: ENDOCRINE DISORDER – OTHER: 1I Brand Name: Generic Name: Xgeva 120mg/1.7ml subcutaneous syringe

Criteria: Member using medication for one of the following: - Hypercalcemia of malignancy, bone metastases from solid tumors, or multiple myeloma with trial and failure of Zometa* - Giant cell tumor of bone (approve)

*Prior Authorization Required

Quantity Limits: 120mg every 4 weeks. During the first month, may give an additional 120mg on Day 8 and Day 15. Date: August 2019 (modified) GTC: ENDOCRINE DISORDER – OTHER: 1I Brand Name: Generic Name: Prolia denosumab 60mg/ml subcutaneous syringe

Criteria: **Diagnosis** Osteoporosis in male or postmenopausal female: 1. T-score of < -2.5 OR history of osteoporotic fracture OR T-score between −1.0 and −2.5 at the femoral neck or spine and a 10-yr probability of a hip fracture of ≥3% or a 10-yr probability of a major osteoporosis-related fracture of ≥20% AND 2. Trial and failure of (or intolerance to) oral bisphosphonate [alendronate] AND 3. Trial and failure of (or intolerance to) IV bisphosphonate [zoledronic acid]*

**Diagnosis** Androgen deprivation-induced bone loss in men with prostate cancer - Trial and failure of IV bisphosphonate [zoledronic acid]*

**Diagnosis** Aromatase inhibitor-induced bone loss in women with breast cancer - Trial and failure of oral bisphosphonate [alendronate] and IV bisphosphonate [zoledronic acid]*

*Prior Authorization Required

Quantity Limits: 60mg as a single dose, once every 6 months.

Date: August 2019 GTC: ENDOCRINE DISORDER – OTHER: 1I Brand Name: Generic Name: Stimate Desmopressin

Criteria: Prescribed by hematologist AND **Diagnosis** of hemophilia A with Factor VIII levels greater than 5% OR **Diagnosis** of mild to moderate von Willebrand disease (type 1) with Factor VIII levels greater than 5%

Quantity Limits: 1 bottle of 2.5mL per Rx

Date: GTC: ENDOCRINE DISORDER – OTHER: 1I Brand Name: Generic Name: Hectorol doxercalciferol

Criteria: **Diagnosis** of secondary hyperparathyroidism due to chronic kidney disease (CKD)

Quantity Limits: Date: October 2018 GTC: ENDOCRINE DISORDER – OTHER: 1I Brand Name: Generic Name: Supprelin LA histrelin acetate 50mg implant

Criteria: Central precocious puberty (early-onset puberty):

**Diagnosis** of central precocious puberty confirmed by GnRH test or third-generation basal LH assay AND - Ages 2-11 years if female, ages 2-12 years if male AND member has advanced bone age (bone age at least 1 yr greater than chronological age) AND intracranial tumor has been ruled out AND onset of secondary sex characteristics occurred at: - Age < 8 years if female - Age < 9 years if male AND Trial and failure of Lupron Depot*

*Prior Authorization Required

Puberty suppression therapy for gender dysphoria: Patient has been diagnosed with gender dysphoria disorder by a qualified mental health professional AND the patient has exhibited the first physical changes of puberty (Tanner stage 2 or 3) AND trial and failure of Lupron Depot*

*Prior Authorization Required

Quantity Limits: A single, subcutaneous 50mg implant, once every 12 months. Date: October 2018 GTC: ENDOCRINE DISORDER – OTHER: 1I Brand Name: Generic Name: Lupron Depot leuprolide acetate

Criteria: DYSFUNCTIONAL UTERINE BLEEDING (off-label indication recommended by MCG guidelines) if Lupron is being used prior to planned endometrical ablation for definitive treatment AND other causes of symptoms or bleeding ruled out (e.g., by endometrical biopsy)

ENDOMETRIOSIS (Lupron Depot 3.75 monthly and/or 11.25 every 3 months – with max treatment of 6 months) Requires **Diagnosis** of endometriosis with symptoms as indicated by dysmenorrhea, dyspareunia OR pelvic pain AND Must be 18 years or older AND prescribed by an appropriate specialist (such as endocrinologist or OB/GYN) AND if patient has inadequate response, intolerable side effect, or contraindication to Orilissa*, NSAIDs, and oral contraceptives (at least 6 months trial)

*Prior Authorization Required

FOR UTERINE LEIOMYOMAS (fibroids) (Lupron Depot 3.75 monthly and/or 11.25 every 3 months – with Max treatment of 3 months) **Diagnosis** of uterine leiomyomas with symptoms as indicated by abnormal uterine bleeding, bulk-related symptoms (e.g., pelvic pain or pressure, dyspareunia, urinary symptoms) OR iron deficiency anemia Must be 18 years or older AND other causes of symptoms or bleeding ruled out (e.g., by endometrial biopsy)

BREAST CANCER (off-label indication recommended by MCG guidelines) (Lupron Depot 3.75 monthly and/or 11.25 every 3 months – with Max treatment of 24 months) Palliative treatment of advanced disease AND patient is premenopausal or perimenopausal

PROSTATE CANCER (Lupron Depot 7.5 monthly, 22.5 every 3 months, 30 every 4 months, and 45 mg every 6 months) Locally advanced (T3b to T4) or metastatic disease OR clinically localized prostate cancer with intermediate risk of recurrence as indicated by 1 of the following: - T2a or lower, and aggressive histologic pattern (Gleason score of 7) - T2a or lower, and PSA 10 to 20 ng/mL (mcg/L) - T2b or T2c

Clinically localized prostate cancer with high risk of recurrence as indicated by 1 of the following: - T2c or lower, and aggressive histologic pattern (Gleason score of 8 to 10) - T2c or lower, and PSA greater than 20 ng/mL (mcg/L) - T3a

Central precocious puberty (early-onset puberty): **Diagnosis** of central precocious puberty confirmed by GnRH test or third-generation basal LH assay AND ages 2-11 years if female, ages 2-12 years if male AND member has advanced bone age (bone age at least 1 yr greater than chronological age) AND intracranial tumor has been ruled out AND onset of secondary sex characteristics occurred at: - Age < 8 years if female - Age < 9 years if male

Puberty suppression therapy for gender dysphoria: Patient has been diagnosed with gender dysphoria disorder by a qualified mental health professional AND the patient has exhibited the first physical changes of puberty (Tanner stage 2 or 3)

Quantity Limits: Date: October 2018 GTC: ENDOCRINE DISORDER – OTHER: 1I Brand Name: Generic Name: Increlex mecasermin

Criteria: Severe primary IGF-1 deficiency: - At least 2 years of age - Basal IGF standard deviation score -3.0 or less - Height standard deviation score of -3.0 or less - Normal or elevated HGH level - Trial and failure of growth hormone* - Epiphyses not yet closed - No active or suspected neoplasia - No chronic treatment with pharmacologic doses of corticosteroids - No hypothyroidism - No malnutrition

*Prior Authorization Required

IGF-1 deficiency due to HGH gene deletion: - At least 2 years of age - HGH gene deletion associated with neutralizing antibodies to HGH - Epiphyses not yet closed - No active or suspected neoplasia - No chronic treatment with pharmacologic doses of corticosteroids - No hypothyroidism - No malnutrition

Quantity Limits: Initial: 0.04-0.08 mg/kg subcutaneous twice daily If tolerated for 7 days, may increase by 0.04 mg/kg/dose Max dose: 0.12 mg/kg twice daily Date: GTC: ENDOCRINE DISORDER – OTHER: 1I Brand Name: Generic Name: H.P. Acthar Gel repository corticotropin injection

Criteria: Prescribed by Neurologist with **Diagnosis** of acute MS flare up in adults AND - Currently on disease modifying therapy with adherence max doses of corticosteroids have been tried and failed during the current exacerbation, preferably trial of IV (e.g. methylprednisolone 500 to 1,000mg IV daily for 3-5 days) - A second opinion by an Alliance-identified American Board of Medical Specialties (ABMS) certified practitioner certified in the area of neurology may be required as well as assignment of an Alliance case manager (RN/MSW) to facilitate process in obtaining second opinion - Prescribed by Rheumatologist with **Diagnosis** of any rheumatic disorder (RA, psoriatic arthritis, SLE, etc) - Max doses of corticosteroids have been tried and failed during the current exacerbation

**Diagnosis** of any Nephrotic Syndrome - T/F corticosteroids (min 8 weeks) and if met, consult with Medical Director - Prescribed by Neurologist with **Diagnosis** of infantile spasms - Less than 2 years of age - No CCS case

Quantity Limits: Maximum of 35mL in 28 days (each 5mL vial contains 400 units) Date: August 2019 GTC: ENDOCRINE DISORDER – OTHER: 1I Brand Name: Generic Name: Evenity Romosozumab-aqqg

Criteria: Osteoporosis in postmenopausal female: Femoral neck, spine, or total hip bone mineral density T-score <2.5 OR Hip or vertebral fragility (ie, low-trauma) fracture in patient older than 50 years OR T-score between −1.0 and −2.5 at the femoral neck or spine AND a 10-yr probability of a hip fracture of ≥3% OR a 10-yr probability of a major osteoporosis-related fracture of ≥20% -Trial and failure of (or intolerance to) oral bisphosphonate [alendronate] AND -Trial and failure of (or intolerance to) IV bisphosphonate [zoledronic acid]* AND -Trial and failure of (or intolerance to) Prolia*

*Prior Authorization Required

Quantity Limits: 210 mg SQ once every month for 12 doses Max 12 doses

Date: GTC: ENDOCRINE DISORDER – OTHER: 1I Brand Name: Generic Name: Human Growth Hormone: Genotropin, Humatrope, Norditropin, somatropin Nordiflex, Nutropin, Nutropin Aq, Nutropin Depot, Saizen, Serostim, Tev-Tropin, Zorbtive, Omnitrope, Genotropin, Humatrope, Norditropin, Nordiflex, Nutropin, Nutropin Aq, Nutropin Depot, Saizen, Serostim, Tev-Tropin, Zorbtive, Omnitrope

Criteria: Please see Milliman Health Care Guidelines (MCG)

Quantity Limits: Date: October 2018 GTC: ENDOCRINE DISORDER – OTHER: 1I Brand Name: Generic Name: Forteo teriparatide 600mcg/2.4ml pen

Criteria: Must meet ALL numbered criteria for a given **Diagnosis** Postmenopausal (female) osteoporosis: - Age 18 years or older - Female with postmenopausal osteoporosis, as indicated by 1 or more of the following - Femoral neck, spine, or total hip bone mineral density T-score of -2.5 or less - Hip or vertebral fragility (ie, low-trauma) fracture in patient older than 50 years - T-score between −1.0 and −2.5 at the femoral neck or spine and a 10-yr probability of a hip fracture of ≥3% Or a 10-yr probability of a major osteoporosis-related fracture of ≥20% - Failure of, inability to tolerate, or contraindication to oral bisphosphonates, IV bisphosphonates*, Tymlos*, AND Prolia*

*Prior Authorization Required

Male osteoporosis: - Age 18 years or older - Male with hypogonadal or primary osteoporosis, as indicated by 1 or more of the following - Femoral neck, spine, or total hip bone mineral density T-score -2.5 or less - Hip or vertebral fragility (ie, low-trauma) fracture in patient older than 50 years - T-score between −1.0 and −2.5 at the femoral neck or spine and a 10-yr probability of a hip fracture of ≥3% or a 10-yr probability of a major osteoporosis-related fracture of ≥20% - Failure of, inability to tolerate, or contraindication to oral bisphosphonates, IV bisphosphonates*, AND Prolia*

*Prior Authorization Required

Chronic corticosteroid treatment: - Age 18 years or older - Chronic corticosteroid treatment, as indicated by ALL of the following - Daily dose equivalent to 7.5 mg or more of prednisone - Duration of therapy expected to be 1 or more of the following: - Three (3) months or more in any patient with history of fragility (ie, low-trauma) fracture - Three (3) months or more in male 50 years or older - Three (3) months or more in postmenopausal female - Failure of, inability to tolerate, or contraindication to oral bisphosphonates, IV bisphosphonates*, AND Prolia*

*Prior Authorization Required

Quantity Limits: 20mcg subcutaneously once daily for up to 2 years Date: January 2019 GTC: ENDOCRINE DISORDER – OTHER: 1I Brand Name: Generic Name: Triptodur triptorelin IM injection Criteria: Central precocious puberty (early-onset puberty):

**Diagnosis** of central precocious puberty 1. Confirmed by GnRH test or third-generation basal LH assay 2. Ages 2-11 years if female, ages 2-12 years if male 3. Member has advanced bone age (bone age at least 1 yr greater than chronological age) 4. Intracranial tumor has been ruled out 5. Onset of secondary sex characteristics occurred at: Age < 8 years if female Age < 9 years if male 6. Trial and failure of Lupron Depot*

*Prior Authorization Required

Puberty suppression therapy for gender dysphoria: 1. The patient has demonstrated a long-lasting and intense pattern of gender nonconformity or gender dysphoria 2. Gender dysphoria emerged or worsened with the onset of puberty 3. Any co-existing psychological, medical, or social problems that could interfere with treatment (e.g., that may compromise treatment adherence) have been addressed, such that the adolescent’s situation and functioning are stable enough to start treatment 4. The patient has exhibited the first physical changes of puberty (Tanner stage 2 or 3) 5. Trial and failure of Lupron Depot*

*Prior authorization required

Quantity Limits: 22.5 mg IM inj once every 6 mo Date: October 2018 GTC: ENDOCRINE DISORDER – OTHER: 1I Brand Name: Generic Name: Trelstar Depot triptorelin pamoate intramuscular injection

Criteria: Medication is being used for the palliative treatment of prostate cancer

Quantity Limits: Date: October 2018 GTC: ENDOCRINE DISORDER – OTHER: 1I Brand Name: Generic Name: Zometa zoledronic acid

Criteria: Patient using medication for one of the following: - Hypercalcemia of malignancy - Multiple myeloma - Bone metastases from solid tumors - Prevention of skeletal related events in men with castration-resistant prostate cancer - Prevention of bone loss associated with aromatase inhibitor therapy for breast cancer in post-menopausal women or premenopausal women on adjuvant ovarian suppression AND trial and failure of oral bisphosphonate (Oral bisphosphanate is only for this dx) - Prevention of bone loss associated with androgen deprivation therapy in men with prostate cancer

Quantity Limits: 4 mg IV (dosing frequency will vary based on condition) Date: August 2019 (modified) GTC: ENDOCRINE DISORDER – OTHER: 1I Brand Name: Generic Name: Reclast zoledronic acid

Criteria: Osteoporosis in male or postmenopausal female: 1. T-score of < -2.5 OR history of osteoporotic fracture OR T-score between −1.0 and −2.5 at the femoral neck or spine and a 10-yr probability of a hip fracture of ≥3% or a 10-yr probability of a major osteoporosis-related fracture of ≥20% AND 2. Trial and failure of (or intolerance to) oral bisphosphonate [alendronate]

Treatment or prevention of glucocorticoid-induced osteoporosis: - Trial and failure of (or intolerance to) oral bisphosphonate [alendronate]

Paget’s Disease: - Trial and failure of (or intolerance to) oral bisphosphonate [alendronate], OR extensive disease in which oral bisphosphonate would not be appropriate

- Symptomatic disease (bone pain, hearing loss, bone deformities, fractures, arthritis) OR patient is at risk of complications from Paget’s disease (such as osteoarthritis, heart failure, kidney stones, fractures)

Quantity Limits: 5 mg IV once yearly Osteoporosis prevention in postmenopausal female: 5 mg IV once every 2 years Paget’s disease: 5 mg IV as a single dose

Date: October 2018 GTC: ENDOCRINE DISORDER – OTHER: 1I Brand Name: Generic Name: Orilissa elagolix sodium 150mg, 200 mg tablet

Criteria: Member meets all of the following criteria: - **Diagnosis** of moderate to severe pain associated with endometriosis - Inadequate response, intolerable side effect, or contraindication to NSAIDs and oral contraceptives (at least 6 months trial) - Prescribed by appropriate specialist (such as endocrinologist or OB/GYN) - Member is at least 18 years of age - Member is not pregnant

Quantity Limits: 150 mg once daily for up to 24 months OR 200 mg twice daily for up to 6 months Date: December 2016 GTC: ENDOCRINE DISORDER – THYROID: 1G Brand Name: Generic Name: Levothroid levothyroxine

Criteria: **Diagnosis** of hypothyroidism AND has contraindication or inadequate response to generic levothyroxine

Quantity Limits: Date: December 2016 GTC: ENDOCRINE DISORDER – THYROID: 1G Brand Name: Generic Name: Levoxyl levothyroxine

Criteria: **Diagnosis** of hypothyroidism AND has contraindication or inadequate response to generic levothyroxine

Quantity Limits: Date: December 2016 GTC: ENDOCRINE DISORDER – THYROID: 1G Brand Name: Generic Name: Synthroid levothyroxine

Criteria: **Diagnosis** of hypothyroidism AND has contraindication or inadequate response to generic levothyroxine

Quantity Limits: Date: December 2016 GTC: ENDOCRINE DISORDER – THYROID: 1G Brand Name: Generic Name: Tirosint levothyroxine capsules

Criteria: **Diagnosis** of hypothyroidism AND has contraindication or inadequate response to generic levothyroxine AND 1 other agent in the same class liothyronine or (Armour Thyroid*, Levothroid*, Levoxyl*, Synthroid*) *Prior Authorization Required

Quantity Limits: Date: December 2016 GTC: ENDOCRINE DISORDER – THYROID: 1G Brand Name: Generic Name: Armour Thyroid thyroid, pork

Criteria: **Diagnosis** of hypothyroidism AND has contraindication or inadequate response to at least 1 generic thyroid (Nature-Throid, NP Thyroid, Westhroid, Westhroid-P, WP Thyroid) formulary alternative

Quantity Limits: Date: June 2018 GTC: EYE - GENERAL DISORDERS: 1A Brand Name: Generic Name: Lastacaft alcaftadine

Criteria: **Diagnosis** of allergic conjunctivitis AND has inadequate response, intolerable side effect, or contraindication to ketotifen (OTC) eye drops AND olopatadine 0.1% ophthalmic drops* AND azelastine ophthalmic drops*

*Prior Authorization Required

Quantity Limits: 1 bottle/Rx

Date: May 2019 GTC: EYE - GENERAL DISORDERS: 1A Brand Name: Generic Name: Azelastine Drops azelastine drops

Criteria: **Diagnosis** of allergic conjunctivitis AND has inadequate response, intolerable side effect, or contraindication to ketotifen (OTC) eye drops

Quantity Limits:

Date: June 2017 GTC: EYE - GENERAL DISORDERS: 1A Brand Name: Generic Name: Bepreve bepotastine 1.5% ophthalmic drops

Criteria: **Diagnosis** of allergic conjunctivitis AND has inadequate response, intolerable side effect, or contraindication to ketotifen (OTC) eye drops AND olopatadine 0.1% ophthalmic drops* AND azelastine ophthalmic drops*

*Prior Authorization Required

Quantity Limits: 1 bottle/rx Date: May 2019 GTC: EYE - GENERAL DISORDERS: 1A Brand Name: Generic Name: Prolensa bromfenac 0.07% drops

Criteria: **Diagnosis** of pain or inflammation in the eye AND has inadequate response, intolerable side effect, or contraindication to formulary alternatives ketorolac AND diclofenac AND bromfenac 0.09% drops*

*Prior authorization required

Quantity Limits: 1 bottle/Rx Date: May 2019 GTC: EYE - GENERAL DISORDERS: 1A Brand Name: Generic Name: Bromsite bromfenac 0.075% drops

Criteria: **Diagnosis** of pain or inflammation in the eye AND has inadequate response, intolerable side effect, or contraindication to formulary alternatives ketorolac AND diclofenac AND bromfenac 0.09% drops*

*Prior authorization required

Quantity Limits: 1 bottle/Rx Date: June 2018 GTC: EYE - GENERAL DISORDERS: 1A Brand Name: Generic Name: Bromday bromfenac 0.09%

Criteria: **Diagnosis** of pain or inflammation in the eye AND has inadequate response, intolerable side effect, or contraindication to formulary alternatives ketorolac AND diclofenac

Quantity Limits: 1 bottle/Rx Date: May 2019 GTC: EYE - GENERAL DISORDERS: 1A Brand Name: Generic Name: Oxervate cenegermin-BKBJ

Criteria: **Diagnosis** of neurotrophic keratoconjunctivitis and member is 2 years of age or older AND member has been evaluated by an ophthalmologist AND member’s condition has continued to progress despite the use of artificial tears drops AND lubricating ophthalmic ointments AND member has tried alternative non-pharm options, including therapeutic soft contact lenses, amniotic membrane graft (Prokera), AND tarsorrhaphy, OR MD has considered them and feels they would not be appropriate

Quantity Limits: 8 boxes of #7 vials each for unilateral disease, or 16 boxes for bilateral disease Limit authorization to 8 weeks

Date: GTC: EYE - GENERAL DISORDERS: 1A Brand Name: Generic Name: Restasis cyclosporine 0.05% ophthalmic emulsion

Criteria: **Diagnosis** of keratoconjunctivitis sicca or dry eye syndrome AND has inadequate response, intolerable side effect, or contraindication to artificial tears ophthalmic solutions AND lubricating ophthalmic ointments.

Quantity Limits: 60 vials/month Date: May 2019 GTC: EYE - GENERAL DISORDERS: 1A Brand Name: Generic Name: Cequa cyclosporine 0.09% drops

Criteria: **Diagnosis** of keratoconjunctivitis sicca or dry eye syndrome AND has inadequate response, intolerable side effect, or contraindication to artificial tears ophthalmic solutions AND lubricating ophthalmic ointments

Quantity Limits: Date: June 2018 GTC: EYE - GENERAL DISORDERS: 1A Brand Name: Generic Name: Dexycu dexamethasone

Criteria: Postoperative inflammation after cataract surgery AND dexterity issues that prevents member from using corticosteroid eye drops OR Medical justification why member cannot use corticosteroid eye drops

Quantity Limits: Dexamethasone 9% (equivalent to 517 mcg) as a single dose per eye per surgery

Date: May 2019 GTC: EYE - GENERAL DISORDERS: 1A Brand Name: Generic Name: Ozurdex dexamethasone 0.7 mg intravitreal implant

Criteria: **Diagnosis** of diabetic macular edema AND has inadequate response, intolerable side effect, or contraindication to anti-VEGF (bevacizumab*, ranibizumab*, aflibercept*) AND Inadequate response to intravitreal triamcinolone* OR **Diagnosis** of non-infective uveitis AND has inadequate response, intolerable side effect, or contraindication to a topical corticosteroid (such as prednisolone) AND inadequate response to intravitreal triamcinolone*

*Prior authorization required

Quantity Limits: Date: June 2018 GTC: EYE - GENERAL DISORDERS: 1A Brand Name: Generic Name: Durezol difluprednate

Criteria: **Diagnosis** of pain or inflammation in the eye AND has inadequate response, intolerable side effect, or contraindication to 2 formulary alternatives (dexamethasone, prednisolone acetate, prednisolone sodium phosphate, fluorometholone)

Quantity Limits: 1 bottle/Rx Date: June 2017 GTC: EYE - GENERAL DISORDERS: 1A Brand Name: Generic Name: Elestat epinastine 0.05% ophthalmic drops

Criteria: **Diagnosis** of allergic conjunctivitis AND has inadequate response, intolerable side effect, or contraindication to ketotifen (OTC) eye drops

Quantity Limits: 1 bottle/rx Date: May 2019 GTC: EYE - GENERAL DISORDERS: 1A Brand Name: Generic Name: Epinastine Drops epinastine drops

Criteria: **Diagnosis** of allergic conjunctivitis AND has inadequate response, intolerable side effect, or contraindication to ketotifen (OTC) eye drops AND azelastine eye drops* *Prior authorization required

Quantity Limits: Date: May 2019 GTC: EYE - GENERAL DISORDERS: 1A Brand Name: Generic Name: Yutiq fluocinolone 0.18 mg intravitreal implant

Criteria: **Diagnosis** of chronic non-infective uveitis AND has inadequate response, intolerable side effect, or contraindication to a topical corticosteroid (such as prednisolone) AND inadequate response to intravitreal triamcinolone*

*Prior authorization required

Quantity Limits: Date: May 2019 GTC: EYE - GENERAL DISORDERS: 1A Brand Name: Generic Name: Retisert fluocinolone 0.59 mg intravitreal implant

Criteria: **Diagnosis** of chronic non-infective uveitis AND has inadequate response, intolerable side effect, or contraindication to a topical corticosteroid (such as prednisolone) AND inadequate response to intravitreal triamcinolone* AND has inadequate response, intolerable side effect, or contraindication to Yutiq*

*Prior authorization required

Quantity Limits: Date: June 2018 GTC: EYE - GENERAL DISORDERS: 1A Brand Name: Generic Name: FML Forte fluorometholone 0.25% suspension

Criteria: **Diagnosis** of ocular inflammation AND trial of one of formulary ophthalmic corticosteroids

Quantity Limits: 1 bottle/Rx Date: May 2019 GTC: EYE - GENERAL DISORDERS: 1A Brand Name: Generic Name: Zirgan ganciclovir ophthalmic gel

Criteria: **Diagnosis** of keratitis related to herpes simplex virus AND trial and failure of trifluridine drops

Quantity Limits: Single 5 gm tube per Rx Date: May 2019 GTC: EYE - GENERAL DISORDERS: 1A Brand Name: Generic Name: Avenova hypochlorous acid/sodium chloride spray

Criteria: Member has foreign material on and around eyelid margin, associated with blepharitis, meibomian gland dysfunction (MGD), or dry eye AND member has tried eyelid cleansing with warm compresses, with insufficient effect OR member lacks the manual dexterity or necessary skill or judgment to do so safely

Quantity Limits: Date: September 2016 GTC: EYE - GENERAL DISORDERS: 1A Brand Name: Generic Name: Xiidra lifitegrast 5% ophthalmic solution

Criteria: **Diagnosis** of keratoconjunctivitis sicca or dry eye syndrome AND has inadequate response, intolerable side effect, or contraindication to artificial tears ophthalmic solutions AND lubricating ophthalmic ointments.

Quantity Limits: Date: May 2019 GTC: EYE - GENERAL DISORDERS: 1A Brand Name: Generic Name: Alomide lodoxamide drops

Criteria: **Diagnosis** of long-term ocular inflammation (such as seasonal allergic conjunctivitis) AND trial and failure of cromolyn sodium drops

Quantity Limits: Date: May 2019 GTC: EYE - GENERAL DISORDERS: 1A Brand Name: Generic Name: Alrex loteprednol 0.2% suspension

Criteria: **Diagnosis** of seasonal allergic conjunctivitis AND trial and failure of ketotifen eye drops ($10/mo) AND trial and failure of cromolyn sodium drops ($16/mo)

Quantity Limits: 1 bottle/Rx Date: May 2019 GTC: EYE - GENERAL DISORDERS: 1A Brand Name: Generic Name: Lotemax loteprednol 0.5% ointment

Criteria: **Diagnosis** of pain or inflammation in the eye AND intolerant of increase in intraocular pressure (IOP) such as glaucoma OR Has inadequate response, intolerable side effect, or contraindication to 2 formulary alternatives (dexamethasone, prednisolone acetate, prednisolone sodium phosphate, fluorometholone)

Quantity Limits: 1 bottle/Rx Date: May 2019 GTC: EYE - GENERAL DISORDERS: 1A Brand Name: Generic Name: Alocril nedocromil drops

Criteria: **Diagnosis** of long-term ocular inflammation (such as seasonal allergic conjunctivitis) AND trial and failure of cromolyn sodium drops

Quantity Limits: Date: May 2019 GTC: EYE - GENERAL DISORDERS: 1A Brand Name: Generic Name: Nevanac nepafenac 0.1% drops

Criteria: **Diagnosis** of pain or inflammation in the eye AND has inadequate response, intolerable side effect, or contraindication to formulary alternatives ketorolac AND diclofenac AND bromfenac 0.09% drops*

*Prior authorization required

Quantity Limits: 1 bottle/Rx Date: May 2019 GTC: EYE - GENERAL DISORDERS: 1A Brand Name: Generic Name: Ilevro nepafenac 0.3% drops

Criteria: **Diagnosis** of pain or inflammation in the eye AND has inadequate response, intolerable side effect, or contraindication to formulary alternatives ketorolac AND diclofenac AND bromfenac 0.09% drops*

*Prior authorization required

Quantity Limits: 1 bottle/Rx Date: October 2018 GTC: EYE - GENERAL DISORDERS: 1A Brand Name: Generic Name: Jetrea ocriplasmin 1.25mg/ml intraocular vial

Criteria: Must have a **Diagnosis** of symptomactic vitreomacular adhesion documented on Optical Coherence Tomography (OCT) AND must be prescribed by an retinal specialist, or an ophthalmologist AND must not have had a prior vitrectomy AND must not be receiving treatment in both eyes within 7 days of each other AND must not have a prior treatment with Jetrea on the affected eye

Quantity Limits: 1 injection per eye, per lifetime. Date: September 2016 GTC: EYE - GENERAL DISORDERS: 1A Brand Name: Generic Name: Patanol olopatadine 0.1% ophthalmic drops

Criteria: **Diagnosis** of allergic conjunctivitis AND has inadequate response, intolerable side effect, or contraindication to ketotifen (OTC) eye drops

Quantity Limits: 1 bottle/Rx Date: June 2017 GTC: EYE - GENERAL DISORDERS: 1A Brand Name: Generic Name: Pataday olopatadine 0.2% ophthalmic drops

Criteria: **Diagnosis** of allergic conjunctivitis AND has inadequate response, intolerable side effect, or contraindication to ketotifen (OTC) eye drops AND olopatadine 0.1% ophthalmic drops* AND azelastine ophthalmic drops*

*Prior Authorization Required

Quantity Limits: 1 bottle/Rx Date: May 2019 GTC: EYE - GENERAL DISORDERS: 1A Brand Name: Generic Name: Pazeo olopatadine 0.7% drops

Criteria: **Diagnosis** of allergic conjunctivitis AND has inadequate response, intolerable side effect, or contraindication to ketotifen (OTC) eye drops AND azelastine ophthalmic drops* AND olopatadine 0.1% ophthalmic drops* AND olopatadine 0.2% drops*

*Prior Authorization Required

Quantity Limits: Date: May 2019 GTC: EYE - GENERAL DISORDERS: 1A Brand Name: Generic Name: Blephamide Drops Susp sulfacetamide/prednisolone acetate 10%-0.2% drops suspension

Criteria: Has inadequate response, intolerable side effect, or contraindication to sulfacetamide-prednisolone drops AND Blephamide S.O.P. ointment

Quantity Limits: Date: GTC: EYE - GENERAL DISORDERS: 1A Brand Name: Generic Name: Zylet tobramycin/ lotepred

Criteria: Has inadequate response, intolerable side effect, or contraindication to or failure of a trial of tobramycin-dexamethasone 3%-0.1%

Quantity Limits: 1 bottle/rx Date: May 2019 GTC: EYE - GENERAL DISORDERS: 1A Brand Name: Generic Name: Tobradex ST tobramycin-dexamethasone 0.3-0.05% drops suspension

Criteria: Has inadequate response, intolerable side effect, or contraindication to or failure of a trial of tobramycin-dexamethasone 3%-0.1%

Quantity Limits: Date: May 2019 GTC: EYE - GENERAL DISORDERS: 1A Brand Name: Generic Name: Triesence triamcinolone intravitreal injection

Criteria:

**Diagnosis** of macular edema AND has inadequate response, intolerable side effect, or contraindication to anti-VEGF (bevacizumab*, ranibizumab*, aflibercept*)

**Diagnosis** of inflammatory ocular condition AND has inadequate response, intolerable side effect, or contraindication to a topical corticosteroid (such as prednisolone)

* Requires Prior Authorization

Quantity Limits: Date: June 2018 GTC: EYE - GLAUCOMA: 1B Brand Name: Generic Name: Betoptic S betaxolol 0.25% suspension

Criteria: **Diagnosis** of open-angle glaucoma or ocular hypertension AND has inadequate response, intolerant side effect, or contraindication to Timolol ophthalmic solution AND Betaxolol 0.5% drops

Quantity Limits: 1 bottle/Rx Date: June 2018 GTC: EYE - GLAUCOMA: 1B Brand Name: Generic Name: Betoptic betaxolol 0.5% drops

Criteria: **Diagnosis** of open-angle glaucoma or ocular hypertension AND has inadequate response, intolerant side effect, or contraindication to Timolol ophthalmic solution

Quantity Limits: 1 bottle/Rx Date: May 2019 GTC: EYE - GLAUCOMA: 1B Brand Name: Generic Name: Lumigan bimatoprost 0.01% drops

Criteria: **Diagnosis** of open-angle glaucoma or ocular hypertension AND has inadequate response, intolerant side effect, or contraindication to Latanoprost AND generic bimatoprost 0.03% drops

Quantity Limits: 1 bottle/Rx Date: May 2019 GTC: EYE - GLAUCOMA: 1B Brand Name: Generic Name: Bimatoprost 0.03% Drops bimatoprost 0.03% drops

Criteria: **Diagnosis** of open-angle glaucoma or ocular hypertension AND has inadequate response, intolerant side effect, or contraindication to Latanoprost

Quantity Limits: 1 bottle/Rx Date: June 2017 GTC: EYE - GLAUCOMA: 1B Brand Name: Generic Name: Alphagan P brimonidine 0.1% ophthalmic drops, brimonidine 0.15% ophthalmic drops

Criteria: **Diagnosis** of open-angle glaucoma or ocular hypertension AND has inadequate response, intolerant side effect, or contraindication to brimonidine 0.2% ophthalmic drops

Quantity Limits: 1 bottle/rx Date: GTC: EYE - GLAUCOMA: 1B Brand Name: Generic Name: Combigan brimonidine tartrate/timolol

Criteria: **Diagnosis** of open-angle glaucoma or ocular hypertension AND justification provided as to why member cannot use timolol and brimonidine separately due to volume limitations, compliance AND/OR dexterity issues

Quantity Limits: 1 bottle/rx

Date: June 2018 GTC: EYE - GLAUCOMA: 1B Brand Name: Generic Name: Azopt brinzolamide 1%

Criteria: **Diagnosis** of open-angle glaucoma or ocular hypertension AND has inadequate response, intolerant side effect, or contraindication to Dorzolamide

Quantity Limits: 1 bottle/Rx Date: June 2017 GTC: EYE - GLAUCOMA: 1B Brand Name: Generic Name: Simbrinza brinzolamide/brimonidine 1%-0.2% ophthalmic drops

Criteria: **Diagnosis** of open-angle glaucoma or ocular hypertension AND has inadequate response, intolerant side effect, or contraindication to dorzolamide AND brimonidine 0.2% ophthalmic drops as separate agents

Quantity Limits: 1 bottle/rx Date: May 2019 GTC: EYE - GLAUCOMA: 1B Brand Name: Generic Name: Methazolamide methazolamide tablet

Criteria: **Diagnosis** of glaucoma and trial and inadequate response, intolerable side effect, or contraindication to acetazolamide

Quantity Limits: Date: May 2019 GTC: EYE - GLAUCOMA: 1B Brand Name: Generic Name: Rhopressa netarsudil drops

Criteria: **Diagnosis** of open-angle glaucoma or ocular hypertension AND Has inadequate response, intolerant side effect, or contraindication to medications from 3 classes of glaucoma eye drops Examples: latanoprost, brimonidine, timolol, dorzolamide, pilocarpine

Quantity Limits: 1 bottle/Rx Date: May 2019 GTC: EYE - GLAUCOMA: 1B Brand Name: Generic Name: Rocklatan netarsudil-latanoprost 0.02%-0.005% drops

Criteria: **Diagnosis** of open-angle glaucoma or ocular hypertension AND has inadequate response, intolerant side effect, or contraindication to medications from 3 classes of glaucoma eye drops (examples: latanoprost, brimonidine, timolol, dorzolamide, pilocarpine) AND trial and failure of Rhopressa* AND latanoprost as separate agents

*Prior authorization required

Quantity Limits: 1 bottle/Rx Date: May 2019 GTC: EYE - GLAUCOMA: 1B Brand Name: Generic Name: Zioptan tafluprost preservative-free drops

Criteria: **Diagnosis** of open-angle glaucoma or ocular hypertension AND has inadequate response, intolerant side effect, or contraindication to Latanoprost OR member requires a preservative-free drop

Quantity Limits: 1 bottle/Rx Date: May 2019 GTC: EYE - GLAUCOMA: 1B Brand Name: Generic Name: Tioptic Ocudose timolol 0.25% preservative-free drop

Criteria: **Diagnosis** of open-angle glaucoma or ocular hypertension AND has inadequate response, intolerable side effect, or contraindication to timolol ophthalmic solution, timolol GFS*, AND timolol once-daily drop* OR **Diagnosis** of open-angle glaucoma or ocular hypertension AND member requires a preservative-free drop AND has inadequate response, intolerable side effect, or contraindication to Zioptan*

*Prior authorization required

Quantity Limits: 1 box of 60 pouches/Rx Date: May 2019 GTC: EYE - GLAUCOMA: 1B Brand Name: Generic Name: Timoptic-XE timolol gel-forming solution (GFS)

Criteria: **Diagnosis** of open-angle glaucoma or ocular hypertension AND has inadequate response, intolerant side effect, or contraindication to timolol ophthalmic solution OR **Diagnosis** of infantile hemangioma (for topical use)

Quantity Limits: 1 bottle/Rx Date: May 2019 GTC: EYE - GLAUCOMA: 1B Brand Name: Generic Name: Istalol timolol once-daily drop

Criteria: **Diagnosis** of open-angle glaucoma or ocular hypertension AND has inadequate response, intolerant side effect, or contraindication to Timolol ophthalmic solution AND Timolol gel-forming solution*

*Prior authorization required

Quantity Limits: 1 bottle/Rx Date: June 2018 GTC: EYE - GLAUCOMA: 1B Brand Name: Generic Name: Cosopt PF timolol/dorzolamide preservative free

Criteria: **Diagnosis** of open-angle glaucoma or ocular hypertension AND intolerant side effect to regular timolol/ dorzolamide

Quantity Limits: Date: June 2018 GTC: EYE - GLAUCOMA: 1B Brand Name: Generic Name: Travatan Z travoprost

Criteria: **Diagnosis** of open-angle glaucoma or ocular hypertension AND has inadequate response, intolerant side effect, or contraindication to Latanoprost

Quantity Limits: 1 bottle/Rx Date: May 2019 GTC: EYE - MISCELLANEOUS: 1C Brand Name: Generic Name: Eylea aflibercept 2 mg/0.05 ml solution for intravitreal injection

Criteria: **Diagnosis** of diabetic macular edema OR Macular edema following central or branch retinal vein occlusion OR Neovascular age-related macular degeneration AND no active intraocular inflammation or infection AND has inadequate response, intolerable side effect, or contraindication to bevacizumab injections* AND Lucentis*

*Requires Prior Authorization

Quantity Limits: Date: May 2019 GTC: EYE - MISCELLANEOUS: 1C Brand Name: Generic Name: Avastin bevacizumab 100 mg/4 ml vial for ophthalmic injection

Criteria: **Diagnosis** of diabetic macular edema OR Macular edema following retinal vein occlusion OR Neovascular age-related macular degeneration AND no concurrent ocular or periocular infection

Quantity Limits: Date: June 2018 GTC: EYE - MISCELLANEOUS: 1C Brand Name: Generic Name: Iluvien fluocinolone implant

Criteria: **Diagnosis** of diabetic macular edema AND has inadequate response, intolerable side effect, or contraindication to anti-VEGF (bevacizumab, ranibizumab, aflibercept) inadequate response to intravitreal triamcinolone, previously treated with a course of intravitreal corticosteroid AND did not have clinically significant rise in intraocular pressure

Quantity Limits: One implant (0.19mg fluocinolone acetonide) per eye One implant per eye every 3 years

Date: May 2019 GTC: EYE - MISCELLANEOUS: 1C Brand Name: Generic Name: Lacrisert hydroxypropyl cellulose ophthalmic insert

Criteria: **Diagnosis** of keratoconjunctivitis sicca, exposure keratitis, decreased corneal sensitivity, or recurrent corneal erosions AND has inadequate response, intolerable side effect, or contraindication to Restasis* AND Xiidra* AND Cequa* for 60 days AND evaluated by ophthalmologist or optometrist

*Prior Authorization Required

Quantity Limits: Box of 60 inserts/Rx Date: May 2019 GTC: EYE - MISCELLANEOUS: 1C Brand Name: Generic Name: Lucentis ranibizumab 0.3 mg/0.05 ml vial for ophthalmic injection

Criteria: **Diagnosis** of diabetic macular edema, central retinal vein occlusion, branch retinal vein occlusion, neovascular age-related macular degeneration, cystoid macular degeneration, or retinal/macular edema AND has inadequate response, intolerable side effect, or contraindication to bevacizumab injections*

*Prior authorization required

Quantity Limits: Date: October 2018 GTC: GASTROINTESTINAL AGENTS: 1N Brand Name: Generic Name: Lotronex alosetron

Criteria: **Diagnosis** of Irritable Bowel Syndrome with diarrhea in women AND has inadequate response, intolerable side effect or contraindication to loperamide OR diphenoxylate-atropine AND two (2) of the following medications: - Bile acid sequestrant (cholestyramine, colestipol) - Antispasmodic (dicyclomine, hyoscyamine) - Tricyclic antidepressant (amitriptyline, nortriptyline)

Quantity Limits: 2 tablets/day Date: October 2018 GTC: GASTROINTESTINAL AGENTS: 1N Brand Name: Generic Name: Mytesi crofelemer DR 125mg oral tablet

Criteria: **Diagnosis** of non-infectious diarrhea in patients with HIV/AIDS on retroviral therapy AND has inadequate response, intolerable side effect or contraindication to loperamide AND diphenoxylate-atropine

Quantity Limits: Date: GTC: GASTROINTESTINAL AGENTS: 1N Brand Name: Generic Name: Ravicti glycerol phenylbutyrate

Criteria: **Diagnosis** of urea cycle disorder AND prescribed by a specialist AND cannot be managed by dietary protein restriction and/or amino acid supplementation alone AND is used as adjunctive therapy with dietary protein restriction and/or amino acid supplementation

Quantity Limits: 4.5-11.2ml/m2/day 3 months Date: October 2018 GTC: GASTROINTESTINAL AGENTS: 1N Brand Name: Generic Name: Kristalose lactulose packet

Criteria: **Diagnosis** of constipation AND medical justification why member cannot use lactulose solution AND trial and failure of 3 formulary laxatives including: - 1 agent from the osmotic class (lactulose, PEG 3350) AND - 1 agent from the stimulant class (senna, bisacodyl) AND - 1 of the following: fiber, docusate, mineral oil, magnesium citrate, magnesium hydroxide or sodium phosphate.

Quantity Limits: 1 packet/day 3 months Date: GTC: GASTROINTESTINAL AGENTS: 1N Brand Name: Generic Name: Linzess linaclotide

Criteria: **Diagnosis** of Irritable Bowel Syndrome with Constipation or Chronic Idiopathic Constipation AND has inadequate response, intolerable side effect or contraindication to 3 formulary laxatives including: - 1 agent from the osmotic class (lactulose, PEG 3350) AND - 1 agent from the stimulant class (senna, bisacodyl) AND - 1 of the following: fiber, docusate, mineral oil, magnesium citrate, magnesium hydroxide or sodium phosphate

Quantity Limits: Date: GTC: GASTROINTESTINAL AGENTS: 1N Brand Name: Generic Name: Amitiza lubiprostone

Criteria: **Diagnosis** of Irritable Bowel Syndrome with Constipation or Chronic Idiopathic Constipation or Opioid-Induced Constipation AND has inadequate response, intolerable side effect or contraindication to 3 formulary laxatives including: - 1 agent from the osmotic class (lactulose, PEG 3350) AND - 1 agent from the stimulant class (senna, bisacodyl) AND - 1 of the following: fiber, docusate, mineral oil, magnesium citrate, magnesium hydroxide or sodium phosphate

Quantity Limits: Date: October 2018 GTC: GASTROINTESTINAL AGENTS: 1N Brand Name: Generic Name: Ocaliva obeticholic acid

Criteria: For the treatment of primary biliary cholangitis/primary biliary cirrhosis (PBC), evaluated by gastroenterology specialist AND inadequate response, intolerable side effect or contraindication to ursodiol

Quantity Limits: 1 tablet/day Date: GTC: GASTROINTESTINAL AGENTS: 1N Brand Name: Generic Name: Opium Tincture opium

Criteria: **Diagnosis** of diarrhea AND has inadequate response, intolerable side effect or contraindication to maximum tolerated dosing of loperamide AND diphenoxylate-atropine

Quantity Limits: 3 months

Date: December 2017 GTC: GASTROINTESTINAL AGENTS: 1N Brand Name: Generic Name: Trulance plecanatide

Criteria: **Diagnosis** of Irritable Bowel Syndrome with Constipation or Chronic Idiopathic Constipation AND has inadequate response, intolerable side effect or contraindication to 3 formulary laxatives including: - 1 agent from the osmotic class (lactulose, PEG 3350) AND - 1 agent from the stimulant class (senna, bisacodyl) AND - 1 of the following: fiber, docusate, mineral oil, magnesium citrate, magnesium hydroxide or sodium phosphate

Quantity Limits: Date: October 2018 GTC: GASTROINTESTINAL AGENTS: 1N Brand Name: Generic Name: Moviprep polyethylene glycol (peg) 3350/sodium sulfate/sodium chloride/potassium chloride/ascorbic acid/sodium ascorbate 7.5-2.691g powder packet

Criteria: For bowel prep for colonoscopy AND has inadequate response, intolerable side effect, or contraindication to formulary polyethylene glycol product (PEG 3350)

Quantity Limits: 1 powder pack Date: GTC: GASTROINTESTINAL AGENTS: 1N Brand Name: Generic Name: Buphenyl sodium phenylbutyrate

Criteria: **Diagnosis** of urea cycle disoders involving deficiencies of carbamylphosphate synthetase (CPS), ornithine transcarbamylase (OTC), or argininosuccinic acid synthetase (AS) AND individual has one of the following: - Neonatal-onset deficiency with complete enzymatic deficiency presenting within the first 28 days of life; OR - Late-onset disease (defined as partial enzymatic deficiency presenting after the first month of life) who have a history of hyperammonemic encephalopathy AND - Prescribed by a specialist AND - Is used as adjunctive therapy with dietary protein restriction and/or amino acid supplementation

Quantity Limits: If patient <20kg: 450-600mg/kg/day If patient >20kg: 9.9-13gm/m2/day 3 months

Date: October 2018 GTC: GASTROINTESTINAL AGENTS: 1N Brand Name: Generic Name: Osmoprep sodium phosphate 1.5g oral tablet (1.102g sodium phosphate monobasic monohydrate, usp and 0.398g sodium phosphate dibasic anhydrous, usp) Criteria: For bowel prep for colonoscopy AND has inadequate response, intolerable side effect, or contraindication to formulary polyethylene glycol product (PEG 3350)

Quantity Limits: 32 tablets/fill Date: October 2018 GTC: GASTROINTESTINAL AGENTS: 1N Brand Name: Generic Name: Prepopik sodium picosulfate/magnesium oxide/ anhydrous citric acid 10mg-3.5mg-12g powder packets for oral solution

Criteria: For bowel prep for colonoscopy AND has inadequate response, intolerable side effect, or contraindication to generic polyethylene glycol product (PEG 3350)

Quantity Limits: 2 packets/fill

Date: October 2018 GTC: GASTROINTESTINAL AGENTS: 1N Brand Name: Generic Name: Suprep Bowel Prep Kit sodium sulfate/potassium sulfate/magnesium sulfate 17.5g-3.13g/1.6g oral solution

Criteria: For bowel prep for colonoscopy AND has inadequate response, intolerable side effect, or contraindication to generic polyethylene glycol product (PEG 3350)

Quantity Limits: 1 bottle (354mL)/fill Date: GTC: GASTROINTESTINAL AGENTS: 1N Brand Name: Generic Name: Gattex teduglutide

Criteria: **Diagnosis** of short bowel syndrome in adults AND patient has been dependent on parenteral nutrition (PN) and/or intravenous (IV) fluids continuously for at least 12 months AND failure or clinically significant adverse effects to somatropin (human growth hormone)

Quantity Limits: 0.05mg/kg SQ QD 3 months

Date: November 2019 GTC: Lower Gastrointestinal Disorders – Other:1N Brand Name: Generic Name: Clenpiq Sodium picosulfate; Magnesium oxide; Anhydrous citric acid Criteria: For bowel prep for colonoscopy AND has inadequate response, intolerable side effect, or contraindication to generic polyethylene glycol product (PEG 3350)

Quantity Limits:

Date: November 2019 GTC: Lower Gastrointestinal Disorders – Other:1N Brand Name: Generic Name: Symproic naldemedine

Criteria: **Diagnosis** of Opioid-Induced Constipation (OIC) AND Current opiate therapy for at least 4 weeks and needs to continue opioids AND

Trial and failure of combination of at least two types of laxatives from 2 different classes: • 1 agent from the osmotic class (PEG 3350, lactulose) AND • 1 agent from the stimulant class (senna, bisacodyl)

Quantity Limits:

Date: November 2019 GTC: Lower Gastrointestinal Disorders – Other:1N Brand Name: Generic Name: Movantik naloxegol

Criteria: **Diagnosis** of Opioid-Induced Constipation (OIC) AND Current opiate therapy for at least 4 weeks and needs to continue opioids AND

Trial and failure of combination of at least two types of laxatives from 2 different classes: • 1 agent from the osmotic class (PEG 3350, lactulose) AND • 1 agent from the stimulant class (senna, bisacodyl)

Quantity Limits: 1 tablet/day

Date: November 2019 GTC: Lower Gastrointestinal Disorders – Other:1N Brand Name: Generic Name: Zelnorm Tegaserod

Criteria: Female with **diagnosis** of IBS-C -Age ≥ 18 years and < 65 years -Trial and failure of Linzess*, Amitiza*, or Trulance* -member does not have any of the following contraindications: a history of myocardial infarction, stroke, transient ischemic attack, or angina

*require prior authorization

Quantity Limits: 2 tablets per day

Date: Nov 2019 GTC: Lower Gastrointestinal Disorders – Other:1N Brand Name: Generic Name: Relistor methylnaltrexone 150mg oral tablet, 8mg/0.4ml & 12mg/0.6ml syringe, 12mg/0.6ml vial

Criteria: **Diagnosis** of Opioid-Induced Constipation (OIC) AND Current opiate therapy for at least 4 weeks and needs to continue opioids AND

Trial and failure of combination of at least two types of laxatives from 2 different classes: • 1 agent from the osmotic class (PEG 3350, lactulose) AND • 1 agent from the stimulant class (senna, bisacodyl) AND trial and failure of Symproic*, Movantik* or Amitiza*

*Prior Authorization Required

Quantity Limits: Oral: 450mg/day Injection (subcutaneous): 12mg/day Date: March 2017 GTC: GOUT AND RELATED DISEASES: 1P Brand Name: Generic Name: Uloric febuxostat oral tablet

Criteria: **Diagnosis** of chronic management of hyperuricemia with gout AND has inadequate response, intolerable side effect, or contraindication to allopurinol

Quantity Limits: Date: October 2018 GTC: GOUT AND RELATED DISEASES: 1P Brand Name: Generic Name: Krystexxa pegloticase 8mg/ml intravenous vial

Criteria: **Diagnosis** of chronic gout with hyperuricemia AND at least 3 gout flares in the previous 18 months that were inadequately controlled by colchicine or nonsteroidal anti-inflammatory drugs (NSAIDS) or oral or injectable corticosteroids; OR At least 1 gout tophus or has chronic gouty arthritis AND documentation of baseline serum uric acid level greater than 8 mg/dL AND failure, contraindication or intolerance to previous therapy with maximum tolerated dose of two (2) xanthine oxidase inhibitors (allopurinol and febuxostat) AND probenecid (alone or in combination with allopurinol or febuxostat)

Quantity Limits: Date: GTC: HEMATOLOGICAL DISORDERS: 1T Brand Name: Generic Name: Agrylin anagrelide

Criteria: **Diagnosis** is the treatment of thrombocythemia secondary to a myeloproliferative disorder AND has been evaluated by an oncologist OR hematologist AND platelets ≥ 400,000/µL

Quantity Limits: Do not exceed 10mg/day

Date: March 2017 GTC: HEMATOLOGICAL DISORDERS: 1T Brand Name: Generic Name: Aggrenox aspirin/dipyridamole 25mg-200mg oral capsule

Criteria: For prevention of recurrent stroke in patients who have experienced a transient ischemic attack or previous ischemic stroke AND experienced recurrent stroke while on aspirin OR failed clopidogrel

Quantity Limits: Date: June 2019 GTC: HEMATOLOGICAL DISORDERS: 1T Brand Name: Generic Name: Yosprala aspirin/omeprazole

Criteria: Previous history of stroke, MI, other cardiovascular/cerebrovascular events AND medical justification why member cannot take aspirin and omeprazole as separate agents AND at risk for developing gastric ulcers (such as ≥55 yo, documented history of gastric ulcers)

Quantity Limits: 1 tablet/ day Date: March 2018 GTC: HEMATOLOGICAL DISORDERS: 1T Brand Name: Generic Name: Pradaxa dabigatran

Criteria: **Diagnosis** of thromboembolism, non-valvular atrial fibrillation, total hip or knee replacement, stroke/DVT prophylaxis, DVT/PE treatment AND has inadequate response, intolerable side effect, or contraindication to apixaban AND rivaroxaban

Quantity Limits: 150mg 2 tabs/day 110mg 2 tabs/day 75mg 2 tabs/day Date: GTC: HEMATOLOGICAL DISORDERS: 1T Brand Name: Generic Name: Aranesp in polysorbate

Criteria: **Diagnosis** is treatment of anemia due to zidovudine therapy, cancer chemo therapy, or chronic renal failure AND documentation of ALL the following: - Hgb ≤ 10g/dL - Transferrin saturation ≥ 20% OR Ferritin ≥ 80 ng/mL OR demonstration of adequate iron stores - Trial and failure of preferred Epogen AND Procrit

Quantity Limits: Date: March 2018 GTC: HEMATOLOGICAL DISORDERS: 1T Brand Name: Generic Name: Savaysa edoxaban

Criteria: **Diagnosis** of thromboembolism, non-valvular atrial fibrillation, stroke/DVT prophylaxis, DVT/PE treatment AND has inadequate response, intolerable side effect, or contraindication to apixaban AND rivaroxaban

Quantity Limits: 60mg 1 tab/day 30mg 1 tab/day Date: October 2018 GTC: HEMATOLOGICAL DISORDERS: 1T Brand Name: Generic Name: Epogen

Criteria: **Diagnosis** is treatment of anemia due to zidovudine therapy, cancer chemo therapy, chronic renal failure, or refusal for blood transfusions before surgery due to cultural/religious reasons AND documentation of the following: - Hgb ≤ 10g/dL AND - Transferrin saturation ≥ 20% OR Ferritin ≥ 80 ng/mL OR demonstration of adequate iron stores - Trial and failure of Retacrit*

*Requires Prior Authorization

Quantity Limits: Date: October 2018 GTC: HEMATOLOGICAL DISORDERS: 1T Brand Name: Generic Name: Procrit epoetin alfa

Criteria: **Diagnosis** is treatment of anemia due to zidovudine therapy, cancer chemo therapy, chronic renal failure, or refusal for blood transfusions before surgery due to cultural/religious reasons AND documentation of the following: - Hgb ≤ 10g/dL AND - Transferrin saturation ≥ 20% OR Ferritin ≥ 80 ng/mL OR demonstration of adequate iron stores - Trial and failure of preferred Retacrit* AND Epogen**

*Requires Prior Authorization **Requires Prior Authorization and subject to trial and failure of Retacrit

Quantity Limits: Date: October 2018 GTC: HEMATOLOGICAL DISORDERS: 1T Brand Name: Generic Name: Retacrit epoetin alfa-epbx

Criteria: **Diagnosis** is treatment of anemia due to zidovudine therapy, cancer chemo therapy, chronic renal failure, or refusal for blood transfusions before surgery due to cultural/religious reasons AND documentation of the following: Hgb ≤ 10g/dL AND Transferrin saturation ≥ 20% OR Ferritin ≥ 80 ng/mL OR Demonstration of adequate iron stores

Quantity Limits: Date: March 2020 GTC: HEMATOLOGICAL DISORDERS 1T Brand Name: Generic Name: Neupogen, Nivestym, Zarxio * 300mcg/ml vial, 480mcg/1.6ml vial, 300mcg/0.5ml syringe, 480mcg/0.8ml syringe, filgrastim-aafi 300mcg/0.5ml syringe, filgrastim-aafi 480mcg/0.8ml syringe, filgrastim-sndz 300mcg/0.5ml syringe, filgrastim-sndz 480mcg/0.8ml syringe

Criteria: For the treatment of neutropenia associated with chemotherapy, Hepatitis C treatment, Bone Marrow transplantation, Acute hematopoietic radiation injury syndrome, Congenital, Idiopathic or Cyclic neutropenia, Peripheral blood progenitor cell collection and therapy OR For primary prophylaxis when the anticipated incidence of neutropenic fever ≥20% with a given regimen [2015 guidelines from ASCO, NCCN guidelines, EORTC and IDSA] OR For secondary prophylaxis when a patient experienced an episode of neutropenic fever or treatment delays due to neutropenia [ASCO and EORTC guidelines]

*NOTE: When filgrastim is requested, Alliance prefers biosimilars Nivestym or Zarxio prior to using the reference product Neupogen. Per CCAH Biosimilars policy (403-1142).

Quantity Limits:

Date: March 2017 GTC: HEMATOLOGICAL DISORDERS: 1T Brand Name: Generic Name: Arixtra fondaparinux

Criteria: For prophylaxis and treatment of DVT OR PE for patients with history of heparin induced thrombocytopenia (HIT) who requires anticoagulation.

Quantity Limits:

Date: March 2020 GTC: HEMATOLOGICAL DISORDERS 1T Brand Name: Generic Name: Droxia Hydroxyurea 200 mg, 300 mg, 400 mg

Criteria: Trial and failure of hydroxyurea 500 mg capsule AND the member is any of the following: • Adult with ≥ 3 moderate to severe pain crises per year • Adult who has sickle cell–associated pain or symptomatic chronic anemia that interferes with daily activities and quality of life • Adult with history of severe or recurrent acute chest syndrome (ACS) • Adults or child with SCD who has chronic kidney disease and is taking

Quantity Limits: Initial approval x 3 months

Date: March 2020 GTC: HEMATOLOGICAL DISORDERS 1T Brand Name: Generic Name: Siklos Hydroxyurea 100 mg, 1,000 mg

Criteria: Approve if the member is a child between 2 – 18 years of age with diagnosis of sickle cell disease

Quantity Limits:

Date: March 2017 GTC: HEMATOLOGICAL DISORDERS: 1T Brand Name: Generic Name: Heparin Flush heparin sodium

Criteria: For patency maintence of indwelling intravenous device: Approve: concentrations of 2 units/mL, 10 units/mL, 50 units/mL, or 100 units/mL Route to RPh: higher concentrations of 1000 units/mL, 5000 units/mL, or 10,000 units/mL

Quantity Limits:

Date: March 2020 GTC: HEMATOLOGICAL DISORDERS 1T Brand Name: Generic Name: Endari L-glutamine

Criteria: Member is any of the following: • Adult with ≥ 3 moderate to severe pain crises per year • Adult who has sickle cell–associated pain or symptomatic chronic anemia that interferes with daily activities and quality of life • Adult with history of severe or recurrent acute chest syndrome (ACS) • Adults or child with SCD who has chronic kidney disease and is taking erythropoietin

AND

Age ≥ 5

AND

Trial and failure of hydroxyurea, defined as experiencing a severe pain crisis (or vaso-occlusive crisis) while using the med, or experiencing other sickle-cell associated symptoms (such as sx of chronic anemia or acute chest syndrome) while using the med

Quantity Limits: Initial approval x 3 months

Date: GTC: HEMATOLOGICAL DISORDERS: 1T Brand Name: Generic Name: Mircera methoxy polyethylene glycol

Criteria: **Diagnosis** is treatment of anemia associated with chronic kidney disease (CKD) in adult patients on dialysis, adult patients not on dialysis, and in pediatric patients 5 to 17 years of age on hemodialysis who are converting from another erythropoiesis-stimulating agent (ESA) after their hemoglobin level was stabilized with an ESA or refusal for blood transfusions before surgery due to cultural/religious reasons AND documentation of the following: - Hgb ≤ 10g/dL AND - Transferrin saturation ≥ 20% OR Ferritin ≥ 80 ng/mL OR demonstration of adequate iron stores - Medical justification for not trying or contuing preferred alternatives Retacrit* AND Epogen**

*Requires Prior Authorization **Requires Prior Authorization and subject to trial and failure of Retacrit

Quantity Limits:

Date: March 2020 GTC: HEMATOLOGICAL DISORDERS 1T Brand Name: Generic Name: Adakveo Crizanlizumab

Criteria: Trial and failure of hydroxyurea 500 mg capsule AND the member is any of the following: • Adult with ≥ 3 moderate to severe pain crises per year • Adult who has sickle cell–associated pain or symptomatic chronic anemia that interferes with daily activities and quality of life • Adult with history of severe or recurrent acute chest syndrome (ACS) • Adults or child with SCD who has chronic kidney disease and is taking erythropoietin

AND

Age ≥ 16

AND

Trial and failure of hydroxyurea, defined as experiencing a severe pain crisis (or vaso-occlusive crisis) while using the med, or experiencing other sickle-cell associated symptoms (such as sx of chronic anemia or acute chest syndrome) while using the med

AND

Trial and failure of Endari*, defined as experiencing a severe pain crisis (or vaso-occlusive crisis) while using the med, or experiencing other sickle-cell associated symptoms (such as sx of chronic anemia or acute chest syndrome) while using the med

*Prior authorization required

Quantity Limits: Initial approval x 3 months

Date: GTC: HEMATOLOGICAL DISORDERS: 1T Brand Name: Generic Name: Neumega oprelvekin

Criteria: **Diagnosis** is treatment OR prophylaxis of thrombocytopenia following chemotherapy AND documentation of the following:

**Diagnosis** of non-myeloid malignancy - Platelets ≤ 20,000/µL OR documented past incidence(s) of platelets ≤ 20,000/µL

Quantity Limits: 50 mcg/kg once daily X 21 days max CrCl ≤ 30 mL/min 25mcg/kg once daily X 21 days max

Date: March 2020 GTC: HEMATOLOGICAL DISORDERS 1T Brand Name: Generic Name: Oxbryta voxelotor

Criteria: Diagnosis of sickle cell disease (SCD) with symptoms of chronic anemia interfering with activities of daily living

AND

Age ≥ 12

AND

Trial and failure of hydroxyurea, defined as experiencing symptoms of chronic anemia interefering with activities of daily living while using the med

AND

Trial and failure of Endari*, defined as experiencing symptoms of chronic anemia interefering with activities of daily living while using the med

AND

Trial and failure of Adakveo*, defined as experiencing symptoms of chronic anemia interefering with activities of daily living while using the med

*Prior authorization required Quantity Limits: Initial approval x 3 months

Date: March 2020 GTC: HEMATOLOGICAL DISORDERS 1T Brand Name: Generic Name: Reblozyl Luspatercept-AAMT

Criteria: Patient is 18 years or older AND Medication is prescribed by, or in coordination with, a hematologist AND The patient has beta thalassemia and requires regular red blood cell (RBC) transfusions Quantity Limits: Initial approval x 3 months

Date: March 2020 GTC: HEMATOLOGICAL DISORDERS 1T Brand Name: Generic Name: Promacta

Criteria: Diagnosis of chronic immune (idiopathic) thrombocytopenic purpura (ITP)

AND

Prescribed by a hematologist or oncologist

AND

Current platelet count less than 50 x 10^9 /L with a clinical risk of bleeding

AND

Patient has insufficient response (or contraindication) to an adequate course of corticosteroids (usually 8-10 weeks) AND an insufficient response (or contraindication) to rituximab and splenectomy

AND

Documentation of why rituximab is not appropriate in the patient

AND

Documentation of why splenectomy is not appropriate in the patient

Quantity Limits: Initial approval x 3 months

Date: March 2020 GTC: HEMATOLOGICAL DISORDERS 1T Brand Name: Generic Name: Neulasta, Neulasta Onpro, Fulphila, Udenyca, Ziextenzo * 6mg/0.6ml syringe, pegfilgrastim-jmdb 6mg/0.6ml syringe, pegfilgrastim-cbqv 6 mg/0.6 mL syringe, pegfilgrastim-bmez 6 mg/0.6 mL syringe

Criteria: For the prevention of chemotherapy induced neutropenia and acute hematopoietic radiation injury syndrome OR For primary prophylaxis when the anticipated incidence of neutropenic fever ≥20% with a given regimen [2015 guidelines from ASCO, NCCN guidelines, EORTC and IDSA] OR For secondary prophylaxis when a patient experienced an episode of neutropenic fever or treatment delays.

*NOTE: When pegfilgrastim is requested for prevention of chemotherapy induced neutropenia (primary and secondary), the Alliance prefers biosimilar products Fulphila, Udenyca, or Ziextenzo prior to using the reference product Neulasta. Per CCAH Biosimilars policy (403-1142).

Quantity Limits:

Date: October 2018 GTC: HEMATOLOGICAL DISORDERS: 1T Brand Name: Generic Name: Mozobil plerixafor 1mg

Criteria: Must be prescribed by a bone marrow transplant specialist, hematologist, or oncologist, patient had been diagnosed with non-Hodgkin’s (NHL) or multiple myeloma AND require hematopoietic stem cell mobilization for collection and subsequent autologous transplantation

- Must be used in combination with one of the following G-CSF: filgrastim, filgrastim-sndz, or tbo-filgrastim Quantity Limits: Approve x 4 days maximum therapy Date: October 2018 GTC: HEMATOLOGICAL DISORDERS: 1T Brand Name: Generic Name: Mozobil plerixafor 24mg/1.2ml vial

Criteria: Must be prescribed by a bone marrow transplant specialist, hematologist, or oncologist, patient had been diagnosed with non-Hodgkin’s lymphoma (NHL) or multiple myeloma, AND require hematopoietic stem cell mobilization for collection and subsequent autologous transplantation

- Must be used in combination with one of the following G-CSF: filgrastim, filgrastim-sndz, or tbo-filgrastim

Quantity Limits: Approve x 4 days maximum therapy Date: October 2018 GTC: HEMATOLOGICAL DISORDERS: 1T Brand Name: Generic Name: Nplate 250mcg subcutaneous vial romiplostim 500mcg subcutaneous vial

Criteria: **Diagnosis** of chronic immune (idiopathic) thrombocytopenic purpura (ITP) who has insufficient response to corticosteroids, immunoglobulin, and splenectomy AND documentation of a treatment-limiting adverse drug reaction to corticosteroids or immunoglobulin AND documentation of why splenectomy not appropriate in patient AND current platelet count less than 50 x 10^9 /L with a clinical risk of bleeding AND prescribed by a hematologist or oncologist

Quantity Limits: Date: June 2018 GTC: HEMATOLOGICAL DISORDERS: 1T Brand Name: Generic Name: Brilinta ticagrelor

Criteria: **Diagnosis** of post-ACS AND has inadequate response, intolerable side effect, or contraindication to clopidogrel OR prasugrel

Quantity Limits: 90mg 2 tabs/day 60mg 2 tabs/day Date: September 2017 GTC: HEMATOLOGICAL DISORDERS: 1T Brand Name: Generic Name: Lysteda tranexamic acid 650mg tablet

Criteria: The member has the **Diagnosis** of heavy menstrual bleeding AND the member tried and failed hormonal therapy, or the provider indicates clinical inappropriateness of hormonal therapy

Quantity Limits: Limit to 5 days per menstrual cycle Date: GTC: HORMONAL DEFICIENCY: 1V Brand Name: Generic Name: Makena 17-hydroxyprogesterone caproate

Criteria: **Diagnosis** of history of singleton spontaneous preterm birth (defined as delivery prior to 37 completed weeks of gestation) AND currently pregnant with a singleton pregnancy - initiate between 16 weeks, 0 days and 20 weeks, 6 days of gestation and continuing through 36 weeks, 6 days gestation

Quantity Limits: 1mL per 7-days; dispense in 28-day or 35-day increments. Infertility Services are not a covered benefit. Date: GTC: HORMONAL DEFICIENCY: 1V Brand Name: Generic Name: Premarin Tablet conjugated estrogens (oral)

Criteria: **Diagnosis** of vasomotor symptoms secondary to menopause AND the member has an inadequate response, intolerable side effect , or contraindication to estradiol tablets AND estradiol patches

Quantity Limits: Date: GTC: HORMONAL DEFICIENCY: 1V Brand Name: Generic Name: Duavee conjugated estrogens/bazedoxifene

Criteria: **Diagnosis** of vasomotor symptoms secondary to menopause AND has inadequate response, intolerable side effect, or contraindication to a formulary combination estrogen/progestin product OR an estrogen AND a progestin as separate agents OR

**Diagnosis** of postmenopausal osteoporosis AND member has tried and failed bisphosphonates

Quantity Limits:

Date: Feb 2020 GTC: HORMONAL DEFICIENCY: 1V Brand Name: Generic Name: Premphase conjugated estrogens/medroxyprogesterone

Criteria: **Diagnosis** of vasomotor symptoms secondary to menopause AND has inadequate response, intolerable side effect, or contraindication to a formulary combination estrogen/progestin product or an estrogen AND a progestin as separate agents

Quantity Limits:

Date: Feb 2020 GTC: HORMONAL DEFICIENCY: 1V Brand Name: Generic Name: Prempro conjugated estrogens/medroxyprogesterone

Criteria: ** Diagnosis** of vasomotor symptoms secondary to menopause AND has inadequate response, intolerable side effect, or contraindication to a formulary combination estrogen/progestin product or an estrogen AND a progestin as separate agents Quantity Limits: Date: GTC: HORMONAL DEFICIENCY: 1V Brand Name: Generic Name: Covaryx, Covaryx H.S. esterified estrogens-methyltestosterone oral tablet

Criteria: **Diagnosis** of vasomotor symptoms secondary to menopause AND has inadequate response, intolerable side effect, or contraindication to a formulary combination estrogen/progestin product OR an estrogen AND a progestin as separate agents

Quantity Limits:

Date: Feb 2020 GTC: HORMONAL DEFICIENCY: 1V Brand Name: Generic Name: Menostar Estradiol 14mcg/24hr

Criteria: For prophylaxis of postmenopausal osteoporosis AND member has tried and failed oral bisphosphonates

Quantity Limits:

Date: Feb 2020 GTC: HORMONAL DEFICIENCY: 1V Brand Name: Generic Name: Alora estradiol (topical)

Criteria: **Diagnosis** of Vasomotor Symptoms of Menopause AND patient has tried one (1) of the following formulary alternatives: Generic Climara (once-weekly) patches, generic Vivelle-Dot (twice-weekly) patches, estradiol tablets.

Quantity Limits:

Date: Feb 2020 GTC: HORMONAL DEFICIENCY: 1V Brand Name: Generic Name: Minivelle estradiol (topical)

Criteria: **Diagnosis** of Vasomotor Symptoms of Menopause AND patient has tried one (1) of the following formulary alternatives: Generic Climara (once-weekly) patches, generic Vivelle-Dot (twice-weekly) patches, estradiol tablets.

Quantity Limits:

Date: Feb 2020 GTC: HORMONAL DEFICIENCY: 1V Brand Name: Generic Name: Divigel estradiol (topical)

Criteria: **Diagnosis** of Vasomotor Symptoms of Menopause AND patient has tried one (1) of the following formulary alternatives: Generic Climara (once-weekly) patches, generic Vivelle-Dot (twice-weekly) patches, estradiol tablets

Quantity Limits:

Date: Feb 2020 GTC: HORMONAL DEFICIENCY: 1V Brand Name: Generic Name: Dotti estradiol (topical)

Criteria: **Diagnosis** of Vasomotor Symptoms of Menopause AND patient has tried one (1) of the following formulary alternatives: Generic Climara (once-weekly) patches, generic Vivelle-Dot (twice-weekly) patches, estradiol tablets Quantity Limits:

Date: Feb 2020 GTC: HORMONAL DEFICIENCY: 1V Brand Name: Generic Name: Elestrin estradiol (topical)

Criteria: **Diagnosis** of Vasomotor Symptoms of Menopause AND patient has tried one (1) of the following formulary alternatives: Generic Climara (once-weekly) patches, generic Vivelle-Dot (twice-weekly) patches, estradiol tablets

Quantity Limits:

Date: Feb 2020 GTC: HORMONAL DEFICIENCY: 1V Brand Name: Generic Name: Evamist estradiol (topical)

Criteria: **Diagnosis** of Vasomotor Symptoms of Menopause AND patient has tried one (1) of the following formulary alternatives: Generic Climara (once-weekly) patches, generic Vivelle-Dot (twice-weekly) patches, estradiol tablets

Quantity Limits:

Date: GTC: HORMONAL DEFICIENCY: 1V Brand Name: Generic Name: Premarin Cream estradiol (vaginal) and conjugated estrogens (vaginal)

Criteria: **Diagnosis** of vasomotor symptoms secondary to menopause AND an inadequate response, intolerable side effect, or contraindication to generic estradiol vaginal cream AND estradiol vaginal insert

Quantity Limits:

Date: Feb 2020 GTC: HORMONAL DEFICIENCY: 1V Brand Name: Generic Name: Femring Estradiol

Criteria: **Diagnosis** of Vasomotor Symptoms of Menopause AND patient has tried one of the following formulary alternatives: Generic Climara (once-weekly) patches, generic Vivelle-Dot (twice-weekly) patches, estradiol tablets.

Quantity Limits:

Date: September 2016 GTC: HORMONAL DEFICIENCY: 1V Brand Name: Generic Name: Estrace estradiol tablets

Criteria: **Diagnosis** of transgender-health issue: Approve

Quantity Limits: Date: Feb 2020 GTC: HORMONAL DEFICIENCY: 1V Brand Name: Generic Name: Climara-Pro Estradiol; Levonorgestrel

Criteria: **Diagnosis** of Vasomotor Symptoms of Menopause AND patient has tried one of the following formulary alternatives: Generic Climara (once-weekly) patches or generic Vivelle-Dot (twice-weekly) patches in combination with oral micronized progesterone (generic Prometrium) or medroxyprogesterone

Quantity Limits:

Date: Feb 2020 GTC: HORMONAL DEFICIENCY: 1V Brand Name: Generic Name: Combipatch estradiol/norethindrone twice weekly patch

Criteria: **Diagnosis** of Vasomotor Symptoms of Menopause AND patient has tried one of the following formulary alternatives: Generic Climara (once-weekly) patches Or generic Vivelle-Dot (twice-weekly) patches in combination with oral micronized progesterone (generic Prometrium) Or medroxyprogesterone

Quantity Limits:

Date: December 2016 GTC: HORMONAL DEFICIENCY: 1V Brand Name: Generic Name: First-Progesterone VGS progesterone (vaginal)

Criteria: Has contraindication or inadequate response to micronized progtesterone.

Quantity Limits: Infertility Services are not a covered benefit.

Date: GTC: HORMONAL DEFICIENCY: 1V Brand Name: Generic Name: Xyosted testosterone enanthate auto-injector

Criteria: **Diagnosis** of hypogonadism in male >18yo, approve if: - Lab confirming low testosterone level AND - Patient must have documented symptoms of hypogonadism AND - An inadequate response, intolerable side effect, or contraindication to generic testosterone vial

Quantity Limits: 4 pens/month Date: September 2016 GTC: HORMONAL DEFICIENCY: 1V Brand Name: Generic Name: Androderm, Androgel, Axiron, Fortesta, Striant, Testim, Vogelxo, testosterone Testopel, Testosterone-Cypionate, Testosterone-Enanthate

Criteria: **Diagnosis** of hypogonadism in male >18yo, approve if: - Lab confirming low testosterone AND - Patient must have documented symptoms of hypogonadism AND - For non-injectable testosterone requests: an inadequate response, intolerable side effect, or contraindication to injectable testosterone and generic topical testosterone **Diagnosis** of transgender-health issue AND request is for preferred injectable: Approve

Quantity Limits:

Date: October 2018 GTC: IMMUNIZATION: 1O Brand Name: Generic Name: Immunization/Vaccines immunization/vaccines

Criteria:

For member under 19 years of age: - Routine vaccines to be administered by VFC provider in accordance with the Advisory Committee on Immunization Practices (ACIP).

For members who are 19 years of age or older: - Routine vaccines in accordance with ACIP

Prior Authorization Required for Travel vaccines AND will be covered if recommended by ACIP or if medically necessary based on CDC (Centers for Disease Control and Prevention) recommendations.

Quantity Limits:

Date: October 2018 GTC: IMMUNOLOGICAL AGENTS: 2E Brand Name: Generic Name: Simulect basiliximab 10mg vial, 20mg vial

Criteria: For prophylaxis of organ rejection in a patient undergoing kidney transplant AND prescribed by a physician experienced in immunosuppressive therapy and management of kidney transplant patients AND used in combination with other immunosuppressants

Quantity Limits: Date: October 2018 GTC: IMMUNOLOGICAL AGENTS: 2E Brand Name: Generic Name: Nulojix belatacept 250ml vial

Criteria: For prophylaxis of organ rejection in a patient undergoing kidney transplant AND patient has no history of liver transplant AND patient has Epstein-Barr virus (EBV) seropositive result AND prescribed by a physician experienced in immunosuppressive therapy and management of kidney transplant patients AND patient must not be able to use tacrolimus or cyclosporine because of a drug allergy or intolerance/toxicity AND used in combination with basiliximab induction, mycophenolate mofetil, and corticosteroids

Quantity Limits: Date: March 2018 GTC: IMMUNOLOGICAL AGENTS: 2E Brand Name: Generic Name: Myfortic mycophenolate sodium DR

Criteria: **Diagnosis** of kidney transplant: - Trial and failure or intolerance to mycophenolate mofetil

Quantity Limits: 180mg 2 tabs/day 360mg 4tabs/day

Date: March 2018 GTC: IMMUNOLOGICAL AGENTS: 2E Brand Name: Generic Name: Astagraf XL tacrolimus ER caps

Criteria: **Diagnosis** of kidney transplant - Trial and failure or intolerance to immediate release tacrolimus

Quantity Limits: Date: March 2018 GTC: IMMUNOLOGICAL AGENTS: 2E Brand Name: Generic Name: Envarsus XR tacrolimus ER tabs

Criteria: **Diagnosis** of kidney transplant - Trial and failure or intolerance to immediate release tacrolimus

Quantity Limits: Date: GTC: IMMUNOSUPPRESSION_MODULATION: 2E Brand Name: Generic Name: Aldara imiquimod 5% cream

Criteria: **Diagnosis** of Actinic keratosis for members 18 years and older

**Diagnosis** of Genital and perianal warts for members 12 years and older

**Diagnosis** of Superficial basal cell carcinoma for member 18 years and older

Quantity Limits: Date: June 2019 GTC: INFECTIOUS DISEASE - BACTERIAL: 0A Brand Name: Generic Name: Cayston aztreonam vial neb

Criteria: Prescribed by or in consultation with infectious disease specialist or pulmonologist AND

**Diagnosis** of cystic fibrosis with pseudomonas or bronchiectasis with pseudomonas AND has inadequate response, intolerable side effect, or contraindication to fluconazole OR other documented medical justification why tobramycin nebulized solution cannot be used

Quantity Limits: 1 vial TID Date: June 2019 GTC: INFECTIOUS DISEASE - BACTERIAL: 0A Brand Name: Generic Name: Teflaro ceftaroline

Criteria: **Diagnosis** of acute bacterial skin and skin structure infection or community acquired AND paitnet has been started and stablilized on Teflaro while in the hospital or has documented sensitivity to Teflaro AND patient has inadequate response, intolerable side effect, or contraindication to first-line antibiotics

Quantity Limits: Date: February 2019 GTC: INFECTIOUS DISEASE - BACTERIAL: 0A Brand Name: Generic Name: Zyvox linezolid

Criteria: Approvable for members who have been started and stabilized on Zyvox (oral or IV) or IV vancomycin or daptomycin while in the hospital or ER OR Physician must submit documentation of VRE (vancomycin resistant enterococcus faccium) AND MRSA (Methicillin resistant staphylococcus aureus) infection with culture AND documented sensitivity to Zyvox OR Physician must submit documentation of an infection with culture and documented sensitivity to Zyvox AND the organism being treated must be resistant or not susceptible to OR member have contraindications, intolerable side effects or drug-drug interactions with the preferred first line antibiotics for that organism (Current IDSA guidelines)

Quantity Limits: 2 per day Date: June 2019 GTC: INFECTIOUS DISEASE - FUNGAL: 0B Brand Name: Generic Name: Cresemba isavuconazonium sulfate

Criteria: Prescribed by or in consultation with infectious disease specialist AND **Diagnosis** of invasive Aspergillosis AND has inadequate response, intolerable side effect, or contraindication to voriconazole or other documented medical justification why voriconazole or itraconazole cannot be used AND has inadequate response, intolerable side effect, or contraindication to or other documented medical justification why amphotericin B liposome (IV – when feasible) cannot be used OR Prescribed by or in consultation with infectious disease specialist AND **Diagnosis** of Mucormycosis

Quantity Limits: Date: June 2019 GTC: INFECTIOUS DISEASE - FUNGAL: 0B Brand Name: Generic Name: Noxafil posaconazole

Criteria: Prescribed by or in consultation with infectious disease specialist AND **Diagnosis** of non-invasive Aspergillosis, has inadequate response, intolerable side effect, or contraindication to voriconazole or other documented medical justification why voriconazole cannot be used

OR

**Diagnosis** of invasive Aspergillosis

OR

**Diagnosis** of Candidiasis or empirical treatment of invasive Candidiasis, has inadequate response, intolerable side effect, or contraindication to fluconazole or other documented medical justification why fluconazole cannot be used

Quantity Limits: Date: GTC: INFECTIOUS DISEASE – FUNGAL: 0B Brand Name: Generic Name: Amphotericin B, Abelce, Ambisome amphotericin b, amphotericin b lipid complex, amphotericin b liosome

Criteria: Prescribed by or in consultation with infectious disease specialist AND **Diagnosis** of invasive Aspergillosis, or Cryptococal systemic fungal infection

OR

**Diagnosis** of Candida prophylaxis or Candidiasis, has inadequate response, intolerable side effect, or contraindication to fluconazole or other documented medical justification why fluconazole cannot be used

Quantity Limits: Amphotericin B 0.5-1mg/kg daily Lipid formulation 3-5mg/kg daily

Date: GTC: INFECTIOUS DISEASE – FUNGAL: 0B Brand Name: Generic Name: Vfend voriconazole

Criteria: Prescribed by or in consultation with infectious disease specialist AND **Diagnosis** of invasive Aspergillosis OR **Diagnosis** of Candidiasis or empirical treatment of invasive Candidiasis AND Has inadequate response, intolerable side effect, or contraindication to fluconazole or other documented medical justification why fluconazole cannot be used

Quantity Limits: 200mg tablet: #2/day 50mg tablet:4/day 200mg/5mL suspension: 5 to 10mL/day

Date: June 2019 GTC: INFECTIOUS DISEASE - MISCELLANEOUS: 0E Brand Name: Generic Name: Sirturo bedaquiline

Criteria: Documented **Diagnosis** of PULMONARY multidrug resistant (MDR-TB) AND member is at least 18 years of age AND Sirturo should only be used in combination with at least three (3) other drugs to which the patient’s MDR-TB isolate has been shown to be susceptible in vitro.

If in vitro testing results are unavailable, treatment may be initiated with Sirturo in combination with at least four (4) other drugs to which the patient’s MDR-TB isolate is likely to be susceptible

Quantity Limits: Date: June 2019 GTC: INFECTIOUS DISEASE - MISCELLANEOUS: 0E Brand Name: Generic Name: Colistimethate colistimethate

Criteria: Prescribed by or in consultation with infectious disease specialist or pulmonologist AND **Diagnosis** of cystic fibrosis with pseudomonas Or bronchiectasis with pseudomonas

Quantity Limits: Date: GTC: INFECTIOUS DISEASE - MISCELLANEOUS: 0E Brand Name: Generic Name: Tobi Podhaler inhaled capsule

Criteria: Prescribed by or in consultation with infectious disease specialist or pulmonologist AND **Diagnosis** of cystic fibrosis with pseudomonas or bronchiectasis with pseudomonas AND documented medical justification on why generic nebulized solution cannot be used

Quantity Limits: CI Pregnancy

Date: August 2019 (modified) GTC: INFECTIOUS DISEASE - MISCELLANEOUS: 0E Brand Name: Generic Name: Kalydeco ivafactor

Criteria: **Diagnosis** of cystic fibrosis AND prescribed by or in consultation with CF specialist or pulmonologist AND documentation of one of the following genetic mutations: G551D, G1244E, G1349D, G178R, G551S, R117H, S1251N, S1255P, S549N, S549R, R117H, A1067T, A455E, D110E, D110H, D1152H, D1270N, D579G, E193K, E56K, F1052V, F1074L, G1069R, K1060T, L206W, P67L, R1070Q, R1070W, R117C, R347H, R352Q, R74W, S945L, S977F, 2789+5G—>A, 3272-26A—>G, 3849+10kbC— >T, 711+3A—>G, or E831X

Reauthorization: Provider must attest that the patient has achieved a clinically meaningful response while on Kalydeco therapy indicated by one or more of the following: • Decreased pulmonary exacerbations compared to pretreatment baseline • Improvement or stabilization of lung function as measured by percent predicted FEV1 compared to baseline or decrease in the rate of decline of lung function • Weight gain • Improvement in quality of life by Cystic Fibrosis Questionnaire-revised (CFQ-R) respiratory domain score

Quantity Limits: Date: September 2016 GTC: INFECTIOUS DISEASE - MISCELLANEOUS: 0E Brand Name: Generic Name: Priftin rifapentine

Criteria: **Diagnosis** of LTBI (latent tuberculosis infection) AND in combination with INH (isoniazid) AND in adults and children 2 years or older OR 12 years or older and who were recently in contact with infectious TB, or who had tuberculin skin test or positive blood test for TB infection conversions

All potential cases for LTBI treatment (with rifapentine) will be either requested by or referred to, the TB Controller/Communicable Disease Unit of the appropriate County.

That County will then prescribe and monitor DOT for 12 weeks.

Quantity Limits: Initial phase: 32 tabs/28 days x 2 months Continuation phase: 16 tabs/28 days x 4 months LTBI: 24 tabs/28 days x 3 months

Date: June 2019 GTC: INFECTIOUS DISEASE - MISCELLANEOUS: 0E Brand Name: Generic Name: Xifaxan rifaximin

Criteria: **Diagnosis** of hepatic encephalopathy AND inadequate response to trial of up to 120 gram (180mL) of lactulose per day or maximally tolerated dose of lactulose OR Has contraindication or other documented medical justification why lactulose cannot be tried is provided.

**Diagnosis** of traveler’s diarrhea AND inadequate response, contraindication, intolerable side effects, or other medical justification why ciprofloxacin and azithromycin cannot be used is provided.

**Diagnosis** of Irritable Bowel Syndrome with diarrhea AND has inadequate response, intolerable side effect or contraindication to loperamide OR diphenoxylate-atropine AND one (1) antispasmodic such as dicyclomine, hyosyamine).

**Diagnosis** of Small intestinal bacterial overgrowth (SIBO) AND has inadequate response, intolerable side effect or contraindication to 1 of the following medications: - Amoxicillin-clauvulanate - Metronidazole - Cephalosporin - Trimethoprim-sulfamethoxazole

Quantity Limits: HE: 550mg 2 tablets/day Traveler’s diarrhea: 200mg 3 tablets/day IBS-D: 550mg 3 tablets/day (for 14 days) SIBO: 550mg 3 tablets/day (14 days)

Date: GTC: INFECTIOUS DISEASE - MISCELLANEOUS: 0E Brand Name: Generic Name: Mycobutin tobramycin ampule-nebulized

Criteria: **Diagnosis** of Mycobacterium avium complex (MAC), prevention of disseminated Mycobacterium avium complex (MAC),

OR

**Diagnosis** of tuberculosis AND contraindication, intolerable side effects, or other medical justification why rifampin cannot be used is provided

OR

Co-**Diagnosis** of HIV

Quantity Limits: 2/day

Date: GTC: INFECTIOUS DISEASE - MISCELLANEOUS: 0E Brand Name: Generic Name: Tobi, Bethkis, Kitabis Pak (Generic Only) tobramycin ampule-nebulized

Criteria: Prescribed by or in consultation with infectious disease specialist or pulmonologist AND

**Diagnosis** of cystic fibrosis with pseudomonas or bronchiectasis with pseudomonas

Quantity Limits: CI Pregnancy 1 vial BID Date: GTC: INFECTIOUS DISEASE - MISCELLANEOUS: 0E Brand Name: Generic Name: Tobi tobramycin ampule-nebulized, inhaled capsule Bethkis Tobi Podhaler

Criteria: **Diagnosis** of cystic fibrosis with pseudomonas or bronchiectasis with pseudomonas

Quantity Limits: Date: GTC: INFECTIOUS DISEASE - MISCELLANEOUS: 0E Brand Name: Generic Name: Vancomycin (IV) vancomycin (IV)

Criteria: Treatment of infection against aerobic gram-positive bacteria AND is not being used for Clostridium difficile infections

Quantity Limits: Variable per renal function Date: June 2018 GTC: INFECTIOUS DISEASE - MISCELLANEOUS: 0E Brand Name: Generic Name: Vancocin vancomycin (oral capsules)

Criteria: **Diagnosis** of Clostridium difficile infection or Clostridium difficile –associated diarrhea AND inadequate response, intolerable side effect, contraindication, or other medical justification why Firvanq cannot be used

Quantity Limits:

Date: August 2019 GTC: INFECTIOUS DISEASE - MISCELLANEOUS: 0E Brand Name: Generic Name: Orkambi lumacaftor/ivacaftor

Criteria: **Diagnosis** of Cystic Fibrosis (CF) AND • The patient is homozygous for the F508del mutation in the CFTR gene AND • Patient is greater than or equal to 2 years of age AND • Prescribed by or in consultation with a specialist affiliated with a CF care center.

Reauthorization: Provider must attest that the patient has achieved a clinically meaningful response while on Orkambi therapy indicated by one or more of the following: • Decreased pulmonary exacerbations compared to pretreatment baseline • Improvement or stabilization of lung function as measured by percent predicted FEV1 compared to baseline or decrease in the rate of decline of lung function • Weight gain • Improvement in quality of life by Cystic Fibrosis Questionnaire-revised (CFQ-R) respiratory domain score

Quantity Limits:

Date: June 2018 GTC: INFECTIOUS DISEASE – PARASITIC: 0D Brand Name: Generic Name: Albenza albendazole

Criteria: **Diagnosis** of pinworm or hookworm, AND has contraindication or inadequate response to pyrantel pamoate documented in claims (2 doses taken 2 weeks apart is recommended by the CDC), AND for pinworm: has contraindication or inadequate response to Emverm*

OR

**Diagnosis** of roundworm or whipworm

OR

**Diagnosis** of neurocysticercosis OR hydatid

*Prior Authorization required

Quantity Limits: Roundworm or Hookworm: 2 tablets per fill Pinworm: 4 tablets per fill Whipworm: 2 tablets/day x 3 days (6 tablets total)

Date: June 2017 GTC: INFECTIOUS DISEASE – PARASITIC: 0D Brand Name: Generic Name: Malarone atovaquone/proguanil

Criteria: Approvable for the treatment and prevention of chloroquine-resistant malaria OR Approvable for member with non-chloroquine-resistant malaria if member has inadequate response, intolerable side effect, or contradindication to chloroquine, and hydroxychloroquine, or other documented medical justification why these cannot be used.

Quantity Limits: 1/day Date: June 2018 GTC: INFECTIOUS DISEASE – PARASITIC: 0D Brand Name: Generic Name: Emverm mebendazole

Criteria: **Diagnosis** of pinworm, hookworm, roundworm, or whipworm AND For pinworm: has contraindication or inadequate response to pyrantel pamoate documented in claims (2 doses taken 2 weeks apart is recommended by the CDC)

For hookworm: Has contraindication or inadequate response to pyrantel pamoate documented in claims (2 doses taken 2 weeks apart is recommended by the CDC), AND has contraindication or inadequate response to Albenza* documented in claims

For roundworm or whipworm: Has contraindication or inadequate response to Albenza* documented in claims

*Requires Prior Authorization

Quantity Limits: Max: 3 days/fill Date: June 2019 GTC: INFECTIOUS DISEASE – PARASITIC: 0D Brand Name: Generic Name: Alinia nitazoxan

Criteria: **Diagnosis** of Giardiasis AND has inadequate response, intolerable side effect or contraindication to tinidazole

Quantity Limits: Date: June 2019 GTC: INFECTIOUS DISEASE – PARASITIC: 0D Brand Name: Generic Name: Paromomycin paromomycin

Criteria: **Diagnosis** of Amebiasis AND has inadequate response, intolerable side effect or contraindication to 1 of the following medications: metronidazole or doxycycline

Quantity Limits: Date: GTC: INFECTIOUS DISEASE – PARASITIC: 0D Brand Name: Generic Name: Pentam, Nebupent pentamidine

Criteria: **Diagnosis** of pneumocystis carinii pneumonia (PCP) AND for prophylaxis, patient must be HIV-infected, with history of PCP or with a CD4 (T4) lymphocyte count ≤ 200 cells/mm3; AND nebulizer system must comply with the specifications in the prescribing information AND T/F of formulary alternatives trimethoprim-sulfamethoxazole (TMP-SMZ) and dapsone* or medical justification why they cannot be used

*Prior Authorizaiton required

Quantity Limits: Date: June 2017 GTC: INFECTIOUS DISEASE – PARASITIC: 0D Brand Name: Generic Name: Daraprim pyrimethamine

Criteria: Approvable for the treatment of toxoplasmic encephalitis OR Approvable for the treatment of congenital toxoplasmosis OR Approvable for secondary prophylaxis of toxoplasmic encephalitis OR Approvable for primary prophylaxis of toxoplasmic encephalitis in members who are intolerant to trimethoprim- sulfamethoxazole (TMP-SMX) after a desensitization protocol or have life threatening reaction to TMP-SMX OR Approvable for treatment or prophylaxis of malaria if prescriber submits medical justification why all other antimalarial agents are not appropriate for the member.

Quantity Limits: Date: June 2017 GTC: INFECTIOUS DISEASE – PARASITIC: 0D Brand Name: Generic Name: Qualaquin quinine sulfate

Criteria: Approvable for the treatment and prevention of chloroquine-resistant malaria OR Approvable for member with non-chloroquine-resistant malaria if member has inadequate response, intolerable side effect, or contraindication to chloroquine, and hydroxychloroquine, or other documented medical justification why these cannot be used

Quantity Limits:

Date: 3/2019 GTC: INFECTIOUS DISEASE – PARASITIC : 0D Brand Name: Generic Name: Plaquenil Hydroxychloroquine

Criteria: **Diagnosis** Prescribed for the treatment of COVID-19 AND The treating physician must document in the medical records: - evidence, indicating possible efficacy - the possible benefits and risks of the treatment for this patient - discussion of these potential benefits and risks with the patient or surrogate decision-maker - consent of the patient or surrogate decision-maker to the off-label treatment OR Will follow most current DHCS, CDC and WHO guidelines

Quantity Limits: FDA confirmed diagnosis: up to 30 day supply

COVID19 diagnosis: Up to 14 day supply

Date: 3/2019 GTC: INFECTIOUS DISEASE – PARASITIC : 0D Brand Name: Generic Name: Aralen Chloroquine

Criteria: **Diagnosis** Prescribed for the treatment of COVID-19 AND The treating physician must document in the medical records: - evidence, indicating possible efficacy - the possible benefits and risks of the treatment for this patient - discussion of these potential benefits and risks with the patient or surrogate decision-maker - consent of the patient or surrogate decision-maker to the off-label treatment OR Will follow most current DHCS, CDC and WHO guidelines

Quantity Limits: Up to 10 day supply

Date: June 2019 GTC: INFECTIOUS DISEASE – PARASITIC: 0D Brand Name: Generic Name: Solosec secnidazole

Criteria: **Diagnosis** of Bacterial Vaginosis AND has inadequate response, intolerable side effect or contraindication to 1 of the following medications: metronidazole or clindamycin

Quantity Limits: 2g x 1. Date: GTC: INFECTIOUS DISEASE - VIRAL: 0C Brand Name: Generic Name: Hepsera adefovir, entecavir

Criteria: Prescribed by or in consultation with infectious disease specialist or GI specialist AND **Diagnosis** of chronic hepatitis B

Quantity Limits: Adefovir: 1 tablet/day

Date: GTC: INFECTIOUS DISEASE - VIRAL: 0C Brand Name: Generic Name: Famvir famciclovir

Criteria: **Diagnosis** of Herpes Labialis, Genital Herpes, and Herpes Zoster AND has inadequate response, intolerable side effect, or contraindication to acyclovir

Quantity Limits: Date: GTC: INFECTIOUS DISEASE - VIRAL: 0C Brand Name: Generic Name: Synagis palivizumab

Criteria: Refer to current American Academy of Pediatrics (AAP) recommendations

Quantity Limits: Date: GTC: INFECTIOUS DISEASE - VIRAL: 0C Brand Name: Generic Name: Valcyte valganciclovir (oral)

Criteria: **Diagnosis** of cytomegalovirus (CMV) prevention or treatment

Quantity Limits: For CMV prevention: 2/day For CMV treatment: 4/day

Date: August 2019 GTC: INFECTIOUS DISEASE - VIRAL: 0C Brand Name: Generic Name: Hcv Agents: hepatitis c virus treatment agents: glecaprevir/pibrentasvir, elbasvir/grazoprevir, sofosbuvir/velpatasvir, Mavyret ledipasvir/sofosbuvir, sofosbuvir, simeprevir, boceprevir, ombitasvir/paritaprevir/ritonavir/dasabuvir, peginterferon Zepatier alfa-2a ribavirin Epclusa Harvoni Sovaldi Olysio Victrelis Viekira Pak Pegasys Ribasphere

Criteria: Refer to DHCS Hepatitis C Utilization and Treatment Policy. Formulary-Preferred Hepatitis C treatment agents for treatment naïve patients (PA-Prior Authorization Required): Generic Epclusa is preferred for all genotypes.

Quantity Limits: Refer to AASLD guidelines for regimen length and dosing

Date: June 2017 GTC: INFECTIOUS DISEASE- BACTERIAL: 0A Brand Name: Generic Name: Suprax cefixime oral capsules, suspension, chewable tablets

Criteria: The organism being treated must be resistant or not susceptible to OR member have contraindications, intolerable side effects or drug-drug interations with formulary 3rd generation cephalosporins (cefdinir, cefpodoxime).

For chewable tablets or suspension requests, and failure of formulary 3rd generation cephalosporins suspensions (cefdinir, cefpodoxime).

Quantity Limits: Date: June 2017 GTC: INFECTIOUS DISEASE- BACTERIAL: 0A Brand Name: Generic Name: Ceftin Suspension cefuroxime axetil suspension (reconstituted)

Criteria: The organism being treated must be resistant or not susceptible to OR member have contraindications, intolerable side effects or drug-drug interactions with formulary 2nd generation cephalosporins (cefprozil)

Quantity Limits: Date: GTC: INFECTIOUS DISEASE- BACTERIAL: 0A Brand Name: Generic Name: Dificid fidaxomicin

Criteria: **Diagnosis** of Clostridium difficile infection or Clostridium difficile –associated diarrhea AND Initial episode or first recurrence of mild to moderate Clostridium difficile infection or Clostridium difficile –associated diarrhea AND Has inadequate response, contraindication, intolerable side effect, or other documented medical justification why oral metronidazole AND oral vancomycin cannot be used is provided OR Second recurrence or severe Clostridium difficile infection or Clostridium difficile –associated diarrhea AND Has inadequate response, contraindication, intolerable side effect to, or other documented medical justification why oral vancomycin cannot be used is provided

Quantity Limits: #2/day Date: June 2017 GTC: INFECTIOUS DISEASE- BACTERIAL: 0A Brand Name: Generic Name: Sivextro tedizolid phosphate

Criteria: Approvable for member who have been started and stabilized on Sivextro (oral or IV) while in the hospital or ER. OR Physician must submit documentation of acute skin and skin structure MRSA (Methicillin resistant staphylococcus aureus) infection with culture and documented sensitivity to Sivextro OR Physician must submit documentation of an infection with culture and documented sensitivity to Sivextro AND the organism being treated must be resistant or not susceptible to OR member have contraindications, intolerable side effects, or drug-drug interactions with the preferred first line antibiotics for that organism (Current IDSA guidelines).

Quantity Limits: 1/day Date: GTC: INFECTIOUS DISEASE- BACTERIAL: 0A Brand Name: Generic Name: Ketek telithromycin

Criteria: **Diagnosis** of community-acquired pneumonia or blood or sputum culture positive for Streptococcus pneumoniae (including multidrug-resistant isolates), Haemophilus influenzae , Moraxella catarrhalis , Chlamydophila pneumoniae , or Mycoplasma pneumonia and documented sensitivity against telithromycin AND Documented resistance to following antibiotics in culture and sensitivity report or inadequate response to trial of macrolide (azithromycin, , or erythromycin), doxycycline, respiratory floroquinolones (moxifloxacin, gemifloxacin, or levofloxacin), AND beta-lactam (amoxicillin, amoxicillin-clavulanate, cefuroxime) plus macrolide with current infection OR Has contraindication, intolerable side effects, or other documented medical justification why susceptible antibiotic options cannot be tried

Quantity Limits: 300mg tablet, #2/day 400mg tablet, max #2/day Date: March 2018 GTC: INFLAMMATORY DISEASE: 1F Brand Name: Generic Name: Orencia

Criteria: **Diagnosis** of rheumatoid arthritis AND : • Has been evaluated by a rheumatologist AND • Has inadequate response, intolerable side effect, or contraindication to one DMARD (such as methotrexate , hydroxychloroquine, leflunomide, or sulfasalazine ) OR • Has severe active rheumatoid arthritis

**Diagnosis** of juvenile idiopathic arthritis AND • Has been evaluated by a rheumatologist AND • Has inadequate response, intolerable side effect, or contraindication to one DMARD (such as methotrexate , hydroxychloroquine, leflunomide, or sulfasalazine ) OR • Has polyarthropathy

**Diagnosis** of psoriatic arthritis AND • Has been evaluated by a rheumatologist/dermatologist AND • Has inadequate response, intolerable side effect, or contraindication to one DMARD (such as methotrexate , hydroxychloroquine, leflunomide, or sulfasalazine ) or apremilast OR • Severe active psoriatic arthritis (axial disease – sacroiliitis or spondylitis)

Quantity Limits: RA/JIA/PsA: IV: Based on weight(500mg-1000mg) Wk 0: 500mg Wk 2: 500mg Wk 4: 500mg and every 4 weeks thereafter SC: 125mg/wk

Date: March 2018 GTC: INFLAMMATORY DISEASE: 1F Brand Name: Generic Name: Humira, Amjevita, Cyltezo

Criteria: **Diagnosis** of rheumatoid arthritis AND : • Has been evaluated by a rheumatologist AND • Has inadequate response, intolerable side effect, or contraindication to one DMARD (such as methotrexate , hydroxychloroquine, leflunomide, or sulfasalazine ) OR • Has severe active rheumatoid arthritis.

**Diagnosis** of psoriatic arthritis AND • Has been evaluated by a rheumatologist/dermatologist AND • Has inadequate response, intolerable side effect, or contraindication to one DMARD (such as methotrexate , hydroxychloroquine, leflunomide, or sulfasalazine ) or apremilast OR • Severe active psoriatic arthritis (axial disease – sacroiliitis or spondylitis)

**Diagnosis** of ankylosing spondylitis AND • Has been evaluated by a rheumatologist AND • Has inadequate response, intolerable side effect, or contraindication to 2 formulary NSAIDs or steroids

**Diagnosis** of juvenile idiopathic arthritis AND • Has been evaluated by a rheumatologist AND • Has inadequate response, intolerable side effect, or contraindication to one DMARD (such as methotrexate , hydroxychloroquine, leflunomide, or sulfasalazine ) OR • Has polyarthropathy

**Diagnosis** of moderate to severe plaque psoriasis AND : • Psoriasis affects > 10% BSA or causes significant functional disability (Palms, soles, genitalia, severe scalp psoriasis) AND • Has inadequate response, intolerable side effect, or contraindication to phototherapy (if available) AND • Has inadequate response, intolerable side effect, or contraindication to acitretin or another DMARD.

**Diagnosis** of moderate to severe Crohn’s disease AND • Has been evaluated by a gastroenterologist AND • Has inadequate response, intolerable side effect, or contraindication to , mercaptopurine or methotrexate. OR • Has severe or refractory disease OR • Perianal fistulizing disease

**Diagnosis** of moderate to severe ulcerative colitis AND  Has been evaluated by a gastroenterologist AND has inadequate response, intolerable side effect, or contraindication to systemic aminosalicylates (sulfasalazine, mesalamine), azathioprine or mercaptopurine OR has severe or refractory disease

**Diagnosis** of non-infectious intermediate, posterior, and pan-uveitis that is chronic, recurrent, treatment refractory or vision threatening disease AND inadequate response, intolerable side effect, or contraindication to systemic corticosteroids AND systemic immunosuppressant (such as methotrexate, azathioprine, mycophenolate, cyclosporine, or tacrolimus)

**Diagnosis** of Hidradenitis Suppurativa (HS) AND has inadequate response, intolerable side effect, or contraindication to systemic antibiotics (such as doxycycline, moxifloxacin, erythromycin) AND one oral retinoid (such as acitretin or isotretinoin). OR Severe and recurrent abscesses (such as multiple interconnected tracts or widely separated and recurrent with sinus tracts and scarring)

Quantity Limits: Quantity Limits: RA/PsA/AS/JIA: 40mg every 2 weeks +MTX

Can be dosed weekly for patients not taking MTX

Psoriasis Induction Dose: Wk 0: 80mg Wk 1: 40mg

Maintenance Dose: 40mg every 2 weeks

Crohn’s/UC Induction Dose: Wk 0: 160mg Wk 2: 80mg Wk 4: 40mg

Crohn’s/UC maintenance dose: 40mg every 2 weeks (some may require weekly therapy)

HS Induction dose: Wk 0: 160mg WK 2: 80mg Wk 4: 40

Date: March 2018 GTC: INFLAMMATORY DISEASE: 1F Brand Name: Generic Name: Otezla apremilast

Criteria: **Diagnosis** of moderate to severe plaque psoriasis AND : • Psoriasis affects > 10% BSA or causes significant functional disability (Palms, soles, genitalia, severe scalp psoriasis) AND • Has inadequate response, intolerable side effect, or contraindication to phototherapy (if available) AND • Has inadequate response, intolerable side effect, or contraindication to acitretin or another DMARD.

**Diagnosis** of psoriatic arthritis AND • Has been evaluated by a rheumatologist/dermatologist AND • Has inadequate response, intolerable side effect, or contraindication to one DMARD (such as methotrexate , hydroxychloroquine, leflunomide, or sulfasalazine ) OR • Severe active psoriatic arthritis (axial disease – sacroiliitis or spondylitis)

Quantity Limits: 10mg used for titration x 1 fill 30mg #2/day

Date: GTC: INFLAMMATORY DISEASE: 1F Brand Name: Generic Name: Ridaura auranofin

Criteria: **Diagnosis** of rheumatoid arthritis AND • Has been evaluated by a rheumatologist; AND • Has inadequate response, intolerable side effect, or contraindication to methotrexate, hydroxychloroquine, leflunomide, and sulfasalazine or medical justification why they cannot be used

Quantity Limits: 2 capsules/day Date: October 2018 GTC: INFLAMMATORY DISEASE: 1F Brand Name: Generic Name: Olumiant baricitnib 2mg tablet

Criteria: **Diagnosis** of moderate to severe rheumatoid arthritis (RA) AND • Prescribed by or in consultation with a rheumatologist AND • Has inadequate response, intolerable side effect, or contraindication to one DMARD (such as methotrexate, hydroxychloroquine, leflunomide, or sulfasalazine )

Quantity Limits: 1/day Date: October 2018 GTC: INFLAMMATORY DISEASE: 1F Brand Name: Generic Name: Benlysta 120mg vial, 400mg vial, 200mg/ml prefilled syringe, 200mg/ml autoinjector syringe

Criteria: **Diagnosis** of active systemic lupus erythematosus • Currently on and has had an inadequate response or intolerance to standard therapy for SLE (e.g., corticosteroids, azathioprine, leflunomide, methotrexate, mycophenolate, hydroxychloroquine) • Member does NOT have severe active lupus nephritis or severe active central nervous system (CNS) lupus

Quantity Limits:

Date: Feb 2020 GTC: INFLAMMATORY DISEASE: 1F Brand Name: Generic Name: Rinvoq ER Upadacitinib

Criteria: **Diagnosis** of moderate to severe rheumatoid arthritis (RA) AND • Prescribed by or in consultation with a rheumatologist AND • Has inadequate response, intolerable side effect, or contraindication to methotrexate AND • Has inadequate response, intolerable side effect, or contraindication to Olumiant (Please note: this step is required only if patient has also failed TNF inhibitor)

Quantity Limits:

Date: December 2016 GTC: INFLAMMATORY DISEASE: 1F Brand Name: Generic Name: Entocort budesonide EC 3mg capsule

Criteria: **Diagnosis** of Crohn’s Disease AND • Has inadequate response, intolerable side effect or contraindication to oral prednisone AND • Has inadequate response, intolerable side effect, or contraindication to sulfasalazine

Quantity Limits: 3 capsules/day Date: December 2016 GTC: INFLAMMATORY DISEASE: 1F Brand Name: Generic Name: Uceris budesonide extended-release 9mg tablet

Criteria: **Diagnosis** of ulcerative colitis AND • Has inadequate response, intolerable side effect or contraindication to oral prednisone AND • Has inadequate response, intolerable side effect, or contraindication to balsalazide or generic oral mesalamine DR

Quantity Limits: 1 tablet/day Date: March 2018 GTC: INFLAMMATORY DISEASE: 1F Brand Name: Generic Name: Berinert c1 esterase inhibitor, human

Criteria: Member must meet ALL of the following criteria: - The medication is being used for treatment of ACUTE hereditary angioedema (HAE) attacks - Must be prescribed by, or in consultation with, a specialist (i.e. allergist, immunologist, hematologist, pulmonologist, etc) - Patient must be at least 5 years old AND Member must have at least ONE of the following clinical presentations (confirmed by testing): - HAE I (C1-Inhibitor deficiency) - HAE II (C1-Inhibitor dysfunction) - HAE with normal C1INH (also known as HAE III)

Quantity Limits: Date: May 2019 GTC: INFLAMMATORY DISEASE: 1F Brand Name: Generic Name: Cimzia certolizumab, pegol

Criteria: **Diagnosis** of rheumatoid arthritis AND • Has been evaluated by a rheumatologist AND • Has inadequate response, intolerable side effect, or contraindication to one DMARD (such as methotrexate , hydroxychloroquine, leflunomide, or sulfasalazine) OR • Has severe active rheumatoid arthritis.

**Diagnosis** of psoriatic arthritis AND • Has been evaluated by a rheumatologist/dermatologist AND • Has inadequate response, intolerable side effect, or contraindication to one DMARD (such as methotrexate , hydroxychloroquine, leflunomide, or sulfasalazine ) or apremilast OR • Severe active psoriatic arthritis (axial disease – sacroiliitis or spondylitis)

**Diagnosis** of ankylosing spondylitis AND • Has been evaluated by a rheumatologist AND • Has inadequate response, intolerable side effect, or contraindication to 2 formulary NSAIDs or steroids

**Diagnosis** of moderate to severe Crohn’s disease AND • Has been evaluated by a gastroenterologist AND • Has inadequate response, intolerable side effect, or contraindication to azathioprine, mercaptopurine or methotrexate. OR • Has severe or refractory disease OR • Perianal fistulizing disease

Quantity Limits: RA/PsA/AS loading dose: Wk 0: 400mg Wk 2: 400mg Wk 4: 400mg Maintenance dose: 200mg every 2 wks or 400mg every 4 weeks Crohn’s Induction Dose: Wk 0: 400mg Wk 2: 400mg Wk 4: 400mg Maintenance dose: 400mg every 4 weeks

Date: March 2018 GTC: INFLAMMATORY DISEASE: 1F Brand Name: Generic Name: Zipsor diclofenac potassium liquid-filled capsule

Criteria: **Diagnosis** of pain or arthritis AND • Has inadequate response, intolerable side effect, or contraindication to 3 formulary oral NSAIDs (such as: ibuprofen, naproxen, meloxicam, diclofenac, sulindac, nabumetone, or etodolac) AND • Trial and failure of Zorvolex*

*Prior authorization required

Quantity Limits: Max: 4/day Date: December 2016 GTC: INFLAMMATORY DISEASE: 1F Brand Name: Generic Name: Zorvolex diclofenac submicronized capsule

Criteria: **Diagnosis** of pain or arthritis AND • Has inadequate response, intolerable side effect, or contraindication to 3 formulary oral NSAIDs, such as: ibuprofen, naproxen, meloxicam, diclofenac, sulindac, nabumetone, or etodolac

Quantity Limits: Max: 3/day Date: March 2018 GTC: INFLAMMATORY DISEASE: 1F Brand Name: Generic Name: Arthrotec-50, Arthrotec-75 diclofenac-misoprostol tablet

Criteria: Trial and failure of diclofenac in combination with either a proton pump inhibitor (PPI) or an H2 blocker OR Member is age 65 or older

Quantity Limits: Date: March 2018 GTC: INFLAMMATORY DISEASE: 1F Brand Name: Generic Name: Enbrel Erelzi

Criteria: **Diagnosis** of rheumatoid arthritis AND : • Has been evaluated by a rheumatologist AND • Has inadequate response, intolerable side effect, or contraindication to one DMARD (such as methotrexate , hydroxychloroquine, leflunomide, or sulfasalazine ) OR • Has severe active rheumatoid arthritis.

**Diagnosis** of psoriatic arthritis AND : • Has been evaluated by a rheumatologist/dermatologist AND • Has inadequate response, intolerable side effect, or contraindication to one DMARD (such as methotrexate , hydroxychloroquine, leflunomide, or sulfasalazine ) or apremilast OR • Severe active psoriatic arthritis (axial disease – sacroiliitis or spondylitis)

**Diagnosis** of ankylosing spondylitis AND : • Has been evaluated by a rheumatologist AND • Has inadequate response, intolerable side effect, or contraindication to 2 formulary NSAIDs for at least 2 months

**Diagnosis** of juvenile idiopathic arthritis AND : • Has been evaluated by a rheumatologist AND • Has inadequate response, intolerable side effect, or contraindication to one DMARD (such as methotrexate , hydroxychloroquine, leflunomide, or sulfasalazine ) OR • Has polyarthropathy

**Diagnosis** of moderate to severe plaque psoriasis AND : • Psoriasis affects > 10% BSA or causes significant functional disability (Palms, soles, genitalia, severe scalp psoriasis) AND • Has inadequate response, intolerable side effect, or contraindication to phototherapy (if available) AND • Has inadequate response, intolerable side effect, or contraindication to methotrexate, acitretin or another DMARD.

Quantity Limits: RA/PsA/AS/ JIA: 50mg/week Psoriasis Induction: 50mg 2x/week for 3 months Maintenance: 50mg/week

Date: March 2018 GTC: INFLAMMATORY DISEASE: 1F Brand Name: Generic Name: Simponi & Simponi Aria golimumab

Criteria: **Diagnosis** of rheumatoid arthritis AND : Has been evaluated by a rheumatologist AND Has inadequate response, intolerable side effect, or contraindication to one DMARD (such as methotrexate , hydroxychloroquine, leflunomide, or sulfasalazine ) OR has severe active rheumatoid arthritis.

**Diagnosis** of psoriatic arthritis AND : Has been evaluated by a rheumatologist/dermatologist AND Has inadequate response, intolerable side effect, or contraindication one DMARD (such as methotrexate , hydroxychloroquine, leflunomide, or sulfasalazine ) or apremilast OR severe active psoriatic arthritis (axial disease – sacroiliitis or spondylitis)

**Diagnosis** of ankylosing spondylitis AND : Has been evaluated by a rheumatologist AND Has inadequate response, intolerable side effect, or contraindication to 2 formulary NSAIDs or steroids

**Diagnosis** of moderate to severe ulcerative colitis AND Has been evaluated by a gastroenterologist AND Has inadequate response, intolerable side effect, or contraindication to systemic aminosalicylates (sulfasalazine, mesalamine), azathioprine or mercaptopurine OR has severe or refractory disease

Quantity Limits: RA/PsA/AS: 50mg SQ once monthly RA/PsA/AS: Simponi Aria: 2mg/kg IV at weeks 0 and 4, then every 8 weekls. UC Induction Dose: Wk 0: 200mg Wk 2: 100mg UC Maintenance Dose: 100mg every 4 weeks

Date: October 2018 GTC: INFLAMMATORY DISEASE: 1F Brand Name: Generic Name: Durolane, Euflexxa, Gel-One, Gelsyn-3, Genvisc 805, Supartz, hyaluronic acid intra-articular injection (viscosupplements) Supartz Fx, Hyalgan, Hymovisc, Monovisc, Orthovisc, Synvisc, Synvisc-One, Trivisc, Visco-3

Criteria: Treatment of osteoarthritis of the knee in which each of the following are met: Member must have been evaluated by an appropriate specialist • Documentation of trial and failure, intolerance, or contraindication to at least 2 or more of the following: i. Prescription strength NSAIDs at adequate doses for 3 months of consistent usage ii. Acetaminophen iii. Tramadol • If intolerant to oral NSAIDs, must have 3 month trial of topical NSAID • Trial and failure of physical therapy • Documentation of 3 intra-articular steroid injections within the last year or documentation of complete lack of response to less than 3 injections (effects lasting less than 8 weeks) • Member does not have any other **Diagnosis** contributing to their knee pain (i.e. meniscus tear)

Quantity Limits: If approved, no more than 2 courses of therapy per year. Date: October 2018 GTC: INFLAMMATORY DISEASE: 1F Brand Name: Generic Name: Remicade, Inflectra, Renflexis infliximab* 100mg intravenous vial, infliximab-dyyb 100mg intravenous vial, infliximab-abda 100mg intravenous vial

Criteria: **Diagnosis** of rheumatoid arthritis AND Has been evaluated by a rheumatologist AND Has inadequate response, intolerable side effect, or contraindication to one DMARD (such as methotrexate, hydroxychloroquine, leflunomide, or sulfasalazine ) OR has severe active rheumatoid arthritis.

**Diagnosis** of psoriatic arthritis AND Has been evaluated by a rheumatologist/dermatologist AND Has inadequate response, intolerable side effect, or contraindication to one DMARD (such as methotrexate , hydroxychloroquine, leflunomide, or sulfasalazine ) or apremilast OR severe active psoriatic arthritis (axial disease – sacroiliitis or spondylitis).

**Diagnosis** of ankylosing spondylitis AND Has been evaluated by a rheumatologist AND Has inadequate response, intolerable side effect, or contraindication to 2 formulary NSAIDs or steroids

**Diagnosis** of moderate to severe plaque psoriasis AND Psoriasis affects > 10% BSA or causes significant functional disability (Palms, soles, genitalia, severe scalp psoriasis) AND Has inadequate response, intolerable side effect, or contraindication to phototherapy (if available) AND Has inadequate response, intolerable side effect, or contraindication to acitretin or another DMARD.

**Diagnosis** of moderate to severe Crohn’s disease AND Has been evaluated by a gastroenterologist AND Has inadequate response, intolerable side effect, or contraindication to azathioprine, mercaptopurine or methotrexate OR has severe or refractory disease OR Perianal fistulizing disease

**Diagnosis** of moderate to severe ulcerative colitis AND Has been evaluated by a gastroenterologist AND Has inadequate response, intolerable side effect, or contraindication to systemic aminosalicylates (sulfasalazine, mesalamine), azathioprine or mercaptopurine OR has severe or refractory disease

*NOTE: When infliximab (Remicade) is requested, Alliance requires a trial of Renflexis* and Inflectra* or medical justification why they cannot be used - Per CCAH Biosimilars policy (403-1142).

* Require prior authorization

Quantity Limits: See package insert.

Date: March 2018 GTC: INFLAMMATORY DISEASE: 1F Brand Name: Generic Name: Ketorolac ketorolac tablet

Criteria: Member meets all of the following: - This medication is being used for moderate-severe acute pain - It is not being used for longer than 5 days - It is being used as a continuation of parenteral (IV or IM) therapy

Quantity Limits: Date: October 2018 GTC: INFLAMMATORY DISEASE: 1F Brand Name: Generic Name: Takhzyro lanadelumab-flyo 300mg/2ml vial

Criteria: INITIAL: • **Diagnosis** of hereditary angioedema (HAE) confirmed by complement testing AND • Medication is being used for prophylaxis to prevent HAE attacks • The patient is 12 years of age or older. • Prescribed by an Allergist/Immunologist or Hematologist

RENEWAL: Physician attestation of improvement (i.e., reductions in attack frequency or attack severity) compared to baseline in HAE attacks with routine prophylaxis

Quantity Limits: 4mL per 28-days Date: GTC: INFLAMMATORY DISEASE: 1F Brand Name: Generic Name: Meclofenamate Capsule meclofenamate capsule

Criteria: T/F of at least 2 NSAIDs including meloxicam, or medical justification for why they cannot be used

Quantity Limits: Date: September 2017 GTC: INFLAMMATORY DISEASE: 1F Brand Name: Generic Name: Rasuvo methotrexate auto-injector 7.5mg/0.15, 10mg/0.2, 12.5mg/0.25, 15mg/0.3, 17.5mg/0.35, 20mg/0.4, 22.5mg/0.45, 25mg/0.5, 27.5mg/0.55, 30mg/0.6ml

Criteria: **Diagnosis** of psoriatic arthritis AND : • Patient has been evaluated by a rheumatologist/dermatologist AND • Has inadequate response, intolerable side effect, or contraindication to generic injectable methotrexate AND oral methotrexate

Quantity Limits: Date: September 2017 GTC: INFLAMMATORY DISEASE: 1F Brand Name: Generic Name: Otrexup methotrexate auto-injector 7.5mg/0.4, 10mg/0.4, 15mg/0.4, 17.5mg/0.4, 20mg/0.4, 22.5mg/0.4, 25mg/0.4ml auto- injector

Criteria: **Diagnosis** of psoriatic arthritis AND : • Patient has been evaluated by a rheumatologist/dermatologist AND • Has inadequate response, intolerable side effect, or contraindication to generic injectable methotrexate AND oral methotrexate

Quantity Limits: Date: GTC: INFLAMMATORY DISEASE: 1F Brand Name: Generic Name: Tivorbex micronized indomethacin capsule

Criteria: Trial and failure of at least 3 NSAIDs including meloxicam and indomethacin, or medical justification why they cannot be used

Quantity Limits: Date: GTC: INFLAMMATORY DISEASE: 1F Brand Name: Generic Name: Vivlodex micronized meloxicam capsule

Criteria: T/F of at least 3 NSAIDs including meloxicam, or medical justification for why they cannot be used

Quantity Limits: Date: GTC: INFLAMMATORY DISEASE: 1F Brand Name: Generic Name: Rayos prednisone delayed-release tablet

Criteria: Member meets ALL of the following: - Trial and failure of prednisone tab - Trial and failure of 2 additional corticosteroid agents (such as prednisolone, methylprednisolone, or dexamethasone), or rationale why they would be inappropriate - Documentation provided for why the delayed-release agent is clinically necessary (as opposed to simply more convenient)

Quantity Limits: Date: March 2018 GTC: INFLAMMATORY DISEASE: 1F Brand Name: Generic Name: Actemra tocilizumab

Criteria: **Diagnosis** of rheumatoid arthritis AND • Has been evaluated by a rheumatologist AND • Has inadequate response, intolerable side effect, or contraindication to one DMARD (such as methotrexate , hydroxychloroquine, leflunomide, or sulfasalazine ) OR • Has severe active rheumatoid arthritis

**Diagnosis** of juvenile idiopathic arthritis AND • Has been evaluated by a rheumatologist AND • Has inadequate response, intolerable side effect, or contraindication to one DMARD (such as methotrexate , hydroxychloroquine, leflunomide, or sulfasalazine ) OR • Has polyarthropathy

Quantity Limits: IV: 4-8mg/kg every 4 weeks SC: 162mg If < 100kg, 162mg every other week If >100kg, 162mg every week Date: March 2018 GTC: INFLAMMATORY DISEASE: 1F Brand Name: Generic Name: Xeljanz, Xeljanz Xr

Criteria: **Diagnosis** of rheumatoid arthritis AND : • Has been evaluated by a rheumatologist AND • Has inadequate response, intolerable side effect, or contraindication to one DMARD (such as methotrexate , hydroxychloroquine, leflunomide, or sulfasalazine ) OR • Has severe active rheumatoid arthritis.

**Diagnosis** of psoriatic arthritis AND : • Has been evaluated by a rheumatologist/dermatologist AND • Has inadequate response, intolerable side effect, or contraindication one DMARD (such as methotrexate , hydroxychloroquine, leflunomide, or sulfasalazine ) or apremilast OR • Severe active psoriatic arthritis (axial disease – sacroiliitis or spondylitis)

Quantity Limits: Xeljanz: 2 tablets/day Xeljanz XR: 1 tablet/day Date: March 2018 GTC: INFLAMMATORY DISEASE: 1F Brand Name: Generic Name: Stelara ustekinumab

Criteria: **Diagnosis** of psoriatic arthritis AND : • Has been evaluated by a rheumatologist/dermatologist AND • Has inadequate response, intolerable side effect, or contraindication to one DMARD (such as methotrexate , hydroxychloroquine, leflunomide, or sulfasalazine ) or apremilast AND • Has inadequate response, intolerable side effect, or contraindication to a tumor necrosis factor-alpha inhibitor (e.g., adalimumab, etanercept, infliximab)

**Diagnosis** of moderate to severe plaque psoriasis AND • Psoriasis affects > 10% BSA or causes significant functional disability disability (Palms, soles, genitalia, severe scalp psoriasis) AND • Has inadequate response, intolerable side effect, or contraindication to phototherapy (if available) AND • Has inadequate response, intolerable side effect, or contraindication to acitretin or another DMARD. AND • Has inadequate response, intolerable side effects to a tumor necrosis factor-alpha inhibitor (e.g., adalimumab, etanercept, infliximab)

**Diagnosis** of moderate to severe Crohn’s disease AND • Has been evaluated by a gastroenterologist AND • Has inadequate response, intolerable side effect, or contraindication to azathioprine, mercaptopurine or methotrexate. • Has inadequate response, intolerable side effect, or contraindication to a tumor necrosis factor-alpha inhibitor (e.g., adalimumab, etanercept, infliximab) OR • Has inadequate response, intolerable side effect or contraindication to Entyvio.

Quantity Limits: PsA and Psoriasis If <100kg: Wk 0: 45mg Wk 4: 45mg and 45mg every 12 weeks thereafter If >100kg: Wk 0:90mg Wk 4:90mg and 90mg every 12 weeks thereafter Crohn Disease: Induction: 55kg or less: Wk 0: 260mg 55kg to 85 kg Wk 0: 390mg More than 85kg Wk 0: 520mg Maintenance: 90mg every 8 weeks.

Date: March 2018 GTC: INFLAMMATORY DISEASE: 1F Brand Name: Generic Name: Kevzara sarilumab

Criteria: **Diagnosis** of rheumatoid arthritis AND : • Has been evaluated by a rheumatologist AND • **Diagnosis** of rheumatoid arthritis AND : • Has been evaluated by a rheumatologist AND • Has inadequate response, intolerable side effect, or contraindication to one DMARD (such as methotrexate , hydroxychloroquine, leflunomide, or sulfasalazine ) OR • Has severe active rheumatoid arthritis

Quantity Limits: Rheumatoid Arthritis: 200mg every 2 weeks Date: GTC: LOCAL ANESTHESIA: 2C Brand Name: Generic Name: Glydo lidocaine 2% gel syringes & applicators

Criteria: For urethral anesthesia only

Quantity Limits: 1 Rx/ procedure 15 ml (male) or 3—5 ml (female) of 2% lidocaine jelly or solution into the urethra

Date: October 2018 GTC: LOWER GASTROINTESTINAL DISORDERS - BOWEL INFLAMMATORY: 1M Brand Name: Generic Name: Giazo balsalazide disodium 1.1g tablet

Criteria: **Diagnosis** of ulcerative colitis AND • Has inadequate response, intolerable side effect, or contraindication to sulfasalazine AND • Has inadequate response, intolerable side effect, or contraindication to balsalazide or generic oral mesalamine DR

Quantity Limits: 6 tabs/day Date: GTC: LOWER GASTROINTESTINAL DISORDERS - BOWEL INFLAMMATORY: 1M Brand Name: Generic Name: Uceris Rectal Foam budesonide 2mg rectal foam

Criteria: **Diagnosis** of ulcerative colitis AND Has inadequate response, intolerable side effect or contraindication to hydrocortisone enema AND mesalamine enema

Quantity Limits: 2 canisters/month Date: October 2018 GTC: LOWER GASTROINTESTINAL DISORDERS - BOWEL INFLAMMATORY: 1M Brand Name: Generic Name: Viberzi eluxadoline

Criteria: **Diagnosis** of Irritable Bowel Syndrome with diarrhea AND • Has inadequate response, intolerable side effect or contraindication to loperamide OR diphenoxylate-atropine AND 2 of the following medications: • Bile acid sequestrant (cholestyramine, colestipol) • Antispasmodic (dicyclomine, hyoscyamine) • Tricyclic antidepressant (amitriptyline, nortriptyline)

Quantity Limits: 2 tablets/day Date: GTC: LOWER GASTROINTESTINAL DISORDERS - BOWEL INFLAMMATORY: 1M Brand Name: Generic Name: Cortifoam hydrocortisone

Criteria: **Diagnosis** of ulcerative colitis AND has inadequate response, intolerable side effect or contraindication to hydrocortisone enema

Quantity Limits: 15g/mth Date: December 2016 GTC: LOWER GASTROINTESTINAL DISORDERS - BOWEL INFLAMMATORY: 1M Brand Name: Generic Name: Canasa mesalamine 1000mg rectal suppository

Criteria: **Diagnosis** of ulcerative colitis AND has inadequate response, intolerable side effect, or contraindication to mesalamine enema AND hydrocortisone enema

Quantity Limits: 1 suppository/day Date: October 2018 GTC: LOWER GASTROINTESTINAL DISORDERS - BOWEL INFLAMMATORY: 1M Brand Name: Generic Name: Pentasa mesalamine 250mg, 500mg er oral capsule

Criteria: **Diagnosis** of ulcerative colitis AND • Has inadequate response, intolerable side effect, or contraindication to sulfasalazine AND • Has inadequate response, intolerable side effect, or contraindication to balsalazide or generic oral mesalamine DR

Quantity Limits: 250mg: 4 capsules/day 500mg: 8 capsules/day

Date: October 2018 GTC: LOWER GASTROINTESTINAL DISORDERS - BOWEL INFLAMMATORY: 1M Brand Name: Generic Name: Delzicol mesalamine delayed-release 400mg capsule

Criteria: **Diagnosis** of ulcerative colitis AND • Has inadequate response, intolerable side effect, or contraindication to sulfasalazine AND • Has inadequate response, intolerable side effect, or contraindication to balsalazide or generic oral mesalamine DR

Quantity Limits: 6/day Date: October 2018 GTC: LOWER GASTROINTESTINAL DISORDERS - BOWEL INFLAMMATORY: 1M Brand Name: Generic Name: Rectiv nitroglycerin 0.4% ointment

Criteria: **Diagnosis** of anal fissures AND has inadequate response to fiber AND stool softeners

Quantity Limits: 30gm/month Date: December 2016 GTC: LOWER GASTROINTESTINAL DISORDERS - BOWEL INFLAMMATORY: 1M Brand Name: Generic Name: Dipentum olsalazine sodium

Criteria: **Diagnosis** of ulcerative colitis AND has inadequate response, intolerable side effect, or contraindication to sulfasalazine AND has inadequate response, intolerable side effect, or contraindication to balsalazide or generic oral mesalamine DR

Quantity Limits: 4 tabs/day Date: December 2016 GTC: LOWER GASTROINTESTINAL DISORDERS - BOWEL INFLAMMATORY: 1M Brand Name: Generic Name: Entyvio vedolizumab

Criteria: **Diagnosis** of moderate to severe Crohn’s disease AND • Has been evaluated by a gastroenterologist AND • Has inadequate response, intolerable side effect, or contraindication to azathioprine or mercaptopurine AND • Has inadequate response, intolerable side effects to Remicade **Diagnosis** of moderate to severe ulcerative colitis AND • Has been evaluated by a gastroenterologist AND • Has inadequate response, intolerable side effect, or contraindication to systemic aminosalicylate AND • Has inadequate response, intolerable side effect, or contraindication to azathioprine or mercaptopurine AND • Has inadequate response, intolerable side effect, or contraindication to Remicade

Quantity Limits: Crohn’s/UC Induction dose: Wk 0: 300mg Wk 2: 300mg Wk 6: 300mg Maintenance dose: 300mg every 8 weeks

Date: GTC: NEUROLOGICAL DISEASE - MISCELLANEOUS: 2I Brand Name: Generic Name: Lemtrada

Criteria: **Diagnosis** of relapsing/remitting MS (RRMS) AND • Has been evaluated by a neurologist AND • Has inadequate response, intolerable side effect, or contraindication to 2 of the following: Copaxone, Avonex, Rebif, Betaseron, Extavia, Plegridy, Aubagio, Tecfidera, Gilenya or Tysabri or medical justification why they can’t be used AND • Not being used in combination with another MS disease-modifying therapy (Copaxone, Avonex, Rebif, Betaseron, Extavia, Plegridy, Aubagio Tecfidera, Gilenya or Tysabri)

Quantity Limits: 1st : 12mg/day x 5 days 2nd: 12mg/day x 3 days - 2nd dose given 12 mths after 1st dose

Date: GTC: NEUROLOGICAL DISEASE - MISCELLANEOUS: 2I Brand Name: Generic Name: Ampyra dalfampridine

Criteria: To improve walking speed in a patient with MS AND • Has been evaluated by a neurologist AND • Patient is ambulatory AND patient has completed a baseline walking 25 ft walk test between 8-45 seconds.

For continuation of therapy: • The patient has demonstrated an improvement from baseline in the timed 25 ft. walk test.

Quantity Limits: 10mg PO BID Date: September 2017 GTC: NEUROLOGICAL DISEASE - MISCELLANEOUS: 2I Brand Name: Generic Name: Nuedexta dextromethorphan/quinidine 20/10mg capsule

Criteria: Patient must be 18 years or older AND **Diagnosis** of PBA (pseudobulbar affect) AND • Must be prescribed by a neurologist or psychiatrist

Quantity Limits: Date: October 2018 GTC: NEUROLOGICAL DISEASE - MISCELLANEOUS: 2I Brand Name: Generic Name: Tecfidera dimethyl fumarate

Criteria: **Diagnosis** of relapsing/remitting MS (RRMS) AND • Has been evaluated by a neurologist AND • Trial and failure of Glatopa* or glatiramer acetate* AND • Not being used in combination with another MS disease-modifying therapy (Copaxone, Avonex, Rebif, Betaseron, Extavia, Aubagio, Gilenya or Tysabri)

*Prior Authorization required

Quantity Limits: Date: October 2018 GTC: NEUROLOGICAL DISEASE - MISCELLANEOUS: 2I Brand Name: Generic Name: Gilenya fingolimod

Criteria: **Diagnosis** of relapsing/remitting MS (RRMS) AND • Has been evaluated by a neurologist AND • Trial and failure of Glatopa* or glatiramer acetate* AND • Not being used in combination with another MS disease-modifying therapy (Copaxone, Avonex, Rebif, Betaseron, Extavia, Aubagio, Tecfidera or Tysabri)

*Prior Authorization required

Quantity Limits: Date: October 2018 GTC: NEUROLOGICAL DISEASE - MISCELLANEOUS: 2I Brand Name: Generic Name: Gralise ER, Gralise 30-Day Starter Pack gabapentin extended-release tablet

Criteria: **Diagnosis** of post-herpetic neuralgia AND • patient tried and failed a dose of at least 1800mg formulary gabapentin AND • Trial and failure of Lyrica AND • Submission of medical records documenting: - Details of failure/intolerance to formulary gabapentin AND - Which attempts were taken to resolve these

Quantity Limits: Date: September 2017 GTC: NEUROLOGICAL DISEASE - MISCELLANEOUS: 2I Brand Name: Generic Name: Horizant gabapentin enacarbil oral tablet, extended release 300mg, 600mg

Criteria: **Diagnosis** of moderate to severe primary restless leg syndrome AND patient is 18 year of age or older AND patient has experienced treatment failure or is intolerant to ropinirole or pramipexole

**Diagnosis** of post-herpetic neuralgia AND patient tried and failed a dose of at least 1800 mg generic gabapentin or experienced intolerance to generic gabapentin

Quantity Limits: **Diagnosis** of RLS: Maximum daily dose of 600mg (600mg at bedtime) **Diagnosis** of post-herpetic neuralgia: Maximum daily dose of 1200mg (600mg twice daily)

Date: October 2018 GTC: NEUROLOGICAL DISEASE - MISCELLANEOUS: 2I Brand Name: Generic Name: Glatiramer Acetate Pre-Filled Syringe glatiramer acetate 20mg/ml & 40mg/ml syringe

Criteria: **Diagnosis** of relapsing/remitting MS (RRMS) AND • Has been evaluated by a neurologist AND • Not being used in combination with another MS disease-modifying therapy (Copaxone, Avonex, Rebif, Betaseron, Extavia, Plegridy, Tecfidera, Gilenya or Tysabri)

Quantity Limits: 20mg: 1 subcutaneous injection every day 40mg: 1 subcutaneous injection 3 times per week

Date: October 2018 GTC: NEUROLOGICAL DISEASE - MISCELLANEOUS: 2I Brand Name: Generic Name: Copaxone glatiramer acetate 20mg/ml & 40mg/ml syringe

Criteria: **Diagnosis** of relapsing/remitting MS (RRMS) AND Has been evaluated by a neurologist AND Trial and failure of Glatopa* or glatiramer acetate* AND Not being used in combination with another MS disease-modifying therapy (Avonex, Rebif, Betaseron, Extavia, Aubagio, Tecfidera, Gilenya or Tysabri)

*Prior Authorization Required

Quantity Limits: 20mg: 1 subcutaneous injection every day 40mg: 1 subcutaneous injection 3 times per week

Date: October 2018 GTC: NEUROLOGICAL DISEASE - MISCELLANEOUS: 2I Brand Name: Generic Name: Glatopa glatiramer acetate 20mg/ml & 40mg/ml syringe

Criteria: **Diagnosis** of relapsing/remitting MS (RRMS) AND • Has been evaluated by a neurologist AND • Not being used in combination with another MS disease-modifying therapy (Copaxone, Avonex, Rebif, Betaseron, Extavia, Plegridy, Tecfidera, Gilenya or Tysabri)

Quantity Limits: 20mg: 1 subcutaneous injection every day 40mg: 1 subcutaneous injection 3 times per week

Date: October 2018 GTC: NEUROLOGICAL DISEASE - MISCELLANEOUS: 2I Brand Name: Generic Name: Avonex interferon beta-1a

Criteria: **Diagnosis** of relapsing/remitting MS (RRMS) AND • Has been evaluated by a neurologist AND • Trial and failure of Glatopa* or glatiramer acetate* AND • Not being used in combination with another MS disease-modifying therapy (Copaxone, Rebif, Betaseron, Extavia, Aubagio, Tecfidera, Gilenya or Tysabri)

*Prior Authorization Required

Quantity Limits: Date: October 2018 GTC: NEUROLOGICAL DISEASE - MISCELLANEOUS: 2I Brand Name: Generic Name: Plegridy interferon beta-1a

Criteria: **Diagnosis** of relapsing/remitting MS (RRMS) AND • Has been evaluated by a neurologist AND • Trial and failure of Glatopa* or glatiramer acetate* AND • Not being used in combination with another MS disease-modifying therapy (Copaxone, Avonex, Rebif, Betaseron, Extavia, Aubagio, Tecfidera, Gilenya or Tysabri)

*Prior Authorization Required

Quantity Limits: Date: October 2018 GTC: NEUROLOGICAL DISEASE - MISCELLANEOUS: 2I Brand Name: Generic Name: Rebif interferon beta-1a

Criteria: **Diagnosis** of relapsing/remitting MS (RRMS) AND • Has been evaluated by a neurologist AND • Trial and failure of Glatopa* or glatiramer acetate* AND • Not being used in combination with another MS disease-modifying therapy (Copaxone, Avonex, Betaseron, Extavia, Aubagio, Tecfidera, Gilenya or Tysabri)

*Prior Authorization Required

Quantity Limits: Date: GTC: NEUROLOGICAL DISEASE - MISCELLANEOUS: 2I Brand Name: Generic Name: Betaseron interferon beta-1b

Criteria: **Diagnosis** of relapsing/remitting MS (RRMS) AND • Has been evaluated by a neurologist AND • Has intolerable side effect to Extavia AND • Not being used in combination with another MS disease-modifying therapy (Copaxone, Avonex, Rebif, Extavia, Aubagio, Tecfidera, Gilenya or Tysabri)

Quantity Limits: 0.3mg SC QOD Date: GTC: NEUROLOGICAL DISEASE - MISCELLANEOUS: 2I Brand Name: Generic Name: Extavia interferon beta-1b

Criteria: **Diagnosis** of relapsing/remitting MS (RRMS) AND • Has been evaluated by a neurologist AND • Not being used in combination with another MS disease-modifying therapy (Copaxone, Avonex, Rebif, Betaseron, Aubagio, Tecfidera, Gilenya or Tysabri)

Quantity Limits: 0.3mg SC QOD Date: GTC: NEUROLOGICAL DISEASE - MISCELLANEOUS: 2I Brand Name: Generic Name: Savella milnacipran

Criteria: **Diagnosis** is fibromyalgia AND If patient has inadequate response, intolerable side effect, or contraindication to duloxetine, a TCA (amitriptyline, imipramine, desipramine, nortriptyline) AND One (1) other formulary agents from the following: gabapentin (>1200mg/day), venlafaxine, cyclobenzaprine, tramadol, or SSRIs (fluoxetine, paroxetine, sertraline, citalopram, escitalopram).

Quantity Limits: 2 capsules/day Dose Pack: 1x authorization for titration

Date: GTC: NEUROLOGICAL DISEASE - MISCELLANEOUS: 2I Brand Name: Generic Name: Novantrone mitoxantrone

Criteria: **Diagnosis** of relapsing/remitting MS (RRMS) or secondary progressive relapsing MS AND • Has been evaluated by a neurologist AND • Has inadequate response, intolerable side effect, or contraindication to 2 of the following: Copaxone, Avonex, Rebif, Betaseron, Extavia, Plegridy, Aubagio, Tecfidera, Gilenya, and Tysabri or medical justification why they can’t be used

Quantity Limits: 12mg/m2 Q 3 months Date: GTC: NEUROLOGICAL DISEASE - MISCELLANEOUS: 2I Brand Name: Generic Name: Tysabri natalizumab

Criteria: **Diagnosis** of relapsing/remitting MS (RRMS) AND • Has been evaluated by a neurologist AND • Has inadequate response, intolerable side effect, or contraindication to one of the following: Copaxone, Avonex, Rebif, Betaseron, Extavia, Plegridy, Aubagio, Tecfidera, or Gilenya or medical justification why they can’t be used AND • Not being used in combination with another MS disease-modifying therapy (Copaxone, Avonex, Rebif, Betaseron, Extavia, Plegridy, Aubagio, Tecfidera, or Gilenya)

**Diagnosis** of moderate to severe Crohn’s disease AND • Has been evaluated by a gastroenterologist AND • Has inadequate response, intolerable side effect, or contraindication to azathioprine or mercaptopurine • Has inadequate response, intolerable side effects to Humira AND Remicade.

Quantity Limits: Crohn’s/MS: 300mg IV every 4 weeks

Date: October 2018 GTC: NEUROLOGICAL DISEASE - MISCELLANEOUS: 2I Brand Name: Generic Name: Ocrevus ocrelizumab 300mg/10ml vial

Criteria: **Diagnosis** of Relapsing Forms of Multiple Sclerosis AND ≥ 18 years of ageAND Trial and failure of Glatopa (glatiramer acetate) and one another MS therapy including Avonex (interferon beta-1a), Rebif (interferon beta 1-a), Betaseron/Extavia (interferon beta-1b), Plegridy (peginterferon beta1a), Copaxone (glatiramer acetate), Aubagio (teriflunomide tablets), Gilenya (fingolimod capsules), Tecfidera (dimethyl fumarate delayed-release capsules), Tysabri (Natalizumab) or Lemtrada (alemtuzumab) or medical justification why they can’t be used. AND Prescribed by a physician who specializes in the treatment of MS and/or a neurologist.

**Diagnosis** of Primary Progressive Multiple Sclerosis AND ≥ 18 years of age AND Prescribe by a physician who specializes in the treatment of MS and/or a neurologist.

Quantity Limits: Date: October 2018 GTC: NEUROLOGICAL DISEASE - MISCELLANEOUS: 2I Brand Name: Generic Name: Aubagio teriflunomide

Criteria: **Diagnosis** of relapsing/remitting MS (RRMS) AND • Has been evaluated by a neurologist AND • Trial and failure of Glatopa* or glatiramer acetate* AND • Not being used in combination with another MS disease-modifying therapy (Copaxone, Avonex, Rebif, Betaseron, Extavia, Tecfidera, Gilenya or Tysabri)

*Prior Authorization Required

Quantity Limits: Date: October 2018 GTC: NEUROLOGICAL DISEASE - MISCELLANEOUS: 2I Brand Name: Generic Name: Ingrezza valbenazine 40mg & valbenazine 80mg oral capsule

Criteria: **Diagnosis** of moderate to severe tardive dyskinesia AND • Prescribed by or in consultation with a neurologist or psychiatrist AND • Must be 18 years of age or older AND • If tardive dyskinesia is caused by a drug, that drug must be switched to an alternative or tried at a lower dose, or provide medical justification on why this cannot be done.

Quantity Limits: 1 capsule/day Date: GTC: NEUROLOGICAL DISEASE - MISCELLANEOUS: 2I Brand Name: Generic Name: Rilutek riluzole

Criteria: **Diagnosis** of amyotrophic lateral sclerosis

Quantity Limits: 2 tablets/day Date: GTC: NOVEL HEART FAILURE MEDICATIONS: 0L Brand Name: Generic Name: Corlanor ivabradine

Criteria: **Diagnosis** of heart failure AND • Has left ventricular ejection fraction ≤ 35% AND • Is in normal sinus rhythm with heart rate ≥70 beats per minute AND • Are on maximally tolerated doses of beta-blockers OR have a contraindication to beta-blocker use

Quantity Limits: 2 tablets/day

Date: December 2017 GTC: NOVEL HEART FAILURE MEDICATIONS: 0L Brand Name: Generic Name: Ranexa ranolazine oral tablet, extended release 500mg, 1000mg

Criteria: **Diagnosis** of Angina AND has inadequate response, intolerable side effect, or contraindication to beta blocker AND calcium channel blocker or Long acting Nitrate

Quantity Limits: Date: December 2017 GTC: NOVEL HEART FAILURE MEDICATIONS: 0L Brand Name: Generic Name: Entresto sacubitril, valsartan oral tablet 24mg-26mg, 49mg-51mg,97mg-103mg

Criteria: **Diagnosis** of heart failure (NYHA Class II-IV) AND left ventricular ejection fraction ≤ 40% AND Prescribed by cardiologist AND Documentation provided regarding patient’s recent hospitalization due to CHF exacerbation or current clinical instability due to CHF

**Diagnosis** of heart failure AND left ventricular ejection fraction ≤ 40% AND has inadequate response, intolerable side effect, or contraindication to 1 ACE inhibitor (lisinopril, benazepril, ramipril, quinapril, fosinopril, enalapril, trandolapril) OR 1 ARB (losartan, valsartan, irbesartan, telmisartan)

Quantity Limits: Date: December 2016 GTC: ORAL/PHARYNGEAL DISORDERS: 1D Brand Name: Generic Name: Arestin minocycline HCL 1mg microspheres

Criteria: **Diagnosis** of periodontitis AND has inadequate response, intolerable side effect, or contraindication to formulary antimicrobials: amoxicillin, metronidazole, azithromycin, and doxycycline

Quantity Limits: Date: June 2018 GTC: OTHER DRUGS: 2H Brand Name: Generic Name: Ferriprox deferiprone 500mg oral tablet, deferiprone 100mg/ml oral solution

Criteria: **Diagnosis** of transfuional iron overload due to thalassemia syndrome AND • Has an indadequate response, intolerance or contraindication to deferoxamine (Desferal) or Exjade or Jadenu AND • Serum ferritin levels that are consistently >2500 mcg/L (demonstrated by at least 2 lab values in the previous 3 months) AND • An absolute neutrophil count (ANC) > 1.5 x 109/L AND • Prescribed by a hematologist/oncologist

Reauthorization: Clinical response to treatment and continues to require therapy for serum ferritin level consistently >500mcg/L (demonstrated by at least 2 lab values in the previous 3 months) AND an absolute neutrophil count > 1.5 x 109/L

Quantity Limits: Date: GTC: OTHER DRUGS: 2H Brand Name: Generic Name: Enteral Nutritional Formulas enteral nutritional formulas Some Examples Are: Ensure, Glucerna, Jevity, Boost, Pediasure, Peptamen

Criteria: Refer to Alliance Enteral Nutrition Products policy 403-1136 which can be found in the provider manual.

Quantity Limits: Date: GTC: OTHER DRUGS: 2H Brand Name: Generic Name: Hydergine ergoloid mesylates

Criteria: **Diagnosis** of dementia AND • Mini Mental State Examination (MMSE) score <23, or an equivalent score on another screening test; AND • Approval for 0.5mg sublingual tablets only

Quantity Limits: 6 tablets/day Date: October 2018 GTC: OTHER DRUGS: 2H Brand Name: Generic Name: Somatuline Depot lanreotide acetate 60mg/0.2ml, 90mg/0.3ml & 120mg/0.5ml syringe

Criteria: **Diagnosis** of Acromegaly AND Member has a high pretreatment IGF-1 level for age and/or gender AND Member had an inadequate or partial response to surgery or radiotherapy OR there is a clinical reason why the member has not had surgery or radiotherapy.

For treatment of gastroenteropancreatic neuroendocrine tumors or carcinoid syndrome.

Quantity Limits: Date: GTC: OTHER DRUGS: 2H Brand Name: Generic Name: Carnitor levocarnitine

Criteria: **Diagnosis** of levocarnitine deficiency

Quantity Limits: 9 tablets/day Date: GTC: OTHER DRUGS: 2H Brand Name: Generic Name: Megace, Megace Es megestrol acetate 20mg & 40mg tablet, 400mg/10ml oral suspension & 625mg/5ml oral suspension

Criteria: **Diagnosis** of weight loss, cachexia, or to stimulate appetite, or for palliative treatment of advanced breast or endometrial carcinoma AND the request is for megestrol acetate 400mg/10ml suspension or tablets

For Megace ES (625mg/5ml) suspension: • Patient has intolerable side effect to megestrol acetate 400mg/10ml.

Quantity Limits: Max dose: 20mL/day Date: October 2018 GTC: OTHER DRUGS: 2H Brand Name: Generic Name: Sandostatin LAR Depot octreotide depot form (for injectable suspension); octreotide acetate lar depot 10mg, 20mg & 30mg kit

Criteria: **Diagnosis** of Acromegaly AND • Member has a high pretreatment IGF-1 level for age and/or gender AND • Member had an inadequate or partial response to surgery or radiotherapy OR there is a clinical reason why the member has not had surgery or radiotherapy AND Member who have responded to and tolerated subcutaneous octreotide and have medical justification for switching to long acting depot form

For treatment of gastroenteropancreatic neuroendocrine tumors or carcinoid syndrome based on NCCN guidelines

Quantity Limits: Date: October 2018 GTC: OTHER DRUGS: 2H Brand Name: Generic Name: Botox onabotulinumtoxina 100-unit & 200-unit vial

Criteria: **Diagnosis** of migraine headaches lasting 4 hours a day or longer with frequency occurring 15 or more days per month for 3 or more months AND Has inadequate response,intolerable side effect, or contraindication to 3 preventative formulary medications x 12 weeks or complete intolerance, including: • 1 agent from beta-blockers (e.g., atenolol, propranolol, metoprolol) • 1 agent from tricyclic antidepressants (TCA) (e.g., amitriptyline) AND • 1agent from anticonvulsants (e.g., divalproex, topiramate)

Quantity Limits: Max dose: 200-units every 12 weeks (84-days) Date: June 2019 GTC: OTHER DRUGS: 2H Brand Name: Generic Name: Tinidazole tinidazole

Criteria: **Diagnosis** of Amebiasis AND Has inadequate response, intolerable side effect or contraindication to 1 of the following medications: metronidazole or doxycycline

**Diagnosis** of Bacterial Vaginosis AND Has inadequate response, intolerable side effect or contraindication to 1 of the following medications: metronidazole or clindamycin

**Diagnosis** of Giardiasis

**Diagnosis** of Trichomoniasis AND Has inadequate response, intolerable side effect or contraindication to metronidazole

Quantity Limits:

Date: June 2018 GTC: OTHER DRUGS: 2H Brand Name: Generic Name: Exjade deferasirox dispersible tablet (for oral suspension); 125mg, 250mg & 500mg dispersible tablet

Criteria: **Diagnosis** of chronic transfusional iron overload due to blood transfusions AND • Prescribed by a hematologist/oncologist AND • Serum ferritin levels are consistently > 1000mcg/L (demonstrated by at least 2 lab values in the previous 3 months) AND • Member is 2 years or older

OR

**Diagnosis** of chronic iron overload resulting from non-tranfusion-dependent thalassemia (NTDT) AND • Liver iron iron levels > 5mg Fe/g and serum ferritin levels > 300mcg/L (demonstrated by lab values in the previous 3 months) AND • Member is 10 years or older

Reauthorization: Chronic iron overload due to blood transfusion AND • Serum ferritin levels are consistently > 500mcg/L OR • NTDT AND • Liver iron iron levels > 5mg Fe/g and serum ferritin levels not less than 300mcg/L.

Quantity Limits:

Date: June 2018 GTC: OTHER DRUGS: 2H Brand Name: Generic Name: Jadenu & Jadenu Sprinkle deferasirox oral tablet; 90mg, 180mg, & 360mg oral tablet, deferasirox granule packet; 90mg, 180mg, & 360mg granule packet Criteria: **Diagnosis** of chronic transfusional iron overload due to blood transfusions AND prescribed by a hematologist/oncologist AND serum ferritin levels are consistently > 1000mcg/L (demonstrated by at least 2 lab values in the previous 3 months) AND member is 2 years or older

OR

**Diagnosis** of chronic iron overload resulting from non-tranfusion-dependent thalassemia (NTDT) AND liver iron iron levels > 5mg Fe/g and serum ferritin levels > 300mcg/L (demonstrated by lab values in the previous 3 months) AND member is 10 years or older

Renewal: Chronic iron overload due to blood transfusion AND serum ferritin levels are consistently > 500mcg/L OR NTDT AND liver iron iron levels > 5mg Fe/g and serum ferritin levels not less than 300mcg/L

Quantity Limits: Date: October 2018 GTC: OTHER RESPIRATORY DISORDERS: 1Y Brand Name: Generic Name: Pulmozyme dornase alfa 1mg/ml ampule

Criteria: Pulmozyme is being used in the management of cystic fibrosis; AND • Pulmozyme will be in conjunction with standard therapies for the management of cystic fibrosis (e.g., chest physiotherapy, bronchodilators, antibiotics, etc.); AND • Documentation must be submitted of a forced vital capacity (FVC) of > 40% of predicted. AND

For any request for twice daily Pulmozyme, documentation must be submitted of an adequate trial of once daily dosing.

Quantity Limits: Date: June 2018 GTC: OTHER RESPIRATORY DISORDERS: 1Y Brand Name: Generic Name: Ofev esylate

Criteria: **Diagnosis** of Idiopathic Pulmonary fibrosis (IPF) confirmed by high resolution computed tomography (HRCT) or surgical lung biopsy AND • Has been prescribed by or in consultation with a pulmonologist AND • Patient has documented Forced Vital Capacity (FVC) greater than or equal 50% at base line within the last 60 days AND • Patient is concurrently not taking Esbriet (pirfenidone)

Quantity Limits: 2 caps per day Date: August 2019 GTC: OTHER RESPIRATORY DISORDERS: 1Y Brand Name: Generic Name: Esbriet pirfenidone

Criteria: **Diagnosis** of Idiopathic Pulmonary fibrosis (IPF) confirmed by high resolution computed tomography (HRCT) or surgical lung biopsy AND • Has been prescribed by or in consultation with a pulmonologist AND • Patient has documented Forced Vital Capacity (FVC) greater than or equal 50% at base line within the last 60 days AND • Patient is not concurrently taking Ofev (nintendanib)

Quantity Limits: Date: June 2018 GTC: OTHER RESPIRATORY DISORDERS: 1Y Brand Name: Generic Name: Symdeko tezacaftor/ivacaftor

Criteria: **Diagnosis** of Cystic Fibrosis (CF) AND Submission of laboratory results documenting one of the following: - The patient is homozygous for the F508del mutation in the CFTR gene or -The patient has at least one of the following mutations in the CFTR gene that is responsive to Symdeko: A455E, A1067T, D110E, D110H, D579G, D1152H, D1270N, E56K, E193K, E831X, F1052V, F1074L, K1060T, L206W, P67L, R74W, R1070W, R117C, R347H, R352Q, 51070W, S945L, S977F, 711+3A→G, 2789+5G→A, 3272-26A→G, 3849+10kbC→T AND -patient is greater than or equal to 12 years of ageAND -prescribed by or in consultation with a specialist affiliated with a CF care center.

Reauthorization: Provider must attent that the patient has achieved a clinically meaningful response while on Symdeko therapy to one or more of the following: - Decreased pulmonary exacerbations compared to pretreatment baseline -Improvement or stabilization of lung function as measured by percent predicted FEV1 compared to baseline or decrease in the rate of decline of lung function - Weight gain -Improvement in quality of life by Cystic Fibrosis Questionnaire-revised (CFQ-R) respiratory domain score

Quantity Limits: 2 tabs per day Date: March 2018 GTC: PAIN MANAGEMENT - ANALGESICS: 0M Brand Name: Generic Name: Duradin acetaminophen; dichloralphenazone; isometheptene

Criteria: **Diagnosis** of migraine AND 18 years of age or older AND Inadequate response, intolerable side effect, or contraindication to - 2 formulary TRIPTANS (sumatriptan AND rizatriptan/ODT) AND - 2 formulary NSAIDS (naproxen, diclofenac, ibuprofen) AND NTE 8 tabs/ day

Quantity Limits: Date: GTC: PAIN MANAGEMENT - ANALGESICS: 0M Brand Name: Generic Name: Butrans buprenorphine patch

Criteria: ***IHSS members only. Carve-out for Medi-Cal*** **Diagnosis** of severe chronic pain 1. Chart notes and clear treatment plan provided by MD 2. Previous treatment with short-acting opioids 3. Inadequate response, intolerable side effect, or contraindication to formulary long-acting opioid morphine sulfate ER tablets (MS Contin) 4. Replacing current equianalgesic (or higher) dose of another opioid

Quantity Limits: 1 patch/wk 4 patches/28 days

Date: March 2018 GTC: PAIN MANAGEMENT - ANALGESICS: 0M Brand Name: Generic Name: Stadol, Stadol NS butophhanol, butophhanol nasal spray

Criteria: **Diagnosis** of migraine AND • 18years of age or older • Inadequate response, intolerable side effect, or contraindication to - 2 TRIPTANS such as rizatriptan/rizatriptan ODT and sumatriptan (oral/ nasal/injectable) AND - 2 NSAIDS (naproxen, diclofenac, ibuprofen)

Quantity Limits: Quantity limit of 1 box per 30 days Date: March 2018 GTC: PAIN MANAGEMENT - ANALGESICS: 0M Brand Name: Generic Name: Cambia diclofenac

Criteria: **Diagnosis** of migraine AND • 18years of age or older • Inadequate response, intolerable side effect, or contraindication to - 2 TRIPTANS such as rizatriptan/rizatriptan ODT and sumatriptan (oral/ nasal/injectable) AND - 2 NSAIDS (naproxen, diclofenac, ibuprofen)

Quantity Limits: Quantity limit of 1 box per 30 days Date: March 2018 GTC: PAIN MANAGEMENT - ANALGESICS: 0M Brand Name: Generic Name: Migranal dihydroergotamine spray

Criteria: **Diagnosis** of migraine AND • 18years of age or older • Inadequate response, intolerable side effect, or contraindication to - 2 TRIPTANS such as rizatriptan/rizatriptan ODT and sumatriptan (oral/ nasal/injectable) AND - 2 NSAIDS (naproxen, diclofenac, ibuprofen)

Quantity Limits: Quantity limit of 1 box per 30 days Date: Modify GTC: PAIN MANAGEMENT - ANALGESICS: 0M Brand Name: Generic Name: Aimovig erenumab-aooe 70mg/ml autoinjector syringe

Criteria: Initial Criteria 1. Prescribed by or in consultation with a neurologist. 2. The member is ≥ 18 years of age. 3. Documentation submitted that meets one of the following: a. A **Diagnosis** of episodic migraines and all of the following must be met: i. Documentation member has at least 4 to 14 migraine days per month, but no more than 14 headache days per month. ii. Trial of at least 3 months and documented failure, contraindication, or intolerance to all of the following prophylactic therapies listed from each of the drug classes below: - Tricyclic antidepressant (TCA) (e.g., amitriptyline) - Anticonvulsants (e.g., divalproex, topiramate) - Beta‐blockers (e.g., atenolol, propranolol, metoprolol) iii. Aimovig will not be used in combination with another CGRP inhibitor (Ajovy, Emgality). iv. Aimovig with not be used in combination with Botox (onabotulinumtoxinA). b. A **Diagnosis** of chronic migraines and all of the following must be met: i. Documentation member has been evaluated for medication overuse headache (MOH) and if MOH is diagnosed then documentation has been submitted the member has successfully tapered off the offending medication. ii. Documentation member has greater than or equal to 15 headache days per month, of which at least 8 must be migraine days for at least 3 months. iii. Trial of at least 3 months and documented failure, contraindication, or intolerance to all of the following prophylactic therapies listed from each of the drug classes below: - Tricyclic antidepressant (TCA) (e.g., amitriptyline) - Anticonvulsants (e.g., divalproex, topiramate) - Beta‐blockers (e.g., atenolol, propranolol, metoprolol). iv. Aimovig will not be used in combination with another CGRP inhibitor (Ajovy, Emgality). v. Aimovig with not be used in combination with Botox (onabotulinumtoxinA).

Continuation Criteria: 1. Documentation submitted member has experienced a positive response to therapy, demonstrated by a reduction in headache frequency and/or intensity compared to baseline. 2. The number of migraine days per month must be documented and submitted. Per prescription claims history the use of acute migraine medications (e.g., NSAIDs, triptans, opiates and other migraine medications) has decreased while on therapy. 3. Per prescription claims history member has demonstrated complete adherence to monthly fills of Aimovig. If nonadherence present then documentation must be submitted, by chart notes, that the provider has addressed the nonadherence and a treatment plan is in place to prevent future non‐adherence. 4. Documentation that member continues to be monitored for Medication Overuse Headache (MOH) and offending medications, if applicable.

Quantity Limits: The use of two (2) 70 mg (140 mg) injections per month will require documentation of failure of 70 mg once a month after a 90 day trial with complete adherence per prescription claims. Failure is defined as not meeting the continuation criteria of a positive response to therapy demonstrated by a reduction in headache frequency and/or intensity compared to baseline. Date: March 2018 GTC: PAIN MANAGEMENT - ANALGESICS: 0M Brand Name: Generic Name: Ergomar ergotamine sublingual tablets

Criteria: **Diagnosis** of migraine AND • 18 years of age or older AND • Inadequate response, intolerable side effect, or contraindication to - 2 formulary TRIPTANS (sumatriptan AND rizatriptan/ODT) AND - 2 formulary NSAIDS (naproxen, diclofenac, ibuprofen)

Quantity Limits: Quantity limit 10 tablets per 30 days Date: March 2018 GTC: PAIN MANAGEMENT - ANALGESICS: 0M Brand Name: Generic Name: Cafergot ergotamine/caffeine

Criteria: **Diagnosis** of migraine AND • 18 years of age or older AND • Inadequate response, intolerable side effect, or contraindication to - 2 formulary TRIPTANS (sumatriptan AND rizatriptan/ODT) AND - 2 formulary NSAIDS (naproxen, diclofenac, ibuprofen)

Quantity Limits: Quantity limit 24 tablets per 30 days Date: GTC: PAIN MANAGEMENT - ANALGESICS: 0M Brand Name: Generic Name: Actiq, Fentora, Onsolis, Abstral, Subsys, Lazanda fentanyl oral lozenge, tablet, spray, film, etc.

Criteria: For management of severe breakthrough cancer pain 1. Clear treatment plan provided by MD 2. Previous treatment with short-acting opioids 3. Must be on maintenance (around-the-clock) opioid concurrently

Quantity Limits: Date: GTC: PAIN MANAGEMENT - ANALGESICS: 0M Brand Name: Generic Name: Duragesic fentanyl patch

Criteria: **Diagnosis** of severe chronic pain AND 1. Chart notes and clear treatment plan provided by MD 2. Previous treatment with short-acting opioids AND 3. Inadequate response, intolerable side effect, or contraindication to formulary long-acting opioid morphine sulfate ER tablets (MS Contin) or Buprenorphine 4. Replacing current equianalgesic (or higher) dose of another opioid which patient was on for at least 1 week

Quantity Limits: Date: September 2016 GTC: PAIN MANAGEMENT - ANALGESICS: 0M Brand Name: Generic Name: Formulary Opioid Medications Limited By Quantity Supply: formulary opioid medications limited by quantity supply: Hydrocodone/APAP, Hydromorphone IR Tablets, Oxycodone/APAP, hydrocodone/APAP, hydromorphone IR tablets, oxycodone/APAP, oxycodone IR, morphine sulfate IR, morphine Oxycodone IR, Morphine Sulfate IR, Morphine Sulfate ER Tablets, sulfate ER tablets, etc. etc.

Criteria: **Diagnosis** of cancer, palliative, or hospice pain Approve as requested under HICL, with 999 fills, and DOS end date: 12/31/2999 (leave end date open in MedAccess)

Quantity Limits: Date: GTC: PAIN MANAGEMENT - ANALGESICS: 0M Brand Name: Generic Name: Ajovy fremanezumab-vfrm 225mg/1.5ml prefilled syringe

Criteria: Initial Criteria 1. Prescribed by or in consultation with a neurologist. 2. The member is ≥ 18 years of age. 3. Documentation submitted that meets one of the following: a. A **Diagnosis** of episodic migraines and all of the following must be met: i. Documentation member has at least 4 to 14 migraine days per month, but no more than 14 headache days per month. ii. Trial of at least 3 months and documented failure, contraindication, or intolerance to all of the following prophylactic therapies listed from each of the drug classes below: - Tricyclic antidepressant (TCA) (e.g., amitriptyline) - Anticonvulsants (e.g., divalproex, topiramate) - Beta‐blockers (e.g., atenolol, propranolol, metoprolol) iii. Ajovy will not be used in combination with another CGRP inhibitor (Aimovig, Emgality). iv. Ajovy with not be used in combination with Botox (onabotulinumtoxinA). b. A **Diagnosis** of chronic migraines and all of the following must be met: i. Documentation member has been evaluated for medication overuse headache (MOH) and if MOH is diagnosed then documentation has been submitted the member has successfully tapered off the offending medication. ii. Documentation member has greater than or equal to 15 headache days per month, of which at least 8 must be migraine days for at least 3 months. iii. Trial of at least 3 months and documented failure, contraindication, or intolerance to all of the following prophylactic therapies listed from each of the drug classes below: - Tricyclic antidepressant (TCA) (e.g., amitriptyline) - Anticonvulsants (e.g., divalproex, topiramate) - Beta‐blockers (e.g., atenolol, propranolol, metoprolol). iv. Ajovy will not be used in combination with another CGRP inhibitor (Aimovig, Emgality). v. Ajovy with not be used in combination with Botox (onabotulinumtoxinA).

Continuation Criteria: 1. Documentation submitted member has experienced a positive response to therapy, demonstrated by a reduction in headache frequency and/or intensity compared to baseline. 2. The number of migraine days per month must be documented and submitted. Per prescription claims history the use of acute migraine medications (e.g., NSAIDs, triptans, opiates and other migraine medications) has decreased while on therapy. 3. Per prescription claims history member has demonstrated complete adherence to monthly fills of Ajovy. If nonadherence present then documentation must be submitted, by chart notes, that the provider has addressed the nonadherence and a treatment plan is in place to prevent future non‐adherence. 4. Documentation that member continues to be monitored for Medication Overuse Headache (MOH) and offending medications, if applicable.

Quantity Limits: 225mg subcutaneous once monthly or 675mg subcutaneous every 3 months. (The 675mg quarterly dosage is administered as three (3) consecutive injections of 225mg each). Date: October 2018 GTC: PAIN MANAGEMENT - ANALGESICS: 0M Brand Name: Generic Name: Emgality galcanezumab-gnlm 120mg/ml prefilled pen

Criteria: Initial Criteria 1. Prescribed by or in consultation with a neurologist. 2. The member is ≥ 18 years of age. 3. Documentation submitted that meets one of the following: **Diagnosis** of episodic migraines and all of the following must be met: i. Documentation member has at least 4 to 14 migraine days per month, but no more than 14 headache days per month. ii. Trial of at least 3 months and documented failure, contraindication, or intolerance to all of the following prophylactic therapies listed from each of the drug classes below: - Tricyclic antidepressant (TCA) (e.g., amitriptyline) - Anticonvulsants (e.g., divalproex, topiramate) - Beta‐blockers (e.g., atenolol, propranolol, metoprolol) iii. Emgality will not be used in combination with another CGRP inhibitor (Aimovig, Ajovy). iv. Emgality with not be used in combination with Botox (onabotulinumtoxinA).

**Diagnosis** of chronic migraines and all of the following must be met: i. Documentation member has been evaluated for medication overuse headache (MOH) and if MOH is diagnosed then documentation has been submitted the member has successfully tapered off the offending medication. ii. Documentation member has greater than or equal to 15 headache days per month, of which at least 8 must be migraine days for at least 3 months. iii. Trial of at least 3 months and documented failure, contraindication, or intolerance to all of the following prophylactic therapies listed from each of the drug classes below: - Tricyclic antidepressant (TCA) (e.g., amitriptyline) - Anticonvulsants (e.g., divalproex, topiramate) - Beta‐blockers (e.g., atenolol, propranolol, metoprolol). iv. Emgality will not be used in combination with another CGRP inhibitor (Aimovig, Ajovy). v. Emgality with not be used in combination with Botox (onabotulinumtoxinA).

Continuation Criteria: 1. Documentation submitted member has experienced a positive response to therapy, demonstrated by a reduction in headache frequency and/or intensity compared to baseline. 2. The number of migraine days per month must be documented and submitted. Per prescription claims history the use of acute migraine medications (e.g., NSAIDs, triptans, opiates and other migraine medications) has decreased while on therapy. 3. Per prescription claims history member has demonstrated complete adherence to monthly fills of Emgality. If nonadherence present then documentation must be submitted, by chart notes, that the provider has addressed the nonadherence and a treatment plan is in place to prevent future non‐adherence. 4. Documentation that member continues to be monitored for Medication Overuse Headache (MOH) and offending medications, if applicable.

Quantity Limits: 240mg subcutaneous loading dose followed by monthly doses of 120mg. (Administered as two (2) consecutive injections of 120mg each).

Date: March 2018 GTC: PAIN MANAGEMENT - ANALGESICS: 0M Brand Name: Generic Name: Exalgo hydromorphone ER formulations /combinations

Criteria: **Diagnosis** is moderate to severe chronic pain AND • Chart notes and clear treatment plan provided by MD • Previous treatment with formulary short-acting opioids • Inadequate response, intolerable side effect, or contraindication to formulary long-acting opioid morphine sulfate ER tablets (MS Contin) or buprenorphine • Replacing current, equianalgesic (or higher) opioid dose

Quantity Limits: Date: GTC: PAIN MANAGEMENT - ANALGESICS: 0M Brand Name: Generic Name: Prodrin isometheptene/caffeine/acetaminophen

Criteria: **Diagnosis** of migraine AND 18 years of age or older AND Inadequate response, intolerable side effect, or contraindication to - 2 formulary TRIPTANS (sumatriptan AND rizatriptan/ODT) AND - 2 formulary NSAIDS (naproxen, diclofenac, ibuprofen)

Quantity Limits: 8 tablets/ day 64 tablets/ month Date: GTC: PAIN MANAGEMENT - ANALGESICS: 0M Brand Name: Generic Name: Dolophine methadone

Criteria: Approve if current **Diagnosis** of: • Cancer, palliative or hospice pain

**Diagnosis** of severe chronic pain 1. Chart notes and clear treatment plan provided by MD 2. Previous treatment with short-acting opioids 3. Inadequate response, intolerable side effect, or contraindication to formulary long-acting opioid morphine sulfate ER tablets (MS Contin) or buprenorphine 4. Member is not concurrently taking any benzodiazepine or carisoprodol 5. Replacing current equianalgesic (or higher) dose of another opioid

Quantity Limits: Date: GTC: PAIN MANAGEMENT - ANALGESICS: 0M Brand Name: Generic Name: Embeda morphine/ naltrexone ER

Criteria: **Diagnosis** of severe chronic pain AND 1. Chart notes documenting history of tampering with opioid tabs/caps 2. Medical justification why formulary MSER cannot be used 3. Medical justification why buprenorphine and methadone* cannot be used 4. Clear treatment plan provided by MD 5. Member is not concurrently taking any benzodiazepine or carisoprodol 6. Replacing current equianalgesic (or higher) dose of another opioid *Requires prior authorization

Quantity Limits: Date: March 2018 GTC: PAIN MANAGEMENT - ANALGESICS: 0M Brand Name: Generic Name: Zohydro ER, Hysingla ER non formulary hydrocodone ER formulations/combinations

Criteria: **Diagnosis** is moderate to severe chronic pain AND • Chart notes and clear treatment plan provided by MD • Previous treatment with short-acting opioids AND • Inadequate response, intolerable side effect, or contraindication to formulary long-acting opioid morphine sulfate ER tablets (MS Contin) or buprenorphine. • Replacing current, equianalgesic (or higher) opioid dose

Quantity Limits: Date: March 2018 GTC: PAIN MANAGEMENT - ANALGESICS: 0M Brand Name: Generic Name: Avinza, Kadian, Arymo ER, Morphabond ER non formulary morphine ER formulations/combinations

Criteria: **Diagnosis** is moderate to severe chronic pain AND • Chart notes and clear treatment plan provided by MD • Previous treatment with short-acting opioids AND • Inadequate response, intolerable side effect, or contraindication to formulary long-acting opioid morphine sulfate ER tablets (MS Contin) or buprenorphine. • Replacing current, equianalgesic (or higher) opioid dose

Quantity Limits: Date: March 2018 GTC: PAIN MANAGEMENT - ANALGESICS: 0M Brand Name: Generic Name: Oxycontin non formulary oxycodone ER formulations/combinations Xtampza

Criteria: **Diagnosis** is moderate to severe chronic pain AND • Chart notes and clear treatment plan provided by MD • Previous treatment with short-acting opioids AND • Inadequate response, intolerable side effect, or contraindication to formulary long-acting opioid morphine sulfate ER tablets (MS Contin) or buprenorphine. • Replacing current, equianalgesic (or higher) opioid dose

Quantity Limits: Date: March 2018 GTC: PAIN MANAGEMENT - ANALGESICS: 0M Brand Name: Generic Name: Allzital, Bupap, Marten, Capacet, Esgic, Fioricet, Phrenilin Forte, non-formulary butalbital formulations/combinations Zebutal, Vanatol, Bac, Repan, Fiorinal

Criteria: **Diagnosis** of migraine headaches AND Has inadequate response, intolerable side effect, or contraindication to 1 formulary formulation such as: - Butalbital/APAP 50/325 mg tablet - Butalbital/APAP/caffeine 50/325/40 mg tablet NTE 6 tablets per 24 hours

Quantity Limits: 6 tablets/ day 48 tablets/ month Initial approval: 6 fills Date: September 2016 GTC: PAIN MANAGEMENT - ANALGESICS: 0M Brand Name: Generic Name: Non-Formulary Opioid Medications: Fentanyl Patches, non-formulary opioid medications: fentanyl patches, hydromorphone ER tablets, oxycodone ER tablets, oxymorphone Hydromorphone ER Tablets, Oxycodone ER Tablets, Oxymorphone ER tablets, morphine sulfate ER capsules, etc. ER Tablets, Morphine Sulfate ER Capsules, etc.

Criteria: **Diagnosis** of cancer, palliative, or hospice pain AND •Has previously approved by a pharmacist •Approve as requested for re-authorization and/or dose titration

Quantity Limits: Date: March 2018 GTC: PAIN MANAGEMENT - ANALGESICS: 0M Brand Name: Generic Name: Axert, Relpax, Frova, Amerge, Zomig, Zomig ODT non-formulary triptan formulations pa criteria: almotriptan, eletriptan, frovatriptan, zolmitriptan, zolmitriptan ODT

Criteria: **Diagnosis** of migraine AND •18 years of age and older •Inadequate response, intolerable side effect, or contraindication to 2 triptans such as rizatriptan/rizatriptan ODT, sumatriptan (oral/nasal/injectable) AND

Quantity Limits: Quantity limit of 9 tablets per 30 day supply Date: March 2018 GTC: PAIN MANAGEMENT - ANALGESICS: 0M Brand Name: Generic Name: Oxycodone 20Mmg/mL Solution oxycodone 20mg/ml soluiton

Criteria: Approve for **Diagnosis** of cancer, palliative or hospice pain

Quantity Limits: Date: GTC: PAIN MANAGEMENT - ANALGESICS: 0M Brand Name: Generic Name: Roxybond oxycodone 5, 15, 30mg

Criteria: **Diagnosis** of severe pain AND 1. Chart notes documenting IV drug abuse 2. Medical justification why formulary MSIR and oxy IR tabs cannot be used 3. Medical justification why buprenorphine cannot be used (if concerned about drug abuse) 4. Clear treatment plan provided by MD 5. Member is not concurrently taking any benzodiazepine or carisoprodol 6. Replacing current equianalgesic (or higher) dose of another opioid

Quantity Limits: Date: GTC: PAIN MANAGEMENT - ANALGESICS: 0M Brand Name: Generic Name: Nalocet oxycodone/apap 2.5/300mg

Criteria: Use preferred morphine, or oxy/APAP 2.5/325mg or oxycodone 5mg (half tablet) + APAP

Quantity Limits: Date: GTC: PAIN MANAGEMENT - ANALGESICS: 0M Brand Name: Generic Name: Primlev oxycodone/APAP 5, 7.5, 10/300mg

Criteria: Use formulary strengths: 5, 7.5, 10/325mg APAP

Quantity Limits: Date: GTC: PAIN MANAGEMENT - ANALGESICS: 0M Brand Name: Generic Name: Percodan, Endodan oxycodone/aspirin 4.8335/325mg

Criteria: Use separate agents

Quantity Limits: Date: GTC: PAIN MANAGEMENT - ANALGESICS: 0M Brand Name: Generic Name: Combunox oxycodone/ibuprofen 5/400mg

Criteria: Use separate agents

Quantity Limits: Date: March 2018 GTC: PAIN MANAGEMENT - ANALGESICS: 0M Brand Name: Generic Name: Opana, Opana Er oxymorphone

Criteria: **Diagnosis** is moderate to severe chronic pain AND - Chart notes and clear treatment plan provided by MD - Previous treatment with formulary short-acting opioids

Oxymorphone ER: All of the above AND - Inadequate response, intolerable side effect, or contraindication to formulary long-acting opioid morphine sulfate ER tablets (MS Contin) or buprenorphine AND - Replacing current, equianalgesic (or higher) opioid dose

Quantity Limits: Date: GTC: PAIN MANAGEMENT - ANALGESICS: 0M Brand Name: Generic Name: Talwin NX pentazocine/ naloxone

Criteria: **Diagnosis** of severe pain AND 1. Chart notes documenting IV drug abuse 2. Medical justification why formulary MSIR and oxy IR tabs cannot be used 3. Medical justification why buprenorphine cannot be used (if concerned about drug abuse) 4. Clear treatment plan provided by MD 5. Member is not concurrently taking any benzodiazepine or carisoprodol 6. Replacing current equianalgesic (or higher) dose of another opioid

Quantity Limits: Date: GTC: PAIN MANAGEMENT - ANALGESICS: 0M Brand Name: Generic Name: Zembrace Symtouch sumatriptan 3mg/0.5ml autoinjector

Criteria: **Diagnosis** of migraine headaches AND •Has inadequate response, intolerable side effect, or contraindication to formulary oral triptans: sumatriptan, rizatriptan AND •Formulary injectable sumatriptan (cartridge or syringe formulation)

Quantity Limits: 4 units/ month Date: GTC: PAIN MANAGEMENT - ANALGESICS: 0M Brand Name: Generic Name: Alsuma, Sumavel Dosepro sumatriptan inj.

Criteria: **Diagnosis** of migraine headaches AND •Has inadequate response, intolerable side effect, or contraindication to formulary oral triptans: sumatriptan, rizatriptan AND •Formulary injectable sumatriptan (cartridge or syringe formulation).

Quantity Limits: 2 doses/day Max: 6 mg/dose up to 12 mg/24h Date: GTC: PAIN MANAGEMENT - ANALGESICS: 0M Brand Name: Generic Name: Zecuity sumatriptan patch

Criteria: **Diagnosis** of migraine headaches AND •Has inadequate response, intolerable side effect, or contraindication to formulary oral triptans: sumatriptan, rizatriptan AND •Formulary injectable sumatriptan (cartridge or syringe formulation).

Quantity Limits: 3 patches/day Date: March 2018 GTC: PAIN MANAGEMENT - ANALGESICS: 0M Brand Name: Generic Name: Nucynta ER tapentadol

Criteria: **Diagnosis** is moderate to severe chronic pain AND •Chart notes and clear treatment plan provided by MD AND •Has inadequate response, intolerable side effect, or contraindication to: - NSAID and - tramadol or tramadol/APAP and •T/F of immediate-release tapentadol AND •Replacing current, equianalgesic (or higher) dose of Nucynta IR

Quantity Limits: Date: March 2018 GTC: PAIN MANAGEMENT - ANALGESICS: 0M Brand Name: Generic Name: Nucynta tapentadol

Criteria: **Diagnosis** is moderate to severe chronic pain AND •Chart notes and clear treatment plan provided by MD AND •Has inadequate response, intolerable side effect, or contraindication to: - NSAID and - tramadol or tramadol/APAP and

Quantity Limits: Date: March 2018 GTC: PAIN MANAGEMENT - ANALGESICS: 0M Brand Name: Generic Name: Ultram ER tramadol ER

Criteria: **Diagnosis** of chronic pain AND •T/F of tramadol or tramadol APAP AND •Replacing current, equianalgesic dose of tramadol IR

Quantity Limits: Date: GTC: PAIN MANAGEMENT - ANALGESICS: 0M Brand Name: Generic Name: Conzip tramadol ER (extended biphasic-release) capsules

Criteria: **Diagnosis** of chronic pain AND 1. Previous treatment with tramadol or tramadol/APAP AND 2. Replacing current, equianalgesic dose of tramadol IR 3. Medical justification why regular tramadol ER* tablets cannot be used or continued *Requires prior authorization

Quantity Limits: Date: March 2018 GTC: PAIN MANAGEMENT - ANALGESICS: 0M Brand Name: Generic Name: Zomig Nasal Spray zolmitriptan

Criteria: **Diagnosis** of migraine headaches AND •12 years of age or older •Inadequate response, intolerable side effect, or contraindication to 1 oral triptan such as sumatriptan, rizatriptan / ODT AND to Sumatriptan nasal spray*

*Prior Authorization required

** No requirement of trial of nasal sumatriptan if < 18 years old**

Quantity Limits: Date: September 2017 GTC: PARKINOSON’S DISEASE: 0P Brand Name: Generic Name: Rytary carbidopa, levodopa oral capsule, extended release 23.75mg-95mg, 36.25mg-145mg, 48.75mg-195mg, 61.25mg- 245mg

Criteria: **Diagnosis** of Parkinson’s disease • Age ≥ 18 years • Documented intolerance or contraindication to carbidopa/levodopa ER tablets (Sinemet CR)

Quantity Limits: The maximum recommended daily dose is 612.5 mg/2,450 mg Date: September 2017 GTC: PARKINOSON’S DISEASE: 0P Brand Name: Generic Name: Mirapex ER pramipexole dihydrochloride oral tablet, extended release 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3mg, 3.75mg, 4.5mg

Criteria: Member had an adequate trial and failure OR Inadequate response (duration of at least 4 weeks) OR Intolerance to pramipexole IR

Quantity Limits: 1 tablet /day Date: September 2017 GTC: PARKINOSON’S DISEASE: 0P Brand Name: Generic Name: Azilect rasagiline oral tablet 0.5mg, 1mg

Criteria: **Diagnosis** of Parkinson disease AND Failure of ≥ 30 days of selegiline unless contraindicated

Quantity Limits: 1 tablet /day Date: September 2017 GTC: PARKINOSON’S DISEASE: 0P Brand Name: Generic Name: Requip XL ropinirole extended-release tablet 2mg, 4mg, 6mg, 8mg, 12mg

Criteria: Member had an adequate trial and failure OR Inadequate response (duration of at least 4 weeks) OR Intolerance to ropinirole IR

Quantity Limits: 1 tablet /day Date: August 2019 GTC: PARKINOSON’S DISEASE: 0P Brand Name: Generic Name: Neupro rotigotine transdermal patch

Criteria: **Diagnosis** of Parkinson’s disease AND • Has inadequate response, intolerable side effect, or contraindication to 3 of the following: ropinirole IR tablets, pramipexole, pramipexole ER* or ropinirole ER* AND • Documentation that member is unable to swallow or take oral medications

*Requires prior authorization

**Diagnosis** of moderate-to-severe Restless Legs Syndrome (RLS) AND • Has inadequate response, intolerable side effect, or contraindication to 3 of the following: ropinirole IR tablets, pramipexole, pramipexole ER* or ropinirole ER* OR • Documentation that member is unable to swallow or take oral medications

*Requires prior authorization

Quantity Limits: Date: September 2017 GTC: SEIZURE DISORDER: 0O Brand Name: Generic Name: Briviact brivaracetam 10mg, 25mg, 50mg, 75mg, 100mg

Criteria: Prescribed by Neurologist or a psychiatrist AND • Diagnosed with seizures AND • Patient is 16 years of age or older AND • Patient has tried and failed at least two (2) formulary anti-epileptic drugs such as: lamotrigine, levetiracetam, oxcarbazepine, topiramate, carbamazepine.

Quantity Limits: 2 tablets / day Date: January 2019 GTC: SEIZURE DISORDER: 0O Brand Name: Generic Name: Epidiolex cannabidiol

Criteria: **Diagnosis** of Dravet syndrome AND • Patient is 2 years of age or older AND • Prescribed by a neurologist AND • Member has had adequete trial of two (2) of the following: clobazam, valproid acid derivative product, topiramate

**Diagnosis** of Lennox-Gastaut Syndrome (LGS) AND • Patient is 2 years of age or older AND • Prescribed by a neurologist AND • Member has had a trial of or contraindication to topiramate or lamotrigine AND clobazam.

Quantity Limits: Date: August 2019 GTC: SEIZURE DISORDER: 0O Brand Name: Generic Name: Sympazan clobazam

Criteria: **Diagnosis** of Lennox-Gastaut syndrome AND • Must be used as adjunctive treatment in combination with lamotrigine or topiramate AND • Must be prescribed by a neurologist • Has inadequate response, intolerable side effect, or contraindication to Onfi tablets AND • Written attestation that member is unable to take Onfi oral suspension (possibly due to dysphagia)

Quantity Limits: Date: September 2016 GTC: SEIZURE DISORDER: 0O Brand Name: Generic Name: Onfi clobazam oral tablets, oral suspension

Criteria: **Diagnosis** of Lennox-Gastaut Syndrome AND

• Has inadequate response, intolerable side effect, or contraindication to 2 formulary anti-seizure medications including: gabapentin, carbamazepine, oxcarbamazepine, divalproex sodium, topiramate, lamotrigine, levetiracetam, phenytoin, phenobabrbital, ethosuximide, and tiagabine.

Onfi oral suspension requires T/F of Onfi tablets or medical justification why tablets cannot be used.

Quantity Limits: 2 tablets/day Date: September 2017 GTC: SEIZURE DISORDER: 0O Brand Name: Generic Name: Klonopin Wafer clonazepam oral disintegrating tablet 0.125mg, 0.25mg, 0.5mg, 1mg, 2mg

Criteria: Patient has a documented inability to swallow tablets OR • Inadequate response to clonazepam tablets

Quantity Limits: Date: July 2018 GTC: SEIZURE DISORDER: 0O Brand Name: Generic Name: Aptiom eslicarbazepine

Criteria: **Diagnosis** of partial seizures AND • Has inadequate response, intolerable side effect, or contraindication to 2 formulary anti-seizure medications including: gabapentin, carbamazepine, oxcarbamazepine, divalproex sodium, topiramate, lamotrigine, levetiracetam, phenytoin, phenobabrbital, or ethosuximide

Quantity Limits: 200mg, 1/day 400mg, 1/day 800mg, 1/day 600mg, 2/day Age ≥ 4 years Date: July 2018 GTC: SEIZURE DISORDER: 0O Brand Name: Generic Name: Felbamate felbamate

Criteria: **Diagnosis** of partial seizures or lennox-gastaut syndrome AND • Has inadequate response, intolerable side effect, or contraindication to 2 formulary anti-seizure medications including: gabapentin, carbamazepine,oxcarbamazepine, divalproex sodium, topiramate, lamotrigine, levetiracetam, phenytoin, phenobabrbital, or ethosuximide

Felbamate oral suspension requires t/f of felbamate tablets or medical justification why tablets cannot be used

Quantity Limits: Date: September 2016 GTC: SEIZURE DISORDER: 0O Brand Name: Generic Name: Vimpat lacosamide oral tablets and oral suspension 50mg, 100mg, 150mg, 200mg, 10mg/ml solution

Criteria: **Diagnosis** of partial seizures AND • Has inadequate response, intolerable side effect, or contraindication to 2 formulary anti-seizure medications including: gabapentin, carbamazepine, oxcarbamazepine, divalproex sodium, topiramate, lamotrigine, levetiracetam, phenytoin, phenobabrbital

Vimpat oral suspension requires T/F of Vimpat tablets or medical justification why tablets cannot be used

Quantity Limits: 2 tablets/day Date: September 2016 GTC: SEIZURE DISORDER: 0O Brand Name: Generic Name: Lamictal XR lamotrigine oral tablet, extended release 25mg, 50mg, 100mg, 200mg, 250mg, 300mg

Criteria: Had an adequate trial and failure OR Inadequate response (duration of at least 4 weeks) OR Intolerance to lamotrigine IR tablets

Quantity Limits: 1 tablet/ day Date: July 2018 GTC: SEIZURE DISORDER: 0O Brand Name: Generic Name: Lamictal ODT lamotrigine orally disintegrating tablet 25mg, 50mg, 100mg, 200mg

Criteria: Patient has a documented inability to swallow tablets OR Inadequate response to lamotrigine IR tablets AND unable to use chew tab

Quantity Limits: 1 tablet /day Date: September 2016 GTC: SEIZURE DISORDER: 0O Brand Name: Generic Name: Keppra XR levetiracetam oral tablet, extended release 500mg, 750mg

Criteria: Patient had an adequate trial and failure OR inadequate response (duration of at least 4 weeks) OR Intolerance to levetiracetam IR tablets

Quantity Limits: 3000mg/day Date: August 2019 GTC: SEIZURE DISORDER: 0O Brand Name: Generic Name: Oxtellar XR oxcarbazepine ER

Criteria: **Diagnosis** of partial seizures in adults and in children ≥6 years of age AND • Must be prescribed by a neurologist • Has inadequate response, intolerable side effect, or contraindication to oxcarbazepine immediate release (Trileptal)

Quantity Limits: Date: July 2018 GTC: SEIZURE DISORDER: 0O Brand Name: Generic Name: Fycompa perampanel oral tablets, oral suspension

Criteria: **Diagnosis** of partial or tonic-clonic (Grand mal) seizures AND • Has inadequate response, intolerable side effect, or contraindication to 2 formulary anti-seizure medications including: gabapentin, carbamazepine, oxcarbamazepine, divalproex sodium, topiramate, lamotrigine, levetiracetam, phenytoin, phenobabrbital, or ethosuximide.

Quantity Limits: Age ≥ 12 years

Date: July 2018 GTC: SEIZURE DISORDER: 0O Brand Name: Generic Name: Banzel rufinamide oral tablets, oral suspension

Criteria: **Diagnosis** of Lennox-Gastaut syndrome AND • Has inadequate response, intolerable side effect, or contraindication to 2 formulary anti-seizure medications including: gabapentin, carbamazepine, oxcarbamazepine, divalproex sodium, topiramate, lamotrigine, levetiracetam, phenytoin, phenobabrbital, ethosuximide

Quantity Limits: Age ≥ 1 years

Date: August 2019 GTC: SEIZURE DISORDER: 0O Brand Name: Generic Name: Diacomit stiripentol

Criteria: **Diagnosis** of Dravet Syndrome for ≥2 years of age AND • Must be prescribed by a neurologist AND • Must be used as an adjunct therapy with at least one other antiepileptic drug (such as topiramate, valproic acid, ONFI) AND • Has inadequate response, intolerable side effect, or contraindication to 2 formulary alternatives such as: topiramate, valproic acid, ONFI, Epidiolex, levetiracetam etc.

Quantity Limits: Date: September 2016 GTC: SEIZURE DISORDER: 0O Brand Name: Generic Name: Gabitril tiagabine oral tablets

Criteria: **Diagnosis** of partial seizures AND • Has inadequate response, intolerable side effect, or contraindication to 2 formulary anti-seizure medications including: gabapentin, carbamazepine, oxcarbamazepine, divalproex sodium, topiramate, lamotrigine, levetiracetam, phenytoin, phenobabrbital, and ethosuximide or medical justification why they cannot be used

Quantity Limits: Max: 56mg/day Date: July 2018 GTC: SEIZURE DISORDER: 0O Brand Name: Generic Name: Qudexy XR topiramate oral capsule extended release sprinkles 24 hour 25mg, 50mg, 100mg, 150mg, 200mg

Criteria: Prescribed by Neurologist or a psychiatrist AND **Diagnosis** of seizures AND patient has had a two (2)-months trial of immediate-release topiramate

Quantity Limits: 1 capsule/ day Date: July 2018 GTC: SEIZURE DISORDER: 0O Brand Name: Generic Name: Trokendi XR topiramate oral capsule, extended release 25mg, 50mg, 100mg, 200mg

Criteria: Prescribed by a Neurologist or a psychiatrist AND Patient is 6 years of age or older and **Diagnosis** of seizures OR Patient is 12 years of age or older AND **Diagnosis** of migraine AND patient has had a two (2)-month trial of immediate-release topiramate AND Topiramate Oral capsule extended release sprinkles 24 hour*

*Prior Authorization Required

Quantity Limits: 1 capsule/day Date: August 2019 GTC: SEIZURE DISORDER: 0O Brand Name: Generic Name: Sabril vigabatrin oral tablet 500mg

Criteria: **Diagnosis** or refractory complex partial seizures AND  Prescribed by neurologist  Age ≥ 10 years  Inadequate response to ≥ 2 alternative anticonvulsant drugs  Vision assessment at baseline and at least every 3 months during therapy  Prescribed daily dose* does not exceed:  Pediatric members age 10 to 16 years: 1,000 mg twice daily (if weight is > 60 kg, dosing should follow adult recommendations)  Adult’s age ≥ 17 years: 1,500 mg twice daily

**Diagnosis** of Infantile Spasms AND  Must be prescribed a neurologist AND  Must be aged 1 month to 2 years AND  Must undergo vision testing prior to beginning treatment

Re-authorization:  Documentation from the prescriber that the member’s condition has improved based upon the prescriber’s assessment while on therapy  Documentation from the prescriber that the member is undergoing vision testing at least every 3 months during treatment with Sabril  Authorizations for infantile spasms are not extended beyond the age of 2 years

Quantity Limits: 3000mg per day Date: October 2018 GTC: SKELETAL MUSCLE DISORDER: 1Q Brand Name: Generic Name: Lioresal Intrathecal (IT) baclofen intrathecal ampule 0.05mg/ml (50mcg/ml) ampule, 10mg/20ml (500mcg/ml), 10 mg/5ml (2000mcg/ml) & 40mg/20ml (2000mcg/ml) ampule kit

Criteria: Must have severe spasticity of spinal or cerebral origin (multiple sclerosis, cerebral palsy, spinal cord injury, or traumatic brain) AND • Age > 4 years AND • Documentation of unacceptable side effects from or intolerance to oral baclofen at an effective dose. OR documentation of unresponsiveness or ineffectiveness to maximal dosing of oral baclofen AND • Must have a positive response to a screening trial. AND • Must be prescribed by a neurologist

Quantity Limits: Date: December 2016 GTC: SKELETAL MUSCLE DISORDER: 1Q Brand Name: Generic Name: Soma carisoprodol

Criteria: **Diagnosis** of ACUTE muscle spasm or pain AND • 16 years of age or older AND =<65 years old • Chart notes and clear treatment plan provided by MD, including anticipated treatment duration • Trial and failure of methocarbamol AND cyclobenzaprine AND • Member is not concurrently taking any benzodiazepine (clonazepam, lorazepam, alprazolam, etc.) • Member is not currently taking any opiate medications (such as hydrocodone/APAP, Tylenol w/Codeine, oxycodone/APAP, morphine sulfate ER, etc.) AND • If all above met, may authorize total duration of therapy up to 3 weeks (NTE 4 tablets per day)

Quantity Limits: Date: GTC: SKELETAL MUSCLE DISORDER: 1Q Brand Name: Generic Name: Lorzone chlorzoxazone

Criteria: **Diagnosis** of ACUTE muscle spasm or pain AND • 18 years of age and older • Chart notes and clear treatment plan provided by MD, including anticipated treatment duration • Trial and failure of formulary methocarbamol AND cyclobenzaprine

Quantity Limits:

Date: October 2018 GTC: SKELETAL MUSCLE DISORDER: 1Q Brand Name: Generic Name: Xiaflex collagenase clostridium histolyticum 0.9mg vial

Criteria: For the treatment of adult patients with Dupuytren’s contracture with a palpable cord.

Quantity Limits: Date: June 2018 GTC: SKELETAL MUSCLE DISORDER: 1Q Brand Name: Generic Name: Amrix cyclobenzaprine ER

Criteria: 1. **Diagnosis** of ACUTE muscle spasm or pain AND 2. Patient is 15 years of age or older and <65 years old AND 3. Chart notes and clear treatment plan provided by MD, including anticipated treatment duration AND 4. Trial and failure of methocarbamol AND cyclobenzaprine AND 5. If all above met, may authorize total duration of therapy up to 3 weeks (NTE 2 tabs per day)

Quantity Limits: Date: GTC: SKELETAL MUSCLE DISORDER: 1Q Brand Name: Generic Name: Dantrium dantrolene

Criteria: **Diagnosis** of clinical spasticity resulting from motor neuron disorders (e.g. spinal cord injury, stroke, cerebral palsy or multiple sclerosis) AND • Failure or clinically significant adverse effects to ONE of the formulary alternatives: baclofen or tizanidine AND • Baseline Liver function test provided • Dose NTE 400mg/day

Quantity Limits: Date: GTC: SKELETAL MUSCLE DISORDER: 1Q Brand Name: Generic Name: Skelaxin metaxalone

Criteria: **Diagnosis** of ACUTE muscle spasm or pain AND • 18 years of age and older • Chart notes and clear treatment plan provided by MD, including anticipated treatment duration • Trial and failure of formulary methocarbamol AND cyclobenzaprine

Quantity Limits: 4/day Date: GTC: SKELETAL MUSCLE DISORDER: 1Q Brand Name: Generic Name: Norflex, Norflex ER orphanadrine, orphenadine ER

Criteria: **Diagnosis** of ACUTE muscle spasm or pain AND • 18 years of age and older • Chart notes and clear treatment plan provided by MD, including anticipated treatment duration • Trial and failure of formulary methocarbamol AND cyclobenzaprine

Quantity Limits: 2/day Date: December 2017 (Updated) GTC: UPPER GASTROINTESTINAL DISORDERS - ULCER DISEASE: 1J Brand Name: Generic Name: Pylera bismuth subcitrate/metronidazole/tetracycline

Criteria: **Diagnosis** of H. Pylori treatment AND inability to use the individual agents concurrently (Bismuth salicylate salt, metronidazole, tetracycline)

Quantity Limits: 120 Date: October 2018 GTC: UPPER GASTROINTESTINAL DISORDERS - ULCER DISEASE: 1J Brand Name: Generic Name: Dexilant DR Capsule dexlansoprazole DR capsule

Criteria: **Diagnosis** of Gastroesophageal Reflux Disease (GERD), GI distress, heartburn, stomach ulcer or Zollinger-Ellison Syndrome AND has inadequate response or intolerable side effect to maximum tolerated dosing of 4 of the preferred alternatives: omeprazole, lansoprazole, pantoprazole, esomeprazole*, or rabeprazole*

*Prior Authorization Required

Quantity Limits: 1 capsule/day Date: October 2018 GTC: UPPER GASTROINTESTINAL DISORDERS - ULCER DISEASE: 1J Brand Name: Generic Name: Nexium Dr Capsule esomeprazole DR capsule

Criteria: **Diagnosis** of Gastroesophageal Reflux Disease (GERD),GI distress, heartburn, stomach ulcer or Zollinger-Ellison Syndrome AND • Has inadequate response or intolerable side effect to maximum tolerated dosing of omeprazole, lansoprazole, and pantoprazole

Quantity Limits: 20mg: 1 capsule/day 40mg: 2 capsules/day Date: October 2018 GTC: UPPER GASTROINTESTINAL DISORDERS - ULCER DISEASE: 1J Brand Name: Generic Name: Nexium Dr Powder For Suspension esomeprazole DR powder for oral suspension packet

Criteria: **Diagnosis** of Gastroesophageal Reflux Disease (GERD), GI distress, heartburn, stomach ulcer OR Zollinger-Ellison Syndrome AND has inadequate response OR intolerable side effect to maximum tolerated dosing of 4 of the following preferred alternatives: omeprazole, lansoprazole, pantoprazole, esomeprazole* DR capsule, OR rabeprazole*

IF unable to swallow the above preferred alternatives: • Unable to use omeprazole OR lansoprazole capsules opened AND sprinkled in applesauce AND • Has inadequate response OR intolerable side effect to First–Omeprazole** AND First-Lansoprazole** suspension.

*Prior Authorization Required **Prior Authorization Required if older than 5yo

Quantity Limits: 1 packet/day

Date: December 2016 GTC: UPPER GASTROINTESTINAL DISORDERS - ULCER DISEASE: 1J Brand Name: Generic Name: Pepcid famotidine oral suspension

Criteria: **Diagnosis** of Gastroesophageal Reflux Disease (GERD), GI distress, heartburn, stomach ulcer, or Zollinger-Ellison AND • Has inadequate response, intolerable side effect, or unable to use ranitidine syrup and famotidine tablets

Quantity Limits: Date: May 2019 GTC: UPPER GASTROINTESTINAL DISORDERS - ULCER DISEASE: 1J Brand Name: Generic Name: Cuvposa glycopyrrolate oral solution

Criteria: **Diagnosis** of chronic drooling AND patient is between ages 3-16 AND patient has inadequate response, intolerable side effect, or contraindication to glycopyrrolate tablets

Quantity Limits: Date: October 2018 GTC: UPPER GASTROINTESTINAL DISORDERS - ULCER DISEASE: 1J Brand Name: Generic Name: Prevacid Solutabs lansoprazole oral disintegrating tablet (ODT)

Criteria: **Diagnosis** of Gastroesophageal Reflux Disease (GERD), GI distress, heartburn, stomach ulcer or Zollinger-Ellison Syndrome AND • Has inadequate response or intolerable side effect to maximum tolerated dosing of 4 of the preferred alternatives: omeprazole, lansoprazole capsule, pantoprazole, esomeprazole*, or rabeprazole*

If unable to swallow above preferred alternatives: • Unable to use omeprazole or lansoprazole capsules opened and sprinkled in applesauce AND • Has inadequate response or intolerable side effect to First–Omeprazole** AND First-Lansoprazole** suspension

*Prior Authorization Required

*Prior Authorization Required if older than 5yo

Quantity Limits: 15mg: 1 tablet/day 30mg: 2 tablets/day Date: GTC: UPPER GASTROINTESTINAL DISORDERS - ULCER DISEASE: 1J Brand Name: Generic Name: Prevpac lansoprazole/amoxicillin/clarithromycin

Criteria: **Diagnosis** of H.Pylori treatment AND inability to use the individual agents concurrently

Quantity Limits: 112 pills Date: December 2016 GTC: UPPER GASTROINTESTINAL DISORDERS - ULCER DISEASE: 1J Brand Name: Generic Name: First-Omeprazole, First-Lansoprazole omeprazole 2mg/ml oral suspension & lansoprazole 3mg/ml oral suspension

Criteria: First-omeprazole and First-lansoprazole are formulary for patients younger than or equal to 5 years of age. For patients older than 5 years of age: • **Diagnosis** of Gastroesophageal Reflux Disease (GERD), GI distress, heartburn, stomach ulcer, or Zollinger-Ellison AND • Unable to use omeprazole or lansoprazole capsules opened and sprinkled in applesauce

Quantity Limits: Date: October 2018 GTC: UPPER GASTROINTESTINAL DISORDERS - ULCER DISEASE: 1J Brand Name: Generic Name: Prilosec DR Granules For Suspension omeprazole granules for oral suspension packet

Criteria: **Diagnosis** of Gastroesophageal Reflux Disease (GERD), GI distress, heartburn, stomach ulcer or Zollinger-Ellison Syndrome AND • Has inadequate response or intolerable side effect to maximum tolerated dosing of 4 of the preferred alternatives: omeprazole, lansoprazole capsule, pantoprazole, esomeprazole*, or rabeprazole*

If unable to swallow above preferred alternatives: • Unable to use omeprazole or lansoprazole capsules opened and sprinkled in applesauce AND • Has inadequate response or intolerable side effect to First–Omeprazole** AND First-Lansoprazole** suspension

*Prior Authorization Required *Prior Authorization Required if older than 5yo

Quantity Limits: 1 packet/day Date: GTC: UPPER GASTROINTESTINAL DISORDERS - ULCER DISEASE: 1J Brand Name: Generic Name: Omeclamox-Pak omeprazole/amoxicillin/clarithromycin

Criteria: **Diagnosis** of H.Pylori treatment AND inability to use the individual agents concurrently

Quantity Limits: 80 pills Date: October 2018 GTC: UPPER GASTROINTESTINAL DISORDERS - ULCER DISEASE: 1J Brand Name: Generic Name: Zegerid Capsule omeprazole/sodium bicarbonate oral capsule

Criteria: **Diagnosis** of Gastroesophageal Reflux Disease (GERD), GI distress, heartburn, stomach ulcer or Zollinger-Ellison Syndrome AND •Has inadequate response or intolerable side effect to maximum tolerated dosing of 4 of the preferred alternatives: omeprazole, lansoprazole, pantoprazole, esomeprazole*, or rabeprazole*

*Prior Authorization Required

Quantity Limits: 1 capsule/day Date: October 2018 GTC: UPPER GASTROINTESTINAL DISORDERS - ULCER DISEASE: 1J Brand Name: Generic Name: Zegerid Powder For Suspension omeprazole/sodium bicarbonate powder packet for oral suspension

Criteria: **Diagnosis** of Gastroesophageal Reflux Disease (GERD), GI distress, heartburn, stomach ulcer or Zollinger-Ellison Syndrome AND • Has inadequate response or intolerable side effect to maximum tolerated dosing of 4 of the preferred alternatives: omeprazole, lansoprazole, pantoprazole, esomeprazole*, or rabeprazole*

If unable to swallow above preferred alternatives: • Unable to use omeprazole or lansoprazole capsules opened and sprinkled in applesauce AND • Has inadequate response or intolerable side effect to First–Omeprazole** AND First-Lansoprazole** suspension

*Prior Authorization Required **Prior Authorization Required if older than 5yo

Quantity Limits: 1 packet/day Date: October 2018 GTC: UPPER GASTROINTESTINAL DISORDERS - ULCER DISEASE: 1J Brand Name: Generic Name: Protonix DR Granules For Suspension pantoprazole granules for oral suspension & packet

Criteria: **Diagnosis** of Gastroesophageal Reflux Disease (GERD), GI distress, heartburn, stomach ulcer or Zollinger-Ellison Syndrome AND • Has inadequate response or intolerable side effect to maximum tolerated dosing of 4 of the preferred alternatives: omeprazole, lansoprazole, pantoprazole, esomeprazole*, or rabeprazole*

If unable to swallow above preferred alternatives: • Unable to use omeprazole or lansoprazole capsules opened and sprinkled in applesauce AND • Has inadequate response or intolerable side effect to First–Omeprazole** AND First-Lansoprazole** suspension

*Prior Authorization Required **Prior Authorization Required if older than 5yo

Quantity Limits: 1 packet/day Date: October 2018 GTC: UPPER GASTROINTESTINAL DISORDERS - ULCER DISEASE: 1J Brand Name: Generic Name: Aciphex DR Sprinkle Capsule rabeprazole DR sprinkle capsule

Criteria: **Diagnosis** of Gastroesophageal Reflux Disease (GERD), GI distress, heartburn, stomach ulcer or Zollinger-Ellison Syndrome AND • Has inadequate response or intolerable side effect to maximum tolerated dosing of 4 of the preferred alternatives: omeprazole, lansoprazole, pantoprazole, esomeprazole*, or rabeprazole*

If unable to swallow above preferred alternatives: • Unable to use omeprazole or lansoprazole capsules opened and sprinkled in applesauce AND • Has inadequate response or intolerable side effect to First–Omeprazole** AND First-Lansoprazole** suspension

*Prior Authorization Required **Prior Authorization Required if older than 5yo

Quantity Limits: 1 capsule/day Date: October 2018 GTC: UPPER GASTROINTESTINAL DISORDERS - ULCER DISEASE: 1J Brand Name: Generic Name: Aciphex DR Tablet rabeprazole DR tablet

Criteria: **Diagnosis** of Gastroesophageal Reflux Disease (GERD),GI distress, heartburn, stomach ulcer or Zollinger-Ellison Syndrome AND has inadequate response or intolerable side effect to maximum tolerated dosing of omeprazole, lansoprazole, and pantoprazole

Quantity Limits: 2 tablets/day Date: December 2016 GTC: UPPER GASTROINTESTINAL DISORDERS - ULCER DISEASE: 1J Brand Name: Generic Name: Zantac ranitidine oral capsules

Criteria: Use ranitidine tablets.

Quantity Limits:

Date: November 2019 GTC: UPPER GASTROINTESTINAL DISORDERS - ULCER DISEASE :1J Brand Name: Generic Name: Motegrity prucalopride

Criteria: **Diagnosis** of Chronic Idiopathic Constipation AND has inadequate response, intolerable side effect or contraindication to 3 formulary laxatives including: - 1 agent from the osmotic class (lactulose, PEG 3350) AND - 1 agent from the stimulant class (senna, bisacodyl) AND - 1 of the following: fiber, docusate, mineral oil, magnesium citrate, magnesium hydroxide or sodium phosphate

Quantity Limits: 1 tablet per day Date: Feb 2020 GTC: URINARY TRACT - FUNCTIONAL DISORDERS: 2B Brand Name: Generic Name: Enablex Darifenacin ER

Criteria: **Diagnosis** of overactive bladder or urinary incontinence or urgency AND has inadequate response or intolerable side effect to maximum tolerated dosing to 2 of the following: oxybutynin ER, tolterodine ER, solifenacin or trospium

Quantity Limits: 1 tab/day Date: Feb 2020 GTC: URINARY TRACT - FUNCTIONAL DISORDERS: 2B Brand Name: Generic Name: Jalyn dutasteride/tamsulosin

Criteria: **Diagnosis** of Benign Prostatic Hyperplasia AND Has inadequate response or intolerable side effect to finasteride Or dutasteride AND tamsulosin as 2 separate drugs taken concurrently

Quantity Limits: 1 tab/day Date: Feb 2020 GTC: URINARY TRACT - FUNCTIONAL DISORDERS: 2B Brand Name: Generic Name: Toviaz Fesoterodine ER

Criteria: **Diagnosis** of overactive bladder or urinary incontinence or urgency AND has inadequate response or intolerable side effect to maximum tolerated dosing to 2 of the following: oxybutynin ER, tolterodine ER, solifenacin or trospium

Quantity Limits: 1 tab/day

Date: Feb 2020 GTC: URINARY TRACT - FUNCTIONAL DISORDERS: 2B Brand Name: Generic Name: Myrbetriq Mirabegron

Criteria: **Diagnosis** of overactive bladder or urinary incontinence or urgency AND Has inadequate response or intolerable side effect to maximum tolerated dosing to 2 of the following: oxybutynin ER, tolterodine ER, Solifenacin or trospium.

Quantity Limits: 1 tab/day Date: GTC: URINARY TRACT - FUNCTIONAL DISORDERS: 2B Brand Name: Generic Name: Gelnique 3% Pump Or 10% Sachet oxybutynin

Criteria: **Diagnosis** of overactive bladder or urinary incontinence or urgency AND • Has inadequate response or intolerable side effect to maximum tolerated dosing to 2 of the following: oxybutynin ER, tolterodine ER or trospium AND • Inadequate response or intolerable side effect to Oxytrol patch (OTC formulation)

Quantity Limits: 1 sachet/day or 92gm/30 day Date: GTC: URINARY TRACT - FUNCTIONAL DISORDERS: 2B Brand Name: Generic Name: Oxytrol 3.9mg/24HR Patch oxybutynin

Criteria: **Diagnosis** of overactive bladder or urinary incontinence or urgency AND • Has inadequate response or intolerable side effect to maximum tolerated dosing to 2 of the following: oxybutynin ER, tolterodine ER or trospium AND

Only required if female: inadequate response or intolerable side effect to Oxytrol For Women patch (OTC formulation)

Quantity Limits: 8 patches/28 days Date: GTC: URINARY TRACT - FUNCTIONAL DISORDERS: 2B Brand Name: Generic Name: Elmiron pentosan polysulfate sodium

Criteria: **Diagnosis** of chronic interstitial cystitis or painful bladder syndrome

Quantity Limits: 3 capsules/day Date: GTC: URINARY TRACT - FUNCTIONAL DISORDERS: 2B Brand Name: Generic Name: Rapaflo silodosin

Criteria: **Diagnosis** of Benign Prostatic Hyperplasia AND • Has inadequate response or intolerable side effect to maximum tolerated dosing to 2 of the 4 formulary alternatives: tamsulosin, alfuzosin, terazosin, or doxazosin.

Quantity Limits: 1 tab/day

Date: GTC: URINARY TRACT - FUNCTIONAL DISORDERS: 2B Brand Name: Generic Name: Vesicare solifenacin

Criteria: **Diagnosis** of overactive bladder OR urinary incontinence OR urgency AND has inadequate response OR intolerable side effect to maximum tolerated dosing to 2 of the following: oxybutynin ER, tolterodine ER OR trospium.

Quantity Limits: 1 tab/day

Date: Feb 2020 GTC: URINARY TRACT - FUNCTIONAL DISORDERS: 2B Brand Name: Generic Name: Sanctura XR Trospium ER Criteria: **Diagnosis** of overactive bladder or urinary incontinence or urgency AND has inadequate response or intolerable side effect to maximum tolerated dosing to 2 of the following: oxybutynin ER, tolterodine ER, solifenacin or trospium Quantity Limits: 1 tab/day

Date: Feb 2020 GTC: VAGINAL DISORDERS: 0Y Brand Name: Generic Name: Estring estradiol vaginal ring

Criteria: **Diagnosis** Diagnosis of Genitourinary syndrome of menopause AND an inadequate response, intolerable side effect, or contraindication to generic estradiol vaginal cream AND estradiol vaginal insert

Quantity Limits:

Date: September 2017 GTC: VITAMINS AND MINERALS DEFICIENCY: 1R Brand Name: Generic Name: Injectafer ferric carboxymaltose 750mg/15ml vial

Criteria: **Diagnosis** of iron-deficiency anemia AND • Laboratory evidence of iron deficiency anemia AND • Has inadequate response, intolerable side effect or contraindication to oral iron therapy AND • Has inadequate response, intolerable side effect or contraindication to 1 of the 3 formulary alternatives: iron sucrose, sodium ferric gluconate or iron dextran.

Quantity Limits: 750mg IV infusion for 2 doses per course of therapy

Date: September 2017 GTC: VITAMINS AND MINERALS DEFICIENCY: 1R Brand Name: Generic Name: Feraheme ferumoxytol 510mg/17ml vial

Criteria: **Diagnosis** of iron-deficiency anemia AND • Laboratory evidence of iron deficiency anemia AND • Has inadequate response, intolerable side effect or contraindication to oral iron therapy AND • Has inadequate response, intolerable side effect or contraindication to 1 of the 3 formulary alternatives: iron sucrose, sodium ferric gluconate or iron dextran.

Quantity Limits: 510mg IV infusion for 2 doses per course of therapy Date: September 2017 GTC: VITAMINS AND MINERALS DEFICIENCY: 1R Brand Name: Generic Name: Infed iron dextran 100mg/2ml vial

Criteria: **Diagnosis** of iron-deficiency anemia AND • Laboratory evidence of iron deficiency anemia AND • Has inadequate response, intolerable side effect or contraindication to oral iron therapy

Quantity Limits: Date: September 2017 GTC: VITAMINS AND MINERALS DEFICIENCY: 1R Brand Name: Generic Name: Venofer iron sucrose 100mg/5ml vial

Criteria: **Diagnosis** of iron-deficiency anemia AND • Laboratory evidence of iron deficiency anemia AND • Has inadequate response, intolerable side effect or contraindication to oral iron therapy

Quantity Limits: Date: September 2016 GTC: VITAMINS AND MINERALS DEFICIENCY: 1R Brand Name: Generic Name: Prenatal 19 pnv #119/iron fumarate/folic acid/dss 29-1-25mg oral tablet

Criteria: Formulary OTC-PNV

Quantity Limits: Date: September 2016 GTC: VITAMINS AND MINERALS DEFICIENCY: 1R Brand Name: Generic Name: Pnv #133/Ferrous Fumarate/Folic Acid 28-0.8Mg Oral Tablet pnv #133/ferrous fumarate/folic acid 28-0.8mg oral tablet

Criteria: Formulary OTC-PNV

Quantity Limits: Date: September 2016 GTC: VITAMINS AND MINERALS DEFICIENCY: 1R Brand Name: Generic Name: Pnv #36/Calcium/Iron/Folic Acid 13.5-0.4Mg Oral Capsule pnv #36/calcium/iron/folic acid 13.5-0.4mg oral capsule

Criteria: Formulary OTC-PNV

Quantity Limits: Date: September 2016 GTC: VITAMINS AND MINERALS DEFICIENCY: 1R Brand Name: Generic Name: One-A-Day Women’S Prenatal DHA, One Daily Prenatal pnv #75/iron fumarate/fa/om3/dha/epa 28-800-440mg oral combo pack (tabs/caps)

Criteria: Formulary OTC-PNV

Quantity Limits: Date: September 2016 GTC: VITAMINS AND MINERALS DEFICIENCY: 1R Brand Name: Generic Name: Pnv #95/Iron Fumarate/Folic Acid 28-0.8Mg Oral Tablet pnv #95/iron fumarate/folic acid 28-0.8mg oral tablet

Criteria: Formulary OTC-PNV

Quantity Limits: Date: September 2016 GTC: VITAMINS AND MINERALS DEFICIENCY: 1R Brand Name: Generic Name: Pnv #96/Ferrous Fumarate/Folic Acid 27-0.8Mg Oral Tablet pnv #96/ferrous fumarate/folic acid 27-0.8mg oral tablet

Criteria: Formulary OTC-PNV

Quantity Limits: Date: July 2018 GTC: VITAMINS AND MINERALS DEFICIENCY: 1R Brand Name: Generic Name: Prenatal prenatal vitamin

Criteria: • Limited to use during pregnancy or lactation • Women of childbearing age • Generic only • Not used as an alternative to regular multivitamin supplementation

Quantity Limits: 1 tablet/day Date: September 2017 GTC: VITAMINS AND MINERALS DEFICIENCY: 1R Brand Name: Generic Name: Ferrlecit sodium ferric gluconate 62.5 mg/5ml vial

Criteria: • **Diagnosis** of iron-deficiency anemia AND • Laboratory evidence of iron deficiency anemia AND • Has inadequate response, intolerable side effect or contraindication to oral iron therapy.

Quantity Limits: Date: GTC: BEHAVIORAL HEALTH - OTHER: 2L Brand Name: Generic Name: Evekeo amphetamine

Criteria: **Diagnosis** of BMI ≥ 30 with no risk factors or ≥ 27 with at least 1 risk factor: • Metabolic Conditions • Hypertension • Dyslipidemia • Prediabetes • Type 2 Diabetes • Metabolic Syndrome • NAFLD/NASH • Sleep Apnea • PCOS • Osteoarthritis • Stress Incontinence • GERD • Disability/Immobility • Psychological Disorder/Stigmatization AND • Patient has failed diet and lifestyle modifications AND • Has inadequate response, intolerable side effect, or contraindication to the preferred alternative phentermine or Alli

Reauthorization after 12 weeks: • Requires at least a 2.5% weight lost from baseline weight Reauthorization after 24 weeks: • Requires at least a 5% weight lost from baseline weight or maintenance of 5% weight lost.

**Diagnosis** is Attention Deficit Hyperactivity Disorder(ADHD) or Attention Deficit Disorder (ADD) AND • Has inadequate response, intolerable side effect or contraindication to formulary ADHD stimulant medications (1 product from the methylphenidate class AND 1 from the amphetamine class)

**Diagnosis** of Narcolepsy • Has inadequate response, intolerable side effect or contraindication to formulary stimulant medications (1 product from the methylphenidate class AND 1 from the amphetamine class) Quantity Limits: 3 tablets/day Date: GTC: WEIGHT REDUCTION – 2K Brand Name: Generic Name: Didrex benzphetamine Regimex

Criteria: **Diagnosis** of BMI ≥ 30 with no risk factors or ≥ 27 with at least 1 risk factor: • Metabolic Conditions • Hypertension • Dyslipidemia • Prediabetes • Type 2 Diabetes • Metabolic Syndrome • NAFLD/NASH • Sleep Apnea • PCOS • Osteoarthritis • Stress Incontinence • GERD • Disability/Immobility • Psychological Disorder/Stigmatization AND • Patient has failed diet and lifestyle modifications AND • Has inadequate response, intolerable side effect, or contraindication to the preferred alternative phentermine or Alli

Reauthorization after 12 weeks: • Requires at least a 2.5% weight lost from baseline weight

Reauthorization after 24 weeks: • Requires at least a 5% weight lost from baseline weight or maintenance of 5% weight lost.

Quantity Limits: 3 tablets/day

Date: GTC: WEIGHT REDUCTION – 2K Brand Name: Generic Name: Tenuate diethylproprion

Criteria: **Diagnosis** of BMI ≥ 30 with no risk factors or ≥ 27 with at least 1 risk factor: • Metabolic Conditions • Hypertension • Dyslipidemia • Prediabetes • Type 2 Diabetes • Metabolic Syndrome • NAFLD/NASH • Sleep Apnea • PCOS • Osteoarthritis • Stress Incontinence • GERD • Disability/Immobility • Psychological Disorder/Stigmatization AND • Patient has failed diet and lifestyle modifications AND • Has inadequate response, intolerable side effect, or contraindication to the preferred alternative phentermine or Alli

Reauthorization after 12 weeks: • Requires at least a 2.5% weight lost from baseline weight

Reauthorization after 24 weeks: • Requires at least a 5% weight lost from baseline weight or maintenance of 5 % weight lost.

Quantity Limits: IR: 4tabs/day ER: 1 tab/day Date: GTC: WEIGHT REDUCTION – 2K Brand Name: Generic Name: Saxenda liraglutide

Criteria: **Diagnosis** of BMI ≥ 30 with no risk factors or ≥ 27 with at least 1 risk factor: • Metabolic Conditions • Hypertension • Dyslipidemia • Prediabetes • Type 2 Diabetes • Metabolic Syndrome • NAFLD/NASH • Sleep Apnea • PCOS • Osteoarthritis • Stress Incontinence • GERD • Disability/Immobility • Psychological Disorder/Stigmatization AND • Patient has failed diet and lifestyle modifications AND • Has inadequate response, intolerable side effect, or contraindication to the preferred alternative phentermine or Alli

Reauthorization after 12 weeks: • Requires at least a 2.5% weight lost from baseline weight

Reauthorization after 24 weeks: • Requires at least a 5% weight lost from baseline weight or maintenance of 5 % weight lost.

Quantity Limits: Date: February 2019 GTC: WEIGHT REDUCTION – 2K Brand Name: Generic Name: Belviq lorcaserin

Criteria: **Diagnosis** of BMI ≥ 30 with no risk factors or ≥ 27 with at least 1 risk factor: • Metabolic Conditions • Hypertension • Dyslipidemia • Prediabetes • Type 2 Diabetes • Metabolic Syndrome • NAFLD/NASH • Sleep Apnea • PCOS • Osteoarthritis • Stress Incontinence • GERD • Disability/Immobility • Psychological Disorder/Stigmatization AND • Patient has failed diet and lifestyle modifications AND • Has inadequate response, intolerable side effect, or contraindication to the preferred alternative phentermine or Alli

Reauthorization after 12 weeks: • Requires at least a 2.5% weight lost from baseline weight

Reauthorization after 24 weeks: • Requires at least a 5% weight lost from baseline weight or maintenance of 5 % weight lost.

Quantity Limits: 2 tabs/day Date: February 2019 GTC: WEIGHT REDUCTION – 2K Brand Name: Generic Name: Belviq XR lorcaserin

Criteria: **Diagnosis** of BMI ≥ 30 with no risk factors or ≥ 27 with at least 1 risk factor: • Metabolic Conditions • Hypertension • Dyslipidemia • Prediabetes • Type 2 Diabetes • Metabolic Syndrome • NAFLD/NASH • Sleep Apnea • PCOS • Osteoarthritis • Stress Incontinence • GERD • Disability/Immobility • Psychological Disorder/Stigmatization AND • Patient has failed diet and lifestyle modifications AND • Has inadequate response, intolerable side effect, or contraindication to the preferred alternative phentermine or Alli

Reauthorization after 12 weeks: • Requires at least a 2.5% weight lost from baseline weight

Reauthorization after 24 weeks: • Requires at least a 5% weight lost from baseline weight or maintenance of 5 % weight lost.

Quantity Limits: 1 tabs/day Date: GTC: WEIGHT REDUCTION – 2K Brand Name: Generic Name: Contrave naltrexone/buproprion ER

Criteria: **Diagnosis** of BMI ≥ 30 with no risk factors or ≥ 27 with at least 1 risk factor: • Metabolic Conditions • Hypertension • Dyslipidemia • Prediabetes • Type 2 Diabetes • Metabolic Syndrome • NAFLD/NASH • Sleep Apnea • PCOS • Osteoarthritis • Stress Incontinence • GERD • Disability/Immobility • Psychological Disorder/Stigmatization AND • Patient has failed diet and lifestyle modifications AND • Has inadequate response, intolerable side effect, or contraindication to the preferred alternative phentermine or Alli

Reauthorization after 12 weeks: • Requires at least a 2.5% weight lost from baseline weight

Reauthorization after 24 weeks: • Requires at least a 5% weight lost from baseline weight or maintenance of 5 % weight lost.

Quantity Limits: 4 tabs/day Date: GTC: WEIGHT REDUCTION – 2K Brand Name: Generic Name: Xenical, Alli orlistat

Criteria: **Diagnosis** of BMI ≥ 30 with no risk factors or ≥ 27 with at least 1 risk factor: • Metabolic Conditions • Hypertension • Dyslipidemia • Prediabetes • Type 2 Diabetes • Metabolic Syndrome • NAFLD/NASH • Sleep Apnea • PCOS • Osteoarthritis • Stress Incontinence • GERD • Disability/Immobility • Psychological Disorder/Stigmatization AND • Patient has failed diet and lifestyle modifications AND • If request is for Xenical, redirect to the preferred alternative Alli

Reauthorization after 12 weeks: • Requires at least a 2.5% weight lost from baseline weight

Reauthorization after 24 weeks: • Requires at least a 5% weight lost from baseline weight or maintenance of 5 % weight lost

Quantity Limits: Xenical: 3 tabs/day Alli: 6 tabs/day Date: GTC: WEIGHT REDUCTION – 2K Brand Name: Generic Name: Bontril phendimetrazine

Criteria: **Diagnosis** of BMI ≥ 30 with no risk factors or ≥ 27 with at least 1 risk factor: • Metabolic Conditions • Hypertension • Dyslipidemia • Prediabetes • Type 2 Diabetes • Metabolic Syndrome • NAFLD/NASH • Sleep Apnea • PCOS • Osteoarthritis • Stress Incontinence • GERD • Disability/Immobility • Psychological Disorder/Stigmatization AND • Patient has failed diet and lifestyle modifications

Reauthorization after 12 weeks: • Requires at least a 2.5% weight lost from baseline weight

Reauthorization after 24 weeks: • Requires at least a 5% weight lost from baseline weight or maintenance of 5 % weight lost

Quantity Limits: IR: 3 tabs/day ER: 1 tab/day Date: GTC: WEIGHT REDUCTION – 2K Brand Name: Generic Name: Adipex phentermine Suprenza ODT

Criteria: **Diagnosis** of BMI ≥ 30 with no risk factors or ≥ 27 with at least 1 risk factor: • Metabolic Conditions • Hypertension • Dyslipidemia • Prediabetes • Type 2 Diabetes • Metabolic Syndrome • NAFLD/NASH • Sleep Apnea • PCOS • Osteoarthritis • Stress Incontinence • GERD • Disability/Immobility • Psychological Disorder/Stigmatization AND • Patient has failed diet and lifestyle modifications

Reauthorization after 12 weeks: • Requires at least a 2.5% weight lost from baseline weight

Reauthorization after 24 weeks: • Requires at least a 5% weight lost from baseline weight or maintenance of 5 % weight lost

Quantity Limits: 2 tablets/day

Date: GTC: WEIGHT REDUCTION – 2K Brand Name: Generic Name: Qsymia phentermine/topiramate ER

Criteria: **Diagnosis** of BMI ≥ 30 with no risk factors or ≥ 27 with at least 1 risk factor: • Metabolic Conditions • Hypertension • Dyslipidemia • Prediabetes • Type 2 Diabetes • Metabolic Syndrome • NAFLD/NASH • Sleep Apnea • PCOS • Osteoarthritis • Stress Incontinence • GERD • Disability/Immobility • Psychological Disorder/Stigmatization AND • Patient has failed diet and lifestyle modifications AND • Has inadequate response, intolerable side effect, or contraindication to the preferred alternative phentermine or Alli

Reauthorization after 12 weeks: • Requires at least a 2.5% weight lost from baseline weight

Reauthorization after 24 weeks: • Requires at least a 5% weight lost from baseline weight or maintenance of 5 % weight lost

Quantity Limits: