Change to the Highmark Health Services Drug

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SEPTEMBER 2013

3rd QUARTER 2013 UPDATE CHANGES TO THE HIGHMARK HEALTH SERVICES DRUG FORMULARIES

The following is the 3rd Quarter 2013 update to the Highmark Health Services Drug Formularies and pharmaceutical management procedures. The formularies and pharmaceutical management procedures are updated on a quarterly basis, and the enclosed changes reflect the decisions made in June 2013 by our Pharmacy and Therapeutics Committee. These updates are effective on the dates noted throughout this document.

Please reference this guide to navigate this communication:

Section I. Highmark Health Services Comprehensive and Progressive Formularies A. Changes to the Highmark Health Services Comprehensive Formulary B. Changes to the Highmark Health Services Progressive Formulary C. Updates to the Pharmacy Utilization Management Programs 1. Updates to the Prior Authorization Program 2. Updates to the Managed Prescription Drug Coverage (MRxC) Program

Section II. Highmark Health Services Medicare-approved Formularies A. Changes to the Highmark Health Services Medicare-approved Closed 2-Tier Formulary B. Changes to the Highmark Health Services Medicare-approved Incentive Formulary C. Changes to the Highmark Health Services Medicare-approved 5-Tier Closed Formulary D. Additions to the Specialty Tier Copay Option E. Updates to the Pharmacy Utilization Management Programs 1. Updates to the Prior Authorization Program 2. Updates to the Managed Prescription Drug Coverage (MRxC) Program

If you have any questions regarding this pharmacy communication or the Highmark Health Services Formularies, please contact your Provider Relations representative or Provider Relations Consultant.

As an added convenience, you can also search the Highmark Health Services Drug Formularies online at https://prc.highmarkblueshield.com/rscprc/hbs/pub?document=https%3A//www.highmarkblueshield.com/ health/documents/pharm-form.html&docId=78. This function allows you to search by the drug name or therapeutic class. (NaviNet® users: Simply click on the Resource Center button and select the Pharmacy/Formulary Information link.)

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Camp Hill, PA 17089

Highmark Health Services Formulary Update – September 2013

SECTION I. Highmark Health Services Comprehensive and Progressive Formularies

A. Changes to the Highmark Health Services Comprehensive Formulary The Highmark Health Services Pharmacy and Therapeutics Committee has reviewed the medications listed in the tables below. Please note that the Highmark Health Services Comprehensive Closed/Incentive Formulary is a complete subset of the Open Formulary; therefore, all medications added to the Comprehensive Closed/Incentive Formulary are automatically added to the Open Formulary. These updates are effective as of the dates noted throughout this document. For your convenience, you can search the Highmark Health Services Comprehensive Formulary online at http://highmark.formularies.com.

Table 1: Products Added (All products added to the formulary effective immediately unless otherwise noted)

Brand Name Generic Name Comments Ophthalmic aminothiol indicated for the treatment of Cystaran™ cysteamine nephropathic cystinosis. Signal Transduction Inhibitor indicated for the treatment of Mekinist™ trametinib unresectable or metastatic malignant melanoma in patients with BRAFV600E or V600K mutations. Kinase inhibitor indicated for the treatment of unresectable or Tafinlar® dabrafenib metastatic malignant melanoma in patients with BRAFV600E mutation.

Table 2: Products Not Added* — effective 8/9/2013

Brand Name Generic Name Preferred Alternatives AcipHex® Sprinkle™ rabeprazole omeprazole, pantoprazole Belviq® lorcaserin Xenical® Breo™ Ellipta™ fluticasone/vilanterol Advair®, Dulera®, Symbicort® Diclegis® doxylamine/pyridoxine Provider discretion Eliquis® apixaban Xarelto®, Pradaxa® Fulyzaq™ crofelemer Provider discretion Ilevro® nepafenac diclofenac, flurbiprofen, ketorolac Invokana™ canagliflozin Various diabetes medications Juxtapid™ lomitapide Provider discretion Karbinal™ ER carbinoxamine maleate diphenhydramine Kynamro® mipomersen sodium Provider discretion Linzess™ linaclotide Amitiza® Liptruzet™ ezetimibe/atorvastatin Zetia®, atorvastatin, simvastatin Ethinyl estradiol and Minastrin™ 24 Fe Gianvi® norethindrone Myrbetriq® mirabegron oxybutynin, Vesicare®, Toviaz® Nymalize™ nimodipine nimodipine Onfi® clobazam lamotrigine, topiramate Osphena™ ospemifene Provider discretion Oxtellar XR™ oxcarbazepine carbamazepine ER, divalproex ER Pertzye® pancrelipase Viokase®, Creon®, Zenpep® Procysbi™ cysteamine bitartrate Provider discretion Prolensa™ bromfenac diclofenac, flurbiprofen, ketorolac Qsymia™ phentermine/topiramate Xenical® 2

ethinyl Quartette™ Seasonique® estradiol/levonorgestrel Sirturo™ bedaquiline Provider discretion Sitavig® acyclovir acyclovir, famciclovir, valacyclovir Tecfidera™ dimethyl fumarate Avonex®, Rebif®, Copaxone® TOBI® Podhaler® tobramycin TOBI® Topicort® desoximetasone Desoximetasone, fluocinonide, betamethasone dipropionate Tudorza™ Pressair™ aclidinium bromide Spiriva® Versacloz™ clozapine clozapine hydrocodone bitartrate and hydrocodone/acetaminophen oral solution, Vituz® chlorpheniramine maleate diphenhydramine oral solution *Physicians may request coverage of these products using the Prescription Drug Medication Request Form, which can be accessed online in our Provider Resource Center; under Provider Forms, select Miscellaneous Forms, and select the form titled Request for Non-Formulary Drug Coverage.

Table 3: Additions to the Specialty Tier Copay Option (Effective upon completion of internal review and operationalization unless otherwise noted)

Brand Name Generic Name Cystaran™ cysteamine Juxtapid™ lomitapide Kynamro® mipomersen sodium Mekinist™ trametinib Procysbi™ cysteamine bitartrate Sirturo™ bedaquiline Tafinlar® dabrafenib Tecfidera™ dimethyl fumarate TOBI® Podhaler® tobramycin

B. Changes to the Highmark Health Services Progressive Formulary For your convenience, you may search the Highmark Health Services Progressive Formulary online at http://highmark.formularies.com. Note: You must click the hyperlink for the Progressive Formulary.

Table 1: Formulary Updates (All products added to the formulary effective immediately unless otherwise noted)

Brand Name Generic Name Tier* Comments Ophthalmic aminothiol indicated for the Cystaran™ cysteamine 3 – Preferred Specialty treatment of nephropathic cystinosis. Signal Transduction Inhibitor indicated for the treatment of unresectable or metastatic Mekinist™ trametinib 3 – Preferred Specialty malignant melanoma in patients with BRAFV600E or V600K mutations. Kinase inhibitor indicated for the treatment of unresectable or metastatic malignant Tafinlar® dabrafenib 3 – Preferred Specialty melanoma in patients with BRAFV600E mutation. Items listed below are non-preferred products — effective 8/9/2013 AcipHex® rabeprazole 3 – Non-formulary Brand omeprazole Sprinkle™ Belviq® lorcaserin 3 – Non-formulary Brand Xenical® Breo™ fluticasone/vilanterol 3 – Non-formulary Brand Dulera®, Symbicort® Ellipta™ Diclegis® doxylamine/pyridoxine 3 – Non-formulary Brand Provider discretion Eliquis® apixaban 3 – Non-formulary Brand warfarin

Fulyzaq™ crofelemer 3 – Non-formulary Brand Provider discretion Ilevro® nepafenac 3 – Non-formulary Brand diclofenac, flurbiprofen, ketorolac Invokana™ canagliflozin 3 – Non-formulary Brand Various diabetes medications Juxtapid™ lomitapide 4 – Non-formulary Specialty Provider discretion Karbinal™ ER carbinoxamine maleate 3 – Non-formulary Brand diphenhydramine Kynamro® mipomersen sodium 4 – Non-formulary Specialty Provider discretion Linzess™ linaclotide 3 – Non-formulary Brand polyethylene glycol Liptruzet™ ezetimibe/atorvastatin 3 – Non-formulary Brand atorvastatin, simvastatin Minastrin™ 24 Ethinyl estradiol and 3 – Non-formulary Brand Gianvi® Fe norethindrone Myrbetriq® mirabegron 3 – Non-formulary Brand oxybutynin, tolterodine, trospium Nymalize™ nimodipine 3 – Non-formulary Brand Provider discretion Onfi® clobazam 3 – Non-formulary Brand lamotrigine, topiramate Osphena™ ospemifene 3 – Non-formulary Brand Provider discretion oxcarbazepine, carbamazepine ER, Oxtellar XR™ oxcarbazepine 3 – Non-formulary Brand divalproex ER Pertzye® pancrelipase 3 – Non-formulary Brand Creon® Procysbi™ cysteamine bitartrate 4 – Non-formulary Specialty Cystagon® Prolensa™ bromfenac 3 – Non-formulary Brand diclofenac, flurbiprofen, ketorolac Qsymia™ phentermine/topiramate 3 – Non-formulary Brand Xenical® ethinyl Quartette™ 3 – Non-formulary Brand levonorgestrel/ethinyl estradiol estradiol/levonorgestrel Sirturo ™ bedaquiline 4 – Non-formulary Specialty Provider discretion Sitavig® acyclovir 3 – Non-formulary Brand acyclovir, famciclovir, valacyclovir Tecfidera™ dimethyl fumarate 4 – Non-formulary Specialty Avonex®, Copaxone® TOBI® tobramycin 4 – Non-formulary Specialty TOBI® Podhaler® Desoximetasone, fluocinonide, Topicort® desoximetasone 3 – Non-formulary Brand betamethasone dipropionate Tudorza™ aclidinium bromide 3 – Non-formulary Brand Spiriva® Pressair™ Versacloz™ clozapine 3 – Non-formulary Brand clozapine hydrocodone bitartrate hydrocodone/acetaminophen oral solution, Vituz® and chlorpheniramine 3 – Non-formulary Brand diphenhydramine oral solution maleate *Tier 1: Formulary generic drugs; Tier 2: Formulary brand drugs; Tier 3: Non-formulary generic drugs, non-formulary brand drugs, formulary specialty drugs; Tier 4: Non-formulary specialty drugs

C. Updates to the Pharmacy Utilization Management Programs 1. Updates to the Prior Authorization Program (If approved, authorization may be granted for up to one year unless otherwise noted.) Policy Drug Name Effective Date Approval Criteria MAP kinase inhibitors When a benefit, MAP kinase inhibitors may be approved when the following criteria are met:

• Vemurafenib and dabrafenib are being used for the treatment of Medications: Mekinist™ 8/9/2013 patients with unresectable or metastatic melanoma with (trametinib), Tafinlar® BRAFV600E mutation as detected by an FDA-approved test OR (dabrafenib), Zelboraf® • Trametinib is being used for the treatment of patients with (vemurafenib) unresectable or metastatic melanoma with BRAFV600E or BRAFV600K mutation as detected by an FDA-approved test AND

• Trametinib is not being used in patients who have received prior BRAF inhibitor therapy (e.g., Zelboraf, Tafinlar).

Use of MAP kinase inhibitors for disease states outside of their FDA- approved indications should be denied based on the lack of clinical data to support their effectiveness and safety in other conditions. When a benefit, Procysbi may be approved when all of the following criteria are met:

1. The member is at least 6 years of age and has a documented Procysbi™ (cysteamine 8/9/2013 diagnosis of nephropathic cystinosis AND bitartrate) 2. The member has had an adequate trial and failure of or intolerance to immediate-release cysteamine bitartrate (Cystagon®).

When a benefit, dimethyl fumarate may be approved when the following criteria are met:

Combination use of disease-modifying MS agents (dimethyl fumarate, fingolimod, interferons, Copaxone, Tysabri, etc.) will not be authorized. Use of dimethyl fumarate for disease states outside of its FDA-approved indications will be denied based on the lack of clinical data to support its effectiveness and safety in other conditions. When a benefit, coverage for a hyperammonium agent may be approved if members meet the following criteria:

Urea cycle disorder 8/9/2013 1. Buphenyl is being prescribed as an adjunct therapy to dietary medications: Buphenyl® protein restriction for chronic management of urea cycle disorders (sodium phenylbutyrate), involving deficiencies of carbamylphosphate synthetase (CPS), Carbaglu® (carglumic acid), Ravicti™ (glycerol argininosuccinic acid synthetase (AAS), or ornithine phenylbutyrate) transcarbamylase (OTC) OR 2. Carbaglu is being prescribed as an adjunct therapy for acute hyperammonemia or maintenance therapy for chronic hyperammonemia due to hepatic enzyme N-acetylglutamate synthase (NAGS) deficiency OR 3. Ravicti is being prescribed with dietary protein restriction for chronic management of a urea cycle disorder (UCD) when the condition cannot be managed by dietary protein restriction alone.

Coverage of Buphenyl, Carbaglu, or Ravicti for disease states outside of their FDA-approved indications should be denied based on the lack of clinical data to support their effectiveness and safety in other conditions.

2. Updates to the Managed Prescription Drug Coverage (MRxC) Program (If approved, authorization may be granted for up to one year unless otherwise noted.) Policy Drug Name Effective Date Automatic Approval Criteria*

When a benefit, coverage for brand HMG-CoA Reductase Inhibitors Brand statin edit: addition 8/15/2013 TM (Statins) may be approved if members meet the following criterion: of LIPTRUZET 5

(atorvastatin/ezetimibe) 1. The member has a documented trial and failure of at least one generic statin (e.g., pravastatin, simvastatin, lovastatin, atorvastatin, etc.).

Additional Approval Criteria Members who meet the criterion as outlined below will receive automatic authorization at the pharmacy point of service without documentation of additional information. Claims will automatically adjudicate online, with no prior authorization required.

1. The member has at least one prescription drug claim within the past 24 months for a generic statin.

When a benefit, buprenorphine may be approved when the following criteria are met:

1. The product is being used for the management of moderate to Butrans™ severe chronic pain in patients requiring a continuous, around- (buprenorphine) non- 9/6/13 the-clock opioid analgesic for an extended period of time AND opioid dependence use The member has tried and failed at least two (2) previous federal legend medications for pain, including NSAIDs (ibuprofen, meloxicam, naproxen, etc.), tramadol, or opioids.

2. Upon approval, coverage will be limited to 4 units of Butrans™ every 28 days. Exceptions to the quantity limit may be approved to accommodate dose titration but will not be approved to accommodate doses greater than 20mcg/hour or the application of multiple transdermal systems.

Subutex® (buprenorphine) and Suboxone® (buprenorphine/naloxone) are indicated for the treatment of opioid dependence and are not eligible for coverage when used for the treatment of chronic pain. For coverage criteria associated with the use of buprenorphine for the treatment of opioid dependence, please refer to Highmark Health Services Pharmacy Policy J-23.

For Medicare Part D beneficiaries, buprenorphine transdermal patches may be approved when used for a medically accepted indication (identified in Drugdex, AFHS Drug Information, or Clinical Pharmacology) as defined by the Centers for Medicare & Medicaid Services (CMS).

Additional Approval Criteria Members who meet the criteria as outlined below will receive automatic authorization at the pharmacy point of service without documentation of additional information. Claims will automatically adjudicate online, with no prior authorization required.

1. The member has at least one prescription drug claim for two unique federal legend medications for pain, including NSAIDs (ibuprofen, meloxicam, naproxen, etc.), tramadol, or opioids, within the last six months.

2. The member has at least one paid claim for Butrans (buprenorphine) within the last six months.

Members who do not meet the above criteria will require prior authorization.

* Standard prior authorization criteria will apply for members who do not meet the automatic approval criteria.

All effective dates are tentative and subject to delay, pending internal review.

SECTION II. Highmark Health Services Medicare-approved Formularies

A. Changes to the Highmark Health Services Medicare-approved Closed 2-Tier Formulary The Highmark Health Services Pharmacy and Therapeutics Committee has reviewed the medications listed in the tables below. For your convenience, you can search the Highmark Health Services Medicare-approved Formularies online at http://highmark.medicare-approvedformularies.com.

Table 1: Products Added (All products added to the formulary effective immediately unless otherwise noted)

Brand Name Generic Name Comments Extended-release injectable atypical antipsychotic indicated for the Abilify Maintena™ aripiprazole treatment of schizophrenia. Ophthalmic aminothiol indicated for the treatment of nephropathic Cystaran™ cysteamine cystinosis. Signal Transduction Inhibitor indicated for the treatment of Mekinist™ trametinib unresectable or metastatic malignant melanoma in patients with BRAFV600E or V600K mutations. Benzodiazepine indicated for the treatment of seizures associated Onfi® clobazam with Lennox-Gastaut syndrome. Antiepileptic indicated for adjunctive therapy in the treatment of Oxtellar XR™ oxcarbazepine partial seizures. Cystine-depleting agent indicated for the management of Procysbi™ cysteamine bitartrate nephropathic cystinosis. Nitrogen-binding agent indicated for hyperammonemia in patients Ravicti™ glycerol phenylbutyrate with urea cycle disorders. Anti-mycobacterial indicated as part of combination therapy for Sirturo™ bedaquiline pulmonary multi-drug-resistant tuberculosis. Kinase inhibitor indicated for the treatment of unresectable or Tafinlar® dabrafenib metastatic malignant melanoma in patients with BRAFV600E mutation. Immunomodulator indicated for the treatment of adults with Tecfidera™ dimethyl fumarate relapsing forms of multiple sclerosis. Antibacterial aminoglycoside indicated for the management of cystic TOBI® Podhaler® tobramycin fibrosis patients with Pseudomonas aeruginosa. Versacloz™ clozapine Atypical antipsychotic indicated for the treatment of schizophrenia.

Table 2: Products Not Added*

Brand Name Generic Name Preferred Alternatives/Comments AcipHex® rabeprazole omeprazole, pantoprazole, lansoprazole Sprinkle™ Breo™ Ellipta™ fluticasone/vilanterol Symbicort® Delzicol™ mesalamine sulfasalazine, Pentasa®, Lialda® Diclegis® doxylamine/pyridoxine Provider discretion Fulyzaq™ crofelemer Provider discretion Ilevro® nepafenac bromfenac, diclofenac, ketorolac Invokana™ canagliflozin Various diabetes medications Karbinal™ ER carbinoxamine maleate levocetirizine Linzess™ linaclotide Amitiza® 7

Liptruzet™ ezetimibe/atorvastatin Zetia®, atorvastatin, simvastatin Ethinyl estradiol and Minastrin™ 24 Fe Gianvi® norethindrone Myrbetriq® mirabegron oxybutynin, Vesicare®, Toviaz® Nymalize™ nimodipine nimodipine Osphena™ ospemifene Provider discretion Pertzye® pancrelipase Creon®, Zenpep® Prolensa™ bromfenac bromfenac, diclofenac, ketorolac ethinyl Quartette™ levonorgestrel/ethinyl estradiol estradiol/levonorgestrel Sitavig® acyclovir acyclovir, famciclovir, valacyclovir Topicort® desoximetasone Desoximetasone, fluocinonide, betamethasone dipropionate Tudorza™ aclidinium bromide Spiriva® Pressair™ hydrocodone bitartrate and hydrocodone/acetaminophen oral solution, diphenhydramine oral Vituz® chlorpheniramine maleate solution *Physicians may request coverage of these products using the Prescription Drug Medication Request Form, which can be accessed online in our Provider Resource Center; under Provider Forms, select Miscellaneous Forms, and select the form titled Request for Non-Formulary Drug Coverage.

B. Changes to the Highmark Health Services Medicare-approved Incentive Formulary The Highmark Health Services Pharmacy and Therapeutics Committee has reviewed the medications listed in the tables below. For your convenience, you can search the Highmark Health Services Medicare-approved Formularies online at http://highmark.medicare-approvedformularies.com.

Table 1: Preferred Products Added (All products added to the formulary effective immediately unless otherwise noted)

Brand Name Generic Name Comments Atypical antipsychotic indicated for the treatment of Versacloz™ clozapine schizophrenia.

Table 2: Non-Preferred Products

Brand Name Generic Name Alternatives/Comments AcipHex® Sprinkle™ rabeprazole omeprazole, pantoprazole, lansoprazole Breo™ Ellipta™ fluticasone/vilanterol Dulera®, Symbicort® Delzicol™ mesalamine sulfasalazine, Pentasa®, Lialda® Diclegis® doxylamine/pyridoxine Provider discretion Fulyzaq™ crofelemer Provider discretion Ilevro® nepafenac bromfenac, diclofenac, ketorolac Invokana™ canagliflozin Various diabetes medications Karbinal™ ER carbinoxamine maleate levocetirizine Kombiglyze™ saxagliptin/metformin Janumet®, Jentadueto® *effective 1/1/2014 Linzess™ linaclotide Amitiza® Liptruzet™ ezetimibe/atorvastatin Zetia®, atorvastatin, simvastatin ethinyl estradiol and Minastrin™ 24 Fe Gianvi® norethindrone Myrbetriq® mirabegron oxybutynin, Vesicare®, Toviaz® Nymalize™ nimodipine nimodipine Onfi® clobazam lamotrigine, topiramate Onglyza® saxagliptin Januvia®, Tradjenta® *effective 1/1/2014 Osphena™ ospemifene Provider discretion 8

Oxtellar XR™ oxcarbazepine oxcarbazepine, carbamazepine ER, divalproex ER Oxycontin® oxycodone morphine ER, oxymorphone ER *effective 1/1/2014 Pertzye® pancrelipase Creon®, Zenpep® Prolensa™ bromfenac bromfenac, diclofenac, ketorolac ethinyl Quartette™ levonorgestrel/ethinyl estradiol estradiol/levonorgestrel Sitavig® acyclovir acyclovir, famciclovir, valacyclovir Topicort® desoximetasone desoximetasone, fluocinonide, betamethasone dipropionate Tudorza™ Pressair™ aclidinium bromide Spiriva® hydrocodone bitartrate and hydrocodone/acetaminophen oral solution, diphenhydramine Vituz® chlorpheniramine maleate oral solution

C. Changes to the Highmark Health Services Medicare-approved 5-Tier Closed Formulary The Highmark Health Services Pharmacy and Therapeutics Committee has reviewed the medications listed in the tables below. For your convenience, you can search the Highmark Health Services Medicare-approved Formularies online at http://highmark.medicare-approvedformularies.com.

Table 1: Preferred Products Added (All products added to the formulary effective immediately unless otherwise noted)

Brand Name Generic Name Comments Atypical antipsychotic indicated for the treatment of Versacloz™ clozapine schizophrenia.

Table 2: Non-Preferred Products

Brand Name Generic Name Comments Kombiglyze™ saxagliptin/metformin Janumet®, Jentadueto® *effective 1/1/2014 Onfi® clobazam lamotrigine, topiramate Onglyza® saxagliptin Januvia®, Tradjenta® *effective 1/1/2014 Oxtellar XR™ oxcarbazepine oxcarbazepine, carbamazepine ER, divalproex ER Oxycontin® oxycodone morphine ER, oxymorphone ER *effective 1/1/2014

Table 3: Products Not Added*

Brand Name Generic Name Preferred Alternatives/Comments AcipHex® Sprinkle™ rabeprazole omeprazole, pantoprazole, lansoprazole Breo™ Ellipta™ fluticasone/vilanterol Symbicort® Delzicol™ mesalamine sulfasalazine, Pentasa®, Lialda® Diclegis® doxylamine/pyridoxine Provider discretion Fulyzaq™ crofelemer Provider discretion Ilevro® nepafenac bromfenac, diclofenac, ketorolac Invokana™ canagliflozin Various Diabetes medications Karbinal™ ER carbinoxamine maleate levocetirizine Liptruzet™ ezetimibe/atorvastatin Zetia®, atorvastatin, simvastatin Linzess™ linaclotide Amitiza® ethinyl estradiol and Minastrin™ 24 Fe Gianvi® norethindrone Myrbetriq® mirabegron oxybutynin, Vesicare®, Toviaz® Nymalize™ nimodipine nimodipine Osphena™ ospemifene Provider discretion 9

Prolensa™ bromfenac bromfenac, diclofenac, ketorolac ethinyl Quartette™ levonorgestrel/ethinyl estradiol estradiol/levonorgestrel Pertzye® pancrelipase Creon®, Zenpep® Sitavig® acyclovir acyclovir, famciclovir, valacyclovir Topicort® desoximetasone desoximetasone, fluocinonide, betamethasone dipropionate Tudorza™ Pressair™ aclidinium bromide Spiriva® hydrocodone bitartrate and hydrocodone/acetaminophen oral solution, diphenhydramine oral Vituz® chlorpheniramine maleate solution *Physicians may request coverage of these products using the Prescription Drug Medication Request Form, which can be accessed online in our Provider Resource Center; under Provider Forms, select Miscellaneous Forms, and select the form titled Request for Non-Formulary Drug Coverage.

D. Additions to the Specialty Tier Copay Option (applicable to the Medicare-approved Incentive Formulary and the Medicare-approved 5-Tier Closed Formulary) (Effective immediately upon CMS approval)

Brand Name Generic Name Abilify Maintena™ aripiprazole Cystaran™ cysteamine Mekinist™ trametinib Procysbi™ cysteamine bitartrate Ravicti™ glycerol phenylbutyrate Sirturo ™ bedaquiline Tafinlar® dabrafenib Tecfidera™ dimethyl fumarate TOBI® Podhaler® tobramycin

E. Updates to the Pharmacy Utilization Management Programs 1. Updates to the Prior Authorization Program (If approved, authorization may be granted for up to one year unless otherwise noted.) Policy Effective Drug Name Date Approval Criteria When a benefit, MAP kinase inhibitors may be approved when the following criteria are met:

• Vemurafenib and dabrafenib are being used for the treatment of patients with unresectable or metastatic melanoma with BRAFV600E mutation as detected by an FDA-approved test OR MAP Kinase • Trametinib is being used for the treatment of patients with unresectable or Inhibitors metastatic melanoma with BRAFV600E or BRAFV600K mutation as detected by an FDA-approved test AND Medications: Immediately • Trametinib is not being used in patients who have received prior BRAF Mekinist™ inhibitor therapy (e.g., Zelboraf, Tafinlar). (trametinib), upon CMS Tafinlar® approval (dabrafenib), Use of MAP kinase inhibitors for disease states outside of their FDA-approved Zelboraf® indications should be denied based on the lack of clinical data to support their (vemurafenib) effectiveness and safety in other conditions.

For Medicare Part D beneficiaries, MAP kinase inhibitors may be approved when used for a medically accepted indication as defined by the Centers for Medicare & Medicaid Services (CMS).

When a benefit, Procysbi may be approved when all of the following criteria are met:

1. The member is at least 6 years of age and has a documented diagnosis of nephropathic cystinosis AND Procysbi™ Immediately 2. The member has had an adequate trial and failure of or intolerance to (cysteamine upon CMS immediate-release cysteamine bitartrate (Cystagon®). bitartrate) approval For Medicare Part D beneficiaries, Procysbi may be approved when used for a medically accepted indication (identified in Drugdex, AFHS Drug Information, or Clinical Pharmacology) as defined by the Centers for Medicare & Medicaid Services (CMS). When a benefit, coverage for Ravicti may be approved if members meet the following criterion: Urea cycle Immediately disorder upon CMS • Ravicti is being prescribed with dietary protein restriction for chronic medications: approval management of a urea cycle disorder (UCD) when the condition cannot Ravicti™ (glycerol be managed by dietary protein restriction alone. phenylbutyrate) Coverage of Ravicti for disease states outside of its FDA-approved indications should be denied based on the lack of clinical data to support its effectiveness and safety in other conditions.

For Medicare Part D beneficiaries, Ravicti may be approved when used for a medically accepted indication as defined by the Centers for Medicare & Medicaid Services (CMS). When a benefit, dimethyl fumarate may be approved when the following criteria are met:

1. Members must have a documented diagnosis of relapsing forms of multiple sclerosis (relapsing-remitting, relapsing secondary progressive, or progressive relapsing multiple sclerosis) AND Tecfidera™ Immediately 2. The prescribed dose of dimethyl fumarate does not exceed 240 mg twice (dimethyl upon CMS daily. fumarate) approval Combination use of disease-modifying MS agents (dimethyl fumarate, fingolimod, interferons, Copaxone, Tysabri, etc.) will not be authorized. Use of dimethyl fumarate for disease states outside of its FDA-approved indications will be denied based on the lack of clinical data to support its effectiveness and safety in other conditions.

2. Updates to the Managed Prescription Drug Coverage (MRxC) Program (If approved, authorization may be granted for up to one year unless otherwise noted.) Policy Effective Drug Name Date Automatic Approval Criteria* When a benefit, buprenorphine may be approved when the following criteria are met:

1. The product is being used for the management of moderate to severe chronic pain in patients requiring a continuous, around-the-clock opioid Butrans™ TBD analgesic for an extended period of time AND (buprenorphine) non-opioid dependence use The member has tried and failed at least two (2) previous federal legend medications for pain, including NSAIDs (ibuprofen, meloxicam, naproxen,

etc.), tramadol, or opioids.

2. The member has at least one paid claim for Butrans (buprenorphine) within the last six months.

Members who do not meet the above criteria will require prior authorization.

* Standard prior authorization criteria will apply for members who do not meet the automatic approval criteria.

All effective dates are tentative and subject to delay, pending internal review or CMS approval.

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