Hepatitis C (HCV) Prior Authorization Requirements for Direct Acting Antiviral Medication Treatment, Are Found in the Next Four Pages of This Document

Home , Enterocolitis

Hepatitis C (HCV) prior authorization requirements for direct acting antiviral medication treatment, are found in the next four pages of this document. AHCCCS MEDICAL POLICY MANUAL CHAPTER 320 – SERVICES WITH SPECIAL CIRCUMSTANCES

320-N - HEPATITIS C (HCV) PRIOR AUTHORIZATION REQUIREMENTS FOR DIRECT ACTING ANTIVIRAL MEDICATION TREATMENT 1 EFFECTIVE DATES: 07/17/14, 01/01/2018

REVISION DATES: 08/01/14, 03/15/15, 10/01/16, 07/06/17

I. PURPOSE

This Policy applies to Acute Care, ALTCS/EPD, CRS, DCS/CMDP, DES/DDD, RBHA Contractors; and Fee-For-Services (FFS) Programs delineated within this Policy including: Tribal ALTCS, TRBHAs, and the American Indian Health Program (AIHP), and all FFS populations, excluding Federal Emergency Services (FES). (For FES, see AMPM Chapter 1100).2 This Policy delineates AHCCCS prior authorization requirements for Title XIX and XXI members twelve3 years and older for coverage of direct acting antiviral medications for treatment of Hepatitis C virus (HCV). All such medications require prior authorization from AHCCCS for FFS members or Contractors, as applicable.

II.POLICY

In order to obtain prior authorization approval of heptitis C direct acting antiviral medications, members must meet all of the following requirements:

1. Diagnosis of chronic hepatitis C infection status which has been confirmed by detectable serum HCV RNA by quantitative assay completed within the past 90 days from the date of the prior authorization request that includes the HCV genotype, viral resistance status (when applicable), hepatic status (Child Pugh Score) and HCV viral load; AND

2. Adult age >18 years or adolescent age between 12 and 18 years old4; and

3. Are prescribed HCV medications by, or in consultation with, a gastroenterologist, hepatologist, or infectious disease physician, and

4. Patient readiness has been assessed and patient attestation of compliance is submitted and on file in the member’s medical record (prescribers shall use the CSPMP as a tool to aid in the review of compliance);5 and

1 Date changes are effective 2 POST APC CHANGE: changed to align with other purposes 3 POST TCN/PC Change: FDA has approved treatment for ages 12 and older. 4 POST TCN/PC Change Added to address the FDA approved age change (for some drugs) 5 POST TCN/PC Change Added to require a record of the member’s agreement to comply with the treatment 320-N - 1 of 4

AHCCCS MEDICAL POLICY MANUAL CHAPTER 320 – SERVICES WITH SPECIAL CIRCUMSTANCES

5. The member agrees to complete the regimen and understands the risks of reinfection and other contributors to liver disease and/or damage, through a signed attestation; and6

6. The prescribing clinician agrees to maintain HCV RNA levels obtained at 12 & 24- weeks post therapy completion to demonstrate the Sustained Virilogic Response (SVR);7 and

7. Member has been screened for Hepatitis A and B and must have received at least one Hepatits A and at least one Hepatitis B vaccine prior to requesting treatment unless the member demonstrates laboratory evidence of immunity;8 and

8. The member must be in remission for the past three months from the request date for treatment and must be engaged in a substance use disorder treatment program at the time of the prior authorization and over the course of the treatment if the member has/had a substance use disorder in the past 12 months.9

A. TREATMENT MONITORING REQUIREMENTS

1. Members prescribed HCV treatment must participate in a treatment adherence program.

2. Providers are required to monitor hemoglobin levels periodically when a member is prescribed ribavirin.

10 B. HEPATITIS C RETREATMENT REQUIREMENTS

For members who have HCV and a history of treatment with a DAA, the following criteria must be met for DAA retreatment approval:

1. The member was adherent to previous DAA therapy as evidenced by medical records and/or pharmacy prescription claims. If prior therapy was discontinued due to adverse effects from the DAA, the medical record must be provided which documents these adverse effects and recommendation of discontinuation by treatment provider; and 2. If a member has a substance use disorder in the past 12 months from the request date for treatment, the member must be in remission for the past three months from the request date for treatment and must be engaged in a substance use disorder treatment program at the time of the prior authorization request and over the course of treatment if the DAA medications are approved.

6 POST TCN/PC Change Added to require the member be informed of treatment risks and reinfection 7 POST TCN/PC Change Added as a standard of care 8 POST TCN/PC Change Requirement was previously listed lower in the policy. 9 POST TCN/PC Change Moved from lower in the policy and reworded. 10 Retreatment guidelines because the One Treatment per lifetime under limitations is being removed. 320-N - 2 of 4 AHCCCS MEDICAL POLICY MANUAL CHAPTER 320 – SERVICES WITH SPECIAL CIRCUMSTANCES

3. Member commits to the documented planned course of treatment including anticipated laboratory, imaging tests, and prescribing provider visits. 4. Resistance-associated polymorphism testing, when applicable, has been completed and submitted with the prior authorization request when11: 1. Requred for regimens whereby the FDA requires such testing prior to treatment to ensure clinical appropriateness; and 2. Deemed medically necessary by the clinical reviewer prior to approval of the requested regimen

Hepatitis C Retreatment shall not be approved when:

1. The life expectancy is less than 12 months and cannot be remediated by treating the HCV infection, by transplantation, or by other directed therapy. 2. A member was non-adherent to the initial DAA treatment regimen as evidenced by medical records and/or pharmacy prescription claims. 3. Is considered an experimental service as defined in R9-22-203. Based on current evidence, this includes more than one retreatment with a DAA and requested retreatment regimens that include more than one DAA.

C. LIMITATIONS

Direct Acting Antiviral HCV treatment coverage is not provided for the following:

1. Monotherapy of: a. Daclatasvir (Daklinza), b. Simeprevir (Olysio), c. Sofosbuvir (Sovaldi).

2. Direct Acting Antiviral Dosages greater than the FDA approved maximum dosage.

3. Ombitasvir, Paritaprevir and Ritonavir (Technivie) or Ombitasvir, Paritaprevir and Ritonavir; Dasabuvir tablets (Viekira Pak) shall not be approved for members whose Child Pugh score is B or C.

4. Grazoprevir/elbasvir (Zepatier) if the NS5A polymorphism testing has not been completed and submitted with the prior authorization request.

5. Members when there is documented non-adherence to prior HCV medications, HCV medical treatment, or failure to complete HCV disease evaluation appointments and laboratory and imaging procedures.

6. Members declining to participate in a treatment adherence program.

11 POST TCN/PC Change Added to ensure the appropriate treatment is provided and the member is not resistant to the proposed tx. 320-N - 3 of 4 AHCCCS MEDICAL POLICY MANUAL CHAPTER 320 – SERVICES WITH SPECIAL CIRCUMSTANCES

7. Members declining to participate in a substance abuse disorder treatment program.

8. Members whose comorbidities are such that their life expectancy is one year or less.

9. Members currently using a potent P-gp inducer drug (St. John’s wart, rifampin, carbamazepine, ritonavir, tipranavir, etc.).

Greater than one Direct Acting Antiviral drug regimen used for retreatment.1213.

10. Lost or stolen medication absent of good cause.

11. Fraudulent use of HCV medications.

D. REQUIRED DOCUMENTATION FOR SUBMISSION OF HCV PRIOR AUTHORIZATION REQUESTS

In order for a prior authorization request for HCV medications to be considered, the following minimum information must be submitted for the member:

1. HCV treatment history and responses.

2. Evidence of Hepatitis A & B vaccinations or laboratory evidence of immunity.

3. Current medication list.

4. Laboratory results for all of the following:

HCV screen, genotype and current baseline viral load, total bilirubin, albumin, INR, CrCl or GFR, LFTs, CBC and drug/alcohol screen completed within the past 90 days.

12 POST TCN/PC Change Limiting retreatment to one regimen based on our conversation with Dr. Manch 13 POST TCN/PC Change Removing and replacing with retreatment guidelines in the policy. 320-N - 4 of 4

Prior authorization requirements for SMOKING CESSATION AIDS are found on the next five pages of this document.

AMPM CHAPTER 300, MEDICAL POLICY FOR COVERED SERVICES EXHIBIT 320-K - 1, PRIOR AUTHORIZATION PROTOCOL THERAPEUTIC CLASS: SMOKING CESSATION AIDS

THERAPEUTIC CLASS: SMOKING CESSATION AIDS FORMULARY STATUS: ON FORMULARY

EDUCATION CLASSES AGENTS

NICOTINE Nicoderm REPLACEMENT THERAPY Nicotine Patch CQ Nicotrol (NRT) PRODUCTS Habitrol  Nicotine Nasal Spray Nicotrol NS Nicotine Inhaler Nicotrol Inhaler Nicotine Gum Nicorette  Nicotine Lozenge Commit Bupropion Wellbutrin  ANTIDEPRESSANTS Bupropion SR Wellbutrin SR , Bupropion 24 hours Zyban Wellbutrin XL NICOTINE RECEPTOR  Verenicline Chantix AGONIST

A. FEDERAL DRUG ADMINISTRATION (FDA) APPROVED INDICATIONS

All products are FDA approved as aids for smoking cessation treatment and to help reduce withdrawal symptoms, including nicotine craving.

B. GUIDELINES FOR APPROVAL

The following criteria apply to AHCCCS members choosing to receive a tobacco cessation product.

1. Members are encouraged to enroll in a tobacco cessation program through Arizona Department of Health Services (ADHS). To enroll in an ADHS cessation program the member must call 1-800-556-6222.

2. Members must contact their Primary Care Provider (PCP) to obtain a prescription for a tobacco cessation product. The PCP will identify an appropriate tobacco cessation product. In order to be covered by AHCCCS all tobacco use medications require a prescription. This includes all tobacco cessation products, including those that are available over-the-counter.

3. The maximum supply a member may receive of a tobacco cessation product is a 12-week supply in a six month time period. The six month time period begins the date the first prescription is filled for the tobacco cessation product.

Revision Date: 03/01/2012 Initial Effective Date: 06/01/2009

AMPM CHAPTER 300, MEDICAL POLICY FOR COVERED SERVICES EXHIBIT 320-K - 1, PRIOR AUTHORIZATION PROTOCOL THERAPEUTIC CLASS: SMOKING CESSATION AIDS

C. PRIOR AUTHORIZATION WILL BE REQUIRED FOR THE FOLLOWING:

1. Members under the age of 18 years old,

2. Brand name medications when a generic product is available, and

3. Bupropion 24 hour / Wellbutrin XL.

D. COVERAGE IS NOT AUTHORIZED FOR:

1. Non-Title XIX Members,

2. Indications other than for as an aid for smoking cessation,

3. Doses greater than the FDA Maximum Allowable,

4. Combination treatment with more than one of the above agents, or

5. Specific drug-disease condition contraindications.

E. COVERAGE FOR DUAL ELIGIBLES:

Medications that are available by prescription only and bear the federal legend, Federal Law Prohibits Dispensing Without a Prescription‖ are to be obtained from and covered by the Medicare Part D Plan.

Medications that are available over-the-counter are to be covered by the AHCCCS Contracted Health Plans and ordered in accordance with Section B, Guidelines for Approval.

Revision Date: 03/01/2012 Initial Effective Date: 06/01/2009

AMPM CHAPTER 300, MEDICAL POLICY FOR COVERED SERVICES EXHIBIT 320-K - 1, PRIOR AUTHORIZATION PROTOCOL THERAPEUTIC CLASS: SMOKING CESSATION AIDS

F. THERAPEUTIC ALTERNATIVES

SMOKING CESSATION MAXIMUM DOSING REGIMEN PRODUCT DAILY DOSE 2-4 sprays per hour 40mg NICOTINE NASAL SPRAY Minimum effective dose is 16 sprays 80 sprays per day (Nicotrol NS) per day 80 sprays = ½ bottle 6-16 cartridges a day individualized NICOTINE INHALER  dosing as needed. 16 cartridges per (Nicotrol Inhaler) day NICOTINE PATCH 7 mg / 24 hours (Nicoderm CQ, 14 mg / 24 hours 21mg per 24 Nicotrol, Habitrol) 21 mg / 24 hours hours 1 piece every 1-2 hours weeks 1-6, NICOTINE GUM then 24 pieces of gum (Nicorette), OR 1 piece every 2-4 hours weeks 7-9, or lozenges per Lozenge (Commit) then day 1 piece every 4-8 hours weeks 10-12. BUPROPION HCL SR 150mg orally every day for the first 3 (Zyban / Wellbutrin days, may increase to 150mg twice a 300mg per day SR) day if tolerated.

Titration Schedule:

0.5mg orally daily for 3 days, then VERENICLINE 0.5mg twice daily for 4 days, 2mg per day (Chantix) then 1mg twice daily to complete the 12 week course of therapy

G. GENERAL INFORMATION

1. Nicotine Replacement Therapy (NRT)

a. Dependence has been recognized as a chronic, relapsing disease

b. Any form can be toxic and addictive

c. Smoking-drug interactions are costly to the health care system

Revision Date: 03/01/2012 Initial Effective Date: 06/01/2009

AMPM CHAPTER 300, MEDICAL POLICY FOR COVERED SERVICES EXHIBIT 320-K - 1, PRIOR AUTHORIZATION PROTOCOL THERAPEUTIC CLASS: SMOKING CESSATION AIDS

2. Bupropion (Wellbutrin, Wellbutrin XL & Zyban)

a. Mechanism of action is unknown

b. In comparative data trials, efficacy is superior to NRT

c. Reduces weight gain after smoking cessation

d. Has several contraindications, precautions and warnings

e. The study, A Controlled Trial of Sustained-Release Bupropion, a Nicotine Patch, or Both for Smoking Cessation (1999), found that sustained release bupropion alone or in combination with a nicotine patch resulted in significantly higher long-term rates of smoking cessation as compared to the use of either the nicotine patch alone or placebo. Abstinence rates were higher with combination therapy than with bupropion alone but the difference was not statistically significant.

3. Verenicline (Chantix)

a. Represents a new class for smoking cessation therapy and acts as a nicotine partial receptor agonist.

b. Dose dependent nausea has been reported in up to 40% of utilizing patients.

c. Long-term safety is unknown.

d. Does not reduce weight gain after smoking cessation.

e. Efficacy of Verenicline as compared to NRT is currently unknown.

f. In comparative trials following 12 weeks of treatment, bupropion naïve patients receiving Verenicline were more likely to quit smoking than patients on bupropion.

g. In one Verenicline study, an additional 12-week course of therapy was given to abstinent patients immediately after the first 12-week course had elapsed. There is currently no data to support the efficacy of re-starting Verenicline after a lapse in therapy following the initial 12-week course.

h. No contraindications (other than drug allergy).

i. Extreme caution should be taken when evaluating a person with serious mental illness for a trial of Verenicline.

4. Abstinence rates were consistently higher with all products when combined with a behavioral modification program. Revision Date: 03/01/2012 Initial Effective Date: 06/01/2009

AMPM CHAPTER 300, MEDICAL POLICY FOR COVERED SERVICES EXHIBIT 320-K - 1, PRIOR AUTHORIZATION PROTOCOL THERAPEUTIC CLASS: SMOKING CESSATION AIDS

5. Based on the clinical trials of all of the products, an assumption can be drawn that Verenicline is superior to Bupropion and NRT. REFERENCES

1. AHCCCS Smoking Cessation Policy, October 2009.

2. Chantix Prescribing Information, Pfizer Labs, May 2006.

3. Vernicline Monograph, Drug Facts and Comparisons, May 2009.

4. Bupropion Monograph, Drug Facts and Comparisons, May 2009.

5. Zyban Prescribing Information, GlaxoSmithKline, December 2008.

6. Central Nervous system Agents, Smoking Deterrents, Nicotine, Drug Facts and Comparisons, May 2009.

7. Jorenby DE, Hays JT, Rigotti NA, et al. Efficacy of varenicline, an α4β2 nicotinic acetylcholine receptor partial agonist, vs placebo or sustained-release bupropion for smoking cessation. JAMA. 2006; 296:56-63.

Revision Date: 03/01/2012 Initial Effective Date: 06/01/2009 App lies to: Care1st Actimmune (interferon gamma-1B)

Covered uses All medically accepted indications

Exclusion Criteria See age restrictions

Required Medical 1) Diagnosis of : Information • Chronic Granulomatous Disease (CGD) • Osteopetrosis

2) Documentation that prior to the beginning of treatment and at three-month intervals during treatment, the following recommended laboratory test are being monitored: • Hematologic tests – including complete blood counts, differential and platelet counts • Blood chemistries – including renal and liver function tests • In patients less than 1 year of age, monthly liver function tests. Age re strictions 1 year of age or older for Chronic Granulomatous Disease (CGD) 1 month and older for severe, malignant osteopetrosis (SMO) Pre scribe r None Restrictions Coverage Duration 1 year Othe r Crite ria None

Reference(s):

1. Actimmune [package insert]. Horizon Pharma USA, Inc. Lake Forest, IL 60045 May, 2017.

Last Updated: 01/2018 Page 1 of 1 App lies to: Care1st Hepsera (adefovir dipivoxil)

Covered uses All medically accepted indications

Exclusion Criteria

Required Medical 1) Trial and failure of preferred alternative Information • Lamivudine (hbv) solution • Lamivudine (hbv) tablets 2) Hepatic function is being monitored before and during treatment

Age re strictions 12 years and older Pre scribe r None Restrictions Coverage Duration 1 year Othe r Crite ria

Reference(s):

1. Adefovir [package insert].Sigmapharm Laboratories,LLC. Bensalem, PA June, 2016.

Last Updated: 02/2018 Page 1 of 1 Applies to: Care1st AZ member < 6 years

Metadate CD (Methylphenidate ER) Ritalin LA 10mg (Methylphenidate ER) Daytrana (Methylphenidate Patch) Vyvanse (Lisdexamphetamine) Focalin IR (Dexmethylphenidate IR) Focalin XR (Dexmethylphenidate ER)

Covered uses All medically accepted indications.

Exclusion Criteria Indications other than ADHD.

Required Medical Diagnosis of Attention-deficit hyperactivity disorder Information -and- 1) The requesting clinician has documented that the child has a diagnosis of ADHD. 2) Psychosocial issues and non-medical interventions are being addressed by the clinical team. 3) Documentation of psychosocial evaluation occurring before request for ADHD medications. 4) Documentation of non-medication alternatives that have been attempted before request for ADHD medications.

Age re strictions Covered without PA requirement for ages 6 years and older.

Pre scribe r Restrictions Coverage Duration 1 year

Othe r Crite ria

Reference(s):

1. Manufacturer Product Information 2. Pliska SR, Greenhill LL, Crismon ML, et al. The Texas children’s medication algorithm project: report of the Texas census conference panel on medication treatment of childhood deficit/hyperactivity disorder. Part 1. J Am Academy Child Adolescent Psychology. 200;39(7):920-927

Last Updated: 12/2017 Page 1 of 1

App lies to: Care1st Albenza (albendazole)

Covered uses All medically accepted indications

Exclusion Criteria See age restrictions

Required Medical 1) Enterobiasis, ascariasis: Medical documentation Information indicating use for treatment for enterobiasis and previous trial and failure to ivermectin and Pin-X

2) Intestinal strongyloidiasis, cutaneous larva migrans, or infection by loa loa: Medical documentation indicating use for treatment for intestinal strongyloidiasis, cutaneous larva migrans, or infection by loa loa and previous trial and failure to ivermectin. Approve for use as empiric treatment for presumptive strongyloides infection in Sub-Saharan Africa refugees from LoaLoa endemic countries, regardless of previous ivermectin use.2

3) Echinococcosis (Hydatid disease), neurocysticercosis: Medical documentation indicating the use for treatment of echinococcosis or neurocysticercosis. Age re strictions 1 year of age or older Pre scribe r Restrictions Coverage Duration 6 months (Hytadid) 1 month for other indications Othe r Crite ria None

Reference(s):

1. Albenza [package insert]. Amedra Pharmaceuticals. Horsham, PA. February, 2013 2. Centers for Disease Control and Prevention. Guidelines for Overseas Presumptive Treatment of Strongyloidiasis, Schistosomiasis, and Soil-Transmitted Helminth Infections. http://www.cdc.gov/immigrantrefugeehealth/guidelines/overseas/intestinalparasites- overseas.html. Accessed August 20, 2014.

Last Updated: 10/2014 Page 1 of 1

Applies to: Care1st

Aralast NP Solution (alpha1-proteinase inhibitor)

Covered uses All medically accepted indications

Exclusion Criteria

Required Medical Documentation of the following: Information 1) Patients must have clinically evident emphysema. 2) Patients must have a pretreatment serum alpha1- proteinase inhibitor level less than 11 micromoles/L (80 mg/dl). Age restrictions 18 years and older Prescriber Restrictions Coverage Duration 12 months Other Criteria

Reference(s):

1. Aralast NP Solution (alpha1-proteinase inhibitor) [prescribing information]. Westlake Village, CA: Baxalta US Inc; September 2017.

Last Reviewed: 09/2018 Page 1 of 1

Applies to: Care1st

Makena (17 alpha-hydroxyprogesterone)

Covered uses All medically accepted indications

Exclusion Criteria <16 years of age >50 years of age

Do not use Makena in women with any of the following conditions: 1) Current or history of thrombosis or thromboembolic disorders 2) Known or suspected breast cancer, other hormone- sensitive cancer, or history of these conditions 3) Undiagnosed abnormal vaginal bleeding unrelated to pregnancy 4) Cholestatic jaundice of pregnancy 5) Liver tumors, benign or malignant, or active liver disease 6) Uncontrolled hypertension Required Medical Statement of need for preterm delivery prophylaxis in females Information with a singleton pregnancy who have a history of singleton spontaneous preterm birth:

1) Must be continued weekly until week 37 or delivery AND 2) Must be initiated between week 16 and week 27 of pregnancy

Age re strictions Women between 16 and 50 years of age

Pre scribe r Obstetrician Restrictions Coverage Duration Up to 21 weeks Othe r Crite ria Max Dose 250mg weekly Makena is not intended for use in women with multiple gestations

Reference(s):

1. Makena [package insert]. Chesterfield, MO: Ther-Rx Corporation; February 2014. 2. How H, Barton J, Istwan N, Prophylaxis with 17 alpha-hydroxyprogesterone caproate for prevention of recurrent preterm delivery: does gestational age ast initiation of treatment matter? American Journal of Obstetrics and Gynecology. 2007 September.

Last Updated: 03/2018 Page 1 of 2 Applies to: Care1st

3. Rebarber A, Roman A, Fox N, Recurrent Preterm Birth Prevention in Women Receiving Prophylactic 17P Experiencing Symptoms of Preterm Labor. Presented at 32nd Annual meeting of the Society for Maternal-Fetal Medicine, Dallas, Texas. February 2012. 4. Gonzalez-Quintero V, Istwan N, Rhea D, Gestational Age at Initiation of 17- hydroxyprogesterone caproate (17P) and recurrent preterm delivery. J Matern Fetal Neonatal Med. 2007 Mar; 20(3): 249-52.

Last Updated: 03/2018 Page 2 of 2 Applies to: Care1st

Letairis (ambrisentan)

Covered uses All FDA Approved Indications Exclusion Criteria 1) Pregnancy 2) Pulmonary Hypertension • World Health Organization group 2 - 5 Required Medical 1) Documented diagnosis of: Information • Pulmonary Arterial Hypertension (Idiopathic, inherited, due to drugs/toxins, connective tissue diseases, etc.) World Health Organization Group 1 with predominately NYHA class II or III symptoms: • To improve exercise ability and delay clinical worsening. • In combination with tadalafil to reduce risks of disease progression and hospitalization for worsening PAH, and to improve exercise ability.

Age re strictions Age 18 years or greater Pre scribe r Cardiologist or Pulmonologist Restrictions Coverage Duration 1 year Othe r Crite ria

Reference(s):

1. Letaitis [package insert]. Gilead Science. Foster City, CA. October 2015 2. N. Galie, J.A. Barbera, A.E. Frost, et al.Initial Use of Ambrisentan plus Tadalafil in Pulmonary Arterial Hypertension. N. Engl. J. Med., 373 (2015), pp. 834–844

Last Updated: 03/2016 Page 1 of 1 Applies to: Care1st

Arimidex (Anastrozole)

Covered uses All FDA approved indications.

Exclusion Criteria 1) Pregnancy 2) Premenopausal women

Required Medical 1) Documented diagnosis of one of the following: Information • Adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer.

• First-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer.

• Treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy..

2. Trial and failure of preferred alternative tamoxifen

Age restrictions 18 years of age and older

Prescriber Oncologist Restrictions Coverage Duration 1 year

Other Criteria

Reference(s):

1. Anastrozole [package insert] ANI Pharmaceuticals, Inc. June 2018.

Last Updated: 09/2018 Page 1 of 1

Applies to: Care1st

Anti-Tussive-Expectorants (Coditussin AC, Guaifenesin-Codeine oral solution)

Covered uses All FDA approved indications

Exclusion Criteria Required Medical 1) Trial and failure of preferred alternatives if under 18 years of Information age: • Guaifenesin-codeine oral solution • Guaifenesin DM oral syrup • Mucus relief cough children’s oral liquid

Age restrictions 18 years and older Prescriber Restrictions Coverage Duration 1 year Other Criteria

Reference(s):

1. Coditussin AC [package insert], Glendale, Inc., Vila Park, IL 60181, May 2016. 2. Guaifenesin/Codeine phosphate solution [package insert], Pharmaceutical Associates, Inc., Greenville, SC 29605, December 2017.

Created: 08/2018 Page 1 of 1

Applies to: Care1st

Anti-TNF Biologic Products Enbrel (etanercept), Humira (adalimumab), Cimzia (cetolizumab pegol), Simponi (golimumab), Simponi Aria (golimumab), Remicade (infliximab)

Covered uses A. FDA Approved Indications 1) Ankylosing spondylitis • Enbrel is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis

• Simponi is indicated as monotherapy for patients 18 years or older for reducing signs and symptoms of active ankylosing spondylitis

• Remicade is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis

• Cimzia is indicated for the treatment of adults with active ankylosing spondylitis

• Humira is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis

2) Plaque psoriasis (PsO) • Enbrel is indicated for the treatment of patients 4 years of age and older with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

• Humira is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. Adalimumab should only be administered to patients who will be closely monitored and have regular follow-up visits with a health care provider.

• Remicade is indicated for the treatment of adult patients with chronic severe (i.e., extensive and/or disabling) plaque psoriasis who are candidates for systemic therapy and when other systemic therapies are medically less appropriate.

3) Polyarticular juvenile idiopathic arthritis (JIA)

Last Updated: 05/2017 Page 1 of 16 Applies to: Care1st

• Enbrel is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older.

• Humira is indicated for reducing signs and symptoms in patients 2 years of age and older with moderately to severely active polyarticular juvenile idiopathic arthritis alone or in combination with methotrexate.

4) Psoriatic arthritis (PsA) • Enbrel is indicated for reducing signs and symptoms, inhibiting the progression of structural damage of active arthritis, and improving physical function in patients with psoriatic arthritis. Enbrel can be used with or without methotrexate.

• Humira is indicated for reducing signs and symptoms of active arthritis, inhibiting the progression of structural damage, and improving physical function in patients with psoriatic arthritis alone or in combination with disease-modifying antirheumatic drugs (DMARDs).

• Simponi is indicated as monotherapy or as adjunct therapy for the treatment of active arthritis in patients age 18 or older with psoriatic arthritis PsA).

• Cimzia is indicated for the treatment of adult patients with active psoriatic arthritis (PsA).

• Remicade is indicated for reducing signs and symptoms of active arthritis, inhibiting the progression of structural damage, and improving physical function in patients with psoriatic arthritis.

5) Rheumatoid arthritis (RA) • Enbrel is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely active RA. Etanercept can be initiated in combination with methotrexate or used alone.

• Humira is indicated for reducing signs and symptoms,

Last Updated: 05/2017 Page 2 of 16 Applies to: Care1st

inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis (RA) alone or in combination with methotrexate or other DMARDs.

• Cimzia is indicated for the treatment of adults with moderately to severely active rheumatoid arthritis (RA).

• Simponi and Simponi Aria are indicated as adjunct therapy for the treatment of moderately to severely active rheumatoid arthritis (RA).

• Remicade, in combination with methotrexate, is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely active rheumatoid arthritis.

6) Crohn’s Disease • Humira is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in patients 6 years and older with moderately to severely active Crohn’s disease who have had an inadequate response to conventional therapy; for reducing signs and symptoms and inducing clinical remission in these patients if they have also lost response to or are intolerant to infliximab.

• Cimzia is indicated for reducing signs and symptoms of Crohn’s disease and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy.

• Remicade is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in patients 6 years and older with moderately to severely active Crohn's disease who have had an inadequate response to conventional therapy.

7) Ulcerative Colitis • Remicade is indicated for reducing signs and symptoms, inducing and maintaining clinical remission and mucosal Last Updated: 05/2017 Page 3 of 16 Applies to: Care1st

healing, and eliminating corticosteroid use in adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy.

• Simponi is indicated in adult patients with moderately to severely active ulcerative colitis who have demonstrated corticosteroid dependence or who have had an inadequate response to or failed to tolerate oral aminosalicylates, oral corticosteroids, azathioprine, or 6-mercaptopurine for: o inducing and maintaining clinical response o improving endoscopic appearance of the mucosa during induction o inducing clinical remission o achieving and sustaining clinical remission in induction responders

• Humira is indicated for inducing and sustaining clinical remission in adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to immunosuppressants such as corticosteroids, azathioprine or 6-mercaptopurine (6-MP). The effectiveness of HUMIRA has not been established in patients who have lost response to or were intolerant to TNF blockers

8) Hidradenitis suppurativa Humira is indicated for the treatment of moderate to severe hidradenitis suppurativa.

9) Uveitis Humira is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients.

Off-labeled Use: Drug therapies must be utilized in accordance with FDA approved † indications OR the uses found within the compendia of literature AND the drug is being prescribed for a medically accepted indication that is recognized as a covered benefit by the applicable health plans’ program. Authorization for off-labeled use of medication will be evaluated on an individual basis. Review of an off-labeled request by the WellCare Pharmacy and Therapeutics Committee will be predicated on the appropriateness of treatment, scientific evidence and full consideration of medical necessity. ††-compendia of current literature: • National Comprehensive Cancer

Last Updated: 05/2017 Page 4 of 16 Applies to: Care1st

Network Drugs and Biologics Compendium • Thomson Micromedex DrugDex

Exclusion Criteria TNF- Alpha Inhibitor combination therapy is considered experimental and will not be approved. Positive TB test Required Medical A. Rheumatoid Arthritis Information 1) Humira or Enbrel will be approved based on all of the following criteria: • Diagnosis of moderate to severe active RA -AND- • Patient is ≥18 years old -AND • Prescribed or recommended by a rheumatologist, or immunologist -AND • History of failure of adequate trial (at least 3 months), contraindication, or intolerance to methotrexate and at least one other DMARD [eg, leflunomide, sulfasalazine, hydroxychloroquine, azathioprine, cyclosporine] -AND • Screen for TB 2) Cimzia will be approved based on all of the following criteria: • Diagnosis of moderate to severe active RA -AND- • Patient is ≥18 years old -AND- • Prescribed or recommended by a rheumatologist or immunologist -AND- • History of failure of adequate trial (at least 3 months), contraindication, or intolerance to methotrexate and at least one other DMARD [eg, leflunomide, sulfasalazine, hydroxychloroquine, azathioprine, cyclosporine] -AND- • History of failure of adequate trial (at least 3 months), contraindication, or intolerance to preferred Humira or Enbrel -AND- • Screen for TB 3) Simponi or Remicade will be approved based on all of the following criteria: • Diagnosis of moderate to severe active RA

Last Updated: 05/2017 Page 5 of 16 Applies to: Care1st

-AND- • Patient is ≥18 years old -AND • Prescribed or recommended by a rheumatologist or immunologist -AND • In combination with methotrexate -AND • History of failure of adequate trial (at least 3 months), contraindication, or intolerance to at least one other DMARD [eg, leflunomide, sulfasalazine, hydroxychloroquine, azathioprine, cyclosporine] -AND • History of failure of adequate trial (at least 3 months), contraindication, or intolerance to preferred Humira or Enbrel -AND • Screen for TB

4) Remicade will be approved based on all of the following criteria: • Diagnosis of moderate to severe active RA -AND- • Patient is ≥18 years old -AND • Prescribed or recommended by a rheumatologist or immunologist -AND • In combination with methotrexate -AND • History of failure of adequate trial (at least 3 months), contraindication, or intolerance to at least one other DMARD [eg, leflunomide, sulfasalazine, hydroxychloroquine, azathioprine, cyclosporine] -AND • History of failure of adequate trial (at least 3 months), contraindication, or intolerance to preferred Humira or Enbrel • Screen for TB

5) Simponi Aria will be approved based on all of the following criteria: • Diagnosis of moderate to severe active RA -AND- • Patient is ≥18 years old -AND

Last Updated: 05/2017 Page 6 of 16 Applies to: Care1st

• Prescribed or recommended by a rheumatologist or immunologist -AND • In combination with methotrexate -AND • Trial and failure of Humira or Enbrel -AND • Screen for TB

B. Polyarticular Juvenile Idiopathic Arthritis 1) Enbrel and Humira will be approved based on all of the following criteria: • Diagnosis of moderate to severely active polyarticular JIA -AND- • The patient’s age is 2 years or older -AND- • Prescribed or recommended by a rheumatologist or immunologist -AND • History of failure (defined as inadequate response or return of symptoms) to one of the following: o Non-steroidal anti-inflammatory drugs (NSAIDs) [eg, Motrin (ibuprofen), Naprosyn (naproxen)] o Corticosteroids (eg, prednisone) -AND- • History of failure after adequate trial (at least 3 months), contraindication, or intolerance to methotrexate (Rheumatrex, Trexall)

C. Psoriatic Arthritis (PsA) 1) Enbrel or Humira will be approved based on all of the following criteria: • Diagnosis of active PsA -AND- • Patient is ≥18 years old -AND- • Prescribed or recommended by one of the following specialists: o Dermatologist o Rheumatologist o Immunologist -AND- • History of failure after adequate trial (at least 3 months), contraindication, or intolerance to one DMARD [eg,

Last Updated: 05/2017 Page 7 of 16 Applies to: Care1st

Rheumatrex/Trexall (methotrexate), Arava (leflunomide), Azulfidine (sulfasalazine)] -AND- • Screen for TB

2) Remicade, Simponi, and Cimzia will be approved based on all of the following criteria: • Diagnosis of active PsA -AND- • Patient is ≥18 years old -AND- • Prescribed or recommended by one of the following specialists:Dermatologist, Rheumatologist, or Immunologist -AND- • History of failure after adequate trial (at least 3 months), contraindication, allergy or intolerance to one DMARD [eg, Rheumatrex/Trexall (methotrexate), Arava (leflunomide), Azulfidine (sulfasalazine)] -AND- • History of failure of adequate trial (at least 3 months), contraindication, or intolerance to preferred Humira or Enbrel • Screen for TB

D. Plaque Psoriasis 1) Humira and Enbrel will be approved based on all of the following criteria: • Diagnosis of moderate to severe chronic plaque psoriasis -AND- • Patient is ≥ 18 years old -AND- • History of failure, contraindication, or intolerance to both of the following (a and b) conventional therapies: o Phototherapy with at least one of the following, unless unavailable to the patient: . Ultraviolet Light B (UVB) used alone or in combination with topical or systemic treatments . Pulsed Dye Laser . Psoralen and exposure to ultraviolet light A (PUVA) . Photochemotherapy -AND- o Systemic or topical therapy with at least one of the

Last Updated: 05/2017 Page 8 of 16 Applies to: Care1st

following: . Methotrexate (Rheumatrex, Trexall) . Cyclosporine (Sandimmune, Neoral, Gengraf) . Topical steroid . Hydroxyurea (Hydrea) . Sulfasalazine (Azulfidine) -AND- • Prescribed or recommended by a dermatologist or immunologist -AND- • Screen for TB

2) Remicade will be approved based on all of the following criteria: • Diagnosis of moderate to severe chronic plaque psoriasis -AND- • Patient is ≥ 18 years old -AND- • History of failure, contraindication, or intolerance to both of the following (a and b) conventional therapies: o Phototherapy with at least one of the following, unless unavailable to the patient: . Ultraviolet Light B (UVB) used alone or in combination with topical or systemic treatments . Pulsed Dye Laser . Psoralen and exposure to ultraviolet light A (PUVA) . Photochemotherapy -AND- o Systemic or topical therapy with at least one of the following: . Methotrexate (Rheumatrex, Trexall) . Cyclosporine (Sandimmune, Neoral, Gengraf) . Topical steroid . Hydroxyurea (Hydrea) . Sulfasalazine (Azulfidine) -AND- • Prescribed or recommended by a dermatologist or immunologist -AND- • History of failure of adequate trial (at least 3 months), contraindication, or intolerance to preferred Humira or Enbrel • Screen for TB

Last Updated: 05/2017 Page 9 of 16 Applies to: Care1st

E. Ankylosing Spondylitis 1) Humira or Enbrel will be approved based on all of the following criteria: • Diagnosis of ankylosing spondylitis. -AND- • Patient is ≥ 18 years old -AND • Prescribed or recommended by a rheumatologist or immunologist -AND • History of failure (no response after maximum tolerated doses), contraindication, or intolerance to two or more NSAIDs [diclofenac, etodolac, ibuprofen, ketoprofen, meloxicam] -AND • Screen for TB

2) Cimzia, Simponi and Remicade will be approved based on all of the following criteria: • Diagnosis of ankylosing spondylitis. -AND- • Patient is ≥ 18 years old -AND • Prescribed or recommended by a rheumatologist or immunologist -AND • History of failure (no response after maximum tolerated doses), contraindication, or intolerance to two or more NSAIDs [diclofenac, etodolac, ibuprofen, ketoprofen, meloxicam] -AND • History of failure of adequate trial (at least 3 months), contraindication, or intolerance to preferred Humira or Enbrel • Screen for TB

F. Crohn’s Disease 1) Humira, will be approved based on all of the following criteria: • Diagnosis of moderate to severe Crohn’s disease -AND • Patient is ≥ 18 years old (≥ 6 years old for pediatric patients) -AND • History of failure, contraindication, or intolerance to one Last Updated: 05/2017 Page 10 of 16 Applies to: Care1st

or more of the following conventional therapies: o Corticosteroids (eg, prednisone, methylprednisone, budesonide) o Immunomodulators [eg, 6-mercaptopurine (Purinethol), Azathioprine (Imuran), Methotrexate (Rheumatrex, Trexall)] o Aminosalicylates [eg, Asacol (mesalamine), Azulfidine (sulfasalazine), Dipentum (olsalazine) -AND- • Prescribed or recommended by a gastroenterologist or immunologist -AND- • Screen for TB

2) Cimzia, or Remicade will be approved based on all of the following criteria: • Diagnosis of moderate to severe Crohn’s disease -AND • Patient is ≥ 18 years old (≥ 6 years old for pediatric patients- Remicade only) -AND • History of failure, contraindication, or intolerance to one or more of the following conventional therapies: o Corticosteroids (eg, prednisone, methylprednisone, budesonide) o Immunomodulators [eg, 6-mercaptopurine (Purinethol), Azathioprine (Imuran), Methotrexate (Rheumatrex, Trexall)] o Aminosalicylates [eg, Asacol (mesalamine), Azulfidine (sulfasalazine), Dipentum (olsalazine) -AND- • Prescribed or recommended by a gastroenterologist or immunologist -AND- • History of failure of adequate trial (at least 3 months), contraindication, or intolerance to preferred Humira -AND- • Screen for TB

G. Ulcerative Colitis (UC) 1) Humira will be approved based on all of the following criteria: • Diagnosis of moderate to severe ulcerative colitis -AND- • Patient is ≥ 18 years old

Last Updated: 05/2017 Page 11 of 16 Applies to: Care1st

-AND- • History of failure, contraindication, or intolerance to one steroid [corticosteroids (eg, prednisone, methylprednisone, budesonide)], and either sulfasalazine or mesalamine -AND- • Prescribed or recommended by a gastroenterologist or immunologist AND- • Screen for TB **KY only also requires • History of failure, contraindication, or intolerance to 6- mercaptopurine and azathioprine

2) Remicade and Simponi will be approved based on all of the following criteria: • Diagnosis of moderate to severe ulcerative colitis -AND- • Patient is ≥ 18 years old -AND- • History of failure, contraindication, or intolerance to one steroid [corticosteroids (eg, prednisone, methylprednisone, budesonide)], and either sulfasalazine or mesalamine -AND- • Prescribed or recommended by a gastroenterologist or immunologist -AND- • History of failure of adequate trial (at least 3 months), contraindication, or intolerance to preferred Humira -AND- • Screen for TB

H. Hidradenitis suppurativa 1) Humira will be approved based on all the following criteria: • Diagnosis of moderate to severe hidradenitis suppurativa -AND- • Patient is ≥ 18 years old -AND- • Prescribed or recommended by a dermatologist or immunologist -AND- • For reauthorization, documented reduction of at least 50% in total abscess and inflammatory nodule count **KY only also requires:

Last Updated: 05/2017 Page 12 of 16 Applies to: Care1st

• History of failure or adequate trial (at least 3 months), contraindication, or intolerance to oral antibiotic therapy (tetracycline 500mg BID OR clindamycin 300mg BID in combination with rifampin 600mg QD or 300mg BID)

I. Uveitis 1) Humira will be approved based on all the following criteria: • Diagnosis of non-infectious intermediate, posterior and panuveitis -AND- • Patient is ≥ 18 years old -AND- • Prescribed or recommended by an ophthalmologist -AND- • Screen for TB and/or active infections, including localized infections -AND- • Concurrent corticosteroid treatment at Humira treatment initiation -AND- • For reauthorization, no documented development of new inflammatory chorioretinal and/or inflammatory retinal vascular lesions, an increase in anterior chamber cell grade or vitreous haze grade, or a decrease in best corrected visual acuity

Age Restriction Diagnosis dependent Prescriber Diagnosis dependent Restriction Coverage Duration 12 months for all diagnoses Other Criteria Dosing: Dosage and administration frequency stated on the request must coincide with FDA approved dosing recommendations

Reauthorization for 12 months will be approved for continuation of therapy based on documentation of clinical improvement from ongoing therapy with the requested medication

Reference(s):

Last Updated: 05/2017 Page 13 of 16 Applies to: Care1st

1. EnbrelTM Prescribing Information. Amgen and Wyeth Pharmaceuticals, November 2016. 2. HumiraTM Prescribing Information. AbbVie Inc., July 2016. 3. Facts and Comparisons, 4.0; 2012. 4. Lichtenstein GR, Abreu MT, Cohen R, Tremaine W. American Gastroenterological Association Institute medical position statement on corticosteroids, immunomodulators, and infliximab in inflammatory bowel disease. Gastroenterology 2006;130:940-987. 5. Smith CH, Anstey AV, et al. British Association of Dermatologists guidelines for use of biological interventions in psoriasis 2005, Brit J of Dermatology 2005;153:486-497. 6. Sidropoulos PI, Hatemi G, Song IH, et al. Evidence-based recommendations for the management of ankylosing spondylitis: systematic literature search of the 3E Initiative in Rheumatology involving a broad panel of experts and practicing rheumatologists. Rheumatology (Oxford) 2008 Mar;47(3):355-61. 7. Sieper J, Rudwaleit M. How early should ankylosing spondylitis be treated with tumor necrosis factor blockers? Ann Rheum Dis 2005 Nov;64 Suppl 4:iv61-4. 8. Zochling, J, Van der Heijde D, Burgos-Vargas R, et al. ASAS/EULAR recommendations for the management of ankylosing spondylitis. Ann Rheum Dis 2006;65;442-452. 9. Rich SJ. Advancements in the treatment of psoriasis: role of biologic agents. J Manag Care Pharm 2004; 10(4):318-25. 10. Luba KM, Stulberg DL. Chronic plaque psoriasis. American Family Physician 2006; 73(4):636-44. 11. Yamauchi PS, Gindi V, Lowe NJ. The treatment of psoriasis and psoriatic arthritis with etanercept: practical considerations on monotherapy, combination therapy, and safety. Dermatol Clin 2004; 22:449-59. 12. Rich SJ, Bello-Quintero CE. Advancements in the treatment of psoriasis: role of biologic agents. JMCP 2004; 10(4):318-25. 13. Pariser DM. Treating psoriasis patients with biologic agents. Managed Care Dec, 2003; 50¬61. 14. Pitarch G, Sanchez-Carazo J.L, Mahiques L, et al. Treatment of psoriasis with adalimumab. Clinical and Experimental Dermatology 2006; 32:18-22. 15. American College of Rheumatology Subcommittee on Rheumatoid Arthritis Guidelines. Guidelines for the management of rheumatoid arthritis, 2002 update. Arthritis Rheum. 2002; 46(2):328-346. 16. American College of Rheumatology 2008 Recommendations for the use of nonbiologic and biologic disease-modifying antirheumatic drugs in rheumatoid arthritis. Arthritis Rheum.2008;59(6):762-784. 17. O’Dell J. Conventional DMARD options for patients with suboptimal response to methotrexate. Journal of Rheumatology 2001 suppl; 62:21-26. 18. Kremer JM. Rational use of new and existing disease-modifying agents in rheumatoid arthritis. Annals of Internal Medicine 2001; 134(8):695-706. 19. Judge, TA, Lichtenstein, GR. Treatment of Fistulizing Crohn’s Disease. Gastroenterology Clinics of North America 2004:33:421-454. 20. Kornbluth A, Sachar DB. Practice Parameters Committee of the American College of Gastroenterology. Ulcerative Colitis Practice Guidelines in Adults (update): American

Last Updated: 05/2017 Page 14 of 16 Applies to: Care1st

College of Gastroenterology, Practice Parameters Committee. American Journal of Gastroenterology. 2004;99:1371-85. 21. Braun J, van den Berg R, Baraliakos X, et al. 2010 update of the ASAS/EULAR recommendations for the management of Ankylosing spondylitis. Ann Rheum Dis. 2011;70:896-904. 22. Beukelman T, Patkar NM, Saag KG, et al. 2011 American College of Rheumatology recommendations for the treatment of juvenile idiopathic arthritis: initiation and safety monitoring of therapeutic agents for the treatment of arthritis and systemic features. Arthritis Care Res. 2011 Apr;63(4):465-82. 23. Lichtenstein GR, Hanauer SB, Sandborn WJ, and The Practice Parameters Committee of the American College of Gastroenterology. Management of Crohn’s disease in adults. Am J Gastroenterol. 2009;104:465-483. 24. van der Heijde, Sieper J, Maksymowych WP, et al. 2010 update of the international ASAS recommendations for the use of anti-TNF agents in patients with axial spondyloarthritis. Ann Rheum Dis. 2011;70:905-908 25. Schreiber S, Rutgeerts P, Fedorak RN, et al. A randomized, placebo-controlled trial of certolizumab pegol (CDP870) for treatment of Crohn's disease. Gastroenterology. 2005; 129(3): 807-18. 26. Sandborn WJ, Feagan BG, Stoinov S, et al. Certolizumab pegol for the treatment of Crohn's disease. N Engl J Med. 2007 Jul 19; 357(3):228-38. 27. Schreiber WJ, Khaliq-Kareemi M, Lawrance IC, et al. Maintenance therapy with certolizumab pegol for Crohn's disease. N Engl J Med. 2007 Jul 19; 357(3):239-50 28. Furst DE, Breedveld FC, Kadlden JR, et al. Updated consensus statement on biological agents, specifically tumor necrosis factor α (TNF-α) blocking agents and interleukin-1 receptor antagonist (IL-1ra), for the treatment of rheumatic diseases. Ann Rheum Dis. 29. 2004;63 (Suppl II):ii2-ii12. Furst DE, Keystone EC, Braun J, et al. Updated consensus statement on biological agents for the treatment of rheumatic diseases. Ann Rheum Dis. 2011;70(Suppl 1):i2-i36. 30. Keystone E, van der Heijde D, Mason Jr. D, et al. Certolizumab pegol plus methotrexate is significantly more effective than placebo plus methotrexate in active rheumatoid arthritis. Arthritis Rheum. 2008; 58(11): 3319-3329. 31. Fleischmann R, Vencovsky J, van Vollenhoven RF, et al. Efficacy and safety of certolizumab pegol monotherapy every 4 weeks in patients with rheumatoid arthritis failing previous disease-modifying antirheumatic therapy: the FAST4WARD study. Ann Rheum Dis. 2009;68: 805-811. 32. Smolen J, Landewe RB, Mease P, et al. Efficacy and safety of certolizumab pegol plus methotrexate in active rheumatoid arthritis: the RAPID 2 study: A randomized controlled trial. Ann Rheum Dis. 2009; 68: 797-804. 33. Felson DT, Anderson JJ, Boers M, et al. American College of Rheumatology preliminary definition of improvement in rheumatoid arthritis. Arthritis Rheum. 1995;38:727-735. 34. Felson DT, Anderson JJ, Boers M, et al. American College of Rheumatology preliminary core set of disease activity measures for rheumatoid arthritis clinical trials. Arthritis Rheum. 1993; 36 (6): 729-740. 35. Simponi [package insert]. Janssen Biotech, Inc. Horsham, PA, 2013.

Last Updated: 05/2017 Page 15 of 16 Applies to: Care1st

36. Singh JA, Furst DE, Bharat A, et.al. 2012 Update of the 2008 American College of Rheumatology recommendations for the use of disease-modifying antirhuematic drugs and biologic agents in the treatment of rheumatoid arthritis. Arthritis Care & Research. Vol.64 No.5, May 2012, pp625-639 37. Remicade [package insert]. Janssen Biotech, Inc. Horsham, PA. November, 201 38. Gulliver W, Zouboulis CC, Prens E, Jemec GB, Tzellos T. Evidence-based approach to the treatment of hidradenitis suppurativa/acne inversa, based on the European guidelines for hidradenitis suppurativa. Rev Endocr Metab Disord. 2016;17(3):343-351. 39. Kornbluth A, Sachar DB. Ulcerative colitis practice guidelines in adults: American College Of Gastroenterology, Practice Parameters Committee. Am J Gastroenterol. 2010;105(3):501-23

Last Updated: 05/2017 Page 16 of 16 Applies to: Care 1st

Abilify Maintena (aripiprazole extended release suspension)

Covered uses All medically accepted indications Exclusion Criteria Required Medical 1) Medical diagnosis of Schizophrenia or Bipolar I disorder Information 2) Must have failed at least 2 weeks of 2 oral atypical antipsychotics (aripiprazole, risperidone, paliperidone, ziprasidone, quetiapine, olanzapine, etc.) OR provide documentation of non-compliance, inability to swallow oral medications, or contraindication to oral atypical antipsychotics.

3) Requested maintenance dose is administered once monthly

Age restrictions 18 years of age and older Prescriber Restrictions Coverage Duration 1 year Other Criteria **If request is for 18 and over: PA is not required when prescribed by a psychiatric clinician, a behavioral health pediatrician or other approved prescribers..

Reference(s):

1. Abilify Maintena (Aripiprazole). National Library of Medicine and National Institutes of Health. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ee49f3b1-1650- 47ff-9fb1-ea53fe0b92b6#S2.5. Updated February 23, 2017. Accessed August 8, 2017.

Created: 09/2018 Page 1 of 1

Applies to: Care 1st

Aristada, Aristada Initio (aripiprazole lauroxil, extended release)

Covered uses All medically accepted indications Exclusion Criteria Required Medical 1) Medical diagnosis of schizophrenia Information 2) Must have failed at least 2 weeks of 2 oral atypical antipsychotics (aripiprazole, risperidone, paliperidone, ziprasidone, quetiapine, olanzapine, etc.) OR provide documentation of non-compliance, inability to swallow oral medications, or contraindication to oral atypical antipsychotics. 3) Requested dose is administered once monthly (442 mg, 662 mg, or 882 mg), every 6 weeks (882 mg only), or every 8 weeks (1064 mg only). Age restrictions 18 years or older Prescriber Behavior Health Restrictions Coverage Duration 1 year Other Criteria **If request is for 18 and over: PA is not required when prescribed by a psychiatric clinician, a behavioral health pediatrician or other approved prescribers.

Reference(s):

1. Aristada [package insert]. Alkermes, Inc. Waltham, MA. February 2017 2. Aristada Initio [package insert]. Alkermes, Inc. Waltham, MA. June 2018.

Created: 09/2018 Page 1 of 1

Applies to: Care 1st

Abilify (aripiprazole tab, ODT)

Covered uses All medically accepted indications Exclusion Criteria Required Medical 1) Medical diagnosis of: Information a. Schizophrenia b. Acute Treatment of Manic and Mixed Episodes associated with Bipolar I Disorder c. Adjunctive Treatment of Major Depressive Disorder d. Irritability Associated with Autistic Disorder e. Treatment of Tourette’s Disorder

Age restrictions 6 years of age and older Prescriber Restrictions Coverage Duration 1 year Other Criteria **If request is for 18 and over: PA is not required when prescribed by a psychiatric clinician, a behavioral health pediatrician or other approved prescribers

Reference(s):

1. Aripiprizole [package insert]. Otsuka America Pharmaceutical, Inc. February 2017

Created: 09/2018 Page 1 of 1

Applies to: Care 1st

Saphris (asenapine tablet)

Covered uses All medically accepted indications Exclusion Criteria Required Medical 1) Medical diagnosis of: Information a. Schizophrenia b. Bipolar I Disorder

Age restrictions 10 years of age and older Prescriber Restrictions Coverage Duration 1 year Other Criteria **If request is for 18 and over: PA is not required when prescribed by a psychiatric clinician, a behavioral health pediatrician or other approved prescribers.

Reference(s):

1. Saphris [package insert]. Otsuka America Pharmaceutical, Inc. February 2017

Created: 09/2018 Page 1 of 1

Applies to: Care1st Inlyta (Axitinib)

Covered uses All medically accepted indications

Exclusion Criteria

Required Medical Documentation of the following: Information • Advanced renal cell carcinoma after failure of one prior systemic therapy • . Age restrictions 18 years and older Prescriber Restrictions Coverage Duration 1 year Other Criteria None

Reference(s):

1. Inlyta [package insert]. Pfizer Inc, 2. New York, NY 10017, August, 2018. 3. Locati LD, Licitra L, Agate L, et al. Treatment of advanced thyroid cancer with axitinib: Phase 2 study with pharmacokinetic/pharmacodynamic and quality-of-life assessments. Cancer. 2014;120(17):2694-703.[PubMed 24844950] 4. Lexi-Drugs. Lexicomp [Internet]. Hudson, OH: Wolters Kluwer Health, Inc. 2018. Axitinib; [cited 2018 Sept 05]. Available from: http://online.lexi.com/lco/action/doc/retrieve/docid/patch_f/3632443

Last Updated: 09/2018 Page 1 of 1

Applies to: Care1st Bexarotene

Covered uses All medically accepted indications

Exclusion Criteria 1) Pregnant women or women who intend to become pregnant Required Medical 1) Documented diagnosis: Information • Primary cutaneous T-cell lymphoma OR • Primary cutaneous T-cell lymphoma, Stage 1A/1B, persistent/refractory after other therapies or unable to tolerate other therapies AND

2) Women of child bearing age must have a negative pregnancy test at initiation of therapy Age restrictions 18 years and older Prescriber Oncologist Restrictions Coverage Duration 1 year Other Criteria 1) Women of reproductive age must be on 2 reliable contraception methods, one of which should be non- hormonal, used simultaneously or continuous abstinence is required for 1 month prior to initiation, during, and at least 1 month after therapy. 2) Male patients must use condoms during and at least 1 month after the last dose. 3) The recommended initial dose of bexarotene capsules is 300 mg/m2/day. Use for up to 97 weeks

Reference(s):

1. Bexarotene. Micromedex Solutions. Truven Health Analytics, Inc. Ann Harbor, MI. Available from http://www.micromedexsolutions.com. 2. Bexarotene [Package Insert]. Mylan Institutional Inc. July 2017. http://dailymed.nlm.nih.gov. .

Last Updated: 09/2018 Page 1 of 1

Applies to: Care1st

Tracleer (bosentan)

Covered uses All FDA approved indications

Exclusion Criteria 1) Pregnancy 2) Pulmonary Hypertension • World Health Organization group 2 - 5 3) Use with cyclosporine A 4) Use with glyburide

Required Medical 1) Documented diagnosis of: Information • Pulmonary Arterial Hypertension (Idiopathic, inherited, due to drugs/toxins, connective tissue diseases, etc.) World Health Organization Group 1 with predominately NYHA class II or III symptoms

Age restrictions Age 18 years or greater

Prescriber Pulmonologist or Cardiologist Restrictions Coverage Duration 12 months Other Criteria

Reference(s):

1. Tracleer [package insert]. Actelion Pharmaceuticals, Inc. South San Francisco, CA. December 2015

Last Updated: 12/2017 Page 1 of 1

Applies to: Care1st

Azopt (brinzolamide) Ophthalmic Drops

Covered uses All medically accepted indications

Exclusion Criteria

Required Medical 1) Diagnosis of : Information • elevated intraocular pressure (IOP) in patients with ocular hypertension or open-angle glaucoma. 2) Trial and failure or contraindications of the preferred: dorzolamide (Trusopt) ophthalmic drops

Age restrictions Must be 18 years and older Prescriber Restrictions Coverage Duration 1 year Other Criteria

Reference(s):

1. Azopt [package insert]. Alcon Laboratories, Inc. Fort Worth, TX 76134, December, 2017.

Last Reviewed: 09/2018 Page 1 of 1

Applies to: Care1st

Pulmicort (budesonide) Inhalation

Covered uses All medically accepted indications

Exclusion Criteria

Required Medical 1) Diagnosis: Information • maintenance treatment of asthma as prophylactic therapy 2) Trial and failure or contraindications of the preferred inhalers: Qvar , Flovent, Asmanex Twisthaler

Age restrictions Prescriber Restrictions Coverage Duration 1 year Other Criteria

Reference(s):

1. Pulmicort [package insert]. AstraZeneca Pharmaceuticals LP, Wilmington DE, October, 2016.

Last Updated: 09/2018 Page 1 of 1

Applies to: Care1st

Myleran (Busulfan)

Covered uses All FDA Approved Indications

Exclusion Criteria Required Medical 1) Stated diagnosis from oncologist of chronic myelogenous Information (myeloid, myelocytic, granulocytic) leukemia (CML).

2) Confirmed diagnosis of CML is required, Busulfan is a potent drug and patients are at risk for secondary malignancies.

Age restrictions

Prescriber Oncologist Restrictions Coverage Duration 6 months Members currently taking this medication at time of enrollment will not Other Criteria be required to meet prerequisites for prior authorization

References:

1. Myleran [package insert]. St Leonards NSW: Aspen Pharmacare Australia Pty Ltd.; 2011. 2. Myleran. In:DRUGDEX System (Micromedex 2.0). Greenwood Village, CO: Truven Health Analytics; c1974-2018. http://www.micromedexsolutions.com/micromedex2/librarian/. Accessed July 30, 2018.

Last Reviewed: 09/2018 Page 1 of 1 Applies to: Care1st

Cabergoline

Covered uses All FDA approved indications

Exclusion Criteria 1) Uncontrolled Hypertension 2) Hypersensitivity to ergot derivatives 3) History of cardiac valvular disorders 4) History of pulmonary, pericardial, retroperitoneal fibrotic disorders

Required Medical Initial Authorization Information 1) Cabergoline will be approved based on the following criteria: • Documented diagnosis of hyperprolactinemia (idiopathic or pituitary adenomas) AND • Laboratory results of elevated serum prolactin AND • Confirmation of a cardiovascular evaluation, including an echocardiogram to exclude the presence of valvular disease AND • Statement that patient will be monitored for manifestations of progressive fibrosis throughout treatment

Reauthorization: 1) Cabergoline will be approved based on the following criteria: • Updated laboratory results of elevated serum prolactin

Age restrictions 18 years of age

Prescriber Restrictions Coverage Duration Initial authorization: 3 months Reauthorization: 1 year

Other Criteria Recommended dosage of cabergoline tablets for initiation of therapy is 0.25 mg twice a week. Dosage may be increased by 0.25 mg twice weekly up to a dosage of 1 mg twice a week according to the patient’s serum prolactin level.

Dosage increases should not occur more rapidly than every 4 weeks

Last Updated: 02/2016 Page 1 of 2

Applies to: Care1st Exception Criteria Xeloda (capecitabine)

Covered uses All medically accepted indications

Exclusion Criteria 1) Contraindicated in patients with severe renal impairment and Dihydropyrimidine dehydrogenase (DPD) deficiency

Required Medical Statement of medically accepted indication: Information 1) Adjuvant colorectal cancer: • Treatment in patients with Duke Stage C colon cancer

2) Metastatic colorectal cancer: • First line as monotherapy when treatment with fluioropyrimidine therapy alone is preferred single agent for adjuvant treatment in patients who have undergone complete resection of the primary tumor.

3) Metastatic breast cancer: • In combination with docetaxel for the treatment of patients after failure of anthracycline-containing chemotherapy (i.e, doxorubicin).

Age restrictions

Prescriber Oncologist Restrictions Coverage Duration 1 year Other Criteria Max dose: 2,500 mg/m2 PO daily on days 1 – 14 every 21 days

Members currently taking this medication at time of enrollment will not be required to meet prerequisites for prior authorization

Reference(s):

1. Product Information: XELODA(R) oral tablets, capecitabine oral tablets. Genentech USA, Inc., South San Francisco, CA, 2009.

Last Reviewed: 09/2018 Page 1 of 1

Applies to: Care1st Celebrex (celecoxib)

Covered uses All medically accepted indications

Exclusion Criteria NSAIDS are contraindicated in the setting of coronary artery bypass graft (CABG) surgery Required Medical 1) Trial and failure or contraindications to the preferred of at Information least 3 preferred NSAIDS ( see PDL for full list)

Age restrictions Juvenile Rheumatoid Arthiritis 2 years and older. All other indications 18 years and older Prescriber Restrictions Coverage Duration 1 year Other Criteria

Reference(s):

1. Celebrex [package insert]. Pfizer, Inc, New York, NY, October, 2017.

Last Updated: 01/2018 Page 1 of 1

Applies to: PDL Exception Criteria

Leukeran (chlorambucil)

Covered uses All medically accepted indications

Exclusion Criteria

Required Medical Stated diagnosis from oncologist of: Information 1) Chronic lymphatic (lymphocytic) leukemia 2) Hodgkin lymphoma 3) Non-Hodgkin’s lymphoma (NHL) 4) Hodgkin’s disease 5) Mycosis fungoides

Age restrictions Age 18 years or greater Prescriber Oncologist Restrictions Coverage Duration 1 year Other Criteria Members currently taking this medication at time of enrollment will not be required to meet prerequisites for prior authorization

Reference(s):

1. Leukeran [package insert]. Aspen Global Incorporated, Grand Bay, Mauritius.. March 2017. 2. Leukeran. In:DRUGDEX System (Micromedex 2.0). Greenwood Village, CO: Truven Health Analytics; c1974-2018. http://www.micromedexsolutions.com/micromedex2/librarian/. Accessed July 30, 2018.

Last Updated: 09/2018 Page 1 of 1 Applies to: Care 1st

Chlorpromazine (tabs, injection)

Covered uses All medically accepted indications Exclusion Criteria Required Medical Documentation of the medical diagnosis of: Information • management of manifestations of psychotic disorder • treatment of schizophrenia. • control nausea and vomiting. • relief of restlessness and apprehension before surgery. • acute intermittent porphyria. • adjunct in the treatment of tetanus. • control the manifestations of the manic type of manic- depressive illness. • relief of intractable hiccups • treatment of severe behavioral problems in children (1 to 12 years of age)

Age restrictions Prescriber Restrictions Coverage Duration 1 year Other Criteria **If request is for 6 and over: PA is not required when prescribed by a psychiatric clinician, a behavioral health pediatrician or other approved prescribers.

Reference(s):

1. Chlorpromazipine injection [package insert]. West-Ward Pharmaceuticals Corp. November 2016 2. Chlorpromazipine tablets [package insert]. Amneal Pharmaceuticals LLC. September 2018

Created: 09/2018 Page 1 of 1

Applies to: Care1st Vistide (cidofovir)

Covered uses Only used for CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS). Exclusion Criteria Serum creatinine concentration > 1.5 mg/dL, OR a calculated creatinine clearance ≤ 55 mL/min, OR a urine protein ≥ 100 mg/dL (equivalent to ≥ 2+ proteinuria) Required Medical Clinical Documentation must indicate: Information 1) Being used to treated CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS). 2) Intravenous pre-hydration with normal saline and administration of probenecid is being used with each infusion. 3) Renal function (serum creatinine and urine protein) test within 48 hours prior to administration 4) Neutrophil counts are being monitored 5) Monitored by Ophthalmologist Age restrictions 18 years and older Prescriber Restrictions Coverage Duration 6 months Other Criteria

Reference(s):

1. Vistide [package insert]. Gilead Sciences, Inc. Forster City, CA September, 2013. 2. The National Institutes of Health, and the HIV Medicine Association of the Infectious Diseases Society of America. Guidelines for the prevention and treatment of opportunistic infections in HIV-infected adults and adolescents: recommendations from the Centers for Disease Control and Prevention. Available at http://aidsinfo.nih.gov/contentfiles/lvguidelines/adult_oi.pdf. Accessed January 19, 2018.

Last Updated: 01/2018 Page 1 of 1

Applies to: Care1st Sensipar (cinacalcet)

Covered uses All medically accepted indications Exclusion Criteria Required Medical Trial and failure of or contraindication preferred products: Information calcitriol capsule or solution AND Stated diagnosis of: 1) Parathyroid Carcinoma 2) Secondary Hyperparathyroidism 3) Primary Hyperparathyroidism 4) Persistent Secondary Hyperparathyroidism after renal transplantation

Other Criteria For Secondary Hyperparathyroidism: 1) Patient has a diagnosis of chronic kidney disease and is on dialysis 2) Patient is concurrently receiving traditional therapy with vitamin D sterols and/or phosphate binders 3) Patient’s serum calcium level is ≥ 8.4 mg/dl

For Primary Hyperparathyroidism: 1) Patient has failed, or has a contraindication to parathyroidectomy 2) Patient has severe hypercalcemia defined as a serum calcium level of 12.5 mg/dl or greater

For Persistent Secondary Hyperparathyroidism after renal transplantation: 1) Patient has had a kidney transplantation 2) Patient’s serum calcium level is ≥ 8.4 mg/dl

Age restrictions The patient must be at least 18 years of age

Prescriber Restrictions Coverage Duration Authorization of therapy will be issued for 6 months for Persistent Secondary Hyperparathyroidism after renal transplantation indication. For all other indications, Authorization of therapy will be issued for 12 months. Other Criteria

Last Updated: 05/2014 Page 1 of 2

Applies to: Care1st

Reference(s):

1. Sensipar [package insert]. Amgen: Thousand Oaks, CA; August 2011. 2. Moe SM, Chertow GM, Coburn JW, et al. Achieving NKF-K/DOQI bone metabolism and disease treatment goals with cinacalcet HCl. Kidney Int. 2005; 67: 760-71. 3. Messa P, Macario F, Yaqoob M, et al. The OPTIMA Study: Assessing a New Cinacalcet (Sensipar/Mimpara) Treatment Algorithm for Secondary Hyperparathyroidism. Clin J Am Soc Nephrol. 2008; 3: 36-45. 4. Block GA, Zeig S, Sugihara J, et al. Combined therapy with cinacalcet and low doses of vitamin D sterols in patients with moderate to severe secondary hyperparathyroidism. Nephrol Dial Transplant. 2008; 23: 2311-2318. 5. Bushinsky DA, Messa P. Efficacy of early treatment with calcimimetics in combination with reduced doses of vitamin D sterols in dialysis patients. Nephrol Dial Transplant. 2008; 1 (suppl 1) i18-i23. 6. Silverberg SJ, Rubin MR, Faiman C, et al. Cinacalcet Hydrochloride Reduces the Serum Calcium Concentration in Inoperable Parathyroid Carcinoma. J Clin Endocrinol Metab. 2007; 92(10): 3803-8. 7. Shane E. Clinical Review 122: Parathyroid Carcinoma. J Clin Endocrinol Metab. 2001; 86(2): 485-93. 8. National Kidney Foundation. K/DOQI Clinical Practice Guidelines for Bone Metabolism and Disease in Chronic Kidney Disease. Am J Kidney Dis. 2003; 42:S1-S202. 9. Leca N, Laftavi M, Gundroo A, et al. Early and Severe Hyperparathyroidism Associated with Hypercalcemia After Renal Transplant Treated with Cinacalcet. Amer J Transplant. 2006; 6: 2391-2395. 10. Bergua C, Torregrosa JV, Fuster D, et al. Effect of cinacalcet on hypercalcemia and bone mineral density in renal transplanted patients with secondary hyperparathyroidism. Transplantation. 2008; 86(3): 413-7. 11. El-Amm JM, Doshi MD, Singh A, et al. Preliminary experience with cinacalcet use in persistent secondary hyperparathyroidism after kidney transplantation. Transplantation. 2007; 83(5): 546-9. 12. Marcen R, Ponte B, Rodriguez-Mendiola N, Fernandez Rodriguez A, et al. Secondary hyperparathyroidism after kidney transplantation: a cross sectional study. 2009; 41(6): 2391¬3. 13. Beruga C, Torregrosa JV, Cofan F, et al. Cinacalcet for the treatment of hypercalcemia in renal transplanted patients with secondary hyperparathyroidism. Transplant Proc. 2007; 39(7): 2254-5. 14. Gomez Marques G, Obrador Mulet A, Vilar Gimeno A, et al. Treatment with cinacalcet of secondary hyperparathyroidism after renal transplantation. Transplant Proc. 2009; 41(6): 2139-43. 15. Apostolou T, Kollia K, Damianou L, et al. Hypercalcemia due to resistant hyperparathyroidism in renal transplant patients treated with the calcimimetic agent cinacalcet. Transplant Proc. 2006; 38(10): 3514-6.

Last Updated: 05/2014 Page 2 of 2

App lies to: Care1st Clobazam Tablet/Solution

Covered uses All medically accepted indications

Exclusion Criteria 1) Clobazam is contraindicated in patients with a history of hypersensitivity to the drug or its ingredients. 2) Concomitant use with benzodiazepines and opioids: • Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. • Limit dosages and durations to the minimum required. • Follow patients for signs and symptoms of respiratory depression and sedation. Required Medical 1) FDA approved for the treatment of seizures associated Information with Lennox-Gastaut Syndrome (seizure) AND

2) Trial and failure of at least one of the following anti- epileptic medications: • Valproate (first line) • Lamotrigine (adjunctive) if therapy with Valproate is ineffective • Felbamate, Topiramate if Lamotrigine is not effective or tolerated. AND 3) For Clobazam Solution Only: Difficulty swallowing Clobazam tablet Age re strictions 2 years and older Pre scribe r Neurologist Restrictions Coverage Duration 1 year Othe r Crite ria A daily dose of ONFI greater than 5 mg should be administered in divided doses twice daily; a 5 mg daily dose can be administered as a single dose. Dose patients according to body weight. Dose of 5-20 mg in <30 kg weight and dose of 10-40mg for >30 kg weight group has been shown to be effective.

Reference(s):

1. Onfi (Clobazam). [Package Insert]. Lundbeck Pharmaceuticals, LLC. February 2017. www.dailymed.nlm.nih.gov. Accessed January 2018. 2. National Institute of Neurological Disorders and Stroke. Lennox-Gastaut Syndrome. American Academy of Neurology. 2018.

Last Updated: 02/2018 Page 1 of 2

App lies to: Care1st http://patients.aan.com/disorders/index.cfm?event=view&disorder_ id=972. Accessed January 2018. 3. National Guideline Clearinghouse (NGC). Guideline summary: The epilepsies: the diagnosis and management of the epilepsies in adults and children in primary and secondary care. In: National Guideline Clearinghouse (NGC) [Web site]. Rockville (MD): Agency for Healthcare Research and Quality (AHRQ); 2012 Jan 01. [Cited 2018 Jan 10]. Available: https://www.guideline.gov. 4. Ng YT, Conry JA, Drummond R, et al: Randomized, phase III study results of clobazam in Lennox-Gastaut syndrome. Neurology 2011; 77(15):1473-1481. 5. Clobazam. Micromedex Solutions. Truven Health Analytics, Inc. Ann Harbor, MI. Available from http://www.micromedexsolutions.com

Last Updated: 02/2018 Page 2 of 2

Applies to: Care1st

Clozapine (tablets, ODT)

Covered uses All FDA approved indications.

Exclusion Criteria Required Medical Documention of: Information • Treatment resisitant Schizophrenia • Reduction in the Risk of Recurrent Suicidal Behavior in Schizophrenia or Schizoaffective Disorders

Age restrictions 9 years of age and older

Prescriber Restrictions Coverage Duration 1 year

Other Criteria **If request is for 18 and over: PA is not required when prescribed by a psychiatric clinician, a behavioral health pediatrician or other approved prescribers.

Reference(s):

1. Clozapine [package insert] Accord Healthcare Inc. June 2017.

Created: 09/2018 Page 1 of 1

Applies to: Care1st Colcrys (colchicine)

Covered uses All medically accepted indications

Exclusion Criteria

Required Medical Clinical Documentation must indicate: Information 1) Diagnosis: • Treatment/Prophylaxis of Gout or • Familial Mediterranean Fever (FMF) 2) Trial and failure or contraindication of preferred: allopurinol tablets Age restrictions Diagnosis: FMF ages 4 and older Prescriber Restrictions Coverage Duration 1 year Other Criteria

Reference(s):

1. Colchicine [package insert]. Amneal Pharmaceuticals, LLC. Bridgewater, NJ August, 2016.

Last Updated: 01/2018 Page 1 of 1

Applies to: Care1st

Compounded Products

Covered uses All medically accepted indications Exclusion Criteria 1) Compounded products ≥ $50 2) Certain cream, ointment, gel, and foam bases with GPI 98

Required Medical All individual ingredients within a compound, regardless of Information RX/OTC status, are covered if the aggregate cost of the compound is < $50

Age restrictions Prescriber Restrictions Coverage Duration Based on submitted request

Other Criteria

Last Updated: 12/2017 Page 1 of 1

Applies to: Care1st

Xalkori (crizotinib)

Covered uses All FDA approved indications

Exclusion Criteria Pregnancy

Required Medical Stated diagnosis of one of the following: Information 1) Late-stage (locally advanced or metastatic), non-small cell lung cancers (NSCLC) with tumors that are anaplastic lymphoma kinase (ALK) positive as detected by an FDA approved test 2) Metastatic NSCLC with tumors that are ROS1-postive Age restrictions 18 years or older

Prescriber Oncologist Restrictions Coverage Duration 1 year Other Criteria Max Dose: 500 mg/day

Approved FDA Test: Vysis ALK Break-Apart fluorescence in situ hybridization (FISH) Probe Kit

Members currently taking this medication at the time of enrollment will not be required to meet prerequisites for Prior Authorization.

Reference(s):

1. National Comprehensive Cancer Network, Inc. 2011, NCCN Clinical Practice Guidelines in Oncology (NCCN®). Version 3.2012 2. Product Information: XALKORI(R) oral capsules, crizotinib oral capsules. Pfizer Labs (per FDA), New York, NY, February 2018.

Last Updated: 09/2018 Page 1 of 1

Applies to: PDL Exception Criteria Cyclophosphamide

Covered uses All medically accepted indications

Exclusion Criteria Required Medical Stated diagnosis from oncologist for one of the following: Information 1) Malignant diseases: • Malignant lymphomas (stages III and IV of the Ann Arbor staging system): Hodgkin’s disease; small lymphocytic lymphoma (nodular or diffuse), mixed-cell type lymphoma, histiocytic lymphoma, Burkitt's lymphoma, • Multiple myeloma. • Leukemias:Acute lymphocytic (ALL), acute myelogenous (AML), lymphocytic leukemia(CML), chronic myelogenous leukemia(CML), acute lymphoblastic (stem-cell) leukemia in children. • Mycosis fungoides: advanced disease. • Neuroblastoma, disseminated disease • Adenocarcinoma of the ovary • Retinoblastoma • Carcinoma of the breast. • Malignant histiocytosis (clinical)Minimal change disease, in patients who fail to respond to or are unable to tolerate adrenocorticosteroid therapy 2) Nephrotic syndrome in children

Age restrictions Age 18 or less (nephrotic syndrome)

Prescriber Oncologist Restrictions Coverage Duration 1 year Other Criteria Members currently taking this medication at time of enrollment will not be required to meet prerequisites for prior authorization

Reference(s):

1. Cyclophosphamide [package insert]. Baxter Healthcare Corporation. Deerfield, IL. June, 2016

Last Updated: 09/2018 Page 1 of 1 Applies to: Care1st

Restasis 0.05% ophthalmic emulsion (Cyclosporine)

Covered uses Statement of FDA approved diagnosis Exclusion Criteria Required Medical Documented diagnosis of: Information 1) Indicated to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca. -and-

2) Documentation confirming condition (see Table below). -and- 3) Documentation of trial and failure of OTC agents such as artificial tears with or without lubricating ointment at night.

Dry eye syndrome diagnostic Findings indicating dry eyes testing Schirmer test < 10 mm

Tear break-up time (TBUT) < 10 seconds

Tear osmolarity > 305 mOsm/L

Ocular surface dye staining: Pattern of exposure zone fluorescein, rose bengal; corneal and bulbar conjunctival lissamine green dyes staining typical Fluorescein clearance test Test result is compared with a standard color scale Lacrimal gland function Decreased tear lactoferrin concentration

Age restrictions Ages 16 years and older Prescriber Ophthalmologist or rheumatologist Restrictions Coverage Duration 1 year Other Criteria

Reference(s):

1. Restasis-cyclosporine emulsion [package insert]. Allergan, Inc. Irvine, CA. Dec 2017.

Last Reviewed: 09/2018 Page 1 of 1

Applies to: PDL Exception Criteria

Sprycel (dasatinib) Covered uses All medically accepted indications

Exclusion Criteria Pregnancy

Required Medical 1) Accelerated phase chronic myeloid leukemia, resistant or Information intolerant to Gleevec (imatinib) or Tasigna (nilotinib) 2) Acute lymphoid leukemia, Philadelphia chromosome-positive, resistant or intolerant to prior therapy 3) Blastic phase chronic myeloid leukemia, resistant or intolerant to Gleeveck (imatinib) or Tasigna (nilotinib) 4) Chronic phase chronic myeloid leukemia, resistant or intolerant to Gleevec (imatinib) or Tasigna (nilotinib) 5) Treatment of newly diagnosed Ph+ CML in chronic phase 6) Treatment of GIST if disease progression has occurred on imatinib AND sunitinib 7) Treatment of pediatric patients with Ph+ CML in chronic phase Age restrictions Age 18 years or greater *Pediatric patients indicated if the diagnosis is Ph+ CML in chronic phase Prescriber Oncologist Restrictions Coverage Duration 1 year Other Criteria Preferred Alternative: 1) Gleevec 2) Tasigna

Criteria for approval: Documented failure, resistance, or intolerance to Gleevec (imatinib) or Tasigna (nilotinib)

Members currently taking this medication at time of enrollment will not be required to meet prerequisites for prior authorization

Reference(s):

1. Product Information: SPRYCEL(R) oral tablets, dasatinib oral tablets. Bristol-Myers Squibb Company (per FDA), Princeton, NJ, January 2018. 2. National Comprehensive Cancer Network, Inc. 2011, NCCN Clinical Practice Guidelines in Oncology (NCCN®). Version 3.2012

Last Updated: 09/2018 Page 1 of 1

Applies to: Care1st Demeclocycline

Covered uses All medically accepted indications

Exclusion Criteria

Required Medical Documentation must include: Information 1) a medically accepted indication 2) Trial and failure or contraindications to the preferred of at least 3 preferred medications: Doxycycline Hyclate capsules, Doxycycline Hyclate tablets, Doxycycline monohydrate capsules, Minocycline HCL capsules Age restrictions 8 years and older Prescriber None Restrictions Coverage Duration 1 year Other Criteria Diagnosis: Gonorrhea 18 years and older

Reference(s):

1. Demeclocycline [package insert]. Amneal Pharmaceuticals, Inc, Paterson, NJ, December, 2012.

Last Updated: 01/2018 Page 1 of 1

Applies to: Care1st DDAVP (Desmopressin)

Covered uses All medically accepted indications

Exclusion Criteria Patients with moderate to severe renal impairment (defined as a creatinine clearance below 50 mL/min). Required Medical Documented diagnosis of one of the following: Information 1) Central (cranial)diabetes insipidus and for the management of temporary polyuria and polydipsia 2) Primary nocturnal enuresis (PNE) Age restrictions 1) Age 4 years or greater: (Diabetes insipidus) 2) Age 6 years or greater: (Nocturnal enuresis) Prescriber None Restrictions Coverage Duration 1 year Other Criteria Preferred Alternative(s): 1) Central (cranial)diabetes insipidus: desmopressin nasal and intranasal solution 2) Primary nocturnal enuresis (PNE) – only tablets indicated for this diagnosis

Reference(s):

1. Product Information: DDAVP(R) injection, desmopressin acetate injection. Sanofi- Aventis US LLC, Bridgewater, NJ, 2007. 2. Product Information: DDAVP(R) nasal spray, desmopressin acetate nasal spray. Sanofi- Aventis US LLC, Bridgewater, NJ, 2007. 3. Product Information: DDAVP(R) rhinal tube, desmopressin acetate rhinal tube. Sanofi- Aventis US LLC, Bridgewater, NJ, 2007. 4. Product Information: DDAVP(R) oral tablets, desmopressin acetate oral tablets. Sanofi- Aventis US LLC, Bridgewater, NJ, 2007.

Last Updated: 01/2018 Page 1 of 1

Care1st Exception criteria

Tecfidera (dimethyl fumarate)

Covered uses All FDA-approved indications

Exclusion Criteria Required Medical 1) Statement of FDA approved indication: Information • Relapsing forms of multiple sclerosis (MS) to reduce the frequency of clinical exacerbations and to delay the accumulation of physical disability AND

2) Laboratory results of lymphocyte level: • CBC (obtained within 30 days of initial use, then at least annually during therapy or as clinically necessary) (Lower limit of normal lymphocyte count 0.91x10^9/L, but in studies no increased incidence of serious infections in patients with lymphocyte counts of 0.5 x 10^9/L) AND

3) Trial and failure or intolerance/contraindication to the following preferred medication(s): Gilenya AND one of the following platform therapies: Rebif, Glatiramer acetate, or Betaseron,

Initial Reauthorization: Submission of the CBC obtained within 30 days of initial use

Subsequent reauthorizations: CBC submitted within 12 months after last authorization period. Lymphocyte counts must not be less than 0.5 x 10^9/L persisting for more than six months

Age restrictions Age 18 years or greater

Prescriber Neurologist Restrictions Coverage Duration Initial authorization of therapy will be issued for 3 months Re- authorization of therapy will be issued for 12 months Other Criteria

Reference(s):

1. Tecfidera [package insert]. Cambridge, MA 02142: Biogen Idec Inc.; 2013

Last Updated: 12/2017 Page 1 of 1 Applies to: Care1st Dofetilide

Covered uses All medically accepted indications

Exclusion Criteria 1) Patients with congenital or acquired long QT syndromes (QTc >440msec) 2) Patients with severe renal impairment (calculated creatinine clearance <20mL/min) 3) Concurrent use of verapamil, ketoconazole, dolutegravir, and hydrochlorothiazide 4) Patients with known hypersensitivity to dofetilide Required Medical 1) Documented diagnosis of highly symptomatic atrial Information fibrillation/atrial flutter with inability to maintain normal sinus rhythm AND 2) Trial and failure of sotalol oral tablet or solution Age restrictions 18 years and older Prescriber Cardiologist Restrictions Coverage Duration 6 months Other Criteria Recommended dosage based on creatinine clearance and QTc. Do not initiate therapy in patients with a QTc >440msec.

Calculated Creatinine Starting Dofetilide Dose Clearance Greater than 60 mL/min 500 mcg orally twice daily 40-60 mL/min 250 mcg orally twice daily 20 to less than 40 mL/min 125 mcg orally twice daily Less than 20 mL/min Contraindicated in these patients Maximum recommended adult dose of dofetilide is 500 mg orally twice daily but only in patients who have a creatinine clearance greater than 60mL/min.

Patients must be monitored for 3 days inpatient upon initiation of dofetilide. For maintenance therapy, patient’s renal function and QTc should be re-evaluated every three months or as medically warranted.

Reference(s):

1. Dofetilide. Micromedex Solutions. Truven Health Analytics, Inc. Ann Harbor, MI. Available from http://www.micromedexsolutions.com.

Last updated: 02/2018 Page 1 of 2

Applies to: Care1st

2. Tikosyn [Package Insert]. Pfizer Laboratories Div Pfizer Inc. October 2017. http://dailymed.nlm.nih.gov. .

Last updated: 02/2018 Page 2 of 2

Applies to: Care1st

Anzemet (Dolasetron)

Covered uses All FDA approved indications.

Exclusion Criteria

Required Medical 1) Indicated for the prevention of nausea and vomiting Information associated with moderately emetogenic cancer chemotherapy, including initial and repeat courses in adults and children 2 years and older. -and-

2) Trial and failure of Ondansetron.

Age restrictions Ages 2 years and older

Prescriber Restrictions Coverage Duration

Other Criteria

Reference(s):

1. Anzemet product information. Aventis Pharmaceuticals Inc. 2. National Comprehensive Cancer Network and American Cancer Society. Nausea and Vomiting: Treatment guidelines for patients with cancer. VIII June 2005 3. American Gastroenterological Association medical position statement: nausea and vomiting. Gastroenterology 2001 Jan;120(1):261-2.

Last Updated: 12/2017 Page 1 of 1

Applies to: Care1st

Aricept (Donepezil)

Covered uses All medically accepted indications

Exclusion Criteria

Required Medical 1) Diagnosis of Alzheimer’s Disease Information

Age restrictions 18 years and older Prescriber None Restrictions Coverage Duration 1 year Other Criteria 1) Mild to Moderate Alzheimer’s Disease • Max daily dose 10 mg 2) Moderate to Severe Alzheimer’s Disease • Max daily dose 23 mg

Reference(s):

1. Donepezil [package insert]. Eisai Inc., Woodcliff Lake, NJ, February, 2016.

Last Updated: 01/2018 Page 1 of 1

Applies to: Care1st

Pulmozyme (dornase alfa)

Covered uses All medically accepted indications

Exclusion Criteria Required Medical 1) Stated diagnosis from a pulmonologist of Cystic Fibrosis Information 2) Stated diagnosis of atelectasis and/or pulmonary mucus plugging in non-cystic fibrosis disease states with trial and failure of preferred alternative

Age restrictions

Prescriber Pulmonologist Restrictions Coverage Duration 1 year

Other Criteria Safety and efficacy of daily administration have not been demonstrated in patients for longer than 12 months.

Preferred Alternative CF: approve Atelectasis and/or mucus plugging: acetylcysteine

Reference(s):

1. Product Information: Pulmozyme(R) inhalation solution, dornase alfa inhalation solution. Genentech, Inc., South San Francisco, CA, 2010.

Last Reviewed: 09/2018 Page 1 of 1

Applies to: Care1st Doxepin

Covered uses All medically accepted indications

Exclusion Criteria 1) Coadministration with or within 2 weeks of an MAOI 2) Glaucoma 3) Hypersensitivity to doxepin or any components of the product 4) Urinary retention, tendency towards or severe Required Medical 1) Documented diagnosis of: Information • Anxiety and depression associated with alcoholism • Treatment of anxiety with or without depression • Treatment of depression with or without anxiety • Treatment of psychotic depressive disorders with associated anxiety • Treatment of insomnia with difficulties in sleep maintenance AND

2) Trial and failure of at least one of the following depending on patient’s diagnosis: • Antidepressants: Sertraline, escitalopram, citalopram, fluoxetine • Anxiolytics: Venlafaxine XR, duloxetine, paroxetine, escitalopram, hydroxyzine, diazepam, alprazolam, lorazepam, clonazepam, buspirone • Insomnia (sleep maintenance meds): Zolpidem, eszopiclone, temazepam, estazolam

Age restrictions 12 years and older unless use is for insomnia then 18 years and older Prescriber 1) Primary Care Physician Restrictions 2) Psychiatrist 3) Sleep specialist Coverage Duration 1 year Other Criteria 1. Insomnia: Recommended dose for adults is 6 mg once daily. Dose for the elderly (>65 years old) is 3mg once daily with a maximum daily dose of 6mg. Take dose within 30 minutes of bedtime. 2. Alcoholism, Anxiety and Depression: 25-50mg once daily for mild illness, 75 mg once daily for mild to moderate illness and 300 mg once day for severe illness

Reference(s):

Last Updated: 02/2018 Page 1 of 2

Applies to: Care1st

1. Silenor. Micromedex Solutions. Truven Health Analytics, Inc. Ann Harbor, MI. Available from http://www.micromedexsolutions.com. 2. Silenor [Package Insert]. Pernix Therapeutics, Inc. January 2018. http://dailymed.nlm.nih.gov. 3. Bonnet, MH. Treatment of Insomnia in Adults. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com (Accessed January 2018). 4. Gautam S, Jain A, Gautam M, Vahia VN, Gautam A. Clinical Practice Guidelines for the Management of Generalized Anxiety Disorder (GAD) and Panic Disorder (PD). Indian Journal of Psychiatry. 2017; 59(Suppl 1):S67-S73. doi:10.4103/0019- 5545.196975.

Last Updated: 02/2018 Page 2 of 2

Applies to: Care1st

DPP-IV Inhibitors Januvia (Sitagliptin), Tradjenta (linagliptin), Onglyza (saxagliptin), Kombiglyze XR (saxagliptin; metformin), Janumet (sitagliptin; metformin), Janumet XR (sitagliptin; metformin), Jentadueto (linagliptin; metformin), Glyxambi (empagliflozin-linagliptin)

Covered uses Statement of FDA approved diagnosis

Exclusion Criteria Should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.

Required Medical 1) Documented diagnosis of: Information • Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus

-and-

• Trial and failure of, or contraindication to preferred alternative(s): glimepiride, glipizide, glipizide XL, glyburide (micronized), glyburide tablets o Metformin,(solution, tablets), Glipizide/Metformin, Glyburide-Metformin, Pioglitazone/Metformin, Pioglitazone/Metformin ER, o Pioglitazone o Starlix, Prandin

-and-

• Documentation showing A1c is between 7 and 8

Age restrictions Ages 18 years and older

Prescriber Restrictions Coverage Duration 1 year

Other Criteria

Reference(s):

Last Updated: 08/2018 Page 1 of 2

Applies to: Care1st

1. Januvia [package insert]. Merck Sharp & Dohme Corp. Whitehouse Station, NJ. Feb 2018. 2. Tradjenta [package insert]. Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT. Aug 2017. 3. Onglyza [package insert]. AstraZeneca Pharmaceuticals LP. Wilmington, DE. April 2018. 4. Kombiglyze XR [package insert]. AstraZeneca Pharmaceuticals LP. Wilmington, DE. Feb 2017. 5. Janumet [package insert]. Merck Sharp & Dohme Corp. Whitehouse Station, NJ. Feb 2018. 6. Janumet XR [package insert]. Merck Sharp & Dohme Corp. Whitehouse Station, NJ. Feb 2018. 7. Jentadueto [package insert]. Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT. Aug 2017. 8. Glyxambi [package insert]. Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT. January 2018.

Last Updated: 08/2018 Page 2 of 2

Applies to: Care1st

Multaq (dronedarone)

Covered uses All FDA approved indications Exclusion Criteria 1) Patients with PERMANENT atrial fibrillation who will not or cannot be cardioverted to normal sinus rhythm 2) Symptomatic heart failure with recent decompensation requiring hospitalization or NYHA Class IV symptoms 3) Concomitant use of a strong CYP3A inhibitor 4) Concomitant use of drugs or herbal products that prolong the QT interval and may induce Torsade de Pointes 5) Pregnant or nursing 6) Liver or lung toxicity related to the previous use of amiodarone 7) Severe hepatic impairment Required Medical 1) Diagnosis of one of the following: Information • Paroxysmal atrial fibrillation (AF) • Persistent AF defined as AF less than 6 months duration AND 2) One of the following: • Patient is in sinus rhythm • Patient is planned to undergo cardioversion to sinus rhythm AND 3) Patient receiving appropriate antithrombotic therapy AND 4) One of following: • Tried and failed amiodarone • Intolerant to or has a hypersensitivity to amiodarone

Age restrictions Adults ≥18 years old Prescriber Cardiologist Restrictions Coverage Duration 12 months Other Criteria

Reference(s):

1. Multaq [Prescribing Information]. Sanofi Winthrop Industrie. Ambares, France. March 2014. 2. 2014 AHA/ACC/HRS Guideline for the Management of Patients With Atrial Fibrillation: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the Heart Rhythm Society. J Am Coll Cardiol. 2014;64(21):2246-2280

Last Updated: 02/2016 Page 1 of 1

App lies to: Care1st Eltrombopag Olamine Tablets

Covered uses All medically accepted indications

Exclusion Criteria 1) Chronic idiopathic thrombocytopenia: • Limit use to patients with an increased risk of bleeding because of their degree of thrombocytopenia and clinical condition. Do not use to normalize platelet count. 2) Thrombocytopenia, Hepatitis C • Only use in patients when the degree of thrombocytopenia prevents initiation of or limits the ability to maintain interferon therapy. Do not use Eltrombopag to normalize platelet counts. Safety and efficacy of Eltrombopag have not been established in combination with direct-acting antiviral agents without interferon.

Required Medical Documented diagnosis of one of the following: Information 1) Thrombocytopenia in adult and pediatric patients with chronic idiopathic (immune) thrombocytopenia (ITP) who has had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. 2) Thrombocytopenia in patients with chronic hepatitis C infection, to initiate and maintain interferon-based therapy. 3) Severe aplastic anemia with insufficient response to immunosuppressive therapy Age re strictions 18 years and older unless the diagnosis is chronic idiopathic thrombocytopenia then 1 year and older Pre scribe r Specialist Restrictions Coverage Duration 1 year Othe r Crite ria 1) Chronic idiopathic thrombocytopenia: Initiate eltrombopag at a dose of 50 mg once daily, except in patients who are of East Asian ancestry (such as Chinese, Japanese, Taiwanese, or Korean) or who have mild to severe hepatic impairment, initiate eltrombopag at a reduced dose of 25 mg once daily. 2) Chronic Hepatitis C-associated thrombocytopenia: Initiate eltrombopag at a dose of 25 mg once daily. 3) Severe aplastic anemia: Initiate eltrombopag at a dose of 50 mg once daily.

Reference(s):

Last Updated: 02/2018 Page 1 of 2

App lies to: Care1st

1. Eltrombopag Olamine. Micromedex Solutions. Truven Health Analytics. Ann Arbor, MI. Available at http://www.micromedexsolutions.com. Accessed January 2018. 2. Promacta [package insert]. Novartis Pharmaceuticals Corporation. 2017. http://dailymed.nlm.nih.gov.

Last Updated: 02/2018 Page 2 of 2

Applies to: Care1st

Prevention of Chemotherapy-Induced Nausea and Vomiting: Emend (aprepitant, and fosaprepitant), Aloxi (palonosetron)

Covered uses All FDA approved indications

Exclusion Criteria 1) Member has received, or will receive chemotherapy regimen with low or minimal emetogenic risk. 2) Treatment for active nausea and vomiting 3) Treatment after day 1 of chemotherapy (should only be administered once) • Exception: Emend for use in pediatrics may be used beyond Day 1 (see Other Criteria) 4) Emend only: Concurrent use with pimozide

Required Medical Requirements for all: Information 1) Member has received, or will receive chemotherapy regimen with moderate to high emetogenic risk 2) Long-acting anti-emetic therapy must be initiated on day 1, 30 minutes before start of chemotherapy.

Requirements for Aloxi only: Must be for FDA-approved indications- 1) Moderately emetogenic cancer chemotherapy -- prevention of acute and delayed nausea and vomiting associated with initial and repeat courses (adults and pediatrics) • Failure, contraindication, or clinically significant adverse event to a serotonin (5-HT3) antagonist PO/IV ± steroid PO/IV is required 2) Highly emetogenic cancer chemotherapy -- prevention of acute nausea and vomiting associated with initial and repeat courses (adults and pediatrics) 3) Prevention of postoperative nausea and vomiting (PONV) for up to 24 hours following surgery (adults only) • Failure, contraindication, or clinically significant adverse events to ondansetron is required

Requirements for Emend only: Must be for FDA-approved indications- 1) Moderately emetogenic cancer chemotherapy -- prevention of acute and delayed nausea and vomiting associated with initial and repeat courses in patients 6 months of age or older. • Failure, contraindication, or clinically significant adverse event to a serotonin (5-HT3) antagonist PO/IV ± steroid PO/IV is required

Last updated: 06/2018 Page 1 of 2

Applies to: Care1st

2) Highly emetogenic cancer chemotherapy -- prevention of acute nausea and vomiting associated with initial and repeat courses in patients 6 monthsof age or older.

Age restrictions Aloxi: 1 month or older Emend (aprepitant & fosaprepitant): 6 months or older

Prescriber Oncologist Restrictions Coverage Duration 1 year

Other Criteria Recommended dosing: 1) Adults: 150 mg on Day 1. 2) Pediatrics (6 months to 17 years): a single-day of EMEND for injection on Day 1 (for single dose chemotherapy regimens) or a 3-day EMEND regimen of EMEND for injection on Day 1 and EMEND capsules or oral suspension on Days 2 and 3 (for single or multi-day chemotherapy regimens).

Reference(s):

1. Product Information: EMEND® intravenous injection. Merck & Co., Inc., Greenville, NC. Updated 4/2018. 2. Product Information: ALOXI® intravenous injection. Eisai, Inc., Woodcliff Lake, NJ. Updated 9/2014. 3. Antiemesis. The NCCN Guidelines. Version 2.2015. Updated 9/2015.

Last updated: 06/2018 Page 2 of 2

Applies to: Care1st Emtricitabine-Tenofovir Disoproxil Fumarate (TDF)

Covered uses All medically accepted indications

Exclusion Criteria 1) Use for the purposes of pre-exposure prophylaxis in individuals with unknown or positive HIV-1 status 2) Use as a component of a triple nucleoside regimen 3) Co-administered with Atripla, Complera, Descovy, Emtriva, Genvoya, Odefsey, Stribild, Vemlidy, Viread or lamivudine-containing products

Required Medical For treatment of HIV-1 infection: Information 1) Documented diagnosis of HIV-1 infection in adults and pediatric patients weighing at least 17kg AND 2) Trial and failure of other anti-retroviral medications

For pre-exposure prophylaxis (PrEP): 1) Use in combination with safer sex practices for PrEP to reduce the risk of sexually acquired HIV-1 in at-risk adults and adolescents weighing at least 35 kg AND 2) Confirmatory negative HIV-1 test in patients prior to using emtricitabine/TDF for PrEP Age restrictions Prescriber Primary Care Physician Restrictions Coverage Duration 1 year Other Criteria 1) The recommended dose of emtricitabine/TDF in adults and in pediatric patients with body weight greater than or equal to 35 kg is one tablet (containing 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) once daily taken orally

2) The recommended oral dose for pediatric patients weighing greater than or equal to 17 kg and who are able to swallow a whole tablet is one emtricitabine/TDF low- strength tablet (emtricitabine [FTC]/tenofovir disoproxil fumarate [TDF]) (167 mg/250 mg, 133 mg/200 mg, or 100 mg/150 mg based on body weight) taken orally once daily

3) The dose of emtricitabine/TDF in HIV-1 uninfected adults and adolescents weighing at least 35 kg is one tablet (containing 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) once daily taken orally.

Last Updated: 06/2018 Page 1 of 2

Applies to: Care1st

Reference(s):

1. Truvada. Micromedex Solutions. Truven Health Analytics, Inc. Ann Harbor, MI. Available from http://www.micromedexsolutions.com. 2. Truvada [Package Insert]. Gilead Sciences, Inc. May 2018 . http://dailymed.nlm.nih.gov. .

Last Updated: 06/2018 Page 2 of 2

Applies to: Care1st

Fuzeon (Enfuvirtide)

Covered uses All medically accepted indications

Exclusion Criteria

Required Medical Must be used in combination with other antiretroviral agents for Information treatment of HIV-1 infection in treatment-experienced patients with evidence of HIV-1 replication despite ongoing antiretroviral therapy. (no studies in treatment naïve patients) Age restrictions 18 years and older Prescriber None Restrictions Coverage Duration 1 year Other Criteria

Reference(s):

1. Fuzeon [package insert]. Genentech, Inc., South San Francisco, CA, November, 2017.

Last Updated: 02/2018 Last Reviewed: 03/2018 Page 1 of 1

Applies to: Care1st

Entecavir

Covered All medically accepted indications uses Exclusion Criteria Required Criteria for approval: Medical 1) Must provide statement indicating FDA approved indication of hepatitis Information B AND 2) Trial and failure of preferred drug

Age Age 16 years or greater restrictions Prescriber Restrictions Coverage 6 months Duration Other Preferred Drug: Criteria • Lamivudine oral tablet 100 mg

1) Entecavir prescribing information contains the following boxed warning: Severe acute exacerbations of hepatitis have been reported in patients who have discontinued anti-Hepatitis B therapy including entecavir. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue anti-Hepatitis B therapy. If appropriate, initiation of anti-hepatitis B therapy may be warranted.

2) Entecavir has not been evaluated in HIV/HBV co-infected patients who were not simultaneously receiving effective HIV treatment. Limited clinical experience suggests there is a potential for the development of resistance to HIV nucleoside reverse transcriptase inhibitors if entecavir is used to treat chronic hepatitis B virus infection in patients with HIV infection that is not being treated. Therefore, therapy with entecavir is not recommended for HIV/HBV co-infected patients who are not also receiving HAART. Before initiating entecavir therapy, HIV antibody testing should be offered to all patients. Entecavir has not been studied as a treatment for HIV infection and is not recommended for this use.

3) Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogue inhibitors, including entecavir, alone or in combination with antiretrovirals. A majority of these cases have been in women. Obesity and prolonged nucleoside inhibitor exposure may be risk factors. Particular caution should be exercised when administering nucleoside analogue inhibitors to any patient with known risk factors for liver disease; however, cases Last Updated: 09/2016 Page 1 of 2

Applies to: Care1st

have also been reported in patients with no known risk factors. Lactic acidosis with entecavir use has been reported, often in association with hepatic decompensation, other serious medical conditions, or drug exposures. Patients with decompensated liver disease may be at higher risk for lactic acidosis. Treatment with entecavir should be suspended in any patient who develops clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity (which may include hepatomegaly and steatosis even in the absence of marked transaminase elevations).

Reference(s):

1. Baraclude [package insert]. Princeton, NJ: Bristol-Myers Squibb; August 2015 2. Entecavir [package insert.]. Dayton, NJ: Aurobindo Pharma USA, Inc.; April 2016. 3. Terrault NA, Bzowej NH, Chang K-M, Hwang JP, Jonas MM, Murad MH. AASLD guidelines for treatment of chronic hepatitis B. Hepatology 2016;63:261-283.

Last Updated: 09/2016 Page 2 of 2

Applies to: Care1st

Inspra (Eplerenone)

Covered uses All medically accepted indications

Exclusion Criteria

Required Medical Diagnosis of: Information 1) Congestive Heart Failure Post-Myocardial Infarction 2) Hypertension 3) Trial and failure or contraindications to the preferred: • Spironolactone, Triamterene Age restrictions 18 years and older Prescriber Restrictions Coverage Duration 1 year Other Criteria

Reference(s):

1. Eplerenone [package insert]. Sandoz, Inc., Princeton, NJ, April, 2017.

Last Updated: 01/2018 Page 1 of 1

Applies to: Care1st Flolan (Epoprostenol)

Covered uses All medically accepted indications

Exclusion Criteria Contraindicated for All patients with heart failure caused by reduced left ventricular ejection fraction Required Medical Documented diagnosis of: Information 1) Management of pulmonary arterial hypertension (PAH; WHO group 1) to improve exercise capacity; in patients with NYHA/WHO functional class III or IV PAH (idiopathic, heritable, or associated with connective tissue diseases) Age restrictions 18 years and older Prescriber Restrictions Coverage Duration 1 year Other Criteria

Reference(s):

1. Epoprostenol [package insert]. Teva, Inc., North Wales, PA, August, 2017.

Last Updated: 01/2018 Page 1 of 1

Applies to: Care1st

Tarceva (erlotinib)

Covered uses All medically accepted indications Exclusion Criteria 1) Use in combination with platinum-based chemotherapy (paclitaxel, cisplatin, carboplatin) 2) Safety and efficacy of Tarceva have not been evaluated as first-line treatment in patients with metastatic NSCLC whose tumors have EGFR mutations other than exon 19 deletions or exon 21 (L858R) substitution Required Medical Documentation of one of the following FDA approved Information indications:

1) Non-Small Cell Lung Cancer (NSCLC) • First-line, maintenance, or second or greater line treatment of patients with metastatic NSCLC whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test after progression following at least one prior chemotherapy regimen

2) Pancreatic Cancer • First-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer in combination with gemcitabine

-AND-

3) Total bilirubin laboratory less than 3x the upper limit of normal (ULN) and liver transaminases less than 5x the ULN values Age restrictions Age 18 years or greater Prescriber Oncologist Restrictions Coverage Duration 1 year Other Criteria Members currently taking this medication at time of enrollment will not be required to meet prerequisites for prior authorization

Reference(s):

1. Tarceva [package insert]. Northbrook, IL: OSI Pharmaceuticals, LLC an affiliate of Astellas Pharma US, Inc: October 2016

Last Updated: 09/2018 Page 1 of 2

Applies to: Care1st

2. National Comprehensive Cancer Network, Inc. 2011, NCCN Clinical Practice Guidelines in Oncology (NCCN®). Version 3.2012

Last Updated: 09/2018 Page 2 of 2

Applies to: Care1st

Early and Periodic Screening, Diagnostic, and Treatment (EPSDT)

Covered uses All medically necessary indications for members 20 years old or younger Exclusion Criteria Required Medical A statement of medical necessity from the prescriber is required Information for FDA approved drugs including but not limited to those within the following classes:

1) Agents used for anorexia, weight gain or weight loss 2) Agents used to promote fertility 3) Agents used for cosmetic purposes or hair growth 4) Drugs for the treatment of erectile dysfunction 5) DESI drugs or drugs that may have been determined to be identical, similar or related 6) Investigational or experimental drugs 7) Age restrictions Applies to members 20 years old or younger

Prescriber Any qualified provider operating within the scope of his or her Restrictions practice, as defined by state law. Coverage Duration

Other Criteria

Reference(s):

1) EPSDT- A Guide for States: Coverage in the Medicaid Benefit for Children and Adolescents. Center for Medicare and Medicaid Services. June 2014. Available at: http://www.medicaid.gov/Medicaid-CHIP-Program-Information/By- Topics/Benefits/Early-and-Periodic-Screening-Diagnostic-and-Treatment.html

Last Updated: 12/2017 Page 1 of 1

Applies to: Care1st

Erythropoiesis Stimulating Agents (ESA) - Aranesp (darbepoetin alfa), Epogen, Procrit (epoetin alfa)

Covered uses All medically accepted indications

Exclusion Criteria 1) Hgb > 10 g/dL – For NON-DIALYSIS associated chronic kidney disease 2) Hgb > 11 g/dL, For DIALYSIS associated chronic kidney disease 3) Aranesp is not indicated for use: • In patients with cancer receiving hormonal agents, biologic products, or radiotherapy, unless also receiving concomitant myelosuppressive chemotherapy. • In patients with cancer receiving myelosuppressive chemotherapy when the anticipated outcome is cure. • As a substitute for RBC transfusions in patients who require immediate correction of anemia • In patients with uncontrolled hypertension • In patients with pure red cell aplasia (PRCA) after treatment with Aranesp or other erythropoietin protein Required Medical Preferred agent for all diagnoses: Epogen Information 1) Documented diagnosis of one of the following indications: • Anemia due to chronic kidney disease • Anemia due to chemotherapy in patients with cancer • Symptomatic anemia in patients with myelodysplastic syndrome (MDS)

2) Laboratory data within the past 90 days of request • Anemia due to chronic kidney disease o Initial: Hgb ≤ 10 g/dL (exclude hemoglobin values due to a recent transfusion) Reauthorization: Hgb ≤ 10 g/dL or Hgb >10 but ≤ 12 g/dL AND prescriber will reduce or interrupt dose (exclude hemoglobin values due to a recent transfusion) o For non-dialysis CKD: serum ferritin >100 ng/mL and TSAT > 20% For dialysis-dependent CKD: serum ferritin > 200 ng/mL and TSAT > 20%

• Anemia due to chemotherapy in patients with cancer o At least two months 2 more months of chemotherapy is expected

Last Updated: 03/2018 Page 1 of 3

Applies to: Care1st

o Initial: Hgb ≤ 10g/dL (exclude hemoglobin values due to a recent transfusion) o Reauthorization: Hgb < 12 g/dL (exclude hemoglobin values due to a recent transfusion)

• Symptomatic anemia in patients with myelodysplastic syndrome (MDS) o Initial: Erythropoietin level ≤ 500 mU/mL and Hgb ≤ 10 g/dL (exclude hemoglobin values due to a recent transfusion) o Reauthorization: Hgb ≤ 11 g/dL or Hgb >11 but ≤ 12 g/dL AND prescriber will reduce or interrupt dose (exclude hemoglobin values due to a recent transfusion)

3) OTHER INDICATIONS i. Subject to approval with appropriate clinical literature to support safety and efficacy Age restrictions Prescriber Oncologist or nephrologist (or prescriber in consultation with either Restrictions specialist)

Coverage Duration 12 weeks Other Criteria 1) Do not increase the dose more frequently than once every 4 weeks. Decreases in dose can occur more frequently. Avoid frequent dose adjustments. 2) If the hemoglobin rises rapidly (e.g., more than 1 g/dL in any 2-week period), reduce the dose of Aranesp by 25% or more as needed to reduce rapid responses. 3) For patients who do not respond adequately, if the hemoglobin has not increased by more than 1 g/dL after 4 weeks of therapy, increase the dose by 25%. 4) For patients who do not respond adequately over a 12-week escalation period, increasing the Aranesp dose further is unlikely to improve response and may increase risks. Use the lowest dose that will maintain a hemoglobin level sufficient to reduce the need for RBC transfusions. Evaluate other causes of anemia. Discontinue Aranesp if responsiveness does not improve 5) Refer to latest package insert for recommended doses

Reference(s):

1. Aranesp [package insert]. Thousand Oaks, CA, Amgen Inc.; October 2017 2. Centers for Disease Control and Prevention. National Chronic Kidney Disease Fact Sheet: General Information and National Estimates on

Last Updated: 03/2018 Page 2 of 3

Applies to: Care1st

Chronic Kidney Disease in the United States, 2010. Atlanta, GA: U.S. Department of Health and Human Services, CDC; 2010. 3. FDA Drug Safety Communication: Modified dosing recommendations to improve the safe use of Erythropoiesis- Stimulating Agents (ESAs) in chronic kidney disease. (6-24-2011) 4. FDA News; BDA Strengthens Safety Information for Erythropoiesis- Stimulating Agents (ESAs). P07-40, 03/09/07. 5. Wauters, Isabelle; Vansteenkiste, Johan Erythropoiesis-stimulating agents in cancer patients: reflections on safety. Expert Review of Clinical Pharmacology. 4(4):467-476, July 2011. 6. KDOQI Clinical Practice Guideline and Clinical Practice Recommendations for Anemia in Chronic Kidney Disease: 2007 Update of Hemoglobin Target

Last Updated: 03/2018 Page 3 of 3

Applies to: Care1st Femring (estradiol acetate)

Covered uses All medically accepted indications

Exclusion Criteria

Required Medical 1) Trial and failure or contraindications to the preferred Information alternatives: • Estradiol Vaginal Ring • Estradiol Vaginal tablets • Estrace Vaginal cream Age restrictions 18 years and older Prescriber Restrictions Coverage Duration 1 year Other Criteria

Reference(s):

1. Femring [package insert]. Allergan, Inc, Irvine, CA, November, 2017.

Last Updated: 01/2018 Page 1 of 1

Applies to: Care1st Estrogens, Conjugated Vaginal Cream

Covered uses All medically accepted indications

Exclusion Criteria 1) Conjugated estrogen vaginal cream therapy should not be used in women with any of the following conditions: • Undiagnosed abnormal genital bleeding • Known, suspected, or history of breast cancer • Known or suspected estrogen-dependent neoplasia • Active DVT, PE, or a history of these conditions • Active arterial thromboembolic disease (for example, stroke and MI), or a history of these conditions • Known anaphylactic reaction or angioedema to conjugated estrogen vaginal cream • Known liver dysfunction or disease • Known protein C, protein S or antithrombin deficiency or other known thrombophilic disorders • Known or suspected pregnancy

Required Medical 2) Diagnosis of one of the following: Information • Atrophic vaginitis • Kraurosis vulvae • Dyspareunia (moderate to severe) in menopausal women AND

3) Trial and failure in therapy or intolerance to at least one alternative vaginal estrogens: • Estradiol vaginal ring • Estradiol vaginal tablets • Estradiol vaginal cream 0.01%

Age restrictions 50-79 years of age Prescriber Gynecologist Restrictions Primary Care Physician Coverage Duration Postmenopausal women should be re-evaluated at 3-6 month intervals as clinically appropriate to determine if treatment is still necessary. Other Criteria Treatment of atrophic vaginitis and kraurosis vulvae : • PREMARIN Vaginal Cream is administered intravaginally in a cyclic regimen (daily for 21 days and then off for 7 days). Generally, women should be started

Last updated: 02/2018 Page 1 of 2

Applies to: Care1st

at the 0.5 g dosage strength.

Treatment of moderate to severe dyspareunia: • PREMARIN Vaginal Cream (0.5 g) is administered intravaginally in a twice-weekly (for example, Monday and Thursday) continuous regimen or in a cyclic regimen of 21 days of therapy followed by 7 days off of therapy

Prescribe the lowest effective dose and for the shortest duration consistent with treatment goals and risks for the individual women.

Reference(s):

1. Premarin Vaginal [package insert]. Wyeth Pharmaceuticals, Inc. a subsidiary of Pfizer Inc. 2017. http://dailymed.nlm.nih.gov. 2. Conjugated Estrogens. Micromedex Solutions. Truven Health Analytics, Inc. Available at http://micromedexsolutions.com.

Last updated: 02/2018 Page 2 of 2

Applies to: Care1st Toposar (etoposide)

Covered uses All medically accepted indications

Exclusion Criteria

Required Medical Stated diagnosis from oncologist of one of the following: Information 1) Refractory testicular tumors in combination with other approved chemotherapeutic agents in patients who have already received appropriate surgical, chemotherapeutic, and radiotherapeutic therapy -OR- 2) Small cell lung cancer in combination with other approved chemotherapy as first line treatment -AND- 3) The following blood test are being monitored before and during therapy: platelet count, hemoglobin, white blood cell count and differential

Age restrictions

Reference(s):

1. Product Information: TOPOSAR(TM) intravenous injection, etoposide intravenous injection. Teva Parenteral Medicines, Inc. (per DailyMed), Irvine, CA, June 2018.

Last Updated: 09/2018 Page 1 of 1

Applies to: Care1st

Afinitor (Everolimus)

Covered uses All medically accepted indications

Exclusion Criteria

Required Medical Medical documentation indicating use for treatment of: Information 1) Postmenopausal women with advanced hormone receptor- positive, HER2- negative breast cancer (advanced HR+ BC) in combination with exemestane after failure of treatment with letrozole or anastrozole.

2) Adults with progressive neuroendocrine tumors of pancreatic origin (PNET) that are unresectable, locally advanced or metastatic. The safety and effectiveness in the treatment of patients with carcinoid tumors have not been established.

3) Adults with advanced renal cell carcinoma (RCC) after failure of treatment with sunitinib or sorafenib.

4) Adults with renal angiomyolipoma and tuberous sclerosis complex (TSC), not requiring immediate surgery.

5) Progressive, well-differentiated non-functional neuroendocrine tumor of gastrointestinal or lung origin that is unresectable, locally advanced or metastatic.

6) Adjunctive treatment of adult and pediatric patients aged 2 years and older with TSC-associated partial-onset seizures

7) Pediatric (ages 1 year and older) and adult patients with tuberous sclerosis complex (TSC) who have subependymal giant cell astrocytoma (SEGA) that requires therapeutic intervention but cannot be curatively resected Age restrictions • 1 year and older for Tuberous Sclerosis Complex (TSC)- associated SEGA • All other diagnosis-minimum age of 18 years

Prescriber Oncologist Restrictions Coverage Duration 1 year

Last Updated: 09/2018 Page 1 of 2

Applies to: Care1st

Other Criteria Members currently taking this medication at time of enrollment will not be required to meet prerequisites for prior authorization.

Reference(s):

1. Afinitor [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; June 2018.

Last Updated: 09/2018 Page 2 of 2

Applies to: Care1st Exemestane tablet

Covered uses All FDA approved indications

Exclusion Criteria Pregnancy Use with estrogen-containing agents

Required Medical Documented diagnosis of one of the following: Information 1) Adjuvant treatment of postmenopausal women with estrogen- receptor positive early breast cancer who have received two to three years of tamoxifen and are switched to exemestane for completion of a total of five consecutive years of adjuvant hormonal therapy 2) Advanced breast cancer in postmenopausal women whose disease has progressed following tamoxifen therapy

AND submitted dosing of one 25 mg tablet once daily Age restrictions 18 years of age and older

Prescriber Oncologist Restrictions Coverage Duration 1 year Other Criteria

Reference(s):

1. Exemestane [package insert] Mylan Pharmaceuticals Inc. Morgantown, WV. June 2018.

Last Reviewed: 09/2018 Page 1 of 1

Applies to: Care1st

Zetia (ezetimibe)

Covered uses All medically accepted indications

Exclusion Criteria Pregnancy

Required Medical 1) Stated diagnosis of primary hyperlipidemia alone or in Information combination with a HMG-CoA Reductase Inhibitor (statin) AND 2) Trial of atorvastatin calcium 80mg OR 3) Stated diagnosis of mixed hyperlipidemia in combination with fenofibrate OR 4) Stated diagnosis of homozygous familial hypercholesterolemia (HoFH), in combination with atorvastatin or simvastatin OR 5) Stated diagnosis of homozygous sitosterolemia (phytosterolemia) OR 6) Contraindication or intolerance to HMG-CoA Reductase Inhibitors (Statin) therapy

Age restrictions Age 10 or greater

Prescriber Restrictions Coverage Duration 1 year

Other Criteria

Reference(s):

1. Lipitor [package insert]. New York, NY: Pfizer Inc.; 2012. 2. Third report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III). National Heart, Lung, and Blood Institute. National Institutes of Health (NIH). 2004 3. Zetia [package insert]. Whitehouse Station, NJ: Merck & Co., Inc.; 2012. 4. Stone NJ, Robinson J, Lichtenstein AH, Bairey Merz CN, Lloyd-Jones DM, Blum CB, McBride P, et al. 2013 ACC/AHA Guideline on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2013 Nov 7.

Last updated: 05/2014 Page 1 of 1

Care1st Exception criteria

Vytorin (ezetimibe/simvastatin)

Covered uses All medically accepted indications Exclusion Criteria 1) Pregnancy 2) Concomitant administration of gemfibrozil, cyclosporine, or danazol Required Medical 1) Stated diagnosis of Primary (heterozygous familial and Information non-familial) hyperlipidemia or mixed hyperlipidemia OR 2) Homozygous familial hypercholesterolemia (HoFH), as an adjunct to other lipid-lowering treatments

AND 3) Trial of atorvastatin calcium 80mg

Age restrictions Age 10 or greater Prescriber Restrictions Coverage Duration 1 year Other Criteria

Reference(s):

1. Lipitor [package insert]. New York, NY: Pfizer Inc.; 2012. 2. Stone NJ, Robinson J, Lichtenstein AH, Bairey Merz CN, Lloyd-Jones DM, Blum CB, McBride P, et al. 2013 ACC/AHA Guideline on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2013 Nov 7. 3. Vytorin [package insert]. Whitehouse Station, NJ: Merck & Co., Inc.; 2012.

Last Updated: 10/2014 Page 1 of 1

Applies to: Care1st Famvir (Famciclovir)

Covered uses All medically accepted indications

Exclusion Criteria

Required Medical Diagnosis of: Information 1) Herpes Labialis (cold sores) 2) Genital Herpes 3) Herpes Zoster (shingles)

Trial and failure or contraindications to the preferred medications: 1) Acyclovir tablets or suspension

Age restrictions 18 years and older Prescriber None Restrictions Coverage Duration 1 year Other Criteria

Reference(s):

1. Famciclovir [package insert]. West-Ward Pharmaceuticals, Corp., Eatontown, NJ, February, 2017.

Last Updated: 01/2018 Page 1 of 1

Applies to: Care1st Febuxostat

Covered uses All medically accepted indications

Exclusion Criteria 1) Concomitant use of azathioprine or mercaptopurine 2) Asymptomatic hyperuricemia Required Medical 1) Documented diagnosis of chronic hyperuricemia in gout Information AND 2) Trial and failure of allopurinol and probenecid. Age restrictions 18 years and older Prescriber Primary Care Physician Restrictions Podiatrist Coverage Duration 1 year Other Criteria Recommended dosage: 1) Initiate at 40 mg orally once daily and may increase to 80 mg once daily if serum uric acid levels of less than 6 mg/dL are not achieved after 2 weeks. 2) Administer an NSAID or colchicine when initiating therapy. Continued use may be useful for up to 6 months

Reference(s):

1. Febuxostat. Micromedex Solutions. Truven Health Analytics, Inc. Ann Harbor, MI. Available from http://www.micromedexsolutions.com. 2. Febuxostat [Package Insert]. AbbVie Inc.December 2017. http://dailymed.nlm.nih.gov. .

Last Updated: 02/2018 Page 1 of 1

Applies to: Care1st

Neupogen (filgrastim)

Covered uses All medically accepted indications Exclusion Criteria

Required Medical Medical documentation of an FDA approved diagnosis (see Information below), and concurrent chemotherapy treatment, if applicable. 1) Decrease the incidence of infection‚ as manifested by febrile neutropenia‚ in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a significant incidence of severe neutropenia with fever 2) Reduce the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML) 3) Reduce the duration of neutropenia and neutropenia- related clinical sequelae‚ e.g.‚ febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation (BMT) 4) Mobilize autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis 5) Reduce the incidence and duration of sequelae of severe neutropenia (e.g.‚ fever‚ infections‚ oropharyngeal ulcers) in symptomatic patients with congenital neutropenia‚ cyclic neutropenia‚ or idiopathic neutropenia (1.5) 6) Increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome) AND 7) Absolute Neutrophil Count (confirm leukocytosis is not present- ANC ≥10,000 mm3) - not required for primary prophylaxis of chemotherapy induced neutropenia

Age restrictions

Prescriber Hematologist or Oncologist Restrictions Coverage Duration 1) Chemotherapy induced neutropenia: 2 months or length of first cycle, whichever is longer (initial authorization) & anticipated duration of chemotherapy (reauthorization) 2) All other diagnoses: requested duration

Last Updated: 12/2017 Page 1 of 2

Applies to: Care1st

Other Criteria 1) Patients with cancer receiving myelosuppressive chemotherapy or induction and/or consolidation chemotherapy for AML • Recommended starting dose is 5 mcg/kg/day subcutaneous injection, short intravenous infusion (15 to 30 minutes), or continuous intravenous infusion. Dose may be escalated in increments of 5 mcg/kg for each chemotherapy cycle, according to duration and severity of absolute neutrophil count (ANC) nadir 2) Patients with cancer undergoing bone marrow transplantation • 10 mcg/kg/day given as an intravenous infusion no longer than 24 hours. 3) Patients undergoing autologous peripheral blood progenitor cell collection and therapy • 10 mcg/kg/day subcutaneous injection • Administer for at least 4 days before first leukapheresis procedure and continue until last leukapheresis 4) Patients with congenital neutropenia • Recommended starting dose is 6 mcg/kg subcutaneous injection twice daily 5) Patients with cyclic or idiopathic neutropenia • Recommended starting dose is 5 mcg/kg subcutaneous injection daily 6) Patients acutely exposed to myelosuppressive doses of radiation • 10 mcg/kg/day subcutaneous injection

Reference(s):

1. Product Information: NEUPOGEN(R) subcutaneous injection, intravenous injection, filgrastim subcutaneous injection, intravenous injection. Amgen Manufacturing, Limited (per Manufacturer), Thousand Oaks, CA, 2013.

Last Updated: 12/2017 Page 2 of 2

Applies to: Care1st Gilenya (fingolimod)

Covered uses All FDA-approved indications

Exclusion Criteria 1) Recent (within the last 6 months) occurrence of: myocardial infarction, unstable angina, stroke, transient ischemic attack, decompensated heart failure requiring hospitalization, or Class III/IV heart failure 2) History or presence of Mobitz Type II 2nd degree or 3rd degree AV block or sick sinus syndrome, unless patient has a pacemaker 3) Baseline QTc interval ≥500 ms 4) Concomitant use of Class Ia (i.e disopyramide) or Class III (i.e amiodarone, sotalol, Tikosyn) anti-arrhythmic drugs 5) AST/ALT levels > 5 x ULN, Bilirubin levels > 1.2 mg/dl 9 6) Lymphocyte count < 0.91x10 /L

Required Medical 1) Statement of FDA approved indication: Relapsing forms of Information multiple sclerosis (MS) to reduce the frequency of clinical exacerbations and to delay the accumulation of physical disability 2) Trial and failure or intolerance to the following preferred medication(s): one of the following platform therapies: Rebif, Glatiramer acetate, or Extavia o Pediatric patients <18 years of age are not required to have tried and failed above agents 3) Baseline AST/ALT, bilirubin, CBC levels (within 30 days of initiation) 4) Baseline ophthalmological examinations 5) Confirmation that baseline ECG was conducted 6) If initiating therapy, a statement that the patient will be observed in doctor's office or other facility for at least 6 hours after the first dose due to risk for bradyarrhythmia and atrioventricular (AV) blocks must be submitted

Recommended dose: 1) Adults/pediatric patients >40 kg: 0.5 mg/day 2) Pediatric patients <40 kg: 0.25 mg/day

Age restrictions Age 10 years or greater

Prescriber Neurologist Restrictions Coverage Duration Initial authorization of therapy will be issued for 3 months. Re- authorization of therapy will be issued for 12 months.

Last Updated: 06/2018 Page 1 of 2

Applies to: Care1st

Other Criteria

Reference(s):

1. Gilenya [package insert]. Novartis Pharmaceuticals Corporation, East Hanover, NJ 07936. May 2018

Last Updated: 06/2018 Page 2 of 2

Applies to: Care1st Fluorouracil topical cream 5%, solution 2%, 5%

Covered uses All medically accepted indications

Exclusion Criteria • Pregnancy • Patients with dihydropyrimidine dehydrogenase (DPD) enzyme deficiency Required Medical • Stated diagnosis from dermatologist of multiple actinic/ Information solar keratoses or superficial basal cell carcinomas (sBCC).

Age restrictions Age 18 years or greater

Prescriber Dermatologist Restrictions Coverage Duration Actinic / solar keratoses:8weeks sBCC: 3 months Other Criteria Members currently taking this medication at time of enrollment will not be required to meet prerequisites for prior authorization.

Reference(s):

1. Efudex [package insert] Valeant Pharmaceuticals, Bridgewater, NJ. May 2014

Last Updated: 09/2014 Page 1 of 1

Applies to: Care1st Prozac Weekly (Fluoxetine)

Covered uses All medically accepted indications

Exclusion Criteria

Required Medical 1) Documentation of diagnosis of: Information • Major depressive disorder (MDD) • Binge-eating and vomiting in patients with moderate- to-severe bulimia nervosa • Obsessive-compulsive disorder (OCD); • Premenstrual dysphoric disorder (PMDD) • Panic disorder with or without agoraphobia • In combination with olanzapine for treatment- resistant or bipolar I depression 2) Trail and failure of at least 2 preferred alternatives: • Citalopram, Escitalopram, Fluoxetine capsules, Sertraline Age restrictions 7 years and older Prescriber Restrictions Coverage Duration 1 year Other Criteria

Reference(s):

1. Fluoxetine [package insert]. Dr. Reddy’s Laboratories Limited, Bachupally,India, May, 2017.

Last Updated: 02/2018 Page 1 of 1

App lies to: Care1st Foscavir (Foscarnet Sodium)

Covered uses 1) CMV retinitis in patients with AIDS 2) Mucocutaneous Acyclovir Resistant HSV infections Exclusion Criteria

Required Medical 1) Documented diagnosis of: Information • CMV retinitis in patients with AIDS • Mucocutaneous Acyclovir Resistant HSV infections 2) Documentation that renal function monitored before and during treatment Age re strictions 18 years and older Pre scribe r Restrictions Coverage Duration 1 year Othe r Crite ria

Reference(s):

1. Foscavir [package insert]. Clinigen Healthcare LTD., Yardley, PA, February, 2017.

Last Updated: 02/2018 Page 1 of 1

Applies to: Care1st Gralise (gabapentin)

Covered uses Postherpetic Neuralgia

Exclusion Criteria

Required Medical 1) Documentation of: Information • Diagnosis of Postherpetic Neuralgia • Trial and failure of gabapentin tablets, solution, capsules Age restrictions 18 years and older Prescriber Restrictions Coverage Duration 1 year Other Criteria

Reference(s):

1. Gralise [package insert]. Depomed, Inc., Newark, CA, September, 2017.

Last Updated: 02/2018 Page 1 of 1

Applies to: Care1st Horizant ER (Gabapentin Enacarbil)

Covered uses All medically accepted indications

Exclusion Criteria Patients who are required to sleep during the day and remain awake at night Required Medical 1) Documented diagnosis of: Information • Moderate-to-severe primary Restless Legs Syndrome (RLS) • Postherpetic neuralgia (PHN) 2) Trial and failure of : • For Restless leg syndrome: Pramipexole , Ropinirole, • For Postherpetic neuralgia (PHN): gabapentin tablets, solution, capsules,

Age restrictions 18 years and older Prescriber Restrictions Coverage Duration 1 year Other Criteria

Reference(s):

1. Horizant ER [package insert]. Arbor Pharmaceuticals, Inc., Atlanta, GA October, 2017.

Last Updated: 02/2018 Page 1 of 1

Applies to: Care1st Razadyne, Razadyne ER (Galantamine)

Covered uses Indicated for the treatment of mild to moderate dementia of the Alzheimer's type. Exclusion Criteria

Required Medical 1) Clinical Documentation must indicate: Information • Diagnosis of mild to moderate dementia of the Alzheimer's type. Age restrictions 18 years and older Prescriber Restrictions Coverage Duration 1 year Other Criteria

Reference(s):

1. Galantamine [package insert]. Teva Pharmaceuticals, Inc., North Wales, PA, January, 2017.

Last Updated: 01/2018 Page 1 of 1

Applies to: Care1st Cytovene (ganciclovir)

Covered uses 1) CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS) 2) CMV disease prophylaxis for transplant recipients Exclusion Criteria

Required Medical 1) Clinical Documentation must indicate: Information • Being used to treated CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS). • Intravenous pre-hydration with normal saline. • Renal function monitored before and during treatment • Neutrophil counts are being monitored • Monitored by Ophthalmologist Age restrictions 18 years and older Prescriber Restrictions Coverage Duration 6 months Other Criteria

Reference(s):

1. Cytovene [package insert]. Genentech, Inc. South San Francisco, CA November, 2017.

Last Updated: 01/2018 Page 1 of 1

Applies to: Care1st Agents used for Gaucher Disease Vpriv, Cerezyme, Elelyso, Cerdelga, Zavesca

Covered uses All FDA approved indications Exclusion Criteria Required Medical 1) Medical diagnosis of Type 1 Gaucher disease Information 2) Enzyme replacement IV therapy (Vpriv, Cerezyme, and Elelyso) should be used before oral inhibitor therapy

1) For Cerdelga capsule or Zavesca capsule: • Trial and failure of Vpriv, Cerezyme, or Elelyso OR • Allergy, hypersensitivity, or poor venous access that limits the use of intravenous enzyme replacement therapies

Age restrictions Prescriber Hematologist or neurologist Restrictions Coverage Duration 1 year Other Criteria

Reference(s):

1. Vpriv [package insert]. Lexington, MA. Shire US Manufacturing. November 2013 2. Elelyso [package insert]. New York, New York. Pfizer laboratories. September 2014 3. Cerezyme [package insert]. Cambridge, MA. Genzyme Corporation. December 2012 4. Zavesca [package insert]. San Francisco, CA. Actelion Pharmaceuticals. February 2014 5. Cerdelga [package insert]. Waterford, Ireland. Genzyme Corporation. August 2014

Last Updated: 03/2015 Page 1 of 1

Applies to: Care1st

Iressa (Gefitinib)

Covered uses Statement of FDA approved diagnosis.

Exclusion Criteria NSCLC whose tumors have EGFR mutations other than exon 19 deletions or exon 21 (L858R) substitution mutations.

Required Medical Documentation of the following: Information 1. First-line treatment of patients with metastatic non-small cell lung cancer (NSCLC), whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions, or exon 21 (L858R) substitution mutations, as detected by an FDA- approved test (therascreen® EGFR RGQ PCR Kit)

Age restrictions Ages 18 years and older

Prescriber Oncologist Restrictions Coverage Duration 6 months

Other Criteria

Reference(s):

1. Iressa [package insert]. AstraZeneca Pharmaceuticals LP. August, 2018

Last updated: 09/2018 Page 1 of 1

Applies to: Care1st

Glatiramer acetate subcutaneous solution

Covered uses All medically accepted indications

Exclusion Criteria Required Medical 1) Preferred agent: Copaxone Information 2) Stated diagnosis from neurologist of one of the following: • Relapsing-remitting MS • Secondary progressive MS with relapses • Progressive-relapsing MS

3) Statement may include: • A first MS attack with document MRI scan abnormalities characteristic of MS, OR • Evaluation documenting EITHER: o History of at least two focal neurological deficits (e.g. loss of vision, double vision, localized numbness or weakness), in which the first resolved and the second followed after a period of at least 6 months, OR o History of one focal neurological deficit which has resolved, and an MRI suggestive of MS.

Age restrictions Age 18 years or greater

Prescriber Neurologist Restrictions Coverage Duration 1 year

Other Criteria

Reference(s):

1. Glatopa [package insert]. Sandoz, Inc. Princeton, NJ. April 2016. 2. Copaxone [package insert]. Teva Neuroscience, Inc. Overland Park, KS. September 2016.

Last Updated: 12/2017 Page 1 of 1

Applies to: Mavyret (Glecaprevir/ pibrentasvir) Care1st

Mavyret (Glecaprevir/pibrentasvir)

Covered Uses For the treatment of adult patients with chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5 or 6 infection without cirrhosis or with compensated cirrhosis (Child Pugh A). Mavyret is also indicated for the treatment of adult patients with HCV genotype 1 infection, who previously have been treated with a regimen containing an HCV NS5A inhibitor or an NS3/4A protease inhibitor (PI), but not both

Exclusion Criteria 1) DAA dosages greater than the FDA approved maximum dosage 2) When there is documented non‐adherence by a member to prior HCV medications, HCV medical treatment, or failure to complete HCV disease evaluation appointments and laboratory and imaging procedures. 3) Members declining to participate in a treatment adherence program. 4) Members declining to participate in a substance abuse disorder treatment program. 5) Member life expectancy is less than 12 months and cannot be remediated by treating the HCV infection, by 6) transplantation, or by other directed therapy. 7) Members currently using a potent P‐gp inducer drug (St. John’s wart, rifampin, carbamazepine, ritonavir, 8) tipranavir, etc.). 9) Greater than one DAA drug regimen used for retreatment. 10) Lost or stolen medication absent of good cause. 11) Fraudulent use of HCV medications.

See State Criteria at https://www.azahcccs.gov/shared/Downloads/MedicalPolicyManual/300/320N.pdf

Required Medical 1) To obtain prior authorization approval of hepatitis C direct acting antiviral (DAA) Information medications, members shall meet all of the following requirements:

• Monitoring Requirements: o Members prescribed HCV treatment must participate in a treatment adherence program. o Providers are required to monitor hemoglobin levels periodically when a member is prescribed Ribavirin.

• Retreatment: o The member was adherent to previous DAA therapy as evidenced by medical records and/or pharmacy prescription claims. If prior therapy was discontinued due to adverse effects from the DAA, the medical record must be provided which documents these adverse effects and recommendation of discontinuation by treatment provider; and

Created: 05/2018 Page 1 of 4

Applies to: Mavyret (Glecaprevir/ pibrentasvir) Care1st

o If a member has a substance use disorder in the past 12 months from the request date for treatment, the member must be in remission for the past three months from the request date for treatment and must be engaged in a substance use disorder treatment program at the time of the prior authorization request and over the course of treatment if the DAA medications are approved.

o Member commits to the documented planned course of treatment including anticipated laboratory, imaging tests, and prescribing provider visits.

o Resistance-associated polymorphism testing, when applicable, has been completed and submitted with the prior authorization request when:

. Required for regimens whereby the FDA requires such testing prior to treatment to ensure clinical appropriateness . Deemed medically necessary by the clinical reviewer prior to approval of the requested regimen

2) Hepatitis C Retreatment shall not be approved when: • The life expectancy is less than 12 months and cannot be remediated by treating the HCV infection, by transplantation, or by other directed therapy. • A member was non-adherent to the initial DAA treatment regimen as evidenced by medical records and/or pharmacy prescription claims. • Is considered an experimental service as defined in R9-22-203. Based on current evidence, this includes more than one retreatment with a DAA and requested retreatment regimens that include more than one DAA.

3) Documentation: • HCV treatment history and responses. • Evidence of Hepatitis A & B vaccinations or laboratory evidence of immunity. • Current Medication List. • Laboratory results for all of the following: o HCV screen o Genotype and current baseline viral load o Total bilirubin o Albumin o INR o CrCl or GFR o LFTs o CBS o Drug/alcohol screen completed within the past 90 days.

Age 18 years or older Restrictions

Created: 05/2018 Page 2 of 4

Applies to: Mavyret (Glecaprevir/ pibrentasvir) Care1st

Prescriber Hepatologist, Gastroenterologist, Infectious Disease specialist, Transplant Physician or a prescriber in Restrictions consultation with at least one of the above listed specialists Coverage Duration Treatment-Naïve HCV Genotype Treatment Duration No Cirrhosis Compensated Cirrhosis ( Child-Pugh A )

1, 2, 3, 4, 5 or 6 8 Weeks 12 Weeks Kidney Transplant Treatment-Naïve HCV Genotype Treatment Duration No Cirrhosis Compensated Cirrhosis ( Child-Pugh A )

1, 2, 3, 4, 5 or 6 12 Weeks 12 Weeks

Treatment-Experienced Treatment Duration HCV Genotype Patients Previously Treated with a No Cirrhosis Compensated Cirrhosis Regiment containing: ( Child-Pugh A ) 1 An NS5A inhibitor ( i.e Harvoni or 16 Weeks 16 Weeks Daklinza+PegIFN+Ribavirin) without prior treatment with an NS3/4A protease inhibitor (i.e. Olysio+Sovaldi, Incivek, Victrelis ) An NS3/ 4a PI (i.e. Olysio+Sovaldi, 12 Weeks 12 Weeks Olysio, Incivek, Victrelis) without prior treatment with an NS5A inhibitor 1, 2, 4, 5 or 6 Interferon (i.e. Roferon, Intron) 8 Weeks 12 Weeks pegylated interferon (i.e. Pegasys, Pegintron, Sylatron), Ribavirin, and/or sofosbuvir (i.e. Sovaldi) 3 Interferon (i.e. Roferon, Intron) 16 Weeks 16 Weeks pegylated interferon (i.e. Pegasys, Pegintron, Sylatron) Kidney Transplant Treatment-Naïve

HCV Genotype Treatment Duration No Cirrhosis Compensated Cirrhosis ( Child-Pugh A )

1, 2, 3, 4, 5 or 6 12 Weeks 12 Weeks

Created: 05/2018 Page 3 of 4

Applies to: Mavyret (Glecaprevir/ pibrentasvir) Care1st

Other Criteria

Reference(s):

1. Mavyret [package insert] North Chicago, IL. AbbVie Inc. December 2017 2. AASLD/IDSA/IAS–USA. Recommendations for testing, managing, and treating hepatitis C. http://www.hcvguidelines.org. Accessed May 2018. 3. AHCCCS Medical Policy Manual (AMPM) Section 320‐N – Services with Special Circumstances, Hepatitis C (HCV) Prior Authorization Requirements for Direct Acting Antiviral Medication Treatment.

Created: 05/2018 Page 4 of 4

Applies to: Care1st

GLP-1 Receptor Agonists Byetta (exenatide), Bydureon (exenatide, extended release), Victoza (liraglutide)

Covered uses All FDA approved indications

Exclusion Criteria Bydureon and Victoza are contraindicated in patients with a personal or family history of medullary thyroid carcinoma (MTC) and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

Required Medical 1) Medical diagnosis of type 2 diabetes mellitus. Information 2) Previous trial (or demonstrated contraindication/intolerance) of a metformin-containing product AND at least 1 of the following agents: sulfonylurea, thiazolidinedione, or DPP-4 inhibitor or SGLT2 inhibitor.

The following applies to Victoza only:

3) If established atherosclerotic cardiovascular disease, must have a previous trial (or demonstrated contraindication/intolerance) of a metformin-containing product AND empagliflozin (Jardiance).

Age restrictions 18 years or older

Prescriber Restrictions Coverage Duration 1 year

Other Criteria 1) Byetta: Requested dose no greater than 20 mcg administered daily. 2) Bydureon: Requested dose is 2 mg administered every 7 days. 3) Victoza: Requested dose no greater than 1.8 mg administered daily.

Reference(s):

1. Byetta [package insert]. AstraZeneca Pharmaceuticals LP. Wilmington, DE. December 2017.

Last Updated: 03/2018 Page 1 of 2

Applies to: Care1st

2. Bydureon [package insert]. AstraZeneca Pharmaceuticals. Wilmington, DE. September 2015. 3. Victoza [package insert]. Novo Nordisk Pharmaceuticals Industries, Inc. Bagsvaerd, Denmark. January 2017.

4. American Diabetes Association Diabetes Care 2018 Jan; 41(Supplement 1): S73-S85. https://doi.org/10.2337/dc18-S008

Last Updated: 03/2018 Page 2 of 2

Applies to: Care 1st

Bevespi (glycopyrrolate and formoterol)

Covered uses For the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. Exclusion Criteria 1) Not indicated for: • Asthma • Acute bronchospasm Required Medical 1) Documentation of COPD including chronic bronchitis and/or Information emphysema

2) Trial and failure of the preferred alternative: • Combivent Respimat, DuoNeb Age restrictions 18 years of age and older

Prescriber Restrictions Coverage Duration 1 year Other Criteria

Reference(s):

1. Bevespi Aerosphere [package insert]. AstraZeneca Pharmaceuticals LP. Wilmington, DE 19850. August 2017.

Created: 08/2018 Page 1 of 1

Applies to: Care1st Granisetron Tablets, Injection

Covered uses All medically accepted indications

Exclusion Criteria

Required Medical 1) Clinical Documentation must indicate: Information • Diagnosis of: o Nausea and/or vomiting associated with initial and repeat courses of emetogenic cancer therapy, including high-dose cisplatin. o (Tablet only)Nausea and vomiting associated with radiation o (injection only)The prevention and treatment of postoperative nausea and vomiting in adults • For nausea and/or vomiting for cancer, radiation only: trial and failure or contraindication of preferred: ondansetron tablets Age restrictions 18 years and older Prescriber Restrictions Coverage Duration 1 year Other Criteria 1) For Chemotherapy induced nausea • 2 years of age and older (injection only)

Reference(s):

1. Granisetron [package insert]. Northstar Rx, LLC., Memphis, TN July, 2017.

Last Updated: 02/2018 Page 1 of 1

Applies to: Care1st

Gauifenesin DAC

Covered uses All FDA approved indications

Exclusion Criteria Required Medical 1) Trial and failure of preferred alternatives if under 18 years of Information age: • biobron sf oral syrup 10-15-350 mg/5ml • biodesp dm oral syrup 5-15-100 mg/5ml • dometuss-dmx oral liquid 10-30-200 mg/5ml Age restrictions 18 years and older Prescriber Restrictions Coverage Duration 1 year Other Criteria

Reference(s):

1. Guaifenesin DAC [package insert], Rising Pharmaceuticals, Allendale, NJ 07401. December 2017.

Created: 08/2018 Page 1 of 1

Applies to: Care 1st

Haloperidol (tabs, injection)

Covered uses All medically accepted indications Exclusion Criteria Required Medical Documentation of any of the following medical diagnoses: Information • Schizophrenia • Psychosis • Tourette syndrome

Reference(s):

1. Haloperidol deconate injection [package insert]. Patriot Pharmaceuticals LLC. September 2018. 2. Haloperidol tablet [package insert]. Cadila Healthcare Limited. November 2017.

Created: 09/2018 Page 1 of 1

Applies to: Care1st Humulin R U-500 (insulin regular)

Covered uses All medically accepted indications

Exclusion Criteria

Required Medical 1) Documentation of the following: Information • Diagnosis of Diabetes Mellitus in which • Patient requires more than 200 units of insulin per day Age restrictions 2 years and older Prescriber Restrictions Coverage Duration 1 year Other Criteria

Reference(s):

1. Humulin [package insert].Eli Lilly and company, LLC., Indianapolis, IN November, 2017.

Last Updated: 02/2018 Page 1 of 1

Applies to: Care1st

Hydrocodone/Homatropine oral syrup and tablets

Covered uses All FDA approved indications

Exclusion Criteria 1) Currently taking CYP3A4 inhibitors or inducers. 2) Use of benzodiazepines or other CNS depressants 3) Pregnancy Required Medical 1) Trial and failure of non-narcotic antitussive: Information • Benzonatate oral capsules

Age restrictions 18 years and older Prescriber Restrictions Coverage Duration 1 year Other Criteria

Reference(s):

1. Hydrocodeone bitartrate and homatropine methylbromide [package insert], KVK-Tech, Inc., Newtown, PA , July 2018

Created: 08/2018 Page 1 of 1

Applies to: Care1st Imbruvica (Ibrutinib)

Covered uses All medically accepted indications

Exclusion Criteria

Required Medical 1) Documented diagnosis of any of the following: Information • Mantle Cell Lymphoma • Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL and CLL/SLL with 17p deletion) • Waldenström's Macroglobulinemia • Marginal Zone Lymphoma • Chronic Graft versus Host Disease (cGVHD) after failure of one or more lines of systemic therapy 2) Clinical documentation of: • Mantle Cell Lymphoma: o Patient must have received one prior therapy • Marginal Zone Lymphoma o Require systemic therapy and o Patients have received at least one prior anti- CD20-based therapy. • Chronic Graft versus Host Disease (cGVHD) o For use after failure of one or more lines of systemic therapy

Age restrictions 18 years and older Prescriber Restrictions Coverage Duration 1 year Other Criteria

Reference(s):

1. Ibruvica [package insert]. Pharmacyclics, LLC, Sunnyvale, CA, June, 2018.

Last Updated: 09/2018 Page 1 of 1

Applies to: Care1st Elaprase (Idursulfase)

Covered uses All medically accepted indications

Exclusion Criteria

Required Medical 1) Documentation of the following: Information • Initial: o Hunter Syndrome (Mucopolysaccharidosis II,MPS II) confirmed by the deficiency of iduronate-2-sulfatase enzyme activity in leukocytes, fibroblasts, or plasma OR o Detection of mutations in the IDS gene by molecular genetic testing; o Baseline • Renewal: o Disease response as defined by maintenance or improvement from baseline in one or more of the following: o 6-minute walk test (6-MWT), predicted %FVC, spleen volume, and/or liver volume AND o Absence of any hypersensitivity/toxicity to Elaprase

Age restrictions 16 months and older Prescriber Restrictions Coverage Duration 1 year Other Criteria

Reference(s):

1. Elaprase [package insert]. Shire US Manufacturing, Inc., Lexington, MA, March, 2016.

2. Scarpa M, Almássy Z, Beck M, et al. Mucopolysaccharidosis type II: European recommendations for the diagnosis and multidisciplinary management of a rare disease.Orphanet J Rare Dis. 2011 Nov 7;6:72. doi: 10.1186/1750-1172-6-72. Accessed March 2018.

Last Updated: 01/2018 Page 1 of 1

Applies to: Care1st Iloprost Solution

Covered uses All medically accepted indications

Exclusion Criteria

Required Medical Documented diagnosis of pulmonary arterial hypertension Information (WHO Group 1) to improve exercise tolerance, symptoms and lack of deterioration. Age restrictions 18 years and older Prescriber 1) Cardiologist Restrictions 2) Pulmonologist Coverage Duration 1 year Other Criteria Dosage considerations: 1. Inhale using the I-neb AAD System 2. The first inhaled dose should be 2.5 mcg and if well tolerated should be increased to 5.0 mcg and maintained at that dose. 3. Take 6-9 times per day but no more than every 2 hours during waking hours. 4. Maximum daily dose is 45mcg/day.

Reference(s):

1. Iloprost. Micromedex Solutions. Truven Health Analytics, Inc. Ann Harbor, MI. Available from http://www.micromedexsolutions.com. 2. Iloprost [Package Insert]. Pfizer Laboratories Div Pfizer Inc. October 2017. http://dailymed.nlm.nih.gov. .

Last Updated: 02/2018 Page 1 of 1

Applies to: Care1st

Gleevec (imatinib)

Covered uses All medically accepted indications

Exclusion Criteria Required Medical Stated diagnosis from oncologist of one of the following: Information 1) Newly Diagnosed Philadelphia Positive Chronic Myeloid Leukemia (Ph+ CML) 2) Ph+ CML in Blast Crisis (BC), Accelerated Phase (AP) or Chronic Phase (CP) After Interferon-alpha (IFN) Therapy 3) Ph+ Acute Lymphoblastic Leukemia (ALL) 4) Myelodysplastic/Myeloproliferative Diseases (MDS/MPD) 5) Aggressive Systemic Mastocytosis (ASM) 6) Hypereosinophilic Syndrome (HES) and/or Chronic Eosinophilic Leukemia (CEL) 7) Dermatofibrosarcoma Protuberans (DFSP) 8) GI stromal tumors – Kit (CD117) positive unresectable and/or metastatic malignant GI stromal tumors 9) Adjuvant treatment of adults following complete gross resection of Kit (CD117) positive GI stromal tumor 10) Pediatric patients with newly diagnosed Philadelphia positive acute lymphoblastic leukemia in combination with chemotherapy. Age restrictions Age 2 years or greater Prescriber Oncologist Restrictions Coverage Duration 1 year Other Criteria Members currently taking this medication at time of enrollment will not be required to meet prerequisites for prior authorization

Reference(s):

1. Gleevec [package insert] Novartis Pharmaceuticals, Inc. East Hanover, NJ. July 2018.

Last Reviewed: 09/2018 Page 1 of 1 Applies to: Care1st Exception Criteria

Aldara Cream 5% (imiquimod)

Covered uses All FDA approved indications

Exclusion Criteria

Required Medical Stated diagnosis of: Information 1) Actinic keratosis (AK) of the face or scalp 2) Superficial basal cell carcinoma (sBCC) 3) External genital warts and external perianal warts (condyloma acuminate) - Criteria for approval includes documentation of trial and failure or intolerance/contraindication to the preferred product: podofilox solution (external genital warts only). Approve for perianal warts Age restrictions Age 12 years or greater (warts) Age 18 years or greater for Actinic keratosis / sBCC Prescriber Restrictions Coverage Duration 4 months (AK, external genital or perianal warts) 2 months (sBCC) Other Criteria

Reference(s):

1. Aldara [package insert] Valeant Pharmaceuticals North America LLC. Bridgewater, NJ. June, 2017.

Last Reviewed: 09/2018 Page 1 of 1

Applies to: Care1st

Alferon N (interferon alfa-n3)

Covered uses All medically accepted indications

Exclusion Criteria

Required Medical 1) Diagnosis of refractory or recurring Condylomata acuminata Information (venereal or genital warts)

Age restrictions Must be 18 years or older Prescriber Restrictions Coverage Duration 8 weeks Other Criteria

Reference(s):

1. Alferon N (interferon alfa-n3) [prescribing information]. Philadelphia, PA: Hemispherx Biopharma; December 2017.

Last Updated: 09/2018 Page 1 of 1

Applies to: Care1st

Avonex (interferon beta-1a)

Covered uses All medically accepted indications Exclusion Criteria Required Medical 1) Diagnosis of a relapsing form of multiple sclerosis by a Information physician 2) Documentation of: • First episode of MS with MRI showing characteristics (e.g. active lesions) suggestive of MS OR • Documentation reporting evidence of development of OR worsening of symptoms (e.g. gait abnormalities, numbness, spasticity, weakness, vision problems, vertigo, cognitive changes) lasting for more than 24 hours in the absence of infection or any other cause after a stable period of at least 1 month. Age restrictions 18 years of age or older Prescriber Neurologist Restrictions Coverage Duration 1 year Other Criteria Dosing: Prefilled syringe or pen 30 mcg/ 0.5 mL per week; max 4 syringes or pens per 30 days

Reference(s):

1. Avonex [package insert]. Cambridge, MA: Biogen Inc.; Revised March 2016.

Created: 12/2017 Page 1 of 1

Applies to: Care1st

Rebif (interferon beta-1a)

FDA approved All medically accepted indications Indications Exclusion Criteria Required Medical Stated diagnosis from neurologist of : Information 1) definite relapsing-remitting MS, 2) secondary progressive MS with relapses, 3) or progressive relapsing MS

Statement may include: 1) a first MS attack with documented MRI scan abnormalities characteristic of MS, OR 2) evaluation documenting EITHER: • history of at least two focal neurological deficits (e.g. loss of vision, double vision, localized numbness or weakness), in which the first resolved and the second followed after a period of at least 6 months, OR • history of one focal neurological deficit which has resolved, and an MRI suggestive of MS

Age restrictions 18 years or older

Prescriber Neurologist Restrictions Coverage Duration 1 year Other Criteria

Reference(s):

1. Product Information: Rebif(R) subcutaneous injection, interferon beta 1a subcutaneous injection. EMD Serono, Inc. and Pfizer Inc. (per FDA), Rockland, MA, 2012.

Last Updated: 05/2014 Page 1 of 1

Applies to: Care1st

Betaseron, Extavia (interferon beta-1b)

Covered uses All medically accepted indications Exclusion Criteria

Required Medical Stated diagnosis from neurologist of : Information 1) definite relapsing-remitting MS, 2) secondary progressive MS with relapses, 3) or progressive relapsing MS

Age restrictions Age 18 years or greater

Prescriber Neurologist Restrictions Coverage Duration 1 year Other Criteria

Reference(s):

1. Extavia [package insert] Novartis Pharmaceuticals, Inc. East Hanover, NJ, March 2012.

Last Updated: 12/2017 Page 1 of 1

Applies to: Care1st

Isotretinoin Products Absorica; Accutane; Amnesteem; Claravis Covered uses Statement of FDA approved diagnosis

Exclusion Criteria 1) Pregnancy 2) Patients with hepatitis

Required Medical 1) Documented diagnosis of: Information • Treatment of Severe Nodular Acne (Nodules are inflammatory lesions with a diameter of 5 mm or greater). • Negative screening test (urine or serum pregnancy test) administered by prescriber. • Psychiatric disorder screening • Prior history of Isotretinoin treatment • Pretreatment serum Triglyceride level

-AND-

2) Trial and failure or contraindication of two of the following preferred agents: Doxycycline Hyclate capsules, Minocycline capsule, Clindamycin capsule, Clindamycin oral solution.

Age restrictions Age ≥ 12 years old and <21 years old

Prescriber Prescriber must be registered and active with the pregnancy risk Restrictions management program, Ipledge.

Coverage Duration 20 weeks

Other Criteria

Reference(s):

1. Accutane drug information. Roche Pharmaceuticals Inc. August 2005 2. American Academy of Dermatology (AAD). Guidelines of care for acne vulgaris management. 2005. 3. American Academy of Family Physicians (AAFP). Diagnosis and treatment of acne. 2004.

Last Updated: 12/2017 Page 1 of 1

Care1st Exception criteria

Corlanor (ivabradine)

Covered uses All FDA Approved Indications Exclusion Criteria 1) Acute decompensated heart failure 2) Severe hepatic impairment (Child-Pugh C) 3) Pregnancy 4) Concomitant use of strong cytochrome CYP3A4 inhibitors Required Medical Approve based on diagnosis of stable, symptomatic chronic heart Information failure with the following: 1) Left ventricular ejection fraction of 35% or less 2) Sinus rhythm with resting heart rate of 70 or greater BPM (before treatment initiation) • Dosage may be adjusted to achieve resting heart rate of 50-60 BPM after treatment has been initiated 3) Currently on maximally tolerated doses beta-blockers or contraindication to beta-blockers Age restrictions Age 18 years or greater Prescriber Cardiologist Restrictions Coverage Duration 1 year Other Criteria Recommended dosing: 5 mg twice daily Maximum dosing: 7.5 mg twice daily

Reference(s):

1. Corlanor (Ivabradine) package insert. Thousand Oaks, CA: Amgen Inc.; 2015 Apr.

Last Updated: 02/2016 Page 1 of 1

Applies to: Care1st

Sklice 0.5% Topical lotion (ivermectin)

Covered uses All FDA approved indications

Exclusion Criteria Caution in use in pregnancy/ breastfeeding

Required Medical 1) Documented FDA approved diagnosis of head lice infestation Information AND

2) Documented clinical failure after use of at least two (2) preferred age appropriate alternatives OR documented intolerance or allergy to preferred alternatives

Age re strictions Age: 6 months and older Pre scribe r Restrictions Coverage Duration 1 month

Othe r Crite ria Preferred Alternatives: 1) Permetherin cream (age 2 months and older) 2) Spinosad external suspension (age 6 months and older)

Reference(s):

1. Sklice [package insert] Sanofi Pasteur, Inc. Swiftwater, PA. February 2012 2. Devore, Cynthia D. Schutze, Gordon E and the Council on School Health and Committee on Infectious Disease. Head Lice. Pediatrics,135;5;1355-1365. http://pediatrics.aappublications.org/content/135/5/e1355.full.html

Last Updated: 12/2017 Page 1 of 1

Applies to: Care1st

Ivermectin

Covered uses All medically accepted indications

Exclusion Criteria 1) Use in pediatrics for diagnosis of rosacea or inflammatory lesions 2) Hypersensitivity to oral ivermectin or any other component of the product Required Medical 1) Documented diagnosis of one of the following: Information • Onchocerciasis (river blindness) • Nondisseminated strongyloidiasis of the intestinal tract • Head lice infestation • Rosacea, inflammatory lesions AND

2) Trial and failure of at least one of the following: • Permethrin 1%,5% (Nix,Elmite) • Permethrin liquid (Nix Crème Rinse) • Pyrethrin (gel, liquid or shampoo) (A-200, Barc, Lucide) Age restrictions 1 year and older with pediatric weight of at least 15 kg; If treating pediculosis capitis then 6 months of age and older Prescriber 1) Primary Care Physician Restrictions 2) Dermatologist 3) Pediatrician Coverage Duration 1 year Other Criteria 1) Pediculosis capitis: Apply Sklice 0.5% lotion to dry hair in an amount sufficient (1 tube).

2) Rosacea, inflammatory lesion: 1% cream, apply thin film topically to affected areas on the face once daily

3) Intestinal strongyloidiasis: 200 mcg/kg oral as a single dose; retreat with a single dose if evidence of larvae is still present after 3 months

4) Onchocerciasis: 150 mcg/kg orally as a single dose; retreat between 3 and 12 months

Reference(s):

1. Ivermectin. Micromedex Solutions. Truven Health Analytics, Inc. Ann Harbor, MI. Available from http://www.micromedexsolutions.com.

Last Updated: 02/2018 Page 1 of 2

Applies to: Care1st

Vimpat tablet (Lacosamide) Covered Uses Statement of FDA approved diagnosis Exclusion Criteria Required Medical 1) Documented diagnosis of: Treatment of partial-onset seizures in patients 4 years of age Information and older.

Recommended Dosage for Adults and Pediatric Patients 4 Years and Older* *when not specified, the dosage is the same for monotherapy and adjunctive therapy Age and Body Initial Dosage Titration Regimen Maintenance Dosage Weight Monotherapy: 100 mg twice daily (200 mg per day) Monotherapy: 150

mg to 200 mg twice Adjunctive Therapy: daily (300 mg to 400 50 mg twice daily (100 Increase by 50 mg mg per day) Adults (17 years and mg per day) twice daily (100 mg older) per day) every week Adjunctive Therapy: Alternate Initial 100 mg to 200 mg Dosage: 200 mg twice daily (200 mg to single loading dose, 400 mg per day) followed 12 hours later by 100 mg twice daily Monotherapy: 150 mg to 200 mg twice daily (300 mg to 400 Pediatric patients Increase by 50 mg mg per day) 50 mg twice daily weighing 50 kg or twice daily (100 mg (100 mg per day) more per day) every week Adjunctive Therapy: 100 mg to 200 mg twice daily (200 mg to 400 mg per day) Increase by 1 mg/kg 2 mg/kg to 4 mg/kg Pediatric patients twice daily (2 1 mg/kg twice daily (2 twice daily (4 weighing 30 kg to less mg/kg/day) every mg/kg/day) mg/kg/day to 8 than 50 kg week mg/kg/day)

3 mg/kg to 6 mg/kg Increase by 1 mg/kg Pediatric patients twice daily (6 1 mg/kg twice daily (2 twice daily (2 weighing 11 kg to less mg/kg/day to 12 mg/kg/day) mg/kg/day) every than 30 kg mg/kg/day) week

Last Updated: 12/2017 Page 1 of 2

Applies to: Care1st

-AND-

2) Documented trial and failure to at least 2 formulary alternatives (Lamotrigine, Phenytoin, Topirimate, Divalproex sodium, or Primidone).

Age Age 4 years and older Restrictions Prescriber Neurologist Restrictions Coverage 1 year Duration Other Criteria

Reference(s):

1. Vimpat [package insert]. UCB, Inc. Smyrna, GA. Dec 2017.

Last Updated: 12/2017 Page 2 of 2

Applies to: Care1st

Tykerb (lapatinib)

Covered uses All medically accepted indications

Exclusion Criteria Required Medical 1) Stated diagnosis of advanced or metastatic breast cancer whose Information tumors overexpress human epidermal receptor type 2 (HER2)

2) Used in combination with capecitabine

AND 3) Statement indicating member has received prior therapy, including an anthracycline, a taxane, and trastuzumab;

OR 4) For the treatment of postmenopausal women when used in combination with letrozole for the treatment of metastatic breast cancer that overexpresses HER2 receptor for whom hormonal therapy is indicated

Age restrictions 18 years or greater

Reference(s):

1. National Comprehensive Cancer Network, Inc. 2011, NCCN Clinical Practice Guidelines in Oncology (NCCN®). Version 3.2012 2. Product Information: TYKERB(R) oral tablets, lapatinib oral tablets. GlaxoSmithKline (per FDA), Research Triangle Park, NC, April 2017.

Last Reviewed: 09/2018 Page 1 of 1

Applies to: Revlimid (Lenalidomide) Care1st Revlimid (Lenalidomide)

FDA approved All medically accepted indications Indications: Exclusion Criteria Pregnancy

Required Medical Diagnosis of: Information 1) Multiple myeloma (MM), in combination with dexamethasone, in patients who have received at least one prior therapy • Cyclophosphamide • Alkeran (Melphalan) • Thalomid (Thalidomide)

• Starting Dosing: 25 mg once daily on Days 1-21 of repeated 28- day cycles. Dexamethasone 40 mg once daily days 1-4, 9-12, and 17-20 of each 28-day cycle for the first 4 cycles of therapy, then once daily orally days 1-4 of every 28 day cycle.

2) Mantle Cell Lymphoma, in combination with dexamethasone, in patients with relapsed or progressive disease after 2 prior therapies, one of which includes Velcade (bortezomib) or bortezomib containing regimen • Starting Dosing: 25mg/day on Days 1-21 of repeated 28-day cycles.

3) Patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q abnormality with or without additional cytogenetic abnormalities • Starting Dosing: 10 mg daily.

Monitoring: CBC with Platelet Count- within last month. Absolute Neutrophil Count- within last month. Age re strictions 18 years or older Coverage Duration 1 year

Othe r Crite ria

Reference(s):

1. Product Information: REVLIMID(R) oral capsules, lenalidomide oral capsules. Celgene Corporation (per FDA), Summit, NJ, 2013.

Last Updated: 03/2016 Page 1 of 1

Applies to: Care1st Leucovorin Calcium Tablets

Covered uses All medically accepted indications

Exclusion Criteria Leucovorin is improper therapy for pernicious anemia and other megaloblastic anemias secondary to the lack of vitamin B12. A hematologic remission may occur while neurologic manifestations continue to progress. Required Medical Clinical Documentation must include: Information 1) Using for leucovorin rescue: • To diminish the toxicity and counteract the effects of impaired methotrexate elimination AND • For inadvertent overdoses of folic acid antagonists (such as: methotrexate, trimethoprim, and pyrimethamine) Age restrictions 2 years and older Prescriber Restrictions Coverage Duration 1 year Other Criteria

Reference(s):

1. Leucovorin [package insert]. Teva Pharmaceuticals USA, Inc., North Wales, PA, August, 2018.

Last Updated: 09/2018 Page 1 of 1

Applies to: Care1st Leucovorin Calcium Tablets

Covered uses All medically accepted indications

Reference(s):

1. Leucovorin [package insert]. Teva Pharmaceuticals USA, Inc., North Wales, PA, August, 2018.

Last Updated: 09/2018 Page 1 of 1

Applies to: Care1st Lupron, Lupron Depot, Lupron Depot-PED, Eligard (leuprolide acetate)

Covered uses All medically accepted indications, Recurrent Ovarian Cancer

Exclusion Criteria Required Medical Stated diagnosis of: Information 1) Central Precocious Puberty 2) Advanced prostatic cancer (palliative) 3) Endometriosis— one of the following: • The patient did not exhibit an adequate response to a trial (at least 12 weeks) of treatment OR the patient experienced an intolerance/adverse reaction to previous therapy OR has a contraindication with one of the following: o Norethindrone acetate; OR o Progesterone; OR o Danazol; OR o An oral contraceptive 4) Anemia, Uterine leiomyomata (fibroids), preoperatively with iron therapy 5) Recurrent Ovarian Cancer • Defined as progression after two consecutive chemotherapy regimens without ever sustaining a clinical benefit, OR • Disease recurs in less than 6 months (platinum resistant) OR • Patient cannot tolerate or has been unsuccessful with cytotoxic regimens

Age restrictions 1) For Central Precocious Puberty: Patient must be less than 11 years old if female, 12 years if male 2) For Endometriosis and Uterine Leiomyomata (fibroids): Patient must be 18 years or older

Prescriber None Restrictions Coverage Duration 1) Authorization will be issued for 12 months for Advanced Prostatic Cancer, Central Precocious Puberty, and Recurrent Ovarian Cancer indications 2) Initial authorization for Endometriosis will be issued for 6 months; re-authorization will be issued for 6 months 3) Initial authorization for Uterine leiomyomata will be issued for 3 months; re-authorization will be issued for 3 months

Last Reviewed: 09/2018 Page 1 of 3

Applies to: Care1st

Other Criteria For Uterine leiomyomata 1) Re-authorization will be approved based on the following: • The patient has received less than 6 months of therapy with Lupron, Lupron Depot, or Eligard AND • The patient has not experienced side effects or adverse reactions to Lupron, Lupron Depot, or Eligard AND • The patient has had a bone density scan that was within normal limits. 2) Re-authorization for all other indications will approved based on the following: • The patient has received less than 12 months of therapy with Lupron, Lupron Depot, or Eligard AND • The patient has not experienced side effects or adverse reactions to Lupron, Lupron Depot, or Eligard AND • The patient has had a bone density scan that was with in normal limits.

Reference(s):

1. Lupron DepotTM Prescribing Information. Abbott Laboratories, July 2010. 2. Lupron Depot-PED TM Prescribing Information. Abbott Laboratories, September 2010. 3. American Fertility Society. Revised American Fertility Society classification of endometriosis: 1985. Fertil Steril. 1985;43:351-352. 4. Balasch J, Creus M, Fábregues F, et al. Visible and nonvisible endometriosis at laparoscopy in fertile and infertile women and in patients with chronic pelvic pain: a prospective study. Hum Reprod. 1996;11:387-391. 5. Carter JE. Combined hysteroscopic and laparoscopic findings in patients with chronic pelvic pain. J Am Assoc Gynecol Laparosc. 1994;2:43-47. 6. Cornillie FJ, Oosterlynck D, Lauweryns JM, Koninckx PR. Deeply infiltrating pelvic endometriosis: Histology and clinical significance. Fertil Steril. 1990;53:978-983. 7. Fedele L, Parazzini F, Bianchi S, Arcaini L, Candiani GB. Stage and localization of pelvic endometriosis and pain. Fertil Steril. 1990;53:155-158. 8. Green TH. Conservative surgical treatment of endometriosis. Clin Obstet Gynecol. 1966;9:293-308. 9. Howard FM. The role of laparoscopy in chronic pelvic pain: Promises and pitfalls. Obstet Gynecol Survey. 1993;48:357-387. 10. Jacobson L. Differential diagnosis of acute pelvic inflammatory disease. Am J Obstet Gynecol. 1980;138:1006-1011.

Last Reviewed: 09/2018 Page 2 of 3

Applies to: Care1st

11. King PM, Myers CA, Ling FW, et al. Musculoskeletal factors in chronic pelvic pain. J Psychosom Obstet Gynecol. 1991;12:87-98. 12. Koninckx PR, Lessaffre E, Meuleman C, Cornillie FJ, Demeyere S. Suggestive evidence that pelvic endometriosis is a progressive disease whereas deeply infiltrating endometriosis is associated with pelvic pain. Fertil Steril. 1991;55:759-765. 13. Lee NC, Dicker RC, Rubin GL, Ory HW. Confirmation of the preoperative diagnosis for hysterectomy. Am J Obstet Gynecol. 1984;150:283-287. 14. Levitan Z, Eibschitz I, Devries K. The value of laparoscopy in women with chronic pelvic pain and a “normal pelvis.” Int J Gynecol Obstet. 1985;23:71-74. 15. Martin DC, Hubert GD, Vander Zwaag R, el-Zeky FA. Laparoscopic appearances of peritoneal endometriosis. Fertil Steril. 1989;51:63-67. 16. Mathias SD, Kuppermann M, Lieberman RF, Lipschutz RC, Steege JF. Chronic pelvic pain: prevalence, health-related quality of life, and economic correlates. Obstet Gynecol. 1996;87:321-327. 17. Sutton C, Hill D. Laser laparoscopy in the treatment of endometriosis. A 5-year study. Br J Obstet Gynaecol. 1990;97:181-185. 18. Waller KG, Shaw RW. Gonadotropin-releasing hormone analogues for the treatment of endometriosis: Long-term follow-up. Fertil Steril. 1993;59:511-515. 19. Wheeler JM, Malinak LR. Recurrent endometriosis: incidence, management, and prognosis. Am J Obstet Gynecol. 1983;146:247-50. 20. Wheeler JM, Malinak LR. Recurrent endometriosis. Contrib Obstet Gynecol. 1987;16:13-21. 21. Winkel CA, Bray M. Treatment of women with endometriosis using excision alone, ablation alone, or ablation in combination with leuprolide acetate. Proceedings of the 4th World Congress on Endometriosis, Yokohama. 1996:55. Journal-Less than 6 authors Finkelstein JS, Hayes A, Hunzelman JL, Wyland JJ, Lee H, Neer RM. The effects of parathyroid hormone, alendronate, or both in men with osteoporosis. N Eng J Med 2003;349:1216-26. 22. Facts and Comparisons, 4.0; 2010. 23. American Society for Reproducticve Medicine. Treatment of pelvic pain associated with endometriosis. Fertil Steril. 2006;84 (Suppl 4):S18-S27. 24. Eligard TM Prescribing Information. Tolmar, Inc., November 2009. 25. Clinical Practice Guidelines in Oncology™. The National Comprehensive Cancer Network (NCCN) Drugs & Biologics. Available at www.nccn.org. 26. Rao GG, Miller DS. Hormonal therapy in epithelial ovarian cancer. Expert Rev Anticancer Ther. 2006; 6: 43-7.

Last Reviewed: 09/2018 Page 3 of 3

Applies to: Care1st Lidocaine Ointment

Covered uses All medically accepted indications

Exclusion Criteria

Required Medical Clinical documentation must include: Information 1) Being used as an anesthetic lubricant for intubation and for the temporary relief of pain associated with minor burns, including sunburn, abrasions of the skin, and insect bites. 2) Trial and failure or contraindication of Lidocaine Cream 4%, 2% Gel, Lotion Age restrictions Prescriber Restrictions Coverage Duration 1 year Other Criteria If being used as part of a compounded product, all active ingredients in the compounded product are FDA approved for topical use.

Reference(s):

1. Lidocaine [package insert]. KBS Solutions, LLC, Baton Rouge, LA, May, 2018.

Last Reviewed: 09/2018 Page 1 of 1

Applies to: Care1st Lidoderm Patches (Lidocaine)

Covered uses Pain associated with post-herpetic neuralgia

Exclusion Criteria Required Medical Clinical Documentation must include: Information 1) Diagnosis of pain associated post-herpetic neuralgia 2) Trial and failure or contraindication to gabapentin

Age restrictions 18 years and older Prescriber Restrictions Coverage Duration 1 year Other Criteria

Reference(s):

1. Lidocaine [package insert]. Endo Pharmaceuticals, Inc, Malvern, PA, January, 2015.

Last Reviewed: 09/2018 Page 1 of 1

Applies to: Care1st

Linzess (Linaclotide)

Covered uses Statement of FDA approved diagnosis

Exclusion Criteria Required Medical Documented diagnosis of one of the following: Information 1) Chronic Idiopathic Constipation (CIC) Linzess will be approved based on the following criteria: • The patient is 18 years of age or older -AND- • The patient has a diagnosis of chronic idiopathic constipation* -AND- • The patient did not exhibit an adequate response to treatment with lactulose and polyethylene glycol (Miralax) -OR- • The patient experienced an intolerance/adverse reaction to previous therapy with lactulose and polyethylene glycol (Miralax) -OR- • The patient has a documented contraindication to treatment with lactulose and polyethylene glycol (Miralax)

* Chronic idiopathic constipation is defined as less than 3 spontaneous bowel movements per week along with one or more of the following symptoms of constipation: 1) very hard stools for at least a quarter of all bowel movements; 2) sensation of incomplete evacuation following at least a quarter of all bowel movements; and 3) straining with defecation at least a quarter of the time.

2) Irritable Bowel Syndrome (IBS) Constipation Linzess will be approved based on the following criteria: • The patient is 18 years of age or older -AND- • The patient has a diagnosis of irritable bowel syndrome with constipation (IBSC) -AND- • The patient did not exhibit an adequate response to

Last Updated: 12/2017 Page 1 of 2

Applies to: Care1st

treatment with lactulose and polyethylene glycol (Miralax) -OR- • The patient experienced an intolerance/adverse reaction to previous therapy with lactulose and polyethylene glycol (Miralax) -OR- • The patient has a documented contraindication to treatment with lactulose and polyethylene glycol (Miralax)

Age re strictions Age 18 years and older

Pre scribe r Restrictions Coverage Duration 1 year

Othe r Crite ria

Reference(s):

1. Linzess- linaclotide capsule [package insert]. Allergan, Inc. Irvine, CA. Dec 2017.

Last Updated: 12/2017 Page 2 of 2

Applies to: Care1st Zyvox (linezolid)

Covered uses All medically accepted indications

Exclusion Criteria Zyvox will not be approved in patients receiving any MAOI, or within two weeks of receiving an MAOI as evidenced by claims history Required Medical 1) Recent (within 30 days of request) Culture and Sensitivity Information report; AND 2) Documentation of one medically accepted indication (listed numerically below); AND 3) Vancomycin-resistant enterococcus faecium (VRE)

4) Nosocomial pneumonia (caused by MRSA)

5) Nosocomial or community acquired pneumonia (caused by MSSA or Streptococcus pneumonia): Trial and failure of two (2) preferred alternatives or resistance to all other appropriate therapies: Amoxicillin/c lavulanic acid, Azithromycin, Cephalexin, Clarithromycin, Dicloxacillin, Doxycycline, Levofloxacin, Trimethoprim-sulfamethoxazole

6) Complicated skin / skin structure infections including diabetic foot infections, without osteomyelitis caused by MRSA Trial and failure of two (2) preferred alternatives or resistance to all other appropriate therapies: Doxycycline, Trimethoprim- sulfamethoxazole

7) Uncomplicated SSI caused by MRSA documented by C/S report or empirical treatment of patients with uncomplicated or community-acquired complicated SSI without osteomyelitis where MRSA infection is likely: Trial and failure of two (2) preferred alternatives or resistance to all other appropriate therapies: Trimethoprim-sulfamethoxazole, Dicloxacillin, Doxycycline, Minocycline, Clindamycin.

8) Uncomplicated or complicated SSI without osteomyelitis caused by MSSA, Streptococcus pyogenes, or Streptococcus agalactiae (complicated SSI only): Trial and failure of two (2) preferred alternatives or resistance to all other appropriate therapies: Amoxicillin/c lavulanic acid, Cephalexin, Ciprofloxacin, Clindamycin, levofloxacin, Trimethoprim/Sulfamethoxazole, Dicloxacillin.

Age re strictions

Last Updated: 02/2017 Page 1 of 2

Applies to: Care1st

Pre scribe r Restrictions Coverage Duration 28 days for Vancomycin-resistant E. Faecium (VRE) 14 Days for all other infections Othe r Crite ria Member must not currently be receiving therapy with any of the following medications: 1) SSRIs 2) SNRIs 3) Triptans 4) MAOIs 5) Mirtazapine, Trazodone

Reference(s):

1. Zyvox [package insert]. New York, NY: Pfizer Pharmaceuticals LLC. 2013.

Last Updated: 02/2017 Page 2 of 2

Applies to: Care 1st

Lithium (tablet, capsules, solution)

Covered uses All medically accepted indications Exclusion Criteria Required Medical Documentation of either of the following medical diagnoses: Information • Treatment of manic episodes • Maintenance treatment of Bipolar I Disorder

Reference(s):

1. Lithium tablet, capsule, solution [package insert]. West-Ward Pharmaceuticals Corp. December 2017.

Created: 09/2018 Page 1 of 1

Applies to: Care1st Exception Criteria

Gleostine (lomustine)

Covered uses All medically accepted indications

Exclusion Criteria Required Medical Stated diagnosis from oncologist for one of the following: Information 1) Brain tumors: Both primary and metastatic, in patients who have already received appropriate surgical and/or radiotherapeutic procedures.

2) Hodgkins Disease: Secondary therapy in combination with other approved drugs in patients who relapse while being treated with primary therapy, or who fail to respond to primary therapy i.e., ABVD [Adriamycin (Doxorubicin), Bleomycin, Vinblastine (Velban), Dacarbazine (DTIC)]

Age restrictions

Reference(s):

1. Gleostine [package insert]. Next Source Biotechology, LLC .Miami, FL.. June 1, 2018, 2. Lomustine. In:DRUGDEX System (Micromedex 2.0). Greenwood Village, CO: Truven Health Analytics; c1974-2018. 3. http://www.micromedexsolutions.com/micromedex2/librarian/. Accessed August 5, 2018

Last Reviewed: 09/2018 Page 1 of 1

Long acting Note: Women of reproductive age should be counseled about opioid use Initial Opioids‐Preferre during pregnancy and neonatal abstinence syndrome (NAS) Approval: d • 6 months STEP criteria for Non‐Preferred Long Acting Narcotics: MSER 1) Failed a minimum of 2 week trials of maximum tolerated doses of Renewal: (Morphine Sulfate ER) at least TWO formulary long‐ ac ting opioids (i.e., fentanyl patch, • 6 months Duragesic Patches morphine sulfate ER) OR have contraindications to all formulary agents. ( Fentanyl Patches) Butrans Patch Criteria for Preferred and other Non‐Formulary Long‐Acting (Buprenorphine) Opioids: Covered Conditions: Embeda 2) Chronic pain that is not related to a malignancy. (Morphine/Naltrexone) 3) Chronic pain related to cancer will be an excluded diagnosis. Clients XTAMPZA ER will not need to meet the below requirements if they have active therapy or (Oxycodone HCL are post‐surgery. Tablet 12- ABUSE Prior Authorization will be required whe n any of the following apply: DETERRANT) 4) The requested product is a long acting opioid analgesic. Ultram ER 5) Due to the high rate of overdose with combining opioids and (Tramadol ER) benzodiazepines, prior authorization requests for high dose, long acting, or non‐preferred narcotics will be denied if the client is concurrently using a benzodiazepine unless the following occurs: • A transition plan is submitted showing a 3‐6 month transition plan of removal on concurrent therapy of benzodiazepine and narcotic. • Authorization will be in 3 month intervals only to ensure the transition plan is being followed. • Requests that are for maintaining continued concurrent therapy and not tapering off will be sent to medical director for review. NOTE: Patients with a seizure diagnosis are exempt from this policy.

General Requirements: For all prior authorization requests: 1) Client must be at least 12 years of age 2) Pain assessment charts must include an assessment filled out by the physician 3) Physician‐patient pain management contract must be provided 4) Documentation must be included for random urine or blood tests twice a year 5) Documentation of the CSPMP reviewed by the prescriber every time a prescription for controlled substance is provided 6) One pharmacy must be selected for all prescription services 7) Patient must not have an active addiction to illicit substances or prescription drugs. Patients should be tapered off if any of the following apply; 8) The patient has committed serious or repeated drug seeking behavior 9) The patient makes no progress toward therapeutic goals 10) Must be for ongoing continuous therapy, not on an as needed basis.

For all patients receiving more than 200 mg morphine or equivalent per 24 hours: 11) If the diagnosis includes an inflammatory pain component, then the patient must have tried or be contraindicated to a non‐steroidal anti‐ inflammatory drug 12) If the diagnosis is a form of neuropathic pain, then patient must first try or be contraindicated to two (2) neuropathic pain medications.

Created: 12/2016 Reviewed: 03/2018 Approved: 03/2018 Page 1 of 1 Applies to: Care 1st

Loxapine (capsules)

Covered uses All medically accepted indications Exclusion Criteria Required Medical Documentation of the diagnosis of Schizophrenia Information Age restrictions Prescriber Restrictions Coverage Duration 1 year Other Criteria **If request is for 6 and over: PA is not required when prescribed by a psychiatric clinician, a behavioral health pediatrician or other approved prescribers.

Reference(s):

1. Loxapine [package insert]. Mylan Pharmaceuticals Inc. March 2017

Created: 09/2018 Page 1 of 1

Applies to: Care1st

Amitiza (lubiprostone)

Covered uses All medically accepted indications

Exclusion Criteria Required Medical A. Chronic Idiopathic Constipation Information 1) Amitiza will be approved based on the following criteria: • The patient is 18 years of age or older -AND- • The patient has a diagnosis of chronic idiopathic constipation* -AND- • One of the following: o The dose prescribed is 24 mcg capsules twice daily o The dose prescribed is 16 mcg twice daily for patients with moderately impaired hepatic function (Child-Pugh Class B) o The dose prescribed is 8 mcg twice daily for patients with severely impaired hepatic function (Child-Pugh Class C) -AND- • The patient did not exhibit an adequate response to treatment with lactulose and polyethylene glycol (Miralax) -OR- • The patient experienced an intolerance/adverse reaction to previous therapy with lactulose and polyethylene glycol (Miralax) -OR- • The patient has a documented contraindication to treatment with lactulose and polyethylene glycol (Miralax)

*Chronic idiopathic constipation is defined as less than 3 spontaneous bowel movements per week along with one or more of the following symptoms of constipation: 1) very hard stools for at least a quarter of all bowel movements; 2) sensation of incomplete evacuation following at least a quarter of all bowel movements; and 3) straining with defecation at least a quarter of the time.

Last Updated: 08/2015 Page 1 of 3

Applies to: Care1st

B. Irritable Bowel Syndrome with Constipation (IBS-C) 2) Amitiza will be approved based on the following criteria: • The patient is 18 years of age or older -AND- • The patient is female -AND- • The patient has a diagnosis of irritable bowel syndrome with constipation (IBSC) -AND- • One of the following: o The dose prescribed is 8 mcg capsules twice daily o The dose prescribed is 8 mcg capsules once daily for patients with severely impaired hepatic function (Child-Pugh Class C)

-AND- • The patient did not exhibit an adequate response to treatment with lactulose and polyethylene glycol (Miralax) -OR- • The patient experienced an intolerance/adverse reaction to previous therapy with lactulose and polyethylene glycol (Miralax) -OR- • The patient has a documented contraindication to treatment with lactulose and polyethylene glycol (Miralax)

C. Opioid induced constipation, in patients with chronic non- cancer pain 3) Amitiza will be approved based on the following criteria: • The patient is 18 years of age or older -AND- • The patient has a diagnosis of chronic idiopathic constipation* -AND- • One of the following: o The dose prescribed is 24 mcg capsules twice daily o The dose prescribed is 16 mcg twice daily for patients with moderately impaired hepatic function (Child-Pugh Class B)

Last Updated: 08/2015 Page 2 of 3

Applies to: Care1st

o The dose prescribed is 8 mcg twice daily for patients with severely impaired hepatic function (Child-Pugh Class C) -AND- • The patient did not exhibit an adequate response to treatment with lactulose and polyethylene glycol (Miralax) -OR- • The patient experienced an intolerance/adverse reaction to previous therapy with lactulose and polyethylene glycol (Miralax) -OR- • The patient has a documented contraindication to treatment with lactulose and polyethylene glycol (Miralax)

Age re strictions Patient must be 18 years of age or older

Pre scribe r Restrictions Coverage Duration 1 year Othe r Crite ria

Reference(s):

1. Amitiza [package insert]. Bethesda, MD: Sucampo Pharma Americas, Inc.; April 2013 2. American College of Gastroenterology Chronic Constipation Task Force. An Evidence- Based Approach to the Management of Chronic Constipation in North America. AM J Gastroenterol. 2005l; 100: S1-S4. 3. Johanson JF, Morton D, Geenen J, et al. Multicenter, 4-Week, Double-Blind, Randomized, Placebo-Controlled Trial of Lubiprostone, a Locally-Acting Type-2 Chloride Channel Activator, in Patients With Chronic Constipation. Am J Gastroenterol. 2008; 103: 170-177. 4. Brandt LJ, Chey WD, Foxx-Orenstein AE, et al. An Evidence-Based Position Statement on the Management of Irritable Bowel Syndrome. Am J Gastroenterol. 2009; 104: S1- S35. 5. Clinical Pharmacology Gold Standard. 2012. 6. Facts and Comparisons 4.0; 2012.

Last Updated: 08/2015 Page 3 of 3

Applies to: Care1st Exception criteria

Orkambi (lumacaftor/ivacaftor)

Covered uses All FDA Approved Indications Exclusion Criteria 1) Patients with only one copy (heterozygote) of F508del mutation 2) Patients with CFTR gene mutations other than F508del 3) Patient is taking Orkambi concurrently with strong CYP3A inducers (i.e. rifampin, St. John’s wort) Required Medical Documentation of the following: Information 1) Diagnosis of cystic fibrosis

2) DNA analysis testing results indicating patient is homozygous (two copies of the mutation) for the F508del mutation on CFTR gene. AND

**Clinical signs or symptoms (such as a positive culture for P. aeruginosa) or family history alone do not confer a diagnosis of CF**

3) Patient is taking background therapy such as short-acting beta- agonist (albuterol), mucolytics (pulmozyme), inhaled antibiotics (tobramycin), pancreatic enzymes, or hypertonic saline AND

4) Documentation that prescriber has conducted appropriate counseling and that patient expressed understanding (i.e. adherence counseling, potential drug interactions, concurrent administration with fat containing food, etc.) AND

5) Submission of forced expiratory volume in one second (FEV1) between 40 to 90 percent of the predicted normal value AND

6) Documentation that AST/ALT (≤ 3x ULN) and bilirubin (≤ 2x ULN)

Reauthorization 1) Patient has stable or improved FEV1 2) Increase in patient’s member’s BMI, improvement in respiratory symptoms (cough, sputum production, and difficulty breathing) 3) Continued treatment on CF background therapy 4) Document AST/ALT (≤ 3x ULN) and bilirubin (≤ 2x ULN)

Last Updated: 09/2018 Page 1 of 2

Applies to: Care1st Exception criteria

5) Member is at 80% adherent to Orkambi therapy per claims data Age restrictions 2 years of age and older Prescriber 1) Pulmonologist Restrictions 2) Prescriber in consultation with a pulmonologist Coverage Duration 6 months Other Criteria

Reference(s):

1. Farrell PM, Rosenstein BJ, White TB, et al. Guidelines for Diagnosis of Cystic Fibrosis in Newborns through Older Adults: Cystic Fibrosis Foundation Consensus Report. The Journal of pediatrics. 2008; 153 (2): S4-S14. doi: 10.1016/j.jpeds.2008.05.005 2. ORKAMBI [package insert]. Vertex Pharmaceuticals, Inc. Boston, MA. August 2018 3. Cystic Fibrosis Pulmonary Guidelines: Chronic Medications for Maintenance of Lung Health" Am J Respir Crit Care Med 2013 Apr; 187(7):680-9. 4. http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/InVitroDiagnosti cs/ucm330711.htm#human

Last Updated: 09/2018 Page 2 of 2

Applies to: Care 1st

Latuda (lurasidone)

Reference(s):

1. Latuda tablet [package insert]. Sunovion Pharmaceuticals Inc. March 2018.

Created: 09/2018 Page 1 of 1

Care1st Exception criteria

Diabetic Macular Edema Agents/ Ophthalmic agent-vascular endothelial growth factor: Avastin (bevacizumab), Ozurdex (dexamethasone), Eylea (aflibercept), Lucentis (ranibizumab), Illuvien (fluocinolone acetonide intravitreal implant)

Covered uses Diabetic Macular Edema (DME)

Exclusion Criteria Eylea, Iluvien, Lucentis, Ozurdex: Contraindicated in patients with active or suspected ocular or periocular infections including most viral disease of the cornea and conjunctiva including active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections or fungal diseases.

Required Medical 1) Avastin: diagnosis of DME Information 2) Iluvien: diagnosis of DME and t/f of Avastin and corticosteroid

3) Lucentis: diagnosis of DME and t/f of Avastin

4) Eylea: • diagnosis of DME and t/f of Avastin AND Lucentis OR • diagnosis of DME with diabetic retinopathy: Approve

5) Ozurdex: diagnosis of DME and t/f of Avastin

Age Restriction 18 years of age or older Prescriber Ophthalmologist Restriction Coverage Duration Through benefit year Other Criteria Avastin (bevacizumab) 1.25 mg intravitreal injection every 6 weeks (max 9 injections in first 12 months). Reauthorization for 12 months will be approved for continuation of therapy based on documentation of clinical improvement from ongoing therapy with the requested medication.

Last Reviewed: 09/2018 Page 1 of 2

Care1st Exception criteria

Ozurdex: 0.7 mg intravitreal implant every 6 months.

Eylea: 2 mg (0.05 mL) administered by intravitreal injection every 4 weeks (monthly) for the first 5 injections followed by 2 mg (0.05 mL) via intravitreal injection once every 8 weeks (2 months). Although EYLEA may be dosed as frequently as 2 mg every 4 weeks (monthly), additional efficacy was not demonstrated when EYLEA was dosed every 4 weeks compared to every 8 weeks.

Lucentis: 0.3 mg (0.05 mL of 6 mg/mL LUCENTIS solution) by intravitreal injection once a month (approximately 28 days).

Iluvien: 0.19 mg intravitreal implant lasting 36 months.

Reference(s):

1. Eylea (aflibercept) [prescribing information]. Tarrytown, NY: Regeneron Pharmaceuticals Inc; October 2014. 2. Korobelnik JF, Do DV, Schmidt-Erfurth U, et al. Intravitreal aflibercept 3. for diabetic macular edema. Ophthalmology. 2014 4. Avastin (bevacizumab) [prescribing information]. South San Francisco, CA: Genentech Inc; November 2014. 5. Product Information: ILUVIEN(R) intravitreal implant, fluocinolone acetonide intravitreal implant. Alimera Sciences, Inc. (per Manufacturer), Alpharetta, GA, 2014. 6. Rajendram R, Fraser-Bell S, Kaines A, et al: A 2-year prospective randomized controlled trial of intravitreal bevacizumab or laser therapy (BOLT) in the management of diabetic macular edema: 24-month data: report 3. Arch Ophthalmol 2012.

Last Reviewed: 09/2018 Page 2 of 2

Applies to: Care1st Selzentry (maraviroc)

Covered uses All medically accepted indications

Exclusion Criteria 1) Patients with severe renal impairment or end stage renal disease (creatinine clearance <30mL per minute) 2) Patients with dual/mixed or CXCR4-tropic HIV-1 infection (not recommended) Required Medical 1) Documented diagnosis of CCR5-tropic human Information immunodeficiency virus type 1 (HIV-1) infection AND

2) Documentation of negative test for CXCR4 tropic HIV-1 or dual/mixed-tropic disease (CCR5+ CXCR4) Age re strictions 2 years and older; pediatric child must weigh at least 10kg Pre scribe r Primary Care Physician Restrictions Coverage Duration 1 year Othe r Crite ria 1) Prior to initiation of therapy, must test all patients for CCR5 tropism using highly sensitive tropism assay 2) Monitor for ALT, AST and bilirubin prior to initiation and during treatment duration 3) Take tablets and oral solution twice daily and must be used in combination with other antiretroviral medications 4) Dosing varies from 150 mg-600 mg twice daily in adult patients and 50 mg to 150 mg twice daily in pediatric patients based on weight.

Reference(s):

1. Selzentry. Micromedex Solutions. Truven Health Analytics, Inc. Ann Harbor, MI. Available from http://www.micromedexsolutions.com. 2. Selzentry [Package Insert]. A-S Medication Solution. December 2017. http://dailymed.nlm.nih.gov.

Last Updated: 02/2018 Page 1 of 1

Applies to: Care1st

Increlex (mecasermin)

Covered uses All medically accepted indications Exclusion Criteria Required Medical Stated diagnosis of: Information 1) Insulin-Like-Growth Factor (IGF-1) deficiency • Evidenced by low IGF-1 (IGF-1/Somatomedin-C) level matched by age and gender (see table below for normal reference values) 2) Growth hormone deletion with antibodies to growth hormone

Age re strictions Patient must be less than 14 years of age, unless epiphyses have been confirmed open through a wrist film evaluation Pre scribe r Prescriber must be an endocrinologist or a pediatric Restrictions endocrinologist. Coverage Duration Initial authorization of therapy will be issued for 12 months. Re-authorization of therapy will be issued for 12 months. Othe r Crite ria 1) For diagnosis of IGF-1 Deficiency: • The patient has a height standard deviation score of ≤ - 3.0 • The patient has normal or elevated growth hormone levels. 2) For re-authorization: • Confirmed diagnosis of one of the following: o Primary IGF-1 deficiency; OR o Growth hormone deletion with antibodies to growth hormone; AND The patient is less than 14 years of age, unless epiphyses have been confirmed open through a wrist film evaluation.

Normal IGF-1 level reference ranges based on gender

Last Updated: 04/2015 Page 1 of 2

Applies to: Care1st

Reference(s):

1. IncrelexTM Prescribing Information. Tercica, Inc., September 2012. 2. Chernausek SD, Backeljauw PF, Frane J, Kuntze J, Underwood LE. Long-term treatment with recombinant insulin-like growth factor (IGF-1) in children with severe IGF-1 deficiency due to growth hormone insensitivity. J Clin Endocrinol Metab 2007;92(3):902-910. 3. Rosenbloom AL. Insulin-like growth factor (rhIGF-1) therapy of short statute. J Pediatr Endocrinol Metab 2008;21:301-315. 4. Collett-Solberg PF, Misra M, Drug and Therapeutics Committee of the Lawson Wilkins Pediatric Endocrine Society. The role of recombinant insulin-like growth factor-I in treating children with short stature. J Clin Endocrinol Metab 2008;93(1):10-8. 5. Facts and Comparisons 4.0; 2012. 6. Clinical Pharmacology Gold Standard. 2012.

Last Updated: 04/2015 Page 2 of 2

Applies to: Care1st Exception Criteria

Alkeran (melphalan)

Covered uses All medically accepted indications

Exclusion Criteria 1) Alkeran should not be used in patients whose disease has demonstrated a prior resistance to this agent. 2) Patients who have demonstrated hypersensitivity to melphalan should not be given the drug. Required Medical 1) Stated diagnosis from oncologist for one of the following: Information • Palliative treatment of non-resectable epithelial carcinoma of the ovary • Palliative treatment of multiple myeloma • Hemopoietic stem cell transplant-multiple myeloma Age restrictions Age 18 years or greater

Prescriber Oncologist

Restrictions Coverage 1 year Duration Other Criteria Members currently taking this medication at time of enrollment will not be required to meet prerequisites for prior authorization

Reference(s):

1. Melphalan. In:DRUGDEX System (Micromedex 2.0). Greenwood Village, CO: Truven Health Analytics; c1974- 2018.http://www.micromedexsolutions.com/micromedex2/librarian/. Accessed August 5, 2018

Last Reviewed: 09/2018 Page 1 of 1

App lies to: Care1st Memantine HCL Solution/Memantine Tablet

Covered uses All medically accepted indications

Exclusion Criteria Memantine Hydrochloride is contraindicated in patients with known hypersensitivity to Memantine Hydrochloride or to any excipients used in the formulation. Required Medical 1) FDA approved for the treatment of moderate to severe Information Alzheimer’s disease. AND

2) For Memantine HCL solution only: Difficulty swallowing Memantine tablet. Age re strictions 18 years or older Pre scribe r Neurologist, Psychiatrist or Geriatrician Restrictions Coverage Duration 1 year Othe r Crite ria 1) Memantine Tablet: Recommended starting dose of 5mg once daily with maintenance dose of 20mg/day (10 mg twice daily)

2) Memantine solution: Recommended starting dose of 5mg (2.5mL) and maintenance dose of 20mg/day (5mL twice daily)

Reference(s):

1. Memantine [package insert]. Lannett Company, Inc. June 2017. www.dailymed.nlm.nih.gov/. Accessed January 2018. 2. Widera, E. Who Prescribes Donepezil or Memantine for Dementia? June 27, 2016. GeriPal. http://www.geripal.org/2016/06/who-prescribes-donepezil-or-memantine.html. Accessed January 2018.

Created: 01/2018 Page 1 of 1

Applies to: Care1st Metformin HCL ER

Covered uses All medically accepted indications

Exclusion Criteria 1) Severe renal impairment (eGFR below 30 mL/min/1.73m2 2) Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. Required Medical 1) Documented diagnosis of diabetes mellitus type 2 AND Information 2) Trial/failure of metformin immediate-release oral tablets and/or oral solution Age re strictions 10 years and older Pre scribe r Primary Care Physician Restrictions Endocrinologist Coverage Duration 1 year Othe r Crite ria Recommended dosage: Initial 500 mg orally once daily with max dose of 2000 mg per day.

Reference(s):

1. Glucophage XR. Micromedex Solutions. Truven Health Analytics, Inc. Ann Harbor, MI. Available from http://www.micromedexsolutions.com. 2. Glucophage [Package Insert]. Bristol-Myers Squibb Company. June 2017. http://dailymed.nlm.nih.gov.

Last Updated: 02/2018 Page 1 of 1

App lies to: Care1st Depo-Medrol (Methylprednisolone Acetate)

Covered uses All medically accepted indications

Exclusion Criteria

Required Medical For LTC Patients only Information

Age re strictions 18 years and older Pre scribe r Restrictions Coverage Duration 1 year Othe r Crite ria

Reference(s):

1. Depo-Medrol [package insert]. Pharmacia and Upjohn Company, LLC, New York, NY, January, 2017.

Last Updated: 01/2018 Page 1 of 1

Applies to: Care1st Methylprednisolone Sodium Succinate

Covered uses All medically accepted indications

Exclusion Criteria 1) Administration of live or attenuated live vaccines 2) Hypersensitivity to methylprednisolone sodium succinate or any constituent of the product 3) IM administration in patients with idiopathic thrombocytopenic purpura 4) Intrathecal route of administration 5) Premature infants 6) Systemic fungal infections Required Medical 1) Documented diagnosis of one of the following: Information • Acute lymphoid leukemia • Allergic condition, severe or intractable • Asthma • Collagen disease • Crohn’s disease • Disorder of the endocrine system • Disorder of the eye • Disorder of hematopoietic structure • Disorder of respiratory system • Disorder of the skin • Exacerbation of multiple sclerosis (acute) • Hypercalcemia of malignancy • Idiopathic thrombocytopenic purpura • Inflammatory disorder of musculoskeletal system (adjunct) • Mycosis fungoides • Nephrotic syndrome • Pulmonary tuberculosis (adjunct) • Rheumatoid carditis (acute, adjunct) • Temporal arteritis • Trichinosis (with neurologic and myocardial involvement) • Tuberculosis of meninges (with subarachnoid block or impending block) • Ulcerative colitis AND

2) For methylprednisolone tablets ONLY: Inability to swallow tablets AND 3) Trial and failure of prednisone products AND 4) Resident of a long term care facility

Last Updated: 02/2018 Page 1 of 2

Applies to: Care1st

Age re strictions Pre scribe r Primary Care Physician Restrictions Specialist Coverage Duration 1 year Othe r Crite ria

Reference(s):

1. Methylprednisolone Sodium Succinate. Micromedex Solutions. Truven Health Analytics, Inc. Ann Harbor, MI. Available from http://www.micromedexsolutions.com. 2. Methylprednisolone Acetate [Package Insert]. Teva Parenteral Medicine, Inc. December 2017. http://dailymed.nlm.nih.gov. .

Last Updated: 02/2018 Page 2 of 2

Applies to: Care1st

Tasigna (nilotinib)

Covered uses All medically accepted indications

Exclusion Criteria Required Medical Stated diagnosis from oncologist of FDA approved indication Information 1) Newly diagnosed adult and pediatric patients greater than or equal to 1 year of age with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase.

2) Treatment of chronic phase (CP) and accelerated phase (AP) Ph+ CML in adult patients resistant or intolerant to prior therapy that included imatinib

3) Pediatric patients greater than or equal to 1 year of age with PH+ CML – CP resistant or intolerant to prior tyrosine-kinase inhibitor therapy

Submission of required labs: 1) WNL Potassium (3.5 – 5.5 mg/dL) & 2) Magnesium (1.5 – 2.5 mg/dL) levels

Hypokalemia or hypomagnesemia must be corrected prior to nilotinib administration and should be periodically monitored.

Documentation that patient does not have long QT syndrome (verified by ECG)

Age restrictions Age 18 years or greater for CP and AP Ph+ CML Age 1 year or greater for newly diagnosed Ph+CML-CP or resistant/intolerant to prior therapy Prescriber Oncologist Restrictions Coverage Duration 1 year Other Criteria Members currently taking this medication at time of enrollment will not be required to meet prerequisites for prior authorization.

Reference(s):

1. Product Information: Tasigna(R) oral capsules, nilotinib oral capsules. Novartis

Last Updated: 09/2018 Page 1 of 1 Applies to: Care1st

Pharmaceuticals Corporation, East Hanover, NJ, July 2018. 2. National Comprehensive Cancer Network, Inc. 2011, NCCN Clinical Practice Guidelines in Oncology (NCCN®). Version 3.2012.

Last Updated: 09/2018 Page 1 of 1 Care1st Exception criteria

Opdivo (nivolumab)

Covered uses All FDA approved indications Exclusion Criteria Required Medical Documented diagnosis of one of the following: Information 1) Classical Hodgkin lymphoma that has relapsed or progressed after autologous hematopoietic stem cell transplantation and post-transplantation brentuximab vedotin (Adcetris). 2) Unresectable or metastatic melanoma (BRAF V600 wild- type, BRAF V600 mutation-positive, treatment in combination with ipilimumab) 3) Metastatic non-small cell lung cancer (with progression on or after platinum-based chemotherapy) 4) Renal cell carcinoma (those who have received prior anti- angiogenic therapy) 5) Intermediate or poor risk, previously untreated advanced renal cell carcinoma (in combination with ipilimumab) 6) Hepatocellular carcinoma who have been previously treated with sorafenib 7) High-risk melanoma with lymph node involvement or metastatic disease following complete surgical resection, for use as adjuvant treatment 8) Metastatic or recurrent squamous cell carcinoma of the head and neck (with progression on or after platinum- based chemotherapy) 9) Locally advanced or metastatic urothelial carcinoma (with progression on or after platinum-based chemotherapy or within 12 months of neoadjuvant/adjuvant treatment with platinum-containing chemotherapy) 10) Microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (progression following regimen of fluoropyrimidine, oxaliplatin, and irinotecan) Age restrictions 18 years of age 12 years for metastatic colorectal cancer Prescriber Oncologist Restrictions Coverage Duration 1 year Other Criteria 1) Recommended Dosing: 3 mg/kg administered as an IV infusion over 60 minutes every 2 weeks until disease progression or unacceptable toxicity

2) Recommended Dosing (w/ ipilimumab): 1 mg/kg

Last Updated: 09/2018 Page 1 of 2

administered as an IV infusion over 60 minutes, followed by ipilimumab on the same day, every 3 weeks for 4 doses

3) Alternative dosing schedule: • 240 mg every 2 weeks OR • 480 mg every 4 weeks (for select indications; please refer to package insert)

Reference(s):

1. Opdivo [Package Insert] Bristol-Myers Squibb. Princeton, NJ. April 2018 2. Crocenzi TS, El-Khoueiry AB, Yau T, et al. Nivolumab (nivo) in sorafenib (sor)- naive and -experienced pts with advanced hepatocellular carcinoma (HCC): CheckMate 040 study.J Clin Oncol. 2017;35 (suppl; abstr 4013).

Last Updated: 09/2018 Page 2 of 2

Applies to: Care 1st

Zyprexa (olanzapine tabs, ODT)

Covered uses All medically accepted indications Exclusion Criteria Required Medical Documentation of either of the following medical diagnoses: Information • Schizophrenia • Bipolar I (acute mixed or manic episodes) as monotherapy or combination therapy (with lithium or valproate)

Reference(s):

1. Olanzapine tablet, ODT [package insert]. Torrent Pharmaceuticals Limited. May 2018.

Created: 09/2018 Page 1 of 1

Applies to: PDL Exception Criteria

Lynparza (Olaparib)

Covered uses Statement of FDA approved diagnosis

Exclusion Criteria

Required Medical Documentation of the following: Information • Capsules and TabletsIndicated for the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy.

Tablets • Maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy.

• Deleterious or suspected deleterious gBRCAm, HER2- negative metastatic breast cancer, who have been treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting. Patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine therapy

Age restrictions 18 years of age and older

Prescriber Oncologist Restrictions Coverage Duration 1 year

Other Criteria

Reference(s):

1. Lynparza Capsule[package insert]. AstraZeneca Pharmaceuticals LP. Wilmington, DE. 2018.

Last Updated: 09/2018 Page 1 of 2

Applies to: PDL Exception Criteria

2. Lynparza Tablet[package insert]. AstraZeneca Pharmaceuticals LP. Wilmington, DE. February 2018.

Last Updated: 09/2018 Page 2 of 2

Care1st Exception criteria

Xolair (omalizumab)

Covered uses All FDA approved indications

Exclusion Criteria Required Medical 1) Documentation of the following: Information o Moderate to severe persistent asthma in adults and adolescents 12 years of age and older who have a positive skin test or in vitro reactivity to a perennial aeroallergen and whose symptoms are inadequately controlled with inhaled corticosteroids (ICS). o IgE levels prior to initiation of therapy AND . IgE level of 30 IU/ml to 700 IU/ml only o RAST or Allergy skin test - Positive skin test or in vitro reactivity to a perennial aeroallergen AND o Weight between 30 - 150kg (current weight must be provided) AND o Peak flow rate less than 80% of predicted with at least a 30% variability AND o Member has been enrolled in WellCare’s Care Management program or a similar program that meets the Global Strategy for Asthma Management and Prevention guidelines for 3 months (or less depending on the clinical situation)

2) Moderate to severe persistent asthma in children 6 to <12 years of age and older who have a positive skin test or in vitro reactivity to a perennial aeroallergen and whose symptoms are inadequately controlled with inhaled corticosteroids (ICS). o Xolair will be used as add-on therapy. AND o Member has been enrolled in WellCare’s Care Management program or a similar program that meets the Global Strategy for Asthma Management and Prevention guidelines for 3 months (or less depending on the clinical situation)

3) Chronic Idiopathic Urticaria (CIU), refractory to all preferred agents: H1 antihistamines, corticosteroids and leukotriene modifiers, each used for a minimum of 30 days within the last 3 months AND for which allergic urticaria and other non- idiopathic urticaria is ruled out.

Reauthorization 1) For asthma, treatment with Xolair has resulted in clinical improvement as documented by one or more of the following:

Last Updated: 09/2018 Page 1 of 2

Care1st Exception criteria

• Decreased utilization of rescue medications OR • Decreased frequency of exacerbations (defined as worsening of asthma that requires an increase in ICS dose or treatment with systemic corticosteroids) OR • Increase in predicted FEV1 from pretreatment baseline OR Reduction in reported asthma-related symptoms, such as, asthmatic symptoms upon awakening, coughing, fatigue, shortness of breath, sleep disturbance, or wheezing.

For Chronic Idiopathic Urticaria (CIU), treatment with Xolair has resulted in reduced itch or hive count. Age restrictions Age 6 years or greater

Prescriber Pulmonologist, Allergist, or Immunologist Restrictions Coverage Duration 1 year Other Criteria

Reference(s):

1. Product Information: XOLAIR(R) subcutaneous injection, omalizumab subcutaneous injection. Genentech, Inc, South San Francisco, CA, May 2018. 2. Product Information: XOLAIR(R) subcutaneous injection powder, omalizumab subcutaneous injection powder. Genentech, Inc. (per manufacturer), South San Francisco, CA, May 2018

Last Updated: 09/2018 Page 2 of 2

Care1st Exception criteria

Botulinum Toxin (Botox, Myobloc, Xeomin, Dysport)

Covered uses All medically accepted indications Exclusion Criteria 1) Cosmetic Purposes: Uses for cosmetic purposes are not a covered benefit.

2) Infection at the injection site.

3) For bladder dysfunction, patients with urinary tract infections at the time of treatment should not be treatment.

4) Not proven effective for episodic migraines (those occurring 14 days or fewer per month). Required Medical 1) Member has one of the following diagnoses associated with the Information requested drug:

• Botox (onabotulinumtoxinA): • Upper Limb Spasticity; OR, • Cervical Dystonia; OR, • Primary Axillary Hyperhidrosis; OR, • Detrusor Over Activity; OR, • Blepharospasm; OR, • Strabismus; OR, • Headache Prophylaxis (Migraines) OR,

• Dysport (abobotulinumtoxina): • Upper Limb Spasticity; OR, • Cervical Dystonia OR,

• Xeomin (incobotulinumtoxina): • Upper Limb Spasicity; OR, • Cervical Dystonia; OR, • Blepharospasm OR,

• Myobloc (rimabotulinumtoxinb) • Cervical Dystonia

2) Member meets the following indication specific criteria:

• Chronic Migraines: Documented history of migraine on 15 or more days of the month with headaches lasting four hours a day or longer

Last Updated: 09/2017 Page 1 of 3

Care1st Exception criteria AND Prerequisite trial of at least 1 drug from 2 different therapeutic drug classes below within the most recent 6 months: • Anti-epileptic drugs (e.g., gabapentin, topiramate, valproic acid); OR, • Beta blockers (e.g., atenolol, metoprolol, nadolol, propranolol,timolol); OR, • Calcium channel blockers (e.g., diltiazem, nifedipine, nimodipine, verapamil); OR, • Anti-depressants (e.g., amitriptyline, clomipramine, doxepin, mirtazapine, nortryptiline, protriptyline); AND Treatment is prescribed by or in consultation with a board certified neurologist.

Upper or Lower Limb Spasticity: Dosing is consistent with FDA labeled recommendations

Cervical Dystonia: Dosing is consistent with FDA labeled recommendations

Severe Primary Axillary Hyperhidrosis: History of failed treatment with prescription strength aluminum chloride (20%) in ethanol or 6.25% aluminum chloride hexahydrate for at least 3 months or documented intolerable side-effects to 20 % aluminum chloride in ethanol or 6.25% aluminum chloride hexahydrate such as irritation or dermatitis not improved with topical corticosteroid application

De trusor Ove ractivity (associated with a neurologic condition)/Overactive Bladder: Documented history of trial and failure or intolerable side effects with 2 of the preferred medications, oxybutynin or trospium

Blepharospasm or Strabismus: Dosing is consistent with FDA labeled recommendations

Reauthorization (Migraine prophylaxis only): Continued treatment for ongoing migraine prophylaxis is approved when the member experiences a beneficial response that may be measured by one of the following:

1) Migraine headache frequency was reduced by 7 days per month or more (when compared to pre-treatment average) by the end of the initial trial; OR,

2) Migraine headache duration was reduced by 100 total hours per month or more (when compared to pre-treatment average) by the end of the month.

Last Updated: 09/2017 Page 2 of 3

Care1st Exception criteria Age re strictions 1) Botox (onabotulinumtoxinA): • 18 years or greater (chronic migraine, upper limb spasticity, primary axillary hyperhidrosis, detrusor over activity) • 16 years or greater (cervical dystonia) • 12 years or greater (blepharospasm and strabismus) 2) Xeomin (incobotulinumtoxinA): • 18 years or greater 3) Myobloc (rimabotulinumtoxinB): • 18 years or greater 4) Dysport (abobotulinumtoxinA): • 18 years or greater

Pre scribe r Restrictions Coverage Duration 12 weeks

Othe r Crite ria

Reference(s): 1. Botox (OnabotulinumtoxinA) [prescribing information]. Irvine, CA: Allergan; January 2016. 2. Dysport (abobotulinumtoxinA) [prescribing information]. Basking Ridge, NJ: Ipsen Biopharmaceuticals; December 2016. 3. Xeomin (IncobotulinumtoxinA) [prescribing information] Raleigh, NC: Merz Pharmaceuticals; December 2015. 4. Myobloc (RimabotulinumtoxinB) [prescribing information]. South San Francisco, CA: Solstice Neurosciences; May 2010

Last Updated: 09/2017 Page 3 of 3

Applies to: Care 1st

Invega Sustenna (paliperidone palmitate)

Covered uses All medically accepted indications Exclusion Criteria Required Medical 1) Medical diagnosis of Schizophrenia or Schizoaffective Information disorder

2) Must have failed at least 2 weeks of 2 oral atypical antipsychotics (aripiprazole, risperidone, paliperidone, ziprasidone, quetiapine, olanzapine, etc.) OR provide documentation of non-compliance, inability to swallow oral medications, or contraindication to oral atypical antipsychotics.

3) Requested maintenance dose is administered once monthly

Reference(s):

1. Invega Sustenna (Paliperidone palmitate). National Library of Medicine and National Institutes of Health. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1af14e42-951d-414d- 8564-5d5fce138554. Updated July 14, 2017. Accessed August 8, 2017. 2. Lehman AF, Lieberman JA, Dixon LB, McGlashan TH, Miller AL, Perkins DO, Kreyenbuhl J. “Treatment of patients with schizophrenia”. American Psychiatric Association. https://psychiatryonline.org/pb/assets/raw/sitewide/practice_guidelines/guidelines/sc hizophrenia.pdf. Published March 2018. Accessed May 2018.

Created: 09/2018 Page 1 of 1

Applies to: Care 1st

Invega Trinza (paliperidone palmitate)

Covered uses All medically accepted indications Exclusion Criteria Required 1) Medical diagnosis of Schizophrenia Medical Information 2) Must have failed at least 2 weeks of 2 oral atypical antipsychotics (aripiprazole, risperidone, paliperidone, ziprasidone, quetiapine, olanzapine, etc.) OR provide documentation of non-compliance, inability to swallow oral medications, or contraindication to oral atypical antipsychotics

3) Documentation of prior treatment with Invega Sustenna for at least 4 consecutive months

4) Requested maintenance dose is administered once every three months

Age restrictions 18 years of age and older Prescriber Restrictions Coverage 1 year Duration Other Criteria **If request is for 18 and over: PA is not required when prescribed by a psychiatric clinician, a behavioral health pediatrician or other approved prescribers

Reference(s):

1. Invega Trinza (Paliperidone palmitate ER). National Library of Medicine and National Institutes of Health. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c39e65d7-fa44-4e4c- 8b12-a654d3ed0eae#S8.1.Updated March 2018.

Created: 09/2018 Page 1 of 1

Applies to: Care1st

Synagis® (Palivizumab) 2017-2018 Season

Covered uses Respiratory syncytial virus (RSV) infection prophylaxis

Exclusion Criteria Required Medical information / Age Dosing Chart restrictions Patient Group Age at the Start of RSV Season Maximum Number of Doses Premature, no CLD, no CHD ≤ 12 months 5 Doses* *** Gestational Age < 29 weeks

Chronic Lung Disease (CLD) In ≤ 12 months 5 Doses*** first year of life

Gestational Age < 32 weeks AND Required >21% oxygen for at least the first 28 days after birth Chronic Lung Disease (CLD) In 13 months to 24 months 5 Doses*** second year of life

Gestational Age < 32 weeks AND Required >21% oxygen for at least the first 28 days after birth AND Continue to require medical support (chronic corticosteroid therapy, diuretic therapy or supplemental oxygen) Hemodynamically significant ≤ 12 months 5 Doses*** (cyanotic) CHD ** Decisions regarding RSV prophylaxis for infants with cyanotic heart defects made in consultation with a pediatric cardiologist Congenital Abnormalities of the ≤ 12 months 5 Doses*** Airway or Neuromuscular Condition that Compromises Handling of Respiratory Secretions

*Total number of Synagis® doses may vary based on birth month. Infants born during the RSV season require less than 5 monthly doses. See dosing chart.

**Infants with CHD not at increased risk of RSV infection and generally should not receive immunoprophylaxis:

Last Updated: 09/2018 Page 1 of 3

Applies to: Care1st

• Infants and children with hemodynamically insignificant heart disease (eg. Secundum atrial septal defect, small ventricular septal defect, pulmonic stenosis, uncomplicated aortic stenosis, mild coarctation of the aorta, and patent ductus arteriosus) • Infants with lesions adequately corrected by surgery unless they continue to require medication for CHF • Infants with mild cardiomyopathy who are not receiving medical therapy for the condition • Children in the second year of life ***5 monthly doses of palivizumab at 15mg/kg per dose will provide more than 6 months (>24weeks) of serum palivizumab concentrations above the desired level for most children.

Dose ♦ Infants and children <2 years of age at high risk of RSV disease: 15 mg/kg of body weight I.M. monthly (approximately every 30 days) with subsequent monthly doses (dependent on length of RSV season) up to the recommended number of doses. ♦ If the dose needed is less than 5 mg over the approved vial size, round down to the nearest vial size. If the dose needed is ≥ 5 mg over the approved vial size, then the new vial size will be approved. ♦ Administer prophylaxis throughout RSV season (which is dependent on state and region; see season chart). ♦ It is recommended that therapy begin prior to the onset of the RSV season. ♦ Cardio-pulmonary bypass: Synagis® serum levels are decreased after cardio-pulmonary bypass. For children who still require prophylaxis, a postoperative dose of palivizumab (15 mg/kg) should be considered as soon as the patient is medically stable. Thereafter, doses should be administered monthly. ♦ Prophylactic serum concentrations are reached within 48 hours of dosing (see pharmacokinetics). ♦ No data exist to support palivizumab use in controlling RSV outbreaks of nosocomial disease3

♦ NOTE: Patients who develop a RSV infection should continue to receive monthly prophylaxis for the recommended number of doses throughout the RSV season because there is more than one strain of RSV that concurrently circulates in a community. ♦ Monthly prophylaxis should be discontinued in any child who experiences a breakthrough RSV hospitalization.

♦ NOTE: If any infant or young child receiving monthly palivizumab prophylaxis experiences a breakthrough RSV hospitalization, monthly prophylaxis should be discontinued because of the extremely low likelihood of a second RSV hospitalization in the same season (<0.5%)

Summary of seasons and injection approval time frame based on AAP 2009 Red Book and National CDC RSV Surveillance reports may be accessed at this website: http://www.cdc.gov/surveillance/nrevss/rsv/index.htmland and RSV Alert – CBSA Reports - https://rsvalert.com/Home

Approval timeframe statewide for Arizona: November through April

Coverage Born before RSV season maximum of 5 doses Duration Born during RSV season maximum of 4 doses

Last Updated: 09/2018 Page 2 of 3

Applies to: Care1st

Other Criteria *Per American Academy of Pediatrics (AAP) guidelines, the last dose of Synagis should be administered one month prior to the end of the season. Doses will be approved during above timeframes.

Reference(s):

1. American Academy of Pediatrics. Respiratory Syncytial Virus. In: Pickering LK, Baker CJ, Kimberlin DW, Long SS, eds. Red Book: 2009 Report of the Committee on Infectious Diseases. 28th ed. Elk Grove Village, IL: American Academy of Pediatrics; 2009. 2. Hawaii American Association of Pediatrics Web site. http://www.hawaiiaap.org/pdfs/Guidelines%20For%20Prophylaxis%20For%20R SV%20Infections%20-%208.1.12.pdf Accessed September 17, 2012. 3. Summary of seasons and injection approval time frame based on AAP 2009 Red Book and National CDC RSV Surveillance reports accessed at this website: http://www.cdc.gov/surveillance/nrevss/rsv/index.html 4. American Academy of Pediatrics. Updated Guidance for Palivizumab Prophylaxis Among Infants and Young Children at Increased risk of Hospitalization for Respiratory Syncytial Virus Infection. Pediatrics. July 28, 2014. 5. Centers for Disease Control and Prevention – RSV State Trends. https://www.cdc.gov/surveillance/nrevss/rsv/state.html#FL 6. RSV Alert – CBSA Reports - https://rsvalert.com/Home

Last Updated: 09/2018 Page 3 of 3

Applies to: Care1st Paroxetine Mesylate

Covered uses All medically accepted indications

Exclusion Criteria The use of paroxetine are contraindicated with: 1) The use of MAOIs intended to treat psychiatric disorders with paroxetine or within 14 days of stopping treatment with paroxetine is contraindicated because of an increased risk of serotonin syndrome. 2) The use of paroxetine within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated. 3) Starting paroxetine in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome 4) Concomittant use with thioridazine or in patients taking pimozide. 5) Patients with a hypersensitivity to paroxetine or any of the inactive ingredients in paroxetine tablets. Required Medical 1) Paroxetine tablets are indicated for the treatment of Information major depressive disorder, obsessive compulsive disorder, panic disorder, generalized anxiety disorder or abnormal vasomotor function (moderate to severe) in menopausal women AND

2) Trial and failure of one of the following medications: • Duloxetine • Sertraline • Venlafaxine • Escitalopram • Fluoxetine (excluding the weekly tablets) • Citalopram • Paroxetine Hydrochloride • Fluvoxamine Age re strictions 18 years and older Pre scribe r Primary Care Physician Restrictions Psychiatrist Coverage Duration 1 year Othe r Crite ria Administer as a single daily dose: 1) Major Depressive Disorder: Initial dose of 20mg/day and maintenance dose of 30-50mg. 2) Obsessive Compulsive Disorder: Initial dose of 20

Last Updated: 02/2018 Page 1 of 2

Applies to: Care1st

mg/day and maintenance dose of 40 mg/day not to exceed 60 mg/day 3) Panic Disorder: Initial dose of 10 mg/day with maintenance dose of 40 mg/day not to exceed 60 mg/day 4) Generalized Anxiety Disorder: Initial dose of 20 mg/day with maintenance dose of 20mg/day.

Reference(s):

1. Paroxetine [Package Insert]. Sebela Pharmaceuticals Inc. December 2017. http://dailymed.nlm.nih.gov. 2. Paroxetine Mesylate. Micromedex Solutions. Truven Health Analytics, Inc. Ann Arbor, MI. Available at http://www.micromedexsolutions.com. Accessed January 2018.

Last Updated: 02/2018 Page 2 of 2

Applies to: Care1st Votrient (pazopanib)

Covered uses All medically accepted indications

Exclusion Criteria 1) Use in the treatment of patients with adipocytic STS or gastrointestinal stromal tumors 2) Pregnant women Required Medical Documentation of the following: Information 1) Diagnosis of advanced renal cell carcinoma (RCC) OR 2) Advanced soft tissue sarcoma (STS) who have received prior chemotherapy AND

3) Plan to monitor serum liver tests before initiation of treatment with VOTRIENT and at Weeks 3, 5, 7, and 9.

Age restrictions 18 years and older Prescriber Oncologist Restrictions Coverage Duration 1 year Other Criteria The recommended starting dose of pazopanib is 800mg orally once daily without food. Do not exceed 800 mg per dose.

Reference(s):

1. Pazopanib. Micromedex Solutions. Truven Health Analytics, Inc. Ann Harbor, MI. Available from http://www.micromedexsolutions.com. 2. Pazopanib [Package Insert]. Novartis Pharmaceuticals Corporation. May 2017. http://dailymed.nlm.nih.gov. .

Last Updated: 09/2018 Page 1 of 1

Care1st Exception criteria

Oncaspar (Pegaspargase)

Covered uses All medically accepted indications

Exclusion Criteria History of serious pancreatitis, serious thrombosis, or serious hemorrhagic events with prior L-asparaginase therapy Required Medical Individual has one of the following diagnoses: Information 1) Acute Lymphoblastic/Lymphocytic Leukemia (ALL) in combination with other agents; OR 2) Acute lymphoblastic leukemia in combination with other agents and hypersensitivity to asparaginase Age restrictions Prescriber Oncologist or Hematologist Restrictions Coverage Duration 1 year Other Criteria

Reference(s):

1. Oncaspar [package insert]. Sigma Tau Pharmaceuticals, Inc. Gaithersburg, MD. Revised December 2017 2. Oncaspar. In:DRUGDEX System (Micromedex 2.0). Greenwood Village, CO: Truven Health Analytics; c1974-2018. 3. http://www.micromedexsolutions.com/micromedex2/librarian/. Accessed August 6, 2018

Last Updated: 09/2018 Page 1 of 1

Applies to: Care1st

Pegfilgrastim

Covered uses All medically accepted indications

Exclusion Criteria 1) Not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation Required Medical Documented diagnosis of febrile neutropenia in patients with Information non-myeloid malignancies receiving myelosuppressive anticancer therapy and to increase the survival in patients acutely exposed to myelosuppressive doses of radiation Age re strictions Pre scribe r Oncologist Restrictions Coverage Duration 1 year Othe r Crite ria The recommended dosage of pegfilgrastim:

1) Patients with cancer receiving myelosuppressive chemotherapy: Single subcutaneous injection of 6 mg administered once per chemotherapy cycle. Do not administer pegfilgrastim between 14 days before and 24 hours after each administration of cytotoxic chemotherapy

2) Patients with hematopoietic subsyndrome of acute radiation syndrome: 2 doses, 6 mg each, administered subcutaneously one week apart

Reference(s):

1. Pegfilgrastim. Micromedex Solutions. Truven Health Analytics, Inc. Ann Harbor, MI. Available from http://www.micromedexsolutions.com. 2. Pegfilgrastim [Package Insert]. Amgen Inc. December 2017. http://dailymed.nlm.nih.gov. .

Last Updated: 02/2018 Page 1 of 1

Applies to: Care1st

Pegasys (peginterferon alfa-2a)

Covered uses All medically accepted indications Exclusion Criteria 1) Prior intolerance to interferon therapy 2) Baseline neutrophil count below 1,500/uL, or platelet count <90,000/mm3 or hemoglobin (Hgb) below 10 g/dL 3) Patients with auto-immune diseases that may be exacerbated by interferon-mediated immune modulation 4) Patients with severe depression or suicidal ideation 5) History of psychosis, schizophrenia, bipolar, schizoaffective disorder 6) History of preexisting cardiac disease (e.g., unstable cardiac disease, new onset of ventricular arrhythmia or cardiovascular decompensation) 7) Refractory diabetes mellitus (e.g., cannot be effectively treated by medication) 8) Untreated thyroid disease 9) Pregnant women

Required Medical Chronic Hepatitis B (HBV): Information 1) Documentation in adult patients with • HBeAg positive ORHBeAg Negative who have evidence of viral replication AND • liver disease (ALT>2 ULN)

Required information for HBV: 2) HBV DNA greater than 20,000 IU/ml 3) ALT concentration greater than 2 times normal

4) Diagnosis of HCV with compensated liver disease AND 5) no signs or symptoms of jaundice, ascites, active gastrointestinal bleeding, and encephalopathy

Age re strictions 18 years or older Pre scribe r Prescribed by a hepatologist, gastroenterologist, infectious Restrictions disease specialist, transplant physician or a prescriber in consultation with at least one of the above listed specialists.

Coverage Duration HBV: 48 weeks

Othe r Crite ria

Last Updated: 12/2017 Page 1 of 2

Applies to: Care1st Reference(s):

1. Ghany, M. G., Nelson, D. R., Strader, D. B., Thomas, D. L. and Seeff, L. B. (2011), An update on treatment of genotype 1 chronic hepatitis C virus infection: 2011 practice guideline by the American Association for the Study of Liver Diseases. Hepatology, 54: 1433–1444. doi: 10.1002/hep.24641 2. Lok, A.S, McMahon, B.J (2009), Chronic Hepatitis B: Update 2009 practice guideline by the American Association for the Study of Liver Diseases. Hepatology, 50: 1-35. 3. Product Information: PEGASYS(R) subcutaneous injection, peginterferon alfa 2a subcutaneous injection. Genentech USA, Inc. (per FDA), South San Francisco, CA, 2013. 4. American Association for the Study of Liver Diseases (AASLD) – HCV Guidance, Updated July 6, 2016.

Last Updated: 12/2017 Page 2 of 2

App lies to: Care1st Elmiron (pentosan polysulfate sodium)

Covered uses All medically accepted indications

Exclusion Criteria

Required Medical A. Initial Authorization Information 1) Elmiron will be approved based on the following criteria: • The patient has a documented diagnosis of bladder pain or discomfort associated with interstitial cystitis

B. Re-Authorization 1) Elmiron will be approved based on the following criteria: • The patient’s pain or discomfort has improved and adverse events are not present

Age re strictions 16 years of age

Pre scribe r Restrictions Coverage Duration Initial authorization of therapy will be issued for 6 months. Re-Authorization of therapy will be issued for 12 months. Othe r Crite ria Recommended dose: 300 mg/day taken as one 100 mg capsule orally three times daily

Reference(s):

® 1. Elmiron [package insert]. Raritan, NJ: Ortho-McNeil-Janssen Pharmaceuticals Inc.; September 2014. 2. Jarrell JF, Vilos GA, Allaire C, et al. Consensus Guidelines for the Management of Chronic Pelvic Pain. JOGC. 2005; 164: 781-801. 3. Homma Y, Ueda T, Tomoe H, et al. Clinical guidelines for interstitial cystitis and hypersensitive bladder syndrome. Int J Urol. 2009: 16; 597-615. 4. Fall M, Baranwoski AP, Elneil S, et al. EAU Guidelines on Chronic Pelvic Pain. Eur Urol. 2010; 57: 35-48.

Last Updated: 11/2015 Page 1 of 1

Applies to: Care 1st

Perphenazine (tabs)

Covered uses All medically accepted indications Exclusion Criteria Required Medical Documentation of any of the following medical diagnoses: Information • Schizophrenia • Severe nausea and vomiting in adults

Reference(s):

1. Perphenazine HCL tablet [package insert]. Sandoz Inc. July 2018.

Created: 09/2018 Page 1 of 1

Applies to: Care1st

Orap (pimozide)

Covered uses All FDA approved indications.

Exclusion Criteria Required Medical Documented diagnosis of: Information • Tourette’s Disorder who have failed to respond satisfactorily to standard treatment Age restrictions 8 and older Prescriber Restrictions Coverage Duration 1 year

Other Criteria **PA REQUIRED FOR AGES UNDER 12. PA isn't required for ages 12 and greater when prescribed by a psychiatric clinician, a behavioral health pediatrician or other approved prescribers.

Reference(s):

1. Orap (pimozide) [package insert]: Teva Select Brands. May 2018.

Created: 09/2018 Page 1 of 1

Applies to: Care1st

Iclusig (ponatinib)

Covered Uses Statement of FDA approved indication Exclusion Iclusig is not indicated and is not recommended for the treatment of Criteria patients with newly diagnosed chronic phase CML

Required Medical Documentation of FDA approved diagnosis: Information 1) Treatment of adult patients with T315l-positive chronic myeloid leukemia (CML) [chronic phase, accelerated phase, or blast phase] or T315l-positive chromosome positive acute lymphoblastic leukemia (Ph+ ALL). 2) Treatment of adult patients with chronic phase, accelerated phase, or blast phase chronic myeloid leukemia or Ph+ ALL for whom no other tyrosine kinase inhibitor (TKI) 3) Documentation that patients will be monitored for arterial occlusion, venous thromboembolism, heart failre, and hepatotoxicity (serum liver test)

Age restrictions 18 years or older

Prescriber Oncologist Restrictions Coverage 1 year Duration Other Criteria The FDA issued a drug safety communication in October 2013 related to the risk of life-threatening blood clots and severe narrowing of blood vessels. Health care professionals (HCPs) may continue to use Iclusig for patients who they determine are responding to the drug and for whom the potential benefits outweigh the risks.

Reference(s):

1. Iclusig (ponatinib): Drug Safety Communication – Increased Reports of Serious Blood Clots in Arteries and Veins. MedWatch: The FDA Safety Information and Adverse Event Reporting Program. U.S Food and Drug Administration. October 11, 2013. 2. Iclusig [package insert] Cambridge, MA; Ariad Pharmaceuticals, Inc. July 2018

Last Updated: 09/2018 Page 1 of 1

Applies to: Care1st

Symlin (pramlintide acetate injection)

Covered uses All medically accepted indications

Exclusion Criteria 1) Exhibits poor compliance with their current insulin regimen 2) Recurrent severe hypoglycemia requiring assistance in the past 6 months 3) Presence of hypoglycemia unawareness 4) Confirmed diagnosis of gastroparesis 5) Require the use of drugs that stimulate gastrointestinal motility 6) Concurrently taking an alpha-glucosidase inhibitor (e.g. acarbose) • For Type II only

Required Medical Stated diagnosis of: Information 1) Type I Diabetes Mellitus 2) Type II Diabetes Mellitus

Other Criteria For Type I Diabetes, all of the following criteria must be met: 1) The patient is currently using both basal (e.g. Lantus) and short-acting (e.g. humalog, humulin) insulin. 2) The patient is receiving three or more insulin injections daily or is on an insulin pump 3) The patient has an HbA1c level >6.5% but <9%

For Type II Diabetes, all of the following criteria must be met: 1) The patient is currently using both basal (e.g. Lantus) and short-acting (e.g. humalog, humulin) insulin 2) The patient is receiving three or more insulin injections daily or is on an insulin pump 3) The patient has an HbA1c level >6.5% but <9% 4) The patient has had an inadequate response to metformin at minimum dose of 1500mg daily for 90 days or is unable to receive/tolerate metformin 5) The patient has had an inadequate response to a thiazolidinedione after 90 days of therapy or is unable to receive/tolerate a thiazolidinedione (e.g. pioglitazone)

Age restrictions Patient must be 15 years of age or older

Prescriber Restrictions

Last Update: 04/2015 Page 1 of 2

Applies to: Care1st

Coverage Duration Authorization of therapy will be issued for 12 months Other Criteria

Reference(s):

1. Symlin® Prescribing Information. Amylin Pharmaceuticals; July 2008. 2. Clinical Pharmacology, Gold Standard 2012. 3. Facts and Comparisons 4.0; 2012. 4. AACE Diabetes Mellitus Clinical Guidelines Task Force. American Association of Clinical Endocrinologists Medical Guidelines for Clinical Practice for the Management of Diabetes Mellitus. Endocr Pract 2007;13(Suppl 1). 5. Nathan DM, Buse JB, Davidson MB, et al. Medical management of hyperglycemia in type 2 diabetes: a consensus algorithm for the initiation and adjustment of therapy: a consensus of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care 2009;32:193-203. 6. Canadian Diabetes Association Clinical Practice Guidelines Expert Committee. Canadian Diabetes Association 2008 clinical practice guidelines for the prevention and management of diabetes in Canada. Can J Diabetes 2008;32:S1- S201.

Last Update: 04/2015 Page 2 of 2

Applies to: Care1st Lyrica (pregabalin)

Covered uses All medically accepted indications Exclusion Criteria Required Medical Treatment of Information 1) As adjunctive therapy for adults with partial-onset seizures • member must try and fail gabapentin 2) Neuropathy • member must try and fail at least two of the following : venlafaxine IR or ER, amitriptyline and gabapentin (1800 mg/day) 3) Postherpetic neuralgia • member must try and fail gabapentin. (1800 mg/day) 4) Fibromyalgia • member must try and fail at least two of the following: venlafaxine IR or ER, amitriptyline, gabapentin (1800 mg/day) and duloxetine. 5) Central pain • member must try and fail gabapentin. (1800 mg/day) 6) General Anxiety Disorder • member must try and fail at least two of the following: venlafaxine IR or ER, paroxetine, and sertraline

Age restrictions Partial onset seizures: Age 4 years or greater All other indications: Age 18 years or greater Prescriber Restrictions Coverage Duration 1 year Other Criteria Preferred Alternative: Neuropathy: Gabapentin, venlafaxine IR or ER, amitriptyline Postherpetic neuralgia: Gabapentin Fibromyalgia: Gabapentin, venlafaxine IR or ER, amitriptyline, duloxetine Central Pain: Gabapentin Generalized Anxiety disorder: Venlafaxine IR or ER, paroxetine, sertraline Required dose of gabapentin tried and failed: 1800 mg/day (neuropathy, neuralgia, fibromyalgia, central pain)

Reference(s):

1. Lyrica [package insert]. Pfizer, Inc. New York, NY. May 2018

Last Updated: 06/2018 Page 1 of 1

Applies to: Care 1st

Seroquel IR (quetiapine)

Covered uses All medically accepted indications Exclusion Criteria Required Medical Documentation of any of the following medical diagnoses: Information • Schizophrenia • Bipolar

Reference(s):

1. Quetiapine [package insert]. BluePoint Laboratories. July 2018.

Created: 09/2018 Page 1 of 1

Applies to: Care1st Rozerem (ramelteon)

Covered uses All medically accepted indications

Exclusion Criteria 1) History of angioedema while taking rozerem 2) Fluvoxamine used in combination with rozerem 3) Patients with severe sleep apnea 4) Pregnant women (unless benefits justifies potential risk) 5) Severe hepatic impairment Required Medical 1) Documented diagnosis of insomnia characterized by Information difficulty with sleep onset AND

2) Trial and failure of one of the following: triazolam, lunesta, zolpidem, lorazepam, or sonata Age restrictions 18 years and older Prescriber Primary Care Physician Restrictions Sleep specialist Coverage Duration 1 year Other Criteria Adult dose is 8mg taken within 30 minutes of going to bed. Total daily dose should not exceed 8mg. Use up to 6 months

Reference(s):

1. Ramelteon. Micromedex Solutions. Truven Health Analytics, Inc. Ann Harbor, MI. Available from http://www.micromedexsolutions.com. 2. Rozerem [Package Insert]. Takeda Pharmaceuticals America, Inc. January 2018. http://dailymed.nlm.nih.gov. 3. Bonnet MH., et al. Treatment of insomnia in adults. January 2018. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com (Accessed January 2018).

Last Updated: 02/2018 Page 1 of 1

Applies to: Care1st

Ranexa (ranolazine)

Covered uses All medically accepted indications Exclusion 1) Strong CYP3A inhibitors (e.g., ketoconazole, clarithromycin, Criteria nelfinavir) 2) CYP3A inducers (e.g., rifampin, phenobarbital, St. John's wort) 3) Liver cirrhosis Required 1) Medical diagnosis of chronic angina. Medical 2) Has the member tried and failed OR has the member experienced Information adverse events (side effects or allergic reaction) to ONE of the following preferred medication in EACH group: • atenolol, carvedilol, metoprolol, nadolol, propranolol • diltiazem, verapamil, amlodipine, nifedipine • nitroglycerin, isosorbide dinitrate, isosorbide mononitrate

Age restrictions 18 years or older Prescriber Restrictions Coverage 1 year Duration Other Criteria Members currently taking this medication at the time of enrollment will not be required to meet prerequisites for authorization

Reference(s):

1. Ranexa package insert. Gilead Sciences, Inc. Foster City, CA. January 2016 2. 2014 AHA/ACC Guideline for the Management of Patients With Non–ST- Elevation Acute Coronary Syndromes; http://www.onlinejacc.org/content/64/24/e139

Created: 03/2018 Page 1 of 1

Care1st Exception criteria

Xifaxan (rifaximin)

Covered uses All FDA Approved Indications Exclusion Criteria Required Medical Stated diagnosis of: Information 1) Traveler’s Diarrhea 2) Hepatic Encephalopathy 3) Irritable Bowel Syndrome with Diarrhea Other Criteria For Traveler’s Diarrhea 1) The patient is ≥ 12 years of age AND 2) The request is for one Xifaxan 200mg tablet three times daily for 3 daysAND 3) The patient has a diagnosis of travelers’ diarrhea caused by non-invasive strains of Escherichia coli AND 4) The patient does not have diarrhea complicated by fever or blood in the stool AND 5) The patient has been previously treated with ciprofloxacin, metronidazole For Hepatic Encephalopathy 1) The patient is ≥ 18 years of age AND 2) The request is for one Xifaxan 550mg tablet twice daily AND 3) The patient has had 2 episodes of overt hepatic encephalopathy (Conn score ≥ 2) associated with hepatic cirrhosis during the previous 6 months AND 4) The patient has score of 25 or less on the Model for End- Stage Liver Disease (MELD) scale AND 5) The patient has been previously treated with lactulose Re-authorization for Hepatic Encephalopathy will be approved based on the following: 6) The patient is ≥ 18 years of age AND 7) The request is for one Xifaxan 550mg tablet twice daily AND 8) The patient has score of 25 or less on the Model for End- Stage Liver Disease (MELD) scale AND 9) Clinical benefit of Xifaxan therapy is documented For Irritable Bowel Syndrome with Diarrhea • The patient is ≥ 18 years of age AND • The request is for one Xifaxan 550 mg tablet three times daily for 14 days AND • The patient has been previously treated with loperamide and dicyclomine Re-authorization for Irritable Bowel Syndrome with Diarrhea

Last Updated: 04/2016 Page 1 of 2 Care1st Exception criteria

will be approved based on the following: 1) The patient is ≥ 18 years of age AND 2) The request is for Xifaxan 550mg tablets PO three times daily for 14 days AND 3) Clinical benefit of Xifaxan therapy is documented AND 4) The patient who experiences recurrence was not retreated more than two times with the same dosage regimen Age restrictions 1) 12 years and older for Traveler’s Diarrhea 2) 18 years and older for Hepatic Encephalopathy and Irritable Bowel Syndrome with Diarrhea Prescriber Restrictions Coverage Duration 1) 3 days for Traveler’s Diarrhea 2) 6 months for initial authorization for Hepatic Encephalopathy 3) 12 months for re-authorization for Hepatic Encephalopathy 4) 14 days for Irritable Bowel Syndrome with Diarrhea 5) 14 days for re-authorization for Irritable Bowel Syndrome with Diarrhea (up to two re-authorizations allowed) Other Criteria

Reference(s):

1. Xifaxan 550® [package insert]. Morrisville, NC: Salix Pharmaceuticals, Inc.; May 2015. 2. Steffen R, Sack DA, Riopel L, et al. Therapy of Traveler’s Diarrhea With Rifaximin on Various Continents. The American Journal of Gastroenterology. 2003; 98(5): 1073-78. 3. Infante RM, Ericsson CD, Zhi-Dong J, et al. Enteroaggregative Escherichia coli Diarrhea in Travelers: Response to Rifaximin Therapy. Clinical Gastroenterology and Hepatology. 2004; 2(2): 135-38. 4. Hill DR, Ericsson CD, Pearson RD, et al. The Practice of Travel Medicine: Guidelines by the Infectious Diseases Society of America. Clinical Infectious Diseases. 2006; 43: 1499-1539. 5. Bass NM, Mullen KD, Sanyal A, et al. Rifaximin Treatment in Hepatic Encephalopathy. New England Journal of Medicine. 2010; 362(12):1071-81. 6. Williams R, James OF, Warnes TW, et al. Evaluation to the efficacy and safety of rifamixin in the treatment of hepatic encephalopathy: a double-blind, randomized, dose-finding multi-centre study. European Journal of Gastroenterology & Hepatology. 2000; 12:203-208. 7. Mas A, Rodes J, Sunyer L, et al. Comparison of rifamixin and lactitol in the treatment of acute hepatic encephalopathy: results of a randomized, double-blind, double-dummy, controlled clinical trial. Journal of Hepatology. 2003; 38: 51-58.

Last Updated: 04/2016 Page 2 of 2 Applies to: Care 1st

Risperdal Consta (risperidone, extended release)

Covered uses All medically accepted indications Exclusion Criteria Required Medical 1) Medical diagnosis of schizophrenia or bipolar 1 disorder Information 2) Must have failed at least 2 weeks of 2 oral atypical antipsychotics (aripiprazole, risperidone, paliperidone, ziprasidone, quetiapine, olanzapine, etc.) OR provide documentation of non-compliance, inability to swallow oral medications, or contraindication to oral atypical antipsychotics.

3) Requested dose is administered every 2 weeks. Age restrictions 18 years or older Prescriber Restrictions Coverage Duration 1 year Other Criteria **If request is for 18 and over: PA is not required when prescribed by a psychiatric clinician, a behavioral health pediatrician or other approved prescribers.

Reference(s):

1. Risperdal Consta [package insert]. Janssen Pharmaceuticals, Inc. Horsham, PA. March 2017

Created: 09/2018 Page 1 of 1

Applies to: Care 1st

Risperidal (risperidone)

Covered uses All medically accepted indications Exclusion Criteria Required Medical Documentation of any of the following medical diagnoses: Information • Schizophrenia • Bipolar mania (monotherapy or as an adjunct to lithium or divalproex) • Bipolar I maintenance (monotherapy or as an adjunct to lithium or divalproex) • Irritability associated with autistic disorder

Age restrictions 5 years and older (autism) Prescriber Restrictions Coverage Duration 1 year Other Criteria **If request is for 6 and over: PA is not required when prescribed by a psychiatric clinician, a behavioral health pediatrician or other approved prescribers.

Reference(s):

1. Risperidone tablet [package insert]. Janssen Pharmaceutical, Inc. September 2018.

Created: 09/2018 Page 1 of 1

Applies to: Care1st Exelon (rivastigmine)

Covered uses All medically accepted indications

Exclusion Criteria 1) Hypersensitivity to rivastigmine or other components of the product 2) History of application site reactions with prior use of the transdermal patch (allergic contact dermatitis; generalized skin reactions) Required Medical 1) Documented diagnosis of dementia of the Alzheimer Information type, mild to severe OR 2) Documented diagnosis of mild to moderate dementia associated with Parkinson disease AND 3) Inability to swallow rivastigmine oral tablets OR 4) Prior application site reactions with prior use of rivastigmine transdermal patch Age restrictions 18 years and older Prescriber Neurologist Restrictions Coverage Duration 1 year Other Criteria 1) Rivastigmine capsules/solution: Initiate at 1.5mg twice a day. Recommended dose is 6 mg to 12 mg per day administered twice daily in Alzheimer’s disease and 3mg to 12 mg twice daily in Parkinson’s disease. 2) Rivastigmine patch: Initiate treatment with one 4.6mg/24 hours applied to the skin once daily. Effective dose is 9.5mg/24 hours or 13.3 mg/24 hours administered once per day. Replace with new patch every 24 hours.

Reference(s):

1. Rivastigmine. Micromedex Solutions. Truven Health Analytics, Inc. Ann Harbor, MI. Available from http://www.micromedexsolutions.com. 2. Rivastigmine capsules. Package Insert]. Actavis Pharma, Inc. October 2017. http://dailymed.nlm.nih.gov. 3. Exelon (Rivastigmine patch, XR) [Package Insert]. Novartis Pharmaceuticals Corporation. December 2017. http://dailymed.nlm.nih.gov. 4. Alzheimer’s Disease. American Academy of Neurology. http://tools.aan.com/professionals/practice/pdfs/dem_pat.pdf. Accessed January 2018.

Last Updated: 02/2018 Page 1 of 1

Applies to: Care1st Exception Criteria

Daliresp™ (roflumilast)

Covered uses All medically accepted indications

Exclusion Criteria Moderate to severe liver impairment (Child-Pugh B or C)

Required Medical A. Initial Therapy Information 1) Daliresp will be approved based on all of the following criteria: • There is a diagnosis of severe COPD associated with chronic bronchitis* -AND- • The patient’s FEV1 < 50% of predicted or FEV1/FVC <0.70 -AND- • The patient has a history of exacerbations with at least one in the previous year -AND- • The patient has a positive history of smoking -AND- • The patient’s symptoms have been inadequately controlled on all of the following: o Treatment regimens including: o Inhaled anticholinergic (e.g. ipratropium, Combivent,); AND o Long-acting beta2-agonist (e.g. Serevent, Foradil); AND o Short-acting beta2-agonist (e.g. Ventolin HFA) for rescue therapy; AND o Inhaled corticosteroid (e.g. Flovent, Qvar, Asmanex)

* Daliresp is not a bronchodilator and is not indicated for the relief of acute bronchospasm. Clinical trials including patients with both emphysema and chronic bronchitis were not shown to have a significant reduction in the rate of COPD exacerbations. Daliresp is only indicated in patients with severe COPD with chronic bronchitis.

Age restrictions

Prescriber Restrictions

Last Reviewed: 09/2018 Page 1 of 2

Applies to: Care1st Exception Criteria

Coverage Duration Initial authorization of therapy will be issued for 12 months.

Other Criteria

Reference(s):

1. DalirespTM Prescribing Information. Genentech, January 2018.

2. National Asthma Education and Prevention Program. Expert Panel Report 2: Guidelines for the Diagnosis and Management of Asthma. National Institutes of Health Publication No. 97- 4051. Bethesda, MD, 1997. 3. National Heart, Lung, and Blood Institute, National Asthma Education and Prevention Program (NAEPP). Expert Report Panel 3: Guidelines for the Diagnosis and Management of Asthma. Update on selected topics-2007. Available at: http://www.nhlbi.nih.gov/guidelines/asthma/asthgdln.pdf 4. Global Initiative for Asthma (GINA). Global strategy for asthma management and prevention – revised 2009. Available at www.ginasthma.com/download.asp?intID=411 5. Buhl R, Soler M, Matz J, et al. Omalizumab provides long-term control in patients with moderate-to-severe allergic asthma. Eur Respir J. 2002;20:73-8. 6. Buhl R. Omalizumab (Xolair) improved quality of life in adult patients with allergic asthma: a review. Respiratory Medicine 2003; 97:123-9. 7. Krishnan J, Gould M. Omalizumab for severe allergic asthma: Dollars and sense. J of Aller and Clin Immunol 2007; 120:1015-17. 8. Owen CE. Anti-immunoglobulin E therapy for asthma. Pulm Pharm & Ther 2002; 15:41724. 9. Plewako H, Arvidsson M, Petrusan K, et al. The effect of omalizumab nasal allergic inflammation. J of Aller and Clin Immunol 2002; 110(1):68-71. 10. Soler M, Matz J, Townley R, et al. The anti-IgE antibody omalizumab reduces exacerbations and steroid requirement in allergic asthmatics. European Resp J 2001; 18:254-61. 11. Busse W, Corren J, Lanier BQ, et al. Omalizumab, anti-IgE recombinant humanized monoclonal antibody, for the treatment of severe allergic asthma. J of Aller and Clin Immunol 2001; 108(2):184-90. 12. Milogrom H, Fick RBJ, Su JQ, et al. Treatment of allergic asthma with monoclonal anti-IgE antibody. New Eng J of Med 1999; 341:1966-73. 13. Corren J, Casale T, Deniz Y, et al. Omalizumab, a recombinant humanized anti-IgE antibody, reduces asthma-related emergency room visits and hospitalizations in patients with allergic asthma. J of Aller and Immnol 2003; 111(1):87-90. 14. Gelman CR, Rumack BH, eds. Micromedex Informatino System. Denver, CO. Micromedex, Inc. 2007. Xolair. URL referenced 2007.

Last Reviewed: 09/2018 Page 2 of 2

Applies to: Care1st

Banzel tablets and suspension (Rufinamide)

Covered uses All FDA approved indications

Exclusion Criteria 1) Monotherapy; 2) Familial Short QT syndrome

Required Medical 1) Documented diagnosis of: Adjunctive treatment of seizures Information associated with Lennox-Gastaut Syndrome in pediatric patients 1 year of age and older and in adults.

–and-

2) Contraindication to the preferred products, or trial and failure of at least one preferred agent: • Lamotrigine • Topiramate • Clobazam

Age restrictions Ages 1 years and older

Prescriber Neurologist Restrictions Coverage Duration 6 months

Other Criteria

Reference(s):

1. Banzel [package insert]. Eisai Inc. Woodcliff Lake, NJ. Dec 2017.

Last Updated: 12/2017 Page 1 of 1

Applies to: Care1st Jakafi® (ruxolitinib)

Covered All medically accepted indications uses Exclusion 1) Platelets < 50 x 109/L Criteria 2) Doses greater than 50mg Required Stated diagnosis: Medical 1) Intermediate or High risk myelofibrosis, including primary Information myelofibrosis, post-polycythemia vera myelofibrosis, and post-essential thrombocytopenia myelofibrosis

-OR-

2) Polycythemia vera who have had an inadequate response to or are intolerant of hydroxyurea.

-AND- 3) Complete blood count and platelet count before initiating therapy 4) Complete blood count and platelet count for dose adjustments

Reauthorization: documented spleen reduction or symptom improvement

Age Age 18 years or greater restrictions

Prescriber Restrictions Coverage 1 year Duration Other The recommended starting dose of Jakafi is based on platelet count.

Criteria

Last Reviewed: 09/2018 Page 1 of 2

Applies to: Care1st

1) No dose increases within 4 weeks of therapy and not more frequently than every 2 weeks. 2) If no spleen reduction or symptom improvement after 6 months then discontinue the drug

Reference(s):

1. Jakafi [package insert]. Wilmington, DE: Incyte Corporation; December 2017

Last Reviewed: 09/2018 Page 2 of 2

Applies to: Care1st Sacrosidase Solution

Covered uses All medically accepted indications

Exclusion Criteria Known hypersensitivity to yeast, yeast products, glycerin (glycerol) or papain.

Required Medical Documented diagnosis of sucrose-isomaltase deficiency, Information congenital.

Age restrictions 5 months and older Prescriber 1) Primary Care Physician Restrictions 2) Pediatrician 3) Gastroenterologist Coverage Duration 1 year Other Criteria The recommended dosage: 1) 1 mL (8,500 I.U.; one full measuring scoop or 28 drops) per meal or snack for patients up to 15kg in body weight 2) 2 mL (17,000 I.U.; two full measuring scoops or 56 drops) per meal or snack for patients over 15kg in body weight. 3) Should be taken orally with each meal or snack diluted with 2 to 4 ounces (60 to 120mL) of water, milk, or infant formula.

Reference(s):

Last Updated: 02/2018 Page 1 of 1

Applies to: Care1st Entresto (sacubitril/valsartan)

Covered All FDA approved indications uses Exclusion 1) NYHA Class I Criteria 2) Pregnancy (Boxed Warning) 3) History of Angioedema relative to previous ACE/ARB therapy 4) Severe hepatic impairment (Child-Pugh C) 5) Concomitant use of aliskiren in diabetics 6) Concomitant use of an ACE inhibitor – washout period required. Required Criteria for approval: Medical 1) Documentation of chronic heart failure status: NYHA Class II – Information IV - AND- 2) Documentation of reduced ejection fraction of ≤ 40% - AND- 3) Must provide information indicating: • The patient does not have a history of angioedema. • The patient does not have severe hepatic impairment. • If diabetic: confirm patient is not taking an aliskiren based medication. • If child-bearing age: confirm negative pregnancy test.- • Confirm patient will be taking in conjunction with a beta blocker indicated for heart failure.

Criteria for reauthorization: Documentation of improvement in ejection fraction, symptoms, decrease in hospitalization, etc. Age Age 18 years or greater restrictions Prescriber Cardiologist Restrictions Cardiac care specialist Coverage 12 months Duration Other 1) Must be administered as a replacement for an ACE inhibitor or Criteria ARB and used in combination with other heart failure therapies.

2) Recommended Dosing: • Initial Therapy: The recommended starting dose is 49/51 mg twice-daily. • Maintenance Dose: Double the dose after 2 to 4 weeks to the target dose of 97/103 mg twice daily, if tolerable.

Last Updated: 05/2016 Page 1 of 2

Applies to: Care1st

1. Dosing Adjustments: Criterion Dose Previously taking low doses of ACE inhibitor/ARB OR has never taken these agents. 24/26 mg twice- (See table below to evaluate)** daily Has history of severe renal impairment 24/26 mg twice- (eGFR<30ml) daily 24/26 mg twice- Moderate hepatic impairment daily * For maintenance, can double the dose every 2 to 4 weeks to the target dose of 97/103 mg twice daily.

Reference(s):

1. Entresto [package insert]. Novartis, East Hanover, NJ. July 2015. 2. ACCF/AHA Practice Guideline: 2013 ACCF/AHA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Clyde W. Yancy, et al. Circulation. 2013;128:e240-e327, published online before print June 5 2013, doi:10.1161/CIR.0b013e31829e8776. 3. Yancy CW, Jessup M, Bozkurt B, et al. 2016 ACC/AHA/HFSA Focused Update on New Pharmacological Therapy for Heart Failure: An Update of the 2013 ACCF/AHA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Failure Society of America. J Am Coll Cardiol. 2016;():. doi:10.1016/j.jacc.2016.05.011.

Last Updated: 05/2016 Page 2 of 2

Applies to: Care1st

Serevent (Salmeterol)

Covered uses All medically accepted indications

Exclusion Criteria Not for use as monotherapy Not used for acute symptoms or exacerbations

Required Medical Documented diagnosis of one of the following: Information 1) Treatment of asthma and in the prevention of bronchospasm only as concomitant therapy with a long-term asthma control medication, such as an inhaled corticosteroid, in patients aged 4 years and older with reversible obstructive airway disease, including patients with symptoms of nocturnal asthma.

2) Long-term, twice-daily administration in the maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD) (including emphysema and chronic bronchitis).

3) Prevention of exercise-induced bronchospasm (EIB) in patients aged 4 years and older. Use of SEREVENT DISKUS as a single agent for the prevention of EIB may be clinically indicated in patients who do not have persistent asthma. In patients with persistent asthma, use of SEREVENT DISKUS for the prevention of EIB may be clinically indicated, but the treatment of asthma should include a long-term asthma control medication, such as an inhaled corticosteroid.

Age restrictions 4 years and older

Prescriber Restrictions Coverage Duration 1 year

Other Criteria

Reference(s):

1. Serevent [package insert]. GlaxoSmithKline LLC September 2016

Last Updated: 09/2018 Page 1 of 1

Care1st Exception criteria

Kuvan (sapropterin dihydrochloride)

Covered uses All medically accepted indications Exclusion Criteria Required Medical 1) Medical statement indicating treatment to reduce blood Information phenylalanine (Phe) levels in patients with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin- (BH4-) responsive Phenylketonuria (PKU). AND 2) Documentation of baseline blood Phe levels

Reauthorization: 1) Documentation of blood Phe levels after 1 month of therapy indicating 30% reduction in Phe levels from baseline.

Age restrictions

Prescriber Restrictions Coverage Duration 1) Initial authorization of therapy will be issued for 2 months. 2) Re-Authorization of therapy will be issued for 12 months. Other Criteria This medication is to be used in conjunction with a Phe-restricted diet. Discontinue sapropterin therapy if blood Phe concentrations do not decrease after 1 month of treatment at 20 mg/kg/day.

Reference(s):

1. Kuvan® Prescribing Information. BioMarin Pharmaceticals, June 2013. 2. Facts and Comparisons 4.0; 20012. 3. National Institutes of Health. Phenylketonuria (PKU): Screening and Management. NIH Consensus Statement 2000 October 16-18;17(3):1-33. Available at: http://consensus.nih.gov/2000/2000Phenylketonuria113Program.pdf.

Last Updated: 04/2015 Page 1 of 1

Applies to: Care1st Emsam (Selegiline)

Covered uses Indicated for the treatment of adults with major depressive disorder (MDD) Exclusion Criteria

Required Medical Clinical Documentation must indicate: Information 1) Diagnosis of major depressive disorder (MDD) AND 2) Patient experienced an inadequate treatment response, intolerance, or contraindication to any one of the following antidepressants: bupropion, trazodone, mirtazapine, serotonin norepinephrine reuptake inhibitors (SNRIs (e.g., venlafaxine)), selective serotonin reuptake inhibitors (SSRIs (e.g., citalopram, fluoxetine, fluvoxamine, paroxetine, sertraline)), tricyclic or tetracyclic antidepressants (e.g., amitriptyline, nortriptyline) OR 3) Patient is unable to swallow oral formulations. Age restrictions 18 years and older Prescriber Restrictions Coverage Duration 1 year Other Criteria

Reference(s):

1. Emsam [package insert]. Mylan Specialty, LP. Morgantown, WV July, 2017.

Last Updated: 01/2018 Page 1 of 1

Applies to: Care1st

Short-acting Opioids—Preferred (Morphine Sulfate IR; Oxycodone/APAP; Hydrocodone/APAP; Oxycodone IR; Meperidine; Tramadol) Covered uses 1) Oncology Diagnosis 2) Traumatic Injury 3) Post‐Surgery 4) Palliative Care: • hospice care • end-of-life care

Exclusion Criteria Active addiction to illicit substances or prescription drugs.

Required Medical Criteria for Preferred and other Non‐Formulary Short‐Acting Information Opioids greater than 7 day supply Covered Conditions: 1) Active Oncology diagnosis 2) Post‐Surgery—maximum of 14 days 3) Traumatic Injury 4) Palliative care 5) Hospice care 6) end-of-life care—other than hospice 7) Patient under 18 years of age on opioid wean at time of hospital discharge

Prior authorization required for greater than 7 day supply, who do not meet the exception: 1) Patient has tried non-opioid options first. Opioids are not first‐line therapy. 2) Chart notes must include a pain assessment filled out by the physician. 3) Physician‐patient pain management contract must be provided. 4) Documentation included for random urine or blood tests twice a year. 5) Documentation of the CSPMP reviewed by the prescriber every time a prescription for controlled substance is provided. 6) One pharmacy must be selected for all prescription services. 7) Patient must not have an active addiction to illicit substances or prescription drugs. 8) Plan to taper off short acting narcotics over the next 14 to 21 days. 9) Plan to address problems such as:

Last Updated: 12/2017 Page 1 of 2

Applies to: Care1st

• The patient has committed serious or repeated drug seeking behavior • The patient makes no progress toward therapeutic goals 10) MED should be less than 50MME/day NOTE: If the patient is on a benzodiazepine, short acting narcotic will be only approved for 14 days.

Age restrictions 4 years of age and older

Prescriber Restrictions Coverage Duration 1) Palliative Care 2) Hospice Care 3) End‐of‐Life care • Approve as requested if within quantity limits, and less than 30 day supply with no refills. • Approve one-time if within quantity limits, and requesting additional fills.

4) Patient under 18 years of age on opioid wean at time of hospital discharge • RPh to determine appropriate approval based on wean plan.

5) Patient met criteria listed without a covered condition: • Approve as requested if within quantity limits, and less than 30 day supply with no refills. • Approve one-time if within quantity limits , and requesting additional fills.

Other Criteria

Reference(s):

1. AHCCCS Medical Policy Manual. Dec 2017.

Last Updated: 12/2017 Page 2 of 2

Applies to: Care1st Revatio suspension Sildenafil tablets Covered uses All FDA approved indications

Exclusion Criteria Sildenafil is not covered for the diagnosis of: 1) Erectile dysfunction/impotence 2) Pulmonary Hypertension • World Health Organization group 2 - 5

Required Medical Documented diagnosis of: Information 1) Pulmonary arterial hypertension (Idiopathic, inherited, due to drugs/toxins, connective tissue diseases, etc.) • World Health Organization group 1 with NYHA class II or III symptoms Age restrictions

Prescriber Pulmonologist or Cardiologist Restrictions Coverage Duration 1 year Other Criteria 1) Requests for Sildenafil tablets: Cover only 20mg tablets three times a day. 2) Sildenafil should not be used in combination with organic nitrates.

Reference(s):

1. Product Information: REVATIO(R) oral tablets, oral suspension, intravenous injection, sildenafil oral tablets, oral suspension, intravenous injection. Pfizer Labs (per FDA), New York, NY, 2014.

Last Updated: 12/2017 Page 1 of 1

Care1st Exception criteria

Xyrem (sodium oxybate)

Covered uses All medically accepted indications Exclusion Criteria Patients concurrently using sedative hypnotics or alcohol Required Medical Stated diagnosis of: Information 1) Narcolepsy confirmed by a sleep study • Not necessary if prescriber provides justification confirming that a sleep study would not be feasible • Trial and failure or contraindication to one of the preferred stimulants: dextroamphetamine tablets, dexmethylphenidate tablets, methylin chewables, methyphenidate IR tablet, methyphenidate ER tablet (10mg or 20 mg) AND modafinil 2) Cataplexy; approve Other Criteria 1) Reauthorization will occur if: • Patient experienced a reduction in the frequency of cataplexy attacks associated with Xyrem therapy OR • Patient experienced a reduction in symptoms of excessive daytime sleepiness associated with Xyrem therapy.

Age restrictions 18 years of age and older

Prescriber Restrictions Coverage Duration Original authorization will be issued for 3 months. Reauthorization will be issued for 12 months. Other Criteria If concurrently using with divalproex sodium, an initial reduction of 20% of Xyrem dose is recommended.

Reference(s):

1. Product Information: Xyrem(R) oral solution, sodium oxybate oral solution. Jazz Pharmaceuticals (per FDA), Palo Alto, CA, November 2017. 2. Xyrem Prescribing Information. Jazz Pharmaceuticals, Inc. November 2005. 3. US Xyrem Multicenter Study Group. A randomized, double blind, placebo- controlled multicenter trial comparing the effects of three doses of orally administered sodium oxybate with placebo for the treatment of narcolepsy. Sleep. 2002;25:42-49.

Created: 06/2018 Page 1 of 2

Care1st Exception criteria

4. US Xyrem Multicenter Study Group. Sodium oxybate demonstrates long-term efficacy for the treatment of cataplexy in patients with narcolepsy. Sleep Med. 2004;5(2):119-23. 5. US Xyrem Multicenter Study Group. A 12-month, open-label, multicenter extension trial of orally administered sodium oxybate for the treatment of narcolepsy. Sleep. 2003;26(1):31- 35. 6. Morgenthaler TI, Kapur VK, Brown TM, Swick TJ, Alessi C, Aurora N, et al. Practice parameters for the treatment of narcolepsy and other hypersomnias of central origin: An American Academy of Sleep Medicine report. Sleep. 2007;30(12):1705-1711. 7. The Xyrem International Study Group. A double-blind, placebo-controlled study demonstrates sodium oxybate is effective for the treatment of excessive daytime sleepiness in narcolepsy. J Clin Sleep Med. 2005;1:391-397. 8. American Academy of Sleep Medicine. International Classification of Sleep Disorders: Diagnostic and Coding Manual. 2nd ed. Westchester, IL: American Academy of Sleep Medicine; 2005. 9. Billiard M, Dauvilliers Y, Dolenc-Groselj L, et al. Chapter 38 : Management of narcolepsy in adults. In: Gilhus NE, Barnes MP, Brainin M, eds. European Handbook of Neurological Management. 2nd ed. Oxford England: Wiley- Blackwell; 2011:513-28. 10. Per clinical consultation with neurologist/sleep specialist. October 9, 2012.

Created: 06/2018 Page 2 of 2

Applies to: Care1st

Genotropin, Norditropin (Somatropin) Covered uses All FDA approved indications including but not limited to the following:

Adults 1) Adult growth hormone deficiency (AGHD)

Pediatrics 1) Growth hormone deficiency (GHD) 2) Children born small for gestational age (SGA) who fail to catch up growth by 2 years of age 3) Prader-Willi Syndrome (PWS - which may include treatment to improve body fat composition or increase in lean body mass) 4) Turner’s syndrome (TS) 5) Idiopathic short stature (ISS), also called non-growth hormone- deficient short stature

Exclusion Criteria Discontinue Growth Hormone (GH)/Exclusions for Reauthorization if :

1) For CRI, SGA, TS, NS, SHOXD, ISS: Attained height at any age is greater than or equal to the 5th percentile for adults (65 inches for men and 60 inches for women) using the latest publicly available CDC Growth Charts.

2) For CRI, SGA, ISS: If there is a poor response to treatment: Defined as failure of the growth velocity to increase by 50%, or by at least 2.5 cm per year during the first year of treatment, whichever is lower, AND failure of the final height prediction based on bone age to increase by at least 1.25 cm (0.5 inches) after one year of therapy.

3) For CRI, SGA, TS, NS, SHOX, ISS: Closed epiphyseal plates in the hand and wrist as determined by a bone age X- ray.

4) For GHD without a history of hypoglycemia, at least one other pituitary hormone deficiency, or severe growth hormone deficiency defined by all growth hormone levels during all stimulation testing being < 3 mcg/L: Closed epiphyseal plates in the hand and wrist as determined by a bone age X-ray. Growth hormone for the purpose of linear

Last Updated: 12/2017 Page 1 of 10

Applies to: Care1st

growth should be discontinued. These patients may then be considered for adult growth hormone therapy if they meet the AGHD criteria.

5) For GHD with a history of hypoglycemia, at least one other pituitary hormone deficiency, or severe growth hormone deficiency defined by all growth hormone levels during all stimulation testing being < 3 mcg/L: These patients should not stop growth hormone therapy unless instructed to do so by a physician. When the epiphyseal plates in the hand and wrist as determined by a bone age X- ray are closed, the patient shall be switched to adult growth hormone therapy.

6) For CRI, SGA, PWS, TS, NS, SHOX, ISS: There are persistent and uncorrectable problems with adherence to treatment.

7) For PWS: o If a current letter from a pulmonologist stating that the patient does not have new onset of signs of upper airway obstruction (including onset of or increased snoring) and/or new onset sleep apnea is not received at the time of renewal. o If patient is at or above18 years of age AND the epiphyseal plates are closed, based upon a bone age X-ray.

Exclusions for Reauthorization—ADULTS ONLY: 1) If a patient without AGHD shows no improvement when maximum dose is achieved, treatment should be discontinued.

Required Medical Preferred agents: Information 1) Genotropin 2) Norditropin

For every authorization we require the following: 1) Height (in/cm) within 90 days 2) Weight (kg/lbs) within 90 days 3) Completed growth chart within 90 days 4) Midparental height 5) Bone age (diagnosis dependent) 6) Epiphyseal x-ray summary (diagnosis dependent)

Calculation for Midparental Height

Last Updated: 12/2017 Page 2 of 10

Applies to: Care1st

Male: [father’s height in cm + mother’s height in cm + 13 cm)]/2 Female: [father’s height in cm + mother’s height in cm – 13 cm]/2

Initial Approval

Pediatric Growth hormone deficiency (GHD) 1) The patient must not be undergoing anti-tumor therapy for a newly diagnosed or recurrent malignancy. 2) If older than five years old, must have open epiphyseal plates, as determined by bone age x-rays. 3) A stimulation test is not required for patients who have had a GH level < 10 mcg/L at the same time as a blood, serum or plasma glucose level <50 mg/dL. 4) A stimulation test is not required for patients with ectopic posterior pituitary, a variation of septo-optic deficiency or optic nerve hypoplasia, a pituitary/sella/hypothalamic lesion, empty sella, history of pituitary/sella/hypothalamic surgery, hydrocephalus, Chiari I malformation, brain tumors, pituitary/sella/hypothalamic irradiation, history of meningitis, pituitary tumor, or a traumatic brain injury, Sheehan’s syndrome, autoimmune hypophysisitis, hypophysisitis associated with an inflammatory condition, such as sarcoidosis, AND at least one other documented pituitary hormone deficiency, AND a low IGF-1 level-for-bone age within 90 days of the free or total T4 being normal-for-age (if the patient has primary hypothyroidism, the TSH must also be normal-for age), AND EITHER short (height or length below the 5th percentile), OR having declining height percentiles, OR having documented episodes of hypoglycemia (blood, serum or plasma glucose below 50 mg/dL). 5) Peak growth hormone concentrations < 10 mcg/L during two of the following stimulation tests, one of which must be an insulin stimulation test unless the patient has a contraindication to an insulin stimulation test (contraindications to an insulin stimulation test are neurologic and cardiac problem, or a history of hypoglycemia): • Arginine, clonidine, glucagon, insulin, levodopa, GHRH, or propranolol. • Total or free T4 (and a TSH level, if the patient has primary, rather than secondary/tertiary, hypothyroidism), must be normal-for-age within 90 days of the stimulation test. If thyroid tests were done more than once, the tests closest to the date(s) of the stimulation test must be normal-for-age.

Last Updated: 12/2017 Page 3 of 10

Applies to: Care1st

• Two stimulation tests can be done sequentially on the same day with administration of the stimulants started at least 90 minutes apart. Stimulation tests conducted in such a way that onset of administration of the stimulants is closer than 90 minutes apart will be considered one stimulation test. • A patient who passes two stimulation tests in a year will be considered to be growth hormone sufficient regardless of the results of other stimulation tests within the one year period. • After passing two stimulation tests, new stimulation test results will be accepted if the new tests were: o Performed more than one year after the prior stimulation tests AND o The patient has a condition that can cause evolving growth hormone deficiency such as an ectopic posterior pituitary, a variant of septo-optic dysplasia or optic nerve hypoplasia, documentation of at least one other pituitary hormone deficiency, a pituitary, sella, or hypothalamic lesion, empty sella, history of pituitary/sella/hypothalamic surgery, hydrocephalus, Chiari I malformation, brain tumors, pituitary/sella/hypothalamic irradiation, history of meningitis, pituitary tumor, or a traumatic brain injury, Sheehan’s syndrome, autoimmune hypophysisitis, hypophysisitis associated with an inflammatory condition, such as sarcoidosis AND the patient’s height percentile has decreased since prior stimulation tests.

Adult Onset Growth Hormone Deficiency 1) The patient must not have an acute critical illness due to complications following open heart or abdominal surgery, multiple accidental trauma or acute respiratory failure. 2) The patient must not be undergoing anti-tumor therapy for a newly diagnosed or recurrent malignancy. 3) If still growing AND the growth/epiphyseal plates on a bone age x-ray are not fused should be considered for Pediatric Growth Hormone Deficiency treatment regardless of chronologic age. 4) Patient is diagnosed with acquired or organic GH deficiency secondary to any of the following: Congenital ectopic posterior pituitary, variant of septo-optic dysplasia or optic

Last Updated: 12/2017 Page 4 of 10

Applies to: Care1st

nerve hypoplasia, hypothalamic, sella or pituitary tumor or cyst, empty sellay, hypothalamic, sellar or pituitary surgical damage, hydrocephalus, Chiari I malformation, brain tumor, hypothalamic disease, pituitary irradiation, traumatic brain injury, pituitary trauma, Sheehan’s syndrome, autoimmune hypophysisitis, hypophysisitis associated with an inflammatory condition, such as sarcoidosis AND 5) Patient has documentation of, at least, one other pituitary hormone deficiency AND 6) If the patient has primary hypothyroidism, the free or total T4, and TSH levels are normal, OR 7) If the patient has secondary/tertiary hypothyroidis, the free or total T4 levels are normal, AND 8) Has failed standardized testing as demonstrated by serum GH concentration <5 mcg/L during an insulin tolerance test or a cross-validated GH threshold in an equivalent test (growth hormone releasing hormone, arginine, or glucagon) OR 9) IGF-1 level below normal and other causes of low IGF have been excluded AND a random growth hormone level is simultaneously <5 mcg/L. 10) Initial dosing at not more than 0.006 mg/kg/day, given as a daily divided dose up to a maximum of 0.025 mg/kg/day if at or below 35 years, and up to a maximum of 0.0125 mg/kg/day if older than 35 years.

Adult diagnosed with childhood GHD 1) Patient meets the criteria as listed in Adult Onset Growth Hormone Deficiency above indicating persistent GHD OR 2) Had Pediatric Growth Hormone Deficiency AND a history of hypoglycemia, OR at least one other pituitary hormone deficiency, OR severe growth hormone deficiency defined by all growth hormone levels during all pediatric stimulation testing being < 3 mcg/L. 3) Had Pediatric Growth Hormone Deficiency AND, at least three months after discontinuing growth hormone, failed standardized testing as demonstrated by serum GH concentration <5 mcg/L during an insulin tolerance test or a cross-validated GH threshold in an equivalent test (growth hormone releasing hormone, arginine, or glucagon). • Initial dosing at not more than 0.04 mg/kg/week, given as a daily divided dose OR between 0.15 to 0.3 mg/day.

Turner Syndrome (TS): 1) The patient must not have an acute critical illness due to

Last Updated: 12/2017 Page 5 of 10

Applies to: Care1st

complications following open heart or abdominal surgery, multiple accidental trauma or acute respiratory failure. 2) The patient must not be undergoing anti-tumor therapy for a newly diagnosed or recurrent malignancy. 3) Documentation of chromosomal abnormality consistent with TS OR 4) Documentation of genetic testing consistent with SHOXD OR NS 5) Open epiphyses plates, determined by a bone age X-ray (not required in children under 5 years)

Prader-Willi Syndrome (PWS) 1) Diagnosis of PWS confirmed by appropriate genetic testing AND 2) Chronologic age below 18 years, OR 3) Open epiphyseal plates on a bone age x-ray, OR 4) A bone age 18 years or lower in a male, 15 years or lower in a female AND 5) Must have a letter from a pulmonologist stating that the patient is not severely obese, have a history of upper airway obstruction or sleep apnea, or have severe respiratory impairment. 6) The patient must not have an acute critical illness due to complications following open heart or abdominal surgery, multiple accidental trauma or acute respiratory failure. 7) The patient must not be undergoing anti-tumor therapy for a newly diagnosed or recurrent malignancy.

Small for Gestational Age (SGA) 1) Diagnosis of SGA as defined as: Birth weight or length <5th percentile for gestational age or 2 SD below mean for gestational age AND 2) Must be at least two years old AND 3) Have open epiphyses plates, determined by a bone age X-ray (not required in children under 5 years). 4) Growth charts plotting growth from birth through age 2 should be submitted for evaluation if available AND 5) The patient must not have an acute critical illness due to complications following open heart or abdominal surgery, multiple accidental trauma or acute respiratory failure AND 6) The patient must not be undergoing anti-tumor therapy for a newly diagnosed or recurrent malignancy.

Idiopathic Short Stature (ISS) 1) Height standard deviation score (SDS) < -2.25 AND

Last Updated: 12/2017 Page 6 of 10

Applies to: Care1st

2) Open epiphyses plates, determined by bone age x-rays, AND 3) Examination of the growth chart(s) and the bone age result suggests that the final height will probably be more than 2.25 SD below the mean (if the bone age is at an age when a Greulich and Pyle final height prediction can be determined, then that predicted final height should be used), AND 4) Other conditions that can cause the short stature such as genetic conditions that are known to cause short stature, hypothyroidism, poorly controlled diabetes mellitus, celiac disease, crohn’s disease, bone dysplasias such as achondroplasia and hypochondroplasia, chronic liver failure, bone metabolism disorders such a vitamin D deficiency rickets and X-linked hypophosphatemic rickets, psychosocial deprivation, nutritional deprivation, severe neurologic disorders, are not present. • If the condition is treatable in such a way as to eliminate any adverse effect upon growth (i.e. levothyroxine replacement in patients with hypothyroidism, gluten free diet in patients with celiac disease, and improved diabetes control in a diabetic, nutritional correction of nutritional deprivation), and such treatment has been successfully implemented for at least 6 months and the height percentiles have not improved, then that condition should no longer be considered to be the cause of the short stature and idiopathic short stature can still be considered.

Reauthorization that WellCare approved previously

Pediatric Growth hormone deficiency (GHD) 1) For GHD without a history of hypoglycemia, at least one other pituitary hormone deficiency, or severe growth hormone deficiency defined by all growth hormone levels during all stimulation testing being < 3 mcg/L, if: • There are open epiphyseal plates in the hand and wrist as determined by a bone age X-ray, OR • A bone age of 18 years or less in a male, 15 years or less in a female • When growth hormone therapy for the purpose of linear growth is eventually discontinued, adult growth hormone therapy may be considered if the AGHD criteria are met. 2) For GHD with a history of hypoglycemia, at least one other pituitary hormone deficiency, or severe growth

Last Updated: 12/2017 Page 7 of 10

Applies to: Care1st

hormone deficiency defined by all growth hormone levels during all stimulation testing being < 3 mcg/L, if: • There are open epiphyseal plates in the hand and wrist as determined by a bone age X-ray, OR • A bone age of 18 years or less in a male, 15 years or less in a female • When growth hormone therapy for the purpose of linear growth is discontinued, adult growth hormone therapy should be immediately started unless the prescribing physician opts against continuing growth hormone.

Adult Onset Growth Hormone Deficiency 1) Continued prescribing physician authorization

Adult diagnosed with childhood GHD 1) Continued prescribing physician authorization

Turner Syndrome (TS) 1) Open epiphyseal plates, determined by bone age X-ray OR 2) Males with bone age 18 years or less or females with bone age 15 years or less.

Prader-Willi Syndrome (PWS) 1) Chronologic age below 18 years OR, if older, 2) Open epiphyseal plates, determined by bone X-ray

Small for Gestational Age (SGA) 1) Open epiphyses plates, determined by bone age X-rays OR 2) Males with bone age 18 years or less or females with bone age 15 years or less.

Increase in Dose Authorization 1) IGF-1 level below the mean for extrapolated or current bone age, or chronologic age in combination with Tanner stages of pubic hair and/or breast development. 2) The dose of growth hormone should be lowered if the IGF-1 level is more than 2 standard deviations above the mean for extrapolated or current bone age, or chronologic age in combination with Tanner stages of pubic hair and/or breast development.

I. Treatment with Genotropin

Last Updated: 12/2017 Page 8 of 10

Applies to: Care1st

1) Pediatric Growth Hormone Deficiency (GHD) Generally, a dose of 0.16 to 0.24 mg/kg body weight/week is recommended.

2) Prader-Willi Syndrome Generally, a dose of 0.24 mg/kg body weight/week is recommended.

3) Turner Syndrome Generally, a dose of 0.33 mg/kg body weight/week is recommended.

4) Idiopathic Short Stature Generally, a dose up to 0.47 mg/kg body weight/week is recommended.

5) Small for Gestational Age Generally, a dose of up to 0.48 mg/kg body weight/week is recommended.

II. Treatment with Norditropin

1) Pediatric Growth Hormone Deficiency (GHD) A dosage of 0.024 to 0.034 mg/kg/day, 6 to 7 times a week, is recommended.

2) Pediatric Patients with Short Stature Associated with Noonan Syndrome Not all patients with Noonan syndrome have short stature; some will achieve a normal adult height without treatment. Therefore, prior to initiating Norditropin for a patient with Noonan syndrome, establish that the patient does have short stature.

A dosage of up to 0.066 mg/kg/day is recommended.

3) Pediatric Patients with Short Stature Associated with Turner Syndrome A dosage of up to 0.067 mg/kg/day is recommended.

4) Pediatric Patients with Short Stature Born Small for Gestational Age (SGA) with No Catch-up Growth by Age 2 to 4 Years A dosage of up to 0.067 mg/kg/day is recommended

Last Updated: 12/2017 Page 9 of 10

Applies to: Care1st

Age restrictions Present for many indications – see above for details

Prescriber Nephrologist (CRI), infectious disease specialist (HIV-related Restrictions indications), endocrinologist (all other indications)

Coverage Duration 1 year

Other Criteria

Reference(s):

1. Kasper, DL et al. Harrison’s Online. 2. Nutropin AQ product information. Genentech. November 2006. 3. The Endocrine Society. Evaluation and treatment of adult growth hormone deficiency: an Endocrine Society clinical practice guideline. 2006. 4. Seaver, L; et. al. AMCG practice guideline: Genetic evaluation of short stature. Genetics in Medicine. 11( 6) June 2009. 465-470 5. Molitch M; et. al. Evaluation and Treatment of Adult Growth Hormone Deficiency: An Endocrine Society Clinical Practice Guideline. Journal of Clinical Endocrinology and Metabolism. 96(6). June 2011. 1587-1609. 6. Human growth hormone (somatropin) for the treatment of growth failure in children. National Instititue for Health and Clinical Excellence (NICE). Issued: May 2010. Review date: May 2013. 7. Wilson et. Al. Update of Guidelines for the Use of Growth Hormone in Children: The Lawson Wilikins Pediatric Endocrinology Society Drug and Therapeutics Committee. The Journal of Pediatrics; October 2003 p 415-421. 8. The American Association of Clinical Endocrinologists Medical Guidelines for Clinical Practice for Growth Hormone Use in Adults and Children – 2003 Update. Endocrine Practice Vol 9, No. 1 January/February 2003. http://www.aace.com/clin/guidelines/hgh.pdf 9. http://bestpractice.bmj.com/best-practice/monograph/839/treatment/guidelines.html 10. Test ID: IGF1 15867. Insulin-Like Growth Factor 1, Serum. Mayo Clinic, Mayo Medical Laboratories. http://www.mayomedicallaboratories.com/test-catalog/print/15867 11. McDowell A, Fryar C, Ogden C, Flegal K. Anthropmetric Reference Data for Children and Adults: United States, 2003-2006. National Health Statistics Reports. Number 10. October 22, 2008.

Last Updated: 12/2017 Page 10 of 10

Applies to: Care1st Sorafenib (Nexavar)

Covered uses All medically accepted indications

Exclusion Criteria 1) Sorafenib in combination with carboplatin and paclitaxel is contraindicated in patients with squamous cell lung cancer

Required Medical Documentation of any of the following diagnosis: Information 1) Unresectable liver carcinoma 2) Advanced renal cell carcinoma 3) Locally recurrent or metastatic, progressive, differentiated thyroid carcinoma that is refractory to radioactive iodine treatment

Documentation that liver function tests (alanine aminotransferase [ALT], aspartate aminotransferase [AST], and bilirubin) are monitored before initiation of treatment, during each cycle of treatment, and as clinically indicated Age restrictions 18 years and older Prescriber Oncologist Restrictions Coverage Duration 1 year Other Criteria The recommended daily dose of Sorafenib is 400 mg (2 x 200 mg tablets) taken twice daily without food (at least 1 hour before or 2 hours after a meal). Treatment should continue until the patient is no longer clinically benefiting from therapy or until unacceptable toxicity occurs.

Reference(s):

1. Nexavar (Sorafenib). [Package Insert]. Bayer HealthCare Pharmaceuticals, Inc. July 2015. www.dailymed.nlm.nih.gov. Accessed August 2018. 2. Sorafenib Tosylate. Micromedex Solutions. Truven Health Analytics, Inc. Ann Arbor, MI. Available at http://www.micromedexsolutions.com. Accessed January 2018.

Last Updated: 09/2018 Page 1 of 1

Applies to: Care1st

Natroba 0.9% topical suspension (Spinosad)

Covered uses Statement of FDA approved diagnosis

Exclusion Criteria

Required Medical 1) Documented diagnosis of: Indicated for the topical treatment Information of head lice infestation

-and-

2) Trial and failure of or contraindication to preferred alternatives: • Permethrin • Pyrethrins-Piperonyl Butoxide shampoo

Age restrictions Age 6 months of age and older

Prescriber Restrictions Coverage Duration Approve up to two times as requested.

Other Criteria

Reference(s):

1. Natroba [package insert]. ParaPRO LLC. Carmel, IN. Dec 2017.

Last Updated: 12/2017 Page 1 of 1

Applies to: Care1st Sutent (sunitinib)

Covered uses All medically accepted indications

Exclusion Criteria

Required Medical Stated diagnosis from oncologist for one of the following: Information 1) Advanced renal cell carcinoma; OR 2) Adjuvant treatment of patients at high risk of recurrent renal cell carcinoma following nephrectomy 3) GI stromal tumor (GIST) intolerant to imatinib (Gleevec) 4) Progressive, well-differentiated pancreatic neuroendocrine tumors (pNET) in patients with unresectable locally advanced or metastatic disease

Age restrictions Age 18 years or greater

Prescriber Oncologist Restrictions Coverage Duration 1 year Other Criteria • CBC’s with platelet count and serum chemistry including phosphate should be performed at the beginning of each treatment cycle.

• Members currently taking this medication at time of enrollment will not be required to meet prerequisites for prior authorization.

Reference(s):

1. National Comprehensive Cancer Network, Inc. 2011, NCCN Clinical Practice Guidelines in Oncology (NCCN®). Version 3.2012 2. Product Information: SUTENT(R) oral capsules, sunitinib malate oral capsules. Pfizer Labs (per FDA), New York, NY, November 2017.

Last Updated: 09/2018 Page 1 of 1

Applies to: Care1st

Adcirca (tadalafil)

Covered uses All FDA Approved Indications Exclusion Criteria Tadalafil is not covered for the diagnosis of: 1) Erectile dysfunction/impotence 2) Pulmonary Hypertension • World Health Organization group 2 - 5

2) PAH combination therapy: Tadalafil is commonly used with ambrisentan

Age restrictions Age 18 years or greater Prescriber Cardiologist or Pulmonologist Restrictions Coverage Duration 1 year

Other Criteria Tadalafil should not be used in combination with organic nitrates.

Reference(s):

1. Adcirca (tadalafil) [product monograph]. Toronto, Ontario, Canada: Eli Lilly Canada Inc; January 2015 2. N. Galie, J.A. Barbera, A.E. Frost, et al.Initial Use of Ambrisentan plus Tadalafil in Pulmonary Arterial Hypertension. N. Engl. J. Med., 373 (2015), pp. 834–844

Last Updated: 12/2017 Page 1 of 1

Applies to: Care1st Tafluprost

Covered uses All medically accepted indications

Exclusion Criteria

Required Medical 1) Documented diagnosis of elevated intraocular pressure Information in patients with open-angle glaucoma or ocular hypertension

-AND-

2) Trial and failure of latanoprost Age restrictions 18 years and older Prescriber 1) Primary Care Physician Restrictions 2) Ophthalmologist Coverage Duration 1 year Other Criteria The recommended dose is one drop in the conjunctival sac of the affected eye (s) once daily in the evening. The dose should not exceed once daily as this may lessen the intraocular pressure lowering effect of the medication.

Reference(s):

1. Tafluprost. Micromedex Solutions. Truven Health Analytics, Inc. Ann Harbor, MI. Available from http://www.micromedexsolutions.com. 2. Tafluprost [Package Insert]. Akorn, Inc. December 2017. http://dailymed.nlm.nih.gov. .

Last Reviewed: 09/2018 Page 1 of 1

Applies to: Care1st Temodar (temozolomide)

Covered uses All medically accepted indications

Exclusion Criteria Known hypersensitivity to dacarbazine (DTIC) or temozolomide

Required Medical Stated diagnosis from oncologist of one of the following: Information 1) Refractory anaplastic astrocytoma in patients who have experienced disease progression on a drug regimen containing nitrosurea and procarbazine OR 2) Newly diagnosed glioblastoma multiforme (GBM) treated concomitantly with radiotherapy (RT) and then as maintenance treatment

Age restrictions

Prescriber Oncologist Restrictions Coverage Duration 1 year Other Criteria 1) Dose for newly diagnosed GBM: 75 mg/m^2 for 42 days with concomitant RT followed by initial maintenance dose of 150mg/m^2 once daily for days 1 – 5 of a 28 day cycle for 6 cycles 2) Dose for refractory anaplastic astrocytoma: Initial dose 150 mg/m^2 once daily for 5 consecutive days per 28 day treatment cycle 3) Members currently taking this medication at time of enrollment will not be required to meet prerequisites for prior authorization.

Reference(s):

1. Product Information: TEMODAR(R) oral capsules, IV injection, temozolomide oral capsules, IV injection. Schering Corporation, Whitehouse Station, NJ, November 2017 2. Temozolomide. In:DRUGDEX System (Micromedex 2.0). Greenwood Village, CO: Truven Health Analytics; c1974-2018. 3. http://www.micromedexsolutions.com/micromedex2/librarian/. Accessed August 6, 2018

Last Updated: 09/2018 Page 1 of 1

Care1st Exception criteria

Aubagio (teriflunomide)

Covered uses All FDA-approved indications Exclusion Criteria 1) Pregnancy 2) Planning pregnancy 3) Severe hepatic impairment 4) Concomitant leflunomide therapy 5) Positive TB test 6) AST/ALT >2 x ULN, Bilirubin levels > 1.2 mg/dl 9 7) Lymphocyte count < 0.91x10 /L Required Medical 1) Statement of FDA approved indication: Relapsing forms Information of multiple sclerosis (MS) 2) Baseline serum AST/ALT, bilirubin and CBC levels (obtained within 30 days of initiation) 3) Screen for TB

Trial and failure or intolerance/contraindication to the following preferred medication(s): 1) Gilenya AND one of the following platform therapies: Rebif, Glatiramer acetate, or Betaseron,

Age restrictions Age 18 years or greater

Prescriber Neurologist Restrictions Coverage Duration 1 year Other Criteria

Reference(s):

1. Aubagio [package insert]. Genzyme Corporation, Cambridge, MA 02142. A Sanofi Company. 2012

Last Updated: 05/2014 Page 1 of 1

Applies to: Care1st

Testosterone products

Covered uses All FDA approved indications Exclusion Criteria Testosterone is not covered for erectile dysfunction (ED) or hypogonadism due to aging.

Required Medical Diagnosis of low testosterone levels due to disorders of the Information testicles, pituitary gland, or brain that can cause hypogonadism 1) Primary hypogonadism (congenital or acquired): testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter’s syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone concentrations and gonadotropins (follicle-stimulating hormone [FSH], luteinizing hormone [LH]) above the normal range 2) Hypogonadotropic hypogonadism (congenital or acquired): idiopathic gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum levels but have gonadotropins in the normal or low range. LABS: Documentation of one of the following conditions- At least one pre-treatment total testosterone level below 300 ng/dl or the normal range for the laboratory test. Baseline PSA and hematocrit levels are required.

For annual reauthorization, labs within the past 60 days including recent testosterone levels, PSA, and hematocrit level within normal limits are required.

Age restrictions Ages 18 years or greater Prescriber Restrictions Coverage Duration 1 year Other Criteria Preferred Products (all require PA): 1) Testosterone cypionate (Depo-Testosterone) 2) Testosterone enanthate 3) Testosterone gel (Androgel) 4) Testosterone patch (Androderm) 5) Testosterone solution (Axiron)

Last Updated: 12/2017 Page 1 of 2

Applies to: Care1st

Criteria for approval: Documented FDA approved diagnosis

References:

1. Product Information: Testim(R) topical gel, testosterone 1% topical gel. Auxilium Pharmaceuticals, Inc (per FDA), Malvern, PA, 2011.

Last Updated: 12/2017 Page 2 of 2

PDL Exception Criteria

SYMDEKO (tezacaftor/ivacaftor)

Covered Uses All FDA approved indications

Exclusion Criteria Required Medical 1) Diagnosis of Cystic Fibrosis Information 2) DNA analysis testing results indicating one of the following CFTR gene mutations: • Homozygous for (two copies of) the F508del-CFTR mutation • Heterozygous for (one copy of) the F508del-CFTR mutation AND a second mutation that results in residual function in the cystic fibrosis transmembrane conductance regulator (CFTR) gene AND 3) Patient is taking background therapy such as short-acting beta-agonist (albuterol), mucolytics (pulmozyme), inhaled antibiotics (tobramycin), pancreatic enzymes, or hypertonic saline AND 4) Prior to treatment, documentation of liver function tests (e.g., ALT, AST) within 90 days of initiation AND 5) If member has documented liver dysfunction, statement of hepatic impairment classification (Child-Pugh Class) Age Restrictions 12 years of age and older Prescriber 1) Pulmonologist Restrictions 2) Prescriber in consultation with a pulmonologist Coverage Duration 12 months

Other Criteria Table 1: Dosage Recommendations for Patients with Hepatic Impairment Morning Evening Mild (Child-Pugh No dose adjustment No dose adjustment Class A) Moderate (Child-Pugh 1 tablet of tezacaftor 100 Class B) mg/ivacaftor 150 mg once daily No ivacaftor 150 mg dose Severe (Child-Pugh 1 tablet of tezacaftor 100 Class C) mg/ivacaftor 150 mg once daily

Reference(s): 1. Product Information: SYMDEKO(TM) oral tablets, tezacaftor ivacaftor oral tablets and ivacaftor oral tablets. Vertex Pharmaceuticals Incorporated (per manufacturer), Boston, MA, 2018. 2. Rowe SM, Daines C, Ringshausen FC, et al. Tezacaftor-Ivacaftor in Residual-Function Heterozygotes with Cystic Fibrosis. N Engl J Med. 2017;377(21):2024-2035. 3. Taylor-Cousar JL, Munck A, Mckone EF, et al. Tezacaftor-Ivacaftor in Patients with Cystic Fibrosis Homozygous for Phe508del. N Engl J Med. 2017;377(21):2013-2023.

Created: 03/2018 Page 1 of 2 PDL Exception Criteria

4. Phase 3 Studies of the Tezacaftor/Ivacaftor Combination Treatment in People with Cystic Fibrosis Ages 12 and Older Published in the New England Journal of Medicine. Investorsvrtx.com. 2017. Available at: http://investors.vrtx.com/releasedetail.cfm?releaseid=1047092. Accessed December 21, 2017. 5. Cystic Fibrosis Pulmonary Guidelines: Chronic Medications for Maintenance of Lung Health. Am J Respir Crit Care Med. 2013; 187(7):680-9.

Created: 03/2018 Page 2 of 2 Applies to: Care1st

Thalomid (Thalidomide)

FDA approved All medically accepted indications Indications: Exclusion Criteria Pregnancy Required Medical 1) Statement indicating use for FDA approved diagnosis; (see Information below) AND 2) Negative pregnancy test; AND 3) WBC with differential - Treatment should not be initiated if patient has an absolute neutrophil count (ANC) below 750/mm3.

4) Multiple Myeloma (MM): Statement indicating newly diagnosed MM with concurrent use of dexamethasone or conventional dose chemotherapy, or combination treatment with high dose chemotherapy or stem cell rescue, or use as salvage therapy in refractory or relapsed MM after primary therapy, or use in combination with dexamethasone, doxorubicin, cyclophosphamide and etoposide as part of induction regimen in preparation for autologous transplant.

5) Erythema Nodosum Leprosum (ENL).: Statement indicating acute treatment of cutaneous manifestations of moderate to severe ENL (but not as monotherapy in presence of moderate to severe neuritis) OR maintenance therapy for prevention and suppression of the cutaneous manifestations of ENL recurrence.

6) Aphthous stomatitis or ulcers (AS): Statement indicating one of the following: a diagnosis of HIB-associated aphthous ulcers, recurrent aphthous stomatitis in immunocompromised patients and refractoriness to other therapies.

7) Crohn's disease: Statement indicating failure of two of the standard treatment regimens, including corticosteroids, 5- aminosalicylic acid, immunomodulators, Humira, and Cimzia.

8) GVHD: Statement indicating diagnosis of chronic or refractory GVHD and failure of two of the following treatment options: Corticosteroids, AND, Tacrolimus, OR Cyclosporine

9) Primary Brain Tumors: Statement indicating use as adjuvant therapy to current cytotoxic therapies or previous failure of cytotoxic therapies and/or tumor resection

HIV associated wasting syndrome or cancer cachexia: Statement

Last Updated: 03/2016 Page 1 of 2

Applies to: Care1st

indicating diagnosis of AIDS wasting or cancer cachexia 1) Nutritional evaluation and hypogonadism screening • failure to respond to hormone replacement therapy in patients with hypogonadism 2) For patients with AIDS wasting – receiving AIDS anti-retroviral therapy 3) Experienced at least a: • 7.5% unintentional weight loss over 6 months • 10% unintentional weight loss over 12 months • 5% body cell mass (BCM) loss within 6 months • BMI < 20 kg/m2 • BCM < 35% male (< 23% female) and a BMI < 27 kg/m2 4) Failure, contraindication or intolerance to megesterol at doses up to 800 mg daily

Age restrictions Greater than 12 years old Prescriber Restrictions Coverage Duration MM: Through benefit year ENL, GVHD, Primary Brain Tumor: 6 months AS: 1 month Other Uses: 3 months Other Criteria Members currently taking this medication at time of enrollment will not be required to meet prerequisites for prior authorization.

Reference(s):

1. Product Information: THALOMID(R) oral capsules, thalidomide oral capsules. Celgene Corporation (per FDA), Summit, NJ, 2013. 2. Clinical Pharmacology. Gold Standard 2013.

Last Updated: 03/2016 Page 2 of 2

Applies to: Care1st Exception Criteria

Tabloid (thioguanine)

Covered uses All medically accepted indications

Exclusion Criteria Not effective in chronic lymphocytic leukemia, Hodgkin’s lymphoma, multiple myeloma, or solid tumors Required Medical Stated diagnosis of: Information 1) Acute nonlymphocytic leukemia 2) Age restrictions

Prescriber Oncologist / Hematologist Restrictions Coverage Duration 1 year Other Criteria Members currently taking this medication at time of enrollment will not be required to meet prerequisites for prior authorization.

Reference(s):

1. Product Information: TABLOID(R) oral tablets, thioguanine oral tablets. Aspen Global Inc., Maritius , May 2018.

Last Updated: 09/2018 Page 1 of 1

Applies to: Care 1st

Thioridazine

Reference(s):

1. Thioridazine tablet [package insert]. Sun Pharmaceutical Industries, Inc. October 2017.

Created: 09/2018 Page 1 of 1

Applies to: Care 1st

Thiothixene

Covered uses All medically accepted indications Exclusion Criteria Required Medical Documentation of the following medical diagnosis: Information • Schizophrenia

Reference(s):

1. Thiothixene [package insert]. Sandoz Inc. October 2011.

Created: 09/2018 Page 1 of 1

Applies to: Care1st Gabitril (tiagabine HCL)

Covered uses All medically accepted indications

Exclusion Criteria Hypersensitivity to tiagabine or any components of the product

Required Medical 1) Documented diagnosis of partial seizure AND Information 2) Current use of at least one other antiepileptic drugs (i.e. valproate, carbamazepine, phenytoin, lamotrigine, topiramate, zonisamide, felbamate) AND 3) Unresponsive to monotherapy on anti-epileptic medication Age restrictions ≥12 years of age Prescriber Neurologist Restrictions Coverage Duration 1 year Other Criteria The recommended dosage: 1) Adults-Initiate at 4 mg once daily with maximum dose of 56 mg a day in divided doses of two to four times daily.

2) Adolescents (12-18 years old)- Initiate at 4 mg once a day to a maximum dose of 32 mg per day in divided doses of two to four times daily.

Tiagabine is to be used as adjunctive therapy with other anti-epileptic medications

Reference(s):

1. Sacrosidase. Micromedex Solutions. Truven Health Analytics, Inc. Ann Harbor, MI. Available from http://www.micromedexsolutions.com. 2. Sacrosidase [Package Insert]. QQL Medical, LLC. May 2015. http://dailymed.nlm.nih.gov. 3. Schachter, SC., et al. Overview of the management of epilepsy in adults. January 16, 2018. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed January 2018. .

Last Updated: 02/2018 Page 1 of 1

Applies to: Care1st Brilinta (ticagrelor)

Covered uses All medically accepted indications

Exclusion Criteria Actively bleeding or who have a history of intracranial hemorrhage Required Medical 1) Diagnosis of Acute coronary syndrome (ACS) or history Information of myocardial infarction (MI) 2) Tried and failure or contraindication/intolerance to preferred: Clopidogrel, Dipyridamole, Cilostazol Age restrictions Must be 18 years and older Prescriber Restrictions Coverage Duration 1 year Other Criteria

Reference(s):

1. Brilinta [package insert]. AstraZeneca Pharmaceuticals LP. Wilmington, DE, April, 2017.

Last Updated: 01/2018 Page 1 of 1

Applies to: Care1st

Stiolto Respimat (tiotropium bromide and olodaterol)

Covered uses Once-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. Exclusion Criteria 1) Not indicated to treat: • Acute deteriorations of COPD • Asthma Required Medical 1) Clinical documentation of chronic obstructive pulmonary disease Information (COPD), including chronic bronchitis and/or emphysema.

2) Trial and failure of preferred alternative: • Combivent Respimat, DuoNeb

Age restrictions 18 years of age and older

Prescriber Restrictions Coverage Duration 1 year Other Criteria

Reference(s):

1. Stiolto Respimat [package insert]. Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT. May 2018.

Created: 08/2018 Page 1 of 1

Applies to: Care1st

Tobramycin nebulized Bethkis; Kitabis Covered uses All FDA approved indications

Exclusion Criteria Efficacy and safety have not been demonstrated in patients with forced expiratory volume in 1 second (FEV1) less than 40% or greater than 80% predicted, or in patients colonized with Burkholderia cepacia. Required Medical 1) Diagnosis of Cystic fibrosis Information AND

LABS: 1) Recent Culture and Sensitivity report with documented diagnosis of Pseudomonas aeruginosa (i.e., positive sputum culture for Pseudomonas aeruginosa).

Age restrictions Age 6 years or greater

Prescriber Pulmonologist, Infectious Disease Specialist Restrictions Coverage Duration 1 year

Other Criteria The recommended dosage for patients six years of age and older is to administer one single-use ampule (300 mg/4 mL) twice daily by oral inhalation in repeated cycles of 28 days on drug, followed by 28 days off drug.

Reference(s):

1. Bethkis [package insert]. Woodstock, IL: Cornerstone Therapeutics Inc.; December 2014.

Last Updated: 12/2017 Page 1 of 1

Applies to: Care1st Fareston (Toremifene Citrate)

Covered uses Treatment of metastatic breast cancer in postmenopausal women with estrogen-receptor positive or unknown tumors. Exclusion Criteria Contraindicated in patients with a diagnosis of : 1) Congenital/acquired QT prolongation (Long QT Syndrome) 2) Uncorrected Hypokalemia 3) Uncorrected Hypomagnesemia Required Medical Clinical Documentation must include Information 1) Diagnosis of: Metastatic Breast Cancer in postmenopausal women with estrogen-receptor positive or unknown tumors

2) Trial and failure or contraindications to the preferred medications: o Tamoxifen Tablets

Age restrictions 18 years and older Prescriber Restrictions Coverage Duration 1 year Other Criteria

Reference(s):

1. Fareston [package insert]. Kyowa Kirin, Inc., Bedminster, NJ, May, 2017.

Last Reviewed: 09/2018 Page 1 of 1

Applies to: Care1st Travatan Z (travoprost Solution)

Covered uses All medically accepted indications

Exclusion Criteria

Required Medical 1) Documented diagnosis of raised intraocular pressure due Information to open angle glaucoma or ocular hypertension AND 2) Trial and failure of lantanoprost (xalatan) Age restrictions 16 years and older Prescriber Ophthalmologist Restrictions Coverage Duration 1 year Other Criteria Recommended dosage: One drop in the affected eye(s) once daily in the evening. Do not use more than once a day.

Reference(s):

1. Travoprost. Micromedex Solutions. Truven Health Analytics, Inc. Ann Harbor, MI. Available from http://www.micromedexsolutions.com. 2. Travoprost [Package Insert]. Par Pharmaceutical, Inc. September 2016. http://dailymed.nlm.nih.gov. .

Last Reviewed: 09/2018 Page 1 of 1

Applies to: Care1st Remodulin (treprostinil sodium solution)

Covered uses All medically accepted indications

Exclusion Criteria

Required Medical 1) Documented diagnosis of one of the following: Information • Pulmonary arterial hypertension (PAH) (WHO Group 1), • NYHA Functional Class II-IV symptoms and etiologies of idiopathic or heritable pulmonary arterial hypertension associated with congenital systemic-to- pulmonary shunts • Pulmonary arterial hypertension associated with connective tissue diseases • Pulmonary arterial hypertension requiring transition from Flolan (epoprostenol sodium) Age restrictions 18 years of age Prescriber Cardiologist Restrictions Coverage Duration 1 year Other Criteria Initiate treprostinil at 1.25 ng/kg/min as a continuous infusion for the first 4 weeks and then increase by 2.5 ng/kg/min per week for the remaining duration of the infusion depending on clinical response.

Reference(s):

1. Treprostinil Injection. Micromedex Solutions. Truven Health Analytics, Inc. Ann Harbor, MI. Available from http://www.micromedexsolutions.com. 2. Remodulin. [Package Insert]. Gilead Sciences, Inc. December 2014. http://dailymed.nlm.nih.gov. Accessed January 2018.

Last Updated: 02/2018 Page 1 of 1

Applies to: Care 1st

Trifluoperazine

Covered uses All medically accepted indications Exclusion Criteria Required Medical Documentation of any of the following medical diagnoses: Information • Schizophrenia • Generalized nonpsychotic anxiety

Age restrictions 6 years and over Prescriber Restrictions Coverage Duration 1 year Other Criteria **If request is for 6 and over: PA is not required when prescribed by a psychiatric clinician, a behavioral health pediatrician or other approved prescribers.

Reference(s):

1. Trifluoperazine tablet [package insert]. Upsher-Smith Laboratories, LLC. August 2018.

Created: 09/2018 Page 1 of 1

Applies to: Care1st Valtrex (valacyclovir HCL)

Covered uses All medically accepted indications

Exclusion Criteria Clinically significant hypersensitivity such as anaphylaxis to valacyclovir, acyclovir or any component of the product.

Required Medical 1) Documented diagnosis of one of the following: Information • Genital herpes simplex, initial and recurrent episodes • Herpes labialis • Herpes zoster, shingles • HIV infection, recurrent genital herpes simplex, suppression • Recurrent genital herpes, suppression and transmission reduction • Varicella AND 2. Trial and failure of oral acyclovir Age restrictions 18 years and older, unless diagnosis of herpes labialis then it is 12 years and older or varicella, 2 years and older Prescriber Primary Care Physician Restrictions Coverage Duration 1 year Other Criteria Recommended dosages: 1) Cold sores (herpes labialis)- 2g twice daily for 1 day taken 12 hours apart. 2) Genital herpes • Initial episode: 1g twice daily for 10 days • Recurrent episode: 500mg twice daily for 3 days • Suppressive therapy: 1g once daily or 500 mg once daily in patients with a history of 9 or fewer recurrences per year • HIV-infected patients with CD4+ count ≥100 cells/mm3 Reduction of Transmission: 500 mg once daily 3) Herpes zoster- 2g twice daily for 1 day taken 12 hours apart 4) Chicken pox • 2-18 years old: 20mg/kg administered three times daily for 5 days. Do not exceed 1g three times daily

Reference(s):

1. Valacyclovir. Micromedex Solutions. Truven Health Analytics, Inc. Ann Harbor, MI. Available from http://www.micromedexsolutions.com. 2. Valacyclovir [Package Insert]. Cipla USA Inc. July 2017. http://dailymed.nlm.nih.gov.

Last Updated: 02/2018 Page 1 of 1

Applies to: Care1st Valcyte (valganciclovir)

Covered uses All medically accepted indications

Exclusion Criteria Hypersensitivity to valganciclovir, ganciclovir or any component of the product Required Medical 1) Valganciclovir is FDA indicated for : Information • Treatment of cytomegalovirus retinitis in patients with acquired immunodeficiency syndrome. • Prevention of cytomegalovirus disease in adult heart, kidney or kidney-pancreas transplant patients at high risk (donor CMV seropositive/recipient CMV seronegative ) AND

2) For valganciclovir solution only: Inability to swallow or for pediatric use only Age restrictions 18 years and older unless for prophylaxis indication, approve usage in pediatric patients 1 month -16 years of age for heart transplant and 4 months-16 years of age for kidney transplant Prescriber Primary Care Physician Restrictions Specialist Coverage Duration 6 months Other Criteria Adult patients should use valganciclovir tablets, not valganciclovir oral solution.

Recommended dosage in adult patients: 1) Treatment of CMV Retinitis Induction: 900 mg orally twice daily for 21 days Maintenance: 900 mg orally once daily (ensure inactive CMV retinitis) 2) Prevention of CMV Disease Heart/Kidney-pancreas transplant: 900 mg orally once a day starting within 10 days of transplantation until 100 days post-transplantation Kidney transplant: 900 mg orally once a day starting within 10 days of transplantation until 200 days post- transplantation

Recommended dosage in pediatric patients: 1. Prevention of CMV disease in heart transplant: daily mg dose (7 x BSA x creatinine clearance( CrCL)) should start within 10 days of transplantation until 100 days post-transplantation .

Last Updated: 02/2018 Page 1 of 2

Applies to: Care1st

Reference(s):

1. Valganciclovir. Micromedex Solutions. Truven Health Analytics, Inc. Ann Harbor, MI. Available from http://www.micromedexsolutions.com. 2. Valganciclovir [Package Insert]. Dr. Reddy’s Laboratories Limited. July 2017. http://dailymed.nlm.nih.gov. .

Last Updated: 02/2018 Page 2 of 2

Applies to: Care1st

Vancocin pulvules (vancomycin capsules) First-Vancomycin oral solution (vancomycin solution) Covered uses All medically accepted indications Exclusion Criteria Required Medical 1) Statement of medically accepted indication Information 2) Antibiotic-associated pseudomembranous colitis caused by Clostridium difficile: • Stool culture within 30 days: (+) C. difficile toxin AND • Trial and failure or contraindication to preferred agent: metronidazole

3) Staphyloccus aureus (including methicillin-resistant strains) enterocolitis: approve Age restrictions Prescriber Restrictions Coverage Duration Initial: 14 Days Patients with multiple relapses: 6 weeks Other Criteria Total daily dose should not exceed 2 grams in pediatric patients

Reference(s):

1. Cohen SH, Gerding, DN, Johnson S, Kelly CP, Loo VG, McDonald LC, Pepin J, et al. Clinical Practice Guidelines for Clostridium difﬁcile Infection in Adults: 2010 Update by the Society for Healthcare Epidemiology of America (SHEA) and the Infectious Diseases Society of America (IDSA) 2. Infect Control Hosp Epidemiol. May 2010;31(5):431-55. Available at: http://www.cdc.gov/HAI/pdfs/cdiff/Cohen-IDSA-SHEA-CDI-guidelines- 2010.pdf. Accessed Feb 2, 2014 3. Product Information: VANCOCIN(R) oral capsules, vancomycin HCl oral capsules. ViroPharma Incorporated (per FDA), Exton, PA, 2011.

Last Updated: 12/2017 Page 1 of 1

Applies to: Care1st

Caprelsa (vandetanib)

Covered Uses: All medically accepted indications. Exclusion Criteria Use in patients with congenital long QT syndrome

Required Medical 1) Stated diagnosis of symptomatic or progressive medullary Information thyroid cancer (MTC) with unresectable locally advanced or metastatic disease. 2) Documentation that prescriber is enrolled in the CAPRELSA REMS Program Age restrictions 18 years or older

Prescriber Oncologist or Endocrinologist Restrictions Coverage Duration 1 year Other Criteria 1) Max dose: 300 mg/day

2) Members currently taking this medication at time of enrollment will not be required to meet prerequisites for prior authorization.

Reference(s):

1. National Comprehensive Cancer Network, Inc. 2011, NCCN Clinical Practice Guidelines in Oncology (NCCN®). Version 3.2012 2. Vandetanib [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; December 2016.

Last Updated: 09/2018 Page 1 of 1

Applies to: Care1st

Zelboraf (vemurafenib)

Covered uses All medically accepted indications

Exclusion Criteria Patients with wild-type BRAF melanoma

Required Medical Documentation of either of the following diagnosis: Information 1) Unresectable or metastatic melanoma with BRAF V600E or K gene mutation detected by an FDA approved test -OR-

2) Erdheim-Chester Disease (ECD) with BRAF V600 gene mutation detected by an FDA approved test Age restrictions 18 years or older Prescriber Oncologist Restrictions Coverage Duration 1 year Other Criteria 1) Members currently taking this medication at the time of enrollment will not be required to meet prerequisites for Prior Authorization.

2) FDA Approved Companion Test device name is COBAS 4800 BRAF V600 Mutation Test

Reference(s):

1. National Comprehensive Cancer Network, Inc. 2011, NCCN Clinical Practice Guidelines in Oncology (NCCN®). Version 3.2012. 2. McArthur GA, Chapman PB, Robert C, et al. Safety and efficacy of vemurafenib in BRAF (V600E) and BRAF (V600K) mutation-positive melanoma (BRIM-3): extended follow-up of a phase 3, randomized, open-label study. Lancet Oncol. 2014:15(3):323-32. 3. Product Information: ZELBORAF(R) oral tablets, vemurafenib oral tablets. Genentech USA, Inc. (per FDA), South San Francisco, CA, December 2017.

Last Updated: 09/2018 Page 1 of 1

Applies to: Care1st Viibryd (vilazodone)

Covered uses All medically accepted indications

Exclusion Criteria 1) Patients taking or within 14 days of stopping, monoamine oxidase inhibitors (including linezolid and methylene blue) 2) Diagnosis of bipolar disorder Required Medical 1) Documented diagnosis of major depressive disorder Information (MDD) AND 2) Screening result for bipolar disorder to rule out bipolar diagnosis AND 3) Trial and failure of at least one other treatment alternatives: Wellbutrin, citalopram, escitalopram, fluoxetine, paroxetine, sertraline, Cymbalta, venlafaxine Age restrictions 18 years and older Prescriber Psychiatrist Restrictions Primary Care Physician Coverage Duration 1 year Other Criteria Recommended dosage: 1) Target dosage should be between 20 to 40 mg orally once daily with food To achieve target dosage, titrate Vilazodone as follows: 1) Start with an initial dosage of 10 mg once daily with food 2) Then increase to 20mg once daily with food 3) The dose may be increased up to 40mg once daily with food after a minimum of 7 days between dosage increases

Reference(s):

1. Vilazodone. Micromedex Solutions. Truven Health Analytics, Inc. Ann Harbor, MI. Available from http://www.micromedexsolutions.com. 2. Vilazodone [Package Insert]. Allergan, Inc. January 2017. http://dailymed.nlm.nih.gov. 3. Armstrong, C. APA Releases Guideline on Treatment of Patients with Major Depressive Disorder. American Family Physician. May 2011. https://www.aafp.org/2011/0515/p1219.html

Last Updated: 02/2018 Page 1 of 1

Applies to: Care1st Zolinza (vorinostat)

FDA approved All medically accepted indications. Indications: Exclusion Criteria

Required Medical 1) Stated diagnosis from Oncologist of cutaneous T-cell lymphoma Information (CTCL) for patients who have progressive, persistent or recurrent disease on or following two systemic therapies.

2) Max dose: 400 mg/day Age restrictions 18 years or older

Reference(s):

1. National Comprehensive Cancer Network, Inc. 2011, NCCN Clinical Practice Guidelines in Oncology (NCCN®). Version 3.2012 2. Zolinza [package insert]. Whitehouse Station, NJ: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.; December 2015.

Last Reviewed: 09/2018 Page 1 of 1

Applies to: Care 1st

Geodon (ziprasidone)

Covered uses All medically accepted indications Exclusion Criteria Required Medical Documentation of any of the following medical diagnoses: Information • Schizophrenia • Bipolar disorder (acute and maintenance as adjuncts to lithium or valproate) Age restrictions Prescriber Restrictions Coverage Duration 1 year Other Criteria **If request is for 6 and over: PA is not required when prescribed by a psychiatric clinician, a behavioral health pediatrician or other approved prescribers.

Reference(s):

1. Geodone capsule [package insert]. Roerig. August 2018.

Created: 09/2018 Page 1 of 1

Applies to: Care1st

Hypnotics (zolpidem products): Ambien (zolpidem), Ambien CR (zolpidem ER), Intermezzo /Edluar (zolpidem SL), Zolpimist Spray

Covered uses All medically accepted indications

Exclusion Criteria

Required Medical 1) Diagnosis of: Information • Edluar SL(5mg/10mg), Zolpimist: short-term treatment of insomnia characterized by difficulties with sleep initiation. • zolpidem ER: treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance (as measured by wake time after sleep onset • Zolpidem SL (1.75mg/3.5mg): middle-of-the night awakening that is followed by difficulty returning to sleep.

2) Tried and failure or contraindication/intolerance to preferred: Zolpidem IR, Eszopiclone, Estazolam, Flurazepam, Temazepam, Triazolam, Zaleplon

Age restrictions Must be 18 years or older Prescriber Restrictions Coverage Duration 1 year Other Criteria Zolpidem IR - Covered without PA requirement for ages 6 years and older.

Reference(s):

1. Edluar® (zolpidem tartrate) sublingual tablets [prescribing information]. Somerset, NJ: Meda Pharmaceuticals Inc, October 2014. 2. INTERMEZZO ® (zolpidem tartrate) sublingual tablets [prescribing information]. Stamford, CT: Purdue Pharma L.P., July 2015 3. AMBIEN® (zolpidem tartrate) tablets [prescribing information]. Bridgewater, NJ: sanofi- aventis U.S. LLC, October 2014. 4. AMBIEN CR ® (zolpidem tartrate extended-release) tablets [prescribing information]. Bridgewater, NJ: sanofi-aventis U.S. LLC, October 2014.

Last Updated: 01/2018 Page 1 of 1