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Highmark Blue Shield is an independent licensee of the Blue Cross and Blue Shield Association. NaviNet is a registered trademark of NaviNet, Inc., which is an independent company that provides a secure, web-based portal between providers and health insurance companies. JANUARY/FEBRUARY 2020 UPDATE CHANGES TO THE HIGHMARK DRUG FORMULARIES Following is the update to the Highmark Drug Formularies and pharmaceutical management procedures for January/February 2020. As of January 2020, the formularies and pharmaceutical management procedures will be updated on a bimonthly basis, rather than quarterly, and the following changes reflect the decisions made in November 2019 by our Pharmacy and Therapeutics Committee. These updates are effective on the dates noted throughout this document. Please reference the guide below to navigate this communication: Section I. Highmark Commercial and Healthcare Reform Formularies A. Changes to the Highmark Comprehensive Formulary and the Highmark Comprehensive Healthcare Reform Formulary B. Changes to the Highmark Progressive Formulary and the Highmark Progressive Healthcare Reform Formulary C. Changes to the Highmark Healthcare Reform Essential Formulary D. Changes to the Highmark National Select Formulary E. Updates to the Pharmacy Utilization Management Programs 1. Prior Authorization Program 2. Managed Prescription Drug Coverage (MRxC) Program 3. Quantity Level Limit (QLL) Programs Section II. Highmark Medicare Part D Formularies A. Changes to the Highmark Medicare Part D 5-Tier Incentive Formulary B. Changes to the Highmark Medicare Part D 5-Tier Closed Formulary C. Additions to the Specialty Tier D. Updates to the Pharmacy Utilization Management Programs 1. Prior Authorization Program 2. Managed Prescription Drug Coverage (MRxC) Program 3. Quantity Level Limit (QLL) Program As an added convenience, you can also search our drug formularies and view utilization management policies on the Provider Resource Center (accessible via NaviNet ® or our website). Click the Pharmacy Program/Formularies link from the menu on the left. JANUARY 2020

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Page 1: JANUARY/FEBRUARY 2020 UPDATES: CHANGES TO THE …...A. Changes to the Highmark Comprehensive Formulary and the Highmark Comprehensive Healthcare Reform Formulary The Highmark Pharmacy

Highmark Blue Shield is an independent licensee of the Blue Cross and Blue Shield Association. NaviNet is a registered trademark of NaviNet, Inc., which is an independent company that provides a secure, web-based portal between providers and health insurance companies.

JANUARY/FEBRUARY 2020 UPDATE CHANGES TO THE HIGHMARK DRUG FORMULARIES Following is the update to the Highmark Drug Formularies and pharmaceutical management procedures for January/February 2020. As of January 2020, the formularies and pharmaceutical management procedures will be updated on a bimonthly basis, rather than quarterly, and the following changes reflect the decisions made in November 2019 by our Pharmacy and Therapeutics Committee. These updates are effective on the dates noted throughout this document. Please reference the guide below to navigate this communication: Section I. Highmark Commercial and Healthcare Reform Formularies

A. Changes to the Highmark Comprehensive Formulary and the Highmark Comprehensive Healthcare Reform Formulary

B. Changes to the Highmark Progressive Formulary and the Highmark Progressive Healthcare Reform Formulary

C. Changes to the Highmark Healthcare Reform Essential Formulary D. Changes to the Highmark National Select Formulary E. Updates to the Pharmacy Utilization Management Programs

1. Prior Authorization Program 2. Managed Prescription Drug Coverage (MRxC) Program 3. Quantity Level Limit (QLL) Programs

Section II. Highmark Medicare Part D Formularies

A. Changes to the Highmark Medicare Part D 5-Tier Incentive Formulary B. Changes to the Highmark Medicare Part D 5-Tier Closed Formulary C. Additions to the Specialty Tier D. Updates to the Pharmacy Utilization Management Programs

1. Prior Authorization Program 2. Managed Prescription Drug Coverage (MRxC) Program 3. Quantity Level Limit (QLL) Program

As an added convenience, you can also search our drug formularies and view utilization management policies on the Provider Resource Center (accessible via NaviNet® or our website). Click the Pharmacy Program/Formularies link from the menu on the left.

JANUARY 2020

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Important Drug Safety Updates Update: Health Professional and Consumer on Recent Recalled Products Due to Detection of Impurities and Potential Risk of Cancer As part of an ongoing investigation into the voluntary recall of products due to the detection of probable human carcinogen impurities and increased risk of cancer, there were six additional voluntary recalls. Health care professionals should be aware that the recalled products pose an unnecessary risk to patients. Pharmacists and physicians may direct patients to alternative treatment prior to returning to their medications. Physicians should evaluate the risk versus the benefit if treatment is stopped immediately, as stopping treatment immediately without alternative treatment may lead to a higher risk of harm to the patient’s health. The additional products that have been recalled due to the impurities are listed below. Not all products from all the manufacturers are recalled. Patients and physicians should check the FDA website to see if the lot number of their medication has been included in the recall.

Manufacturer Recalled Drugs Detected Impurity Dr. Reddy’s Laboratories Ltd.

Ranitidine tablets and capsules

N-Nitrosodimethylamine (NDMA)

Lannett Company Ranitidine syrup N-Nitrosodimethylamine (NDMA)

Novitium Pharma LLC Ranitidine hydrochloride capsules

N-Nitrosodimethylamine (NDMA)

Aurobindo Pharma USA, Inc.

Ranitidine tablets, capsules, and syrup

N-Nitrosodimethylamine (NDMA)

Amneal Pharmaceuticals, LLC

Ranitidine tablets and syrup N-Nitrosodimethylamine (NDMA)

Glenmark Pharmaceutical Inc.

Ranitidine tablets N-Nitrosodimethylamine (NDMA)

Mavyret, Zepatier, and Vosevi: Drug Safety Communication – FDA Warns About Rare Occurrence of Serious Liver Injury On August 28, 2019, the FDA announced it had received reports that the use of Mavyret, Zepatier, or Vosevi to treat chronic hepatitis C in patients with moderate to severe liver impairment has resulted in rare cases of worsening liver function or liver failure. These medicines are not indicated for use in patients with moderate to severe liver impairment. Health care professionals should continue to prescribe Mavyret, Zepatier, or Vosevi as indicated in the prescribing information for patients without liver impairment or with mild liver impairment (Child-Pugh A). Discontinue these medicines in patients who develop signs and symptoms of liver decompensation or as clinically indicated.

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Ibrance (palbociclib), Kisqali (ribociclib), and Verzenio (abemaciclib): Drug Safety Communication – FDA Warns About Rare But Severe Lung Inflammation On September 13, 2019, the FDA issued a warning that Ibrance (palbociclib), Kisqali (ribociclib), and Verzenio (abemaciclib) used to treat some patients with advanced breast cancers may cause rare but severe inflammation of the lungs. The overall benefit of CDK 4/6 inhibitors is still greater than the risks when used as prescribed. Health care professionals should monitor patients regularly for pulmonary symptoms indicative of interstitial lung disease (ILD) and/or pneumonitis. Interrupt CDK 4/6 inhibitor treatment in patients who have new or worsening respiratory symptoms, and permanently discontinue treatment in patients with severe ILD and/or pneumonitis. Alprazolam Tablets by Mylan Pharmaceuticals Inc.: Recall – Potential of Foreign Substance On October 25, 2019, Mylan Pharmaceuticals Inc. announced a recall of one lot of Alprazolam tablets, schedule IV controlled substance (C-IV) 0.5 mg. The affected product was recalled due to the potential presence of foreign substance. Levetiracetam Oral Solution by Lannett Company, Inc.: Recall – Contamination On December 18, 2019, Lannett Company, Inc. announced a recall of two lots of Levetiracetam Oral Solution, 100mg/mL. The affected product was recalled due to contamination with Bacillus subtilis, which makes it possible that a severe infection may occur in immunocompromised patients. Adverse events or side effects related to the use of these products should be reported to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.

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Highmark Formulary Update – January 2020

SECTION I. Highmark Commercial and Healthcare Reform Formularies A. Changes to the Highmark Comprehensive Formulary and the Highmark Comprehensive Healthcare Reform Formulary The Highmark Pharmacy and Therapeutics Committee has reviewed the medications listed in the tables below. Please note that the Highmark Comprehensive Closed/Incentive Formulary is a complete subset of the Open Formulary; therefore, all medications added to the Comprehensive Closed/Incentive Formulary are also added to the Open Formulary. These updates are effective on the dates noted throughout this document. For your convenience, you can search the following formularies online:

Highmark Comprehensive Formulary: (https://client.formularynavigator.com/Search.aspx?siteCode=8103967260) Highmark Comprehensive Healthcare Reform Formulary: (https://client.formularynavigator.com/Search.aspx?siteCode=4906449921)

Highmark is happy to inform you that Table 1 includes products that have been added to the formulary. Adding products to the formulary may mean lower copays or coinsurance rates for members. By adding products to the formulary, Highmark hopes to promote adherence to medication protocols and improve the overall health of our members.

Table 1. Products Added (All products added to the formulary effective December 20, 2019, unless otherwise noted.)

Brand Name Generic Name Comments Baqsimi nasal spray glucagon Nasal spray for treatment of severe

hypoglycemia in patients with diabetes mellitus. Gvoke glucagon Prefilled syringe for treatment of severe

hypoglycemia in patients with diabetes mellitus. Rinvoq** upadacitinib Janus Kinase (JAK) inhibitor for the treatment of

moderate-to-severe rheumatoid arthritis Harvoni oral pellets* ledipasvir/sofosbuvir Direct acting antiviral (DAA) for the treatment of

chronic hepatitis C virus (HCV) *Effective date to be determined. ** Effective date 11/07/2019 Coverage may be contingent upon plan benefits.

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Table 2. Products Not Added**

Brand Name Generic Name Preferred Alternatives Hadlima* adalimumab-bwwd Humira Accrufer* ferric maltol ferrous sulfate tablet, ferrous gluconate tablet Wakix pitolisant modafinil tablet, dextroamphetamine/

amphetamine tablet, methylphenidate HCl tablet

pretomanid pretomanid Isoniazid tablet, Levofloxacin Hemihydrate tablet

Rozlytrek entrectinib Vitrakvi, Xalkori Inrebic fedratinib Jakafi Xenleta oral lefamulin Moxifloxacin HCl, Levofloxacin Hemihydrate Nourianz istradefylline selegiline capsule, selegiline tablet, entacapone

tablet Riomet ER oral solution* metformin Metformin HCl ER tablet, extended release 24

hour Ibsrela* tenapanor Amitiza, Linzess Ozobax baclofen baclofen 10 mg tablet, baclofen 20 mg tablet Rybelsus semaglutide Ozempic, Victoza Fasenra autoinjector benralizumab Asmanex twisthaler/HFA, Flovent Diskus/HFA,

Arnuity Ellipta Hemady* dexamethasone dexamethasone tablet Bonsity* teriparatide Alendronate tablets, Ibandronate tablets,

Tymlos Aklief trifaotene tretinoin cream, tretinoin gel (gram) 0.01%,

0.025% Reyvow* lasmiditan sumatriptan succinate tablet, rizatriptan tablet,

zolmitriptan tablet Secuado* asenapine olanzapine tablet, olanzapine ODT, risperidone

tablet Amzeeq topical foam minocycline clindamycin phosphate gel (gram), clindamycin

phosphate solution non-oral, erythromycin solution non-oral

Trikafta elexacaftor/ivacaftor/texacaftor Provider discretion Sovaldi oral pellets* sofosbuvir Harvoni, ledipasvir-sofosbuvir

Coverage may be contingent upon plan benefits. *Effective date to be determined. **Physicians may request coverage of these products using the Prescription Drug Medication Request Form, which can be accessed online in Highmark’s Provider Resource Center. Under Provider Forms, select Miscellaneous Forms, and select the form titled Request for Non-Formulary Drug Coverage.

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Table 3. Additions to the Specialty Tier Copay Option Note: The specialty tier does not apply to Highmark Delaware Healthcare Reform members; see Highmark Delaware’s online Provider Resource Center and access the Pharmacy Program/Formularies link for details on the formularies and formulary options that apply to Highmark Delaware Healthcare Reform members.

(Effective upon completion of internal review and implementation unless otherwise noted.)

Brand Name Generic Name Hadlima addalimumab-bwwd Accrufer ferric maltol Wakix pitolisant Rozlytrek entrectinib Rinvoq upadacitinib Inrebic fedratinib Xenleta oral lefamulin Nourianz istradefylline Harvoni oral pellets ledipasvir/sofosbuvir Sovaldi oral pellets sofosbuvir Ozobax baclofen Fasenra autoinjector benralizumab Hemady dexamethasone Bonsity teriparatide Trikafta elexacaftor/ivacaftor/texacaftor

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B. Changes to the Highmark Progressive Formulary and the Highmark Healthcare Reform Progressive Formulary

Note: The Progressive Formulary does not apply to Highmark Delaware members; see Highmark Delaware’s online Provider Resource Center and access the Pharmacy Program/Formularies link for details on the formularies and formulary options that apply to Highmark Delaware members. For your convenience, you may search the following formularies online:

Highmark Progressive Formulary: (https://client.formularynavigator.com/Search.aspx?siteCode=1176922773) Highmark Healthcare Reform Progressive Formulary: (https://client.formularynavigator.com/Search.aspx?siteCode=4909431197)

Table 1. Formulary Updates (All products added to the formulary effective December 20, 2019, unless otherwise noted.)

Brand Name Generic Name Tier Comments/Preferred

Alternatives Items listed below are preferred products

Baqsimi nasal spray glucagon 2 – Preferred brand Nasal spray for treatment of severe hypoglycemia in patients with diabetes mellitus.

Gvoke glucagon 2 – Preferred brand Prefilled syringe for treatment of severe hypoglycemia in patients with diabetes mellitus.

Rinvoq** upadacitinib 3 – Preferred specialty

Janus Kinase (JAK) inhibitor for the treatment of moderate-to-severe rheumatoid arthritis Additional preferred products: Actemra (tocilizumab), Enbrel (etanercept), Humira (adalimumab), Xeljanz/Xeljanz XR (tofacitinib)

Harvoni oral pellets* ledipasvir/sofosbuvir 3 – Preferred specialty

Direct acting antiviral (DAA) for the treatment of chronic HCV

Items listed below are non-preferred products pretomanid pretomanid 3 – Non-preferred

brand Isoniazid tablet, Levofloxacin Hemihydrate tablet

Riomet ER oral solution*

metformin 3 – Non-preferred brand

Metformin HCL ER tablet, extended release 24 hour

Ibsrela* tenapanor 3 – Non-preferred brand

Provider discretion

Rybelsus semaglutide 3 – Non-preferred brand

Ozempic, Victoza

Aklief trifaotene 3 – Non-preferred brand

tretinoin cream, tretinoin gel (gram) 0.01%, 0.025%

Reyvow* lasmiditan 3 – Non-preferred brand

sumatriptan succinate tablet, rizatriptan tablet, zolmitriptan tablet

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Secuado* asenapine 3 – Non-preferred brand

olanzapine tablet, olanzapine ODT, risperidone tablet

Amzeeq topical foam minocycline 3 – Non-preferred brand

clindamycin phosphate gel (gram), clindamycin phosphate solution non-oral, erythromycin solution non-oral

Hadlima* adalimumab-bwwd 4 – Non-preferred specialty

Humira

Accrufer* ferric maltol 4 – Non-preferred specialty

Provider discretion

Wakix pitolisant 4 – Non-preferred specialty

modafinil tablet, dextroamphetamine/amphetamine tablet, methylphenidate HCl tablet

Rozlytrek entrectinib 4 – Non-preferred specialty

Vitrakvi, Xalkori

Inrebic fedratinib 4 – Non-preferred specialty

Jakafi

Xenleta oral lefamulin 4 – Non-preferred specialty

Moxifloxacin HCl^, Levofloxacin Hemihydrate

Nourianz istradefylline 4 – Non-preferred specialty

selegiline capsule, selegiline tablet, entacapone tablet^

Ozobax baclofen 4 – Non-preferred specialty

baclofen 10 mg tablet, baclofen 20 mg tablet, tizanidine tablet

Fasenra autoinjector benralizumab 4 – Non-preferred specialty

Asmanex twisthaler/HFA, Flovent Diskus/HFA, Arnuity Ellipta

Hemady* dexamethasone 4 – Non-preferred specialty

dexamethasone tablet

Bonsity* teriparatide 4 – Non-preferred specialty

Alendronate tablets, Ibandronate tablets, Tymlos

Trikafta elexacaftor/ivacaftor/ texacaftor

4 – Non-preferred specialty

Provider discretion

Sovaldi oral pellets* sofosbuvir 4 – Non-preferred specialty

Harvoni, ledipasvir-sofosbuvir

Coverage may be contingent upon plan benefits. *Effective date to be determined. **Effective date 11/07/2019 Tier 1: Preferred generic drugs; Tier 2: Preferred brand drugs; Tier 3: Non-preferred generic drugs, non-preferred brand drugs, preferred specialty drugs; Tier 4: Non-preferred specialty drugs. ^Applies to Commercial only.

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C. Changes to the Highmark Healthcare Reform Essential Formulary The Essential Formulary is a closed formulary for select Healthcare Reform (HCR) Individual plans. A list of drugs included on the Essential Formulary, listed by therapeutic class, is available at https://client.formularynavigator.com/Search.aspx?siteCode=6571849149. Table 1. Formulary Updates (All formulary changes effective December 20, 2019 unless otherwise noted.)

Brand Name Generic Name Tier Comments/Preferred Alternatives Items listed below were added to the formulary

Baqsimi nasal spray

glucagon 3 Nasal spray for treatment of severe hypoglycemia in patients with diabetes mellitus.

Gvoke glucagon 3 Prefilled syringe for treatment of severe hypoglycemia in patients with diabetes mellitus.

Rinvoq** upadacitinib 4 Janus Kinase (JAK) inhibitor for the treatment of moderate-to-severe rheumatoid arthritis Additional preferred products: Actemra (tocilizumab), Enbrel (etanercept), Humira (adalimumab), Xeljanz/Xeljanz XR (tofacitinib)

Harvoni oral pellets*

ledipasvir/sofosbuvir 4 Direct acting antiviral (DAA) for the treatment of chronic HCV

Trikafta elexacaftor/ivacaftor/texacaftor

4 Combination ion channel modulator for the treatment of cystic fibrosis in patients who have at least one F508del mutation.

Items listed below were not added to the formulary Hadlima* adalimumab-bwwd NF Humira Accrufer* ferric maltol NF Provider discretion Wakix pitolisant NF modafinil tablet, dextroamphetamine/amphetamine

tablet, methylphenidate HCl tablet pretomanid pretomanid NF Isoniazid tablet, Levofloxacin Hemihydrate tablet Rozlytrek entrectinib NF Vitrakvi, Xalkori Inrebic fedratinib NF Jakafi Xenleta oral lefamulin NF Moxifloxacin HCl, Levofloxacin Hemihydrate Nourianz istradefylline NF selegiline capsule, selegiline tablet, entacapone

tablet Sovaldi oral pellets*

sofosbuvir NF Harvoni, ledispavir-sofosbuvir

Riomet ER oral solution*

metformin NF Metformin HCL ER tablet, extended release 24 hour

Ibsrela* tenapanor NF Amitiza, Linzess Ozobax baclofen NF baclofen 10 mg tablet, baclofen 20 mg tablet,

tizanidine tablet Rybelsus semaglutide NF Ozempic, Victoza Fasenra autoinjector

benralizumab NF Asmanex twisthaler/HFA, Flovent Diskus/HFA, Arnuity Ellipta

Hemady* dexamethasone NF dexamethasone tablet

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Brand Name Generic Name Tier Comments/Preferred Alternatives Bonsity* teriparatide NF Alendronate tablets, Ibandronate tablets, Tymlos Aklief trifaotene NF tretinoin cream, tretinoin gel (gram) 0.01%,

0.025% Reyvow* lasmiditan NF sumatriptan succinate tablet, rizatriptan tablet,

zolmitriptan tablet Secuado* asenapine NF olanzapine tablet, olanzapine ODT, risperidone

tablet Amzeeq topical foam

minocycline NF clindamycin phosphate gel (gram), clindamycin phosphate solution non-oral, erythromycin solution non-oral

Formulary options: Tier 1, Tier 2, Tier 3, Tier 4, Non-formulary (NF). *Effective date to be determined. ** Effective date 11/07/2019 D. Changes to the Highmark National Select Formulary The National Select Formulary is an incentive formulary with a non-formulary drug list to manage products in therapeutic categories for which preferred alternatives are available. The National Select Formulary is available for select Commercial self-funded (ASO) plans. A list of drugs included on the National Select Formulary, listed by therapeutic class, is available at https://client.formularynavigator.com/Search.aspx?siteCode=3442182690. Table 1. Formulary Updates

Brand Name Generic Name Tier Comments/Preferred Alternatives Items listed below were added to the formulary (preferred)

Baqsimi nasal spray

glucagon 2 Nasal spray for treatment of severe hypoglycemia in patients with diabetes mellitus.

Rozlytrek entrectinib 2 Oral kinase inhibitor for the treatment of ROS1-positive non-small cell lung cancer and for solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known resistance mutation.

Fasenra autoinjector

benralizumab 2 Self-administered auto-injector formulation of Fasenra for the treatment of patients with severe eosinophilic asthma.

Rybelsus semaglutide 2 Oral glucagon-like peptide-1 (GLP-1) receptor agonist for the treatment of type 2 diabetes.

Gvoke glucagon 2 Prefilled syringe for treatment of severe hypoglycemia in patients with diabetes mellitus.

Trikafta elexacaftor/ivacaftor/texacaftor

2 Combination ion channel modulator for the treatment of cystic fibrosis in patients who have at least one F508del mutation.

Rinvoq upadacitinib 2 Janus Kinase (JAK) inhibitor for the treatment of moderate-to-severe rheumatoid arthritis

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Brand Name Generic Name Tier Comments/Preferred Alternatives Additional preferred products: Actemra (tocilizumab), Enbrel (etanercept), Humira (adalimumab), Xeljanz/Xeljanz XR (tofacitinib)

Amzeeq topical foam

minocycline 2 clindamycin phosphate gel (gram), clindamycin phosphate solution non-oral, erythromycin solution non-oral

Items listed below were added to the formulary (non-preferred) Xenleta oral lefamulin 3 Moxifloxacin HCl, Levofloxacin Hemihydrate Hadlima* adalimumab-bwwd 3 Humira Accrufer* ferric maltol 3 ferrous sulfate tablet, ferrous gluconate tablet Wakix* pitolisant 3 modafinil tablet, dextroamphetamine/

amphetamine tablet, methylphenidate HCl tablet pretomanid* pretomanid 3 Isoniazid tablet, Levofloxacin Hemihydrate tablet Nourianz* istradefylline 3 selegiline capsule, selegiline tablet, entacapone

tablet Riomet ER oral solution*

metformin 3 Metformin HCL ER tablet, extended release 24 hour

Ibsrela* tenapanor 3 Linzess, Trulance Hemady* dexamethasone 3 dexamethasone tablet Bonsity* teriparatide 3 Alendronate tablets, Ibandronate tablets, Tymlos,

Forteo Aklief* trifaotene 3 tretinoin cream, tretinoin gel (gram) 0.01%,

0.025% Reyvow* lasmiditan 3 sumatriptan succinate tablet, rizatriptan tablet,

zolmitriptan tablet Secuado* asenapine 3 olanzapine tablet, olanzapine ODT, risperidone

tablet Sovaldi oral pellets*

sofosbuvir 3 Epclusa, Harvoni, Vosevi, Zepatier

Harvoni oral pellets*

ledipasvir/sofosbuvir 3 Epclusa, Harvoni, Vosevi, Zepatier

Items listed below were not added to the formulary Inrebic fedratinib NF Jakafi Ozobax baclofen NF baclofen 10 mg tablet, baclofen 20 mg tablet,

tizanidine Formulary options: Tier 1, Tier 2, Tier 3, Non-formulary (NF). *Effective date and final formulary position to be determined.

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Table 2. Additions to the Specialty Tier Copay Option (Effective upon completion of internal review and implementation unless otherwise noted.)

Brand Name Generic Name Hadlima adalimumab-bwwd Accrufer ferric maltol Wakix pitolisant Rozlytrek entrectinib Rinvoq upadacitinib Inrebic fedratinib Xenleta oral lefamulin Nourianz istradefylline Harvoni oral pellets ledipasvir/sofosbuvir Sovaldi oral pellets sofosbuvir Ozobax baclofen Fasenra autoinjector benralizumab Hemady dexamethasone Bonsity teriparatide Trikafta elexacaftor/ivacaftor/texacaftor

E. Updates to the Pharmacy Utilization Management Programs 1. Prior Authorization Program

Policy Name* Policy

Effective Date**

Updates and/or Approval Criteria

Anti-Obesity – Commercial and Healthcare Reform

11/7/2019 Policy revised to allow for reauthorization for maintenance therapy as long as the member has maintained weight loss from baseline.

Accrufer (ferric maltol) – Commercial and Healthcare Reform

Best Date New policy created for Accrufer (ferric maltol) to ensure appropriate use in adults with iron deficiency. Member has tried and failed dietary modification and over-the-counter iron replacement therapy for at least 3 months. Reauthorization attesting positive clinical response added.

Adalimumab BIOSIMILARS – Commercial and Healthcare Reform

TBD Policy revised to include the newly FDA-approved Hadlima (adalimumab biosimilar). The policy split out the recommended age group for each diagnosis. Policy revised to include exception criteria for members that may require initial biologic therapy for juvenile idiopathic arthritis and revise step through two immunosuppressants to one corticosteroid for severe ulcerative colitis. The maintenance therapy quantity limit was updated to allow use of four (4) prefilled syringes every four (4) weeks when there is clinical documentation that treatment with two (2) prefilled syringes every four (4) weeks was ineffective for plaque psoriasis and ulcerative colitis indications. The induction therapy quantity limit was updated to allow for six (6)

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Policy Name* Policy

Effective Date**

Updates and/or Approval Criteria

prefilled syringes within the first four (4) weeks of therapy to mirror the quantity limit in place for Crohn’s disease.

Adcirca and Alyq (tadalafil) – Healthcare Reform Essential Formulary

11/25/2019 Policy revised for Adcirca (tadalafil) by adding Alyq (tadalafil) and removing criteria that prescriber has ruled out other causes of pulmonary hypertension. If request is for brand Adcirca or Alyq, trial and failure of generic tadalafil. Reauthorization attesting positive clinical response added.

Androgen Receptor Inhibitors – Commercial and Healthcare Reform

12/10/2019 New policy created to ensure appropriate use of the androgen receptor inhibitors Nubeqa (darolutamide) and Erleada (apalutamide) for the treatment of non-metastatic castration-resistant prostate cancer, and Xtandi (enzalutamide) for the treatment of castration-resistant prostate cancer. Criteria require these agents be used in combination with a gonadotropin releasing hormone analog or bilateral orchiectomy. Reauthorization criteria added to Erleada and Nubeqa to ensure the member has had disease improvement or delayed disease progression. Reauthorization criteria for Erleada changed to require documentation of disease improvement or delayed disease progression. Authorization duration for Xtandi changed from 12 months to 2 years. Additional criteria for Xtandi added requiring utilization in combination with a gonadotropin-releasing hormone (GnRH) analog or previous orchiectomy.

Anti-Angiogenesis and VEGF Kinase Inhibitors – Commercial and Healthcare Reform

11/25/2019 Policy revised for Cabometyx (cabozantinib) for approval of additional quantities when taken concurrently with a strong cytochrome P450 3A4 (CYP3A4) inducer.

Anti-EGFR and HER2 Kinase Inhibitors – Commercial and Healthcare Reform

10/14/2019 Policy revised for Nerlynx (neratinib) to remove criteria for Hormone Receptor (HR)-positive status to align with FDA-approved indication.

Arakoda and Krintafel (tafenoquine) – Commercial and Healthcare Reform

11/25/2019 Policy revised to reflect updated CDC guidelines that Krintafel (tafenoquine) can be used for the treatment of malaria, added age restrictions based upon FDA approved indications, and added a limitation of coverage for Arakoda (tafenoquine) in patients with a history of psychotic disorders or current psychotic symptoms.

BCR-ABL Kinase Inhibitors – Commercial and HCR

11/25/2019 Policy revised to add criteria for Sprycel (dasatinib) in adults with Philadelphia chromosome-positive acute lymphoblastic leukemia with resistance or intolerance to prior therapy.

Bruton’s Tyrosine Kinase Inhibitors – Commercial and Healthcare Reform

11/26/2019 Policy revised for Calquence (acalabrutinib) for approval of additional quantities when taken concurrently with a strong CYP3A4 inducer.

CaroSpir (spironolactone) – Commercial and Healthcare Reform

12/7/2019 Policy revised for CaroSpir (spironolactone) to ensure appropriate use in members 18 years of age or older, has inability to swallow tablets, and has experienced trial and failure of spironolactone tablets which can be crushed.

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Policy Name* Policy

Effective Date**

Updates and/or Approval Criteria

Reauthorization attesting positive clinical response and continues to have an inability to swallow tablets added.

CFTR Modulators – Commercial and Healthcare Reform

12/16/2019 Policy revised to include Trikafta (elexacaftor/tezacaftor ivacaftor) and criteria for age, diagnosis of cystic fibrosis and appropriate cystic fibrosis transmembrane (CFTR) mutation

Chelating Agents – Commercial and Healthcare Reform

4/1/2020 New policy created for Exjade and Jadenu (deferasirox) and Ferriprox (deferiprone) for chronic iron overload due to blood transfusions in those of appropriate age, transfusion history with packed red blood cells, serum ferritin, and trial and failure of generic deferasirox. Reauthorization attesting positive clinical response, and serum ferritin. For chronic iron overload in non-transfusion dependents member is appropriate age, liver iron concentration, serum ferritin, and trial and failure of generic deferasirox. Reauthorization attesting positive clinical response and liver iron concentration.

Chronic Inflammatory Diseases – Commercial and Healthcare Reform

11/15/2019 Policy revised to add Rinvoq (upadacitinib) for rheumatoid arthritis, Taltz's (ixekizumab) expanded indication for ankylosing spondylitis, and move Xeljanz (tofacitinib) to non-preferred for ulcerative colitis. Stelara (ustekinumab) expanded indication and Cimzia (certolizumab pegol) prescriber attestation of diagnosis.

Copaxone and Glatopa (glatiramer acetate) – Commercial

TBD Policy revised to include additional FDA-approved indications, added HCR into policy (preliminarily). Criteria revised to require use of Glatopa OR glatiramer acetate prior to coverage of Copaxone. This policy has not been active yet, and will continue to be on hold until additional cost/rebate information is available and discussed.

Cystic Fibrosis Inhaled Medications – Commercial, Commercial NSF, and Healthcare Reform

12/8/2019 Policy revised to ensure exclusion of diagnoses of Burkholderia cepacia complex.

Delaware - Step Therapy Exception – Commercial and Healthcare Reform

3/18/2020 New policy created to allow a step therapy override when appropriate criteria are met. This policy is mandated by DE legislative House Bill 105, effective 3/18/2020.

Diclofenac Containing Products – Commercial and Healthcare Reform

1/1/2020 Policy revised to remove 'excluding National Select formulary' disclaimer. Criteria now aligned between Commercial formularies.

Diclofenac Containing Products – Commercial NSF

1/1/2020 NSF policy terminated. NSF combined back into Commercial policy.

Dupixent (dupilumab) – Commercial and Healthcare Reform

11/18/2019 Policy revised to remove steroid and crisaborole step and add that a specialist attested to the member has a diagnosis of moderate-to-severe atopic dermatitis. For asthma, replaced statement about forced expiratory volume (FEV) reversibility with documentation of FEV % based upon age.

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Policy Name* Policy

Effective Date**

Updates and/or Approval Criteria

EGFR-Targeting Kinase Inhibitors – Commercial and Healthcare Reform

12/7/2019 Policy revised for Tarceva (erlotinib) for approval of additional quantities when taken concurrently with a strong CYP3A4 inducer or if the member smokes cigarettes.

Entresto (sacubitril; valsartan) – Commercial and Healthcare Reform

12/8/2019 Policy revised for Entresto (sacubritil; valsartan) to include expanded indication of pediatric heart failure with left ventricular ejection fraction less than or equal to 40% and is not receiving concomitant angiotensin converting enzyme (ACE) inhibitor angiotensin II receptor blockers (ARB). Policy revised to include pediatric situations when quantity limit override is appropriate. Prior authorization only applies to HCR. Quantity limit applies to Commercial and HCR.

Erleada (apalutamide) – Commercial and Healthcare Reform

12/11/2019 Policy terminated to be combined into new policy Androgen Receptor Inhibitors - Commercial and Healthcare Reform

Hemady (dexamethasone) – Commercial and Healthcare Reform

Best Date New policy created for Hemady (dexamethasone) to ensure appropriate use in adults with Multiple Myeloma in combination with other anti-myeloma agents who have tried generic dexamethasone.

Hepatitis C Oral Agents – Commercial, Commercial Core, and Healthcare Reform

Best Date Policy revised to include criteria for Harvoni (ledipasvir/sofosbuvir) and Sovaldi (sofosbuvir) oral pellet formulations in the treatment of patients 3 years of age and older with chronic hepatitis C virus (HCV), who have the inability to swallow tablets. Policy revised to include updated treatment duration of Mavyret (glecaprevir/pibrentasvir) for patients with chronic HCV with compensated cirrhosis.

Increlex (mecasermin) – Commercial and Healthcare Reform

12/8/2019 Policy revised to require documentation of height standard deviation less than or equal to 3 standard deviations below normal for approval of Increlex (mecasermin).

Interleukin (IL)-5 Antagonists – Commercial and Healthcare Reform

12/16/2019 Policy revised to include Nucala's (mepolizumab) expanded indication for severe asthma in patients 6 years of age or older and Fasenra (benralizumab) to the policy now that it is available as a self-administered product.

Interleukin-1β blockers – Commercial and Healthcare Reform

12/8/2019 Policy revised to include age restrictions (12 and older for Arcalyst [rilonacept] and 4 and over for Illaris [canakinumab]), updated references.

JAK Inhibitors – Commercial and Healthcare Reform

12/16/2019 Policy revised for Jakafi (ruxolitinib) and Inrebic (fedratinib) to expand risk factors for risk status stratification. New criteria created for Inrebic to ensure intermediate-2 or high risk primary or secondary myelofibrosis in adults, for new starts to therapy baseline platelet count and trial and failure to Jakafi. If continuing therapy or requesting reauthorization there is reduction in spleen size or improvement in symptoms for polycythemia vera or myelofibrosis.

Market Watch Programs – PA, WV, and DE

12/26/2019 Policy revised to include Relafen DS (nabumetone) as a target for the High Cost Low Value Program with therapeutic alternatives of nabumetone, meloxicam, and ibuprofen. Ozobax (baclofen) as a target with therapeutic alternatives of

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Policy Name* Policy

Effective Date**

Updates and/or Approval Criteria

baclofen and tizanidine. Hemady (dexamethasone) as a target with therapeutic alternative of dexamethasone.

Nitisinone (Nityr and Orfadin) – Commercial and Healthcare Reform

1/1/2020 Policy revised to remove 'excluding National Select formulary' disclaimer. Criteria now aligned between Commercial formularies.

Nitisinone (Nityr and Orfadin) – Commercial NSF

1/1/2020 NSF policy terminated. NSF combined back into Commercial policy.

Nourianz (istradefylline) – Commercial and Healthcare Reform

12/17/2019 New policy created to ensure appropriate use of Nourianz (istradefylline) as an adjunct to levodopa/carbidopa for Parkinson's disease "off" episodes in patients who have tried and failed selegiline and entacapone. Reauthorization criteria added to ensure that the member has experienced a positive clinical response.

NTRK Inhibitors – Commercial and Healthcare Reform

12/12/2019 Policy revised to include criteria for Rozlytrek (entrectinib) in the treatment of solid tumors with NTRK gene fusion and ROS1-mutated non-small cell lung cancer (NSCLC); and for approval of additional quantities of Vitrakvi (entrectinib) if taken concurrently with a strong CYP3A4 inducer.

Ofev (nintedanib) and Esbriet (pirfenidone) – Commercial and Healthcare Reform

12/7/2019 Policy revised to include criteria for Ofev's (nintedanib) expanded systemic sclerosis-associated interstitial lung disease indication including member's diagnosis, pulmonologist prescriber, appropriate baseline pulmonary function tests, patient is a non-smoker, and step through cyclophosphamide and renamed policy as medications are no longer only indicated for idiopathic pulmonary fibrosis.

Orilissa (elagolix) – Commercial and Healthcare Reform

12/8/2019 Policy revised to remove requirement of the member receiving a 150 mg dose once daily for reauthorization of Orilissa (elagolix).

Ozobax (baclofen) – Commercial and Healthcare Reform

12/26/2019 New policy created for Ozobax (baclofen) to ensure appropriate use in patients with spasticity due to multiple sclerosis, spinal cord injury, or spinal cord disease who are unable to swallow tablets, have therapeutic failure or intolerance to generic baclofen and in patients over 18, therapeutic failure or intolerance to tizanidine tablets.

Parathyroid Hormone Analogs – Commercial and Healthcare Reform

Best Date Policy revised to include Bonsity (teriparatide) to require appropriate diagnosis and risk of fracture, trial and failure of a bisphosphonate, if postmenopausal female with high risk of fracture trial and failure of Tymlos (abaloparatide), and cumulative dose does not exceed 24 months.

Parathyroid Hormone Analogs – NSF

Best Date Policy revised to include Bonsity (teriparatide) to require appropriate diagnosis and risk of fracture, trial and failure of a bisphosphonate, if postmenopausal female with high risk of fracture trial and failure of Tymlos (abaloparatide) and Forteo (teriparatide), if male requiring increase of bone mass or male or female with sustained systemic glucocorticoid therapy trial

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Policy Name* Policy

Effective Date**

Updates and/or Approval Criteria

and failure of Forteo, and cumulative dose does not exceed 24 months.

PARP Kinase Inhibitors – Commercial and Healthcare Reform

12/8/2019 Policy revised to add FDA expanded indication for Zejula (niraparib) in advanced ovarian, fallopian tube, or primary peritoneal cancer in adults; criteria revised for coverage approval in adults with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer per FDA-approved indication. Policy revised to add for Lynparza (olaparib) (in ovarian cancer indications only), Rubraca (rucaparib), and Talzenna (talazoparib): approval criteria for adults.

Pretomanid – Commercial and Healthcare Reform

12/26/2019 New policy created for Pretomanid (pretomanid) to ensure appropriate use for extensively drug resistant (XDR), treatment-intolerant or nonresponsive multidrug-resistant tuberculosis in patients who have tried and failed first-line medications.

Pulmonary Hypertension – Commercial and Select Healthcare Reform

TBD Policy revised to require all drugs to try and fail generic sildenafil. If request is for brand Adcirca/Alyq (tadalafil), Letairis (ambrisentan), Tracleer (bosentan), or Revatio (sildenafil) the member must also try and fail the respective generic.

Rybelsus (semaglutide) – Commercial and Healthcare Reform

12/17/2019 New policy created for Rybelsus (semaglutide) to ensure appropriate use in patients with type 2 diabetes mellitus who have experienced therapeutic failure, contraindication or intolerance to a metformin-containing product, or taking Rybelsus (semaglutide) in addition to a metformin-containing product. Attestation that the member requires additional therapy with Rybelsus (semaglutide) is required for reauthorization.

Thrombopoiesis Stimulating Agents – Commercial and Healthcare Reform

12/8/2019 Policy revised to add approvable quantity limit overrides for Promacta (eltrombopag). Policy revised for Nplate (romiplostim) to include expanded indication of immune thrombocytopenia.

Topical Non-Steroid Therapy for Atopic Dermatitis – Commercial

1/1/2020 Policy revised to remove 'excluding National Select formulary' disclaimer. Criteria now aligned between Commercial formularies.

Topical Non-Steroid Therapy for Atopic Dermatitis – Commercial NSF

1/1/2020 NSF policy terminated. NSF combined back into Commercial policy.

Turalio (pexidartinib) – Commercial and Healthcare Reform

12/12/2019 New policy created to ensure appropriate use of Turalio (pexidartinib) for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not amenable to improvement with surgery. Reauthorization criteria added to ensure the member has tolerated the therapy and experienced a therapeutic response.

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Policy Name* Policy

Effective Date**

Updates and/or Approval Criteria

Veltassa (patiromer) and Lokelma (sodium zirconium cyclosilicate) – Commercial and Select Healthcare Reform

TBD Policy revised for Veltassa (patiromer) and Lokelma (sodium zirconium cyclosilicate) to remove requirement that chronic kidney disease patients have discontinued or reduced medications known to cause hyperkalemia.

Vimpat (lacosamide) – Commercial

TBD New policy created to ensure appropriate use of Vimpat (lacosamide) for the treatment of partial-onset seizures as monotherapy and adjunctive therapy in patients 4 years of age or older.

Vivlodex (meloxicam) – Commercial and Healthcare Reform

12/8/2019 Policy revised to add reauthorization criteria and reduce authorization duration to 6 months.

Vyleesi (bremelanotide) – Commercial and Healthcare Reform

12/8/2019 Policy revised to remove requirement of increased satisfying sexual events from reauthorization criteria.

Wakix (pitolisant) – Commercial and Healthcare Reform

12/12/2019 New policy created to require a documented diagnosis of narcolepsy, documentation of baseline excessive daytime sleepiness (EDS), documented treatment failure, intolerance or contraindication to modafinil as well as one additional central nervous system (CNS) stimulant OR wakefulness/stimulant meds are clinically inappropriate or there is a legitimate concern of illegal drug diversion.

West Virginia - Step Therapy/Prior Authorization Override Exception – Commercial and Healthcare Reform

TBD Policy revised with administrative changes; also, to add initial authorization and reauthorization criteria as well as authorization.

Xtandi (enzalutamide) – Commercial and Healthcare Reform

12/11/2019 Policy terminated to be combined into new policy Androgen Receptor Inhibitors - Commercial and Healthcare Reform.

Yosprala (aspirin/omeprazole) – Commercial and Healthcare Reform

11/25/2019 Policy revised for Yosprala (aspirin and omeprazole) to ensure appropriate use in members with need for secondary prevention of cardiovascular and cerebrovascular events. Reauthorization attesting positive clinical response and requires additional courses of treatment.

Zytiga and Yonsa (abiraterone acetate) – Commercial and Healthcare Reform

12/9/2019 Policy revised for Zytiga (abiraterone acetate) in Healthcare Reform, and Yonsa (abiraterone acetate): that generic abiraterone was ineffective or not tolerated; and for approval of additional quantities of Zytiga (abiraterone acetate) and Yonsa (abiraterone acetate) when taken concurrently with a strong CYP3A4 inducer.

*For policies that require step therapy, an exception may be made for commercial and HCR members enrolled in a West Virginia plan. For additional details, refer to pharmacy policy bulletin J-513 (West Virginia – Step Therapy Override Exception). **All effective dates are tentative and subject to delay pending internal review or approval.

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2. Managed Prescription Drug Coverage (MRxC) Program

Policy Name Policy

Effective Date

Updates and Automatic Approval Criteria

Acute Migraine Therapies – Commercial and Healthcare Reform

Best Date Policy revised to include Reyvow (lasmiditan). Limitations of coverage updated to reflect Reyvow quantity limit.

Ampyra (dalfampridine) – Commercial and Healthcare Reform

TBD Policy revised to require trial or intolerance to generic dalfampridine for requests for brand Ampyra.

Amrix (cyclobenzaprine) – Commercial and Healthcare Reform

1/1/2020 Policy revised to change authorization duration from 12 months to 3 months, and remove automatic criteria.

Atypical Antipsychotics – Commercial

1/1/2020 Policy revised to include step through generic quetiapine ER or aripiprazole prior to Rexulti (brexpiprazole) and Vraylar (cariprazine). Coverage criteria added for Seroquel XR (quetiapine fumarate) when used for the adjunctive treatment of major depressive disorder. Automatic approval language updated to align with current rule coding. Reauthorization criteria also added.

Atypical Antipsychotics – Healthcare Reform

1/1/2020 Policy revised to include step through generic quetiapine ER or aripiprazole prior to Rexulti (brexpiprazole). Automatic approval language updated to align with current rule coding. Reauthorization criteria also added.

Azilect (rasagiline) – Commercial

1/1/2020 New policy created requiring age of 18 years old, diagnosis of Parkinson’s Disease (PD), failure/intolerance to generic selegiline and one additional medication from specified list.

Azilect (rasagiline) – Healthcare Reform

Best Date Policy revised to remove orphenadrine (off-label use) and procyclidine and biperiden (no longer available). Reauthorization criteria added and authorization duration changed to 2 years.

Benzonatate – Commercial and Healthcare Reform

Best Date Policy revised to change authorization duration and automatic approval criteria from 1 year to 3 months.

Brand and Extended Release Metformin – Commercial and Healthcare Reform

Best Date Policy revised to add Riomet ER (metformin hydrochloride) to ensure members have tried and failed metformin ER (generic Glucophage XR), and to ensure appropriate utilization in members who are unable to swallow tablets containing metformin.

Branded Antiandrogen Therapy – Commercial

11/25/2019 Policy revised to change authorization duration from lifetime to 2 years.

Branded Aromatase Inhibitors – Commercial

11/26/2019 Policy revised to change authorization duration from lifetime to 2 years.

Buprenorphine (non-opioid dependence use) – Commercial, Healthcare Reform

11/26/2019 Policy revised to move quantity limit information to background section, added an age restriction to those 18 years of age and older.

Duaklir (aclidinium bromide and formoterol fumarate) – Commercial and Healthcare Reform

Best Date New policy created to ensure appropriate use for patients with chronic obstructive pulmonary disease (COPD) and trial of Anoro Ellipta (umeclidinium and vilanterol) and Stiolto Respimat (tiotropium bromide and olodaterol).

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Policy Name Policy

Effective Date

Updates and Automatic Approval Criteria

Duexis (ibuprofen, famotidine) – Commercial, Commercial NSF, and Healthcare Reform

1/1/2020 Policy revised to add a limitation of coverage that Duexis (ibuprofen/famotidine) will not be approved to increase patient adherence or convenience and removed automatic approval criteria.

Ibsrela (tenapanor) – Commercial and Healthcare Reform

Best Date New policy created for Ibsrela (tenapanor) to ensure appropriate use in adults with irritable bowel syndrome with constipation (IBS-C) in adults and trial and failure of Amitiza (lubiprostone) and Linzess (linaclotide). Reauthorization criteria attesting positive clinical response.

Leukotriene Modifiers (Accolate, Zyflo) – Commercial and Healthcare Reform

Best Date Policy revised to add a single step through an inhaled corticosteroid (ICS) or ICS/long-acting beta agonist (LABA) and montelukast for Accolate (zafirlukast) and added additional step through generic zileuton ER for Zyflo/Zyflo CR (zileuton/zileuton ER) and zafirlukast (Accolate) for brand Accolate

Naproxen and Fenoprofen Containing Products and Relafen DS – Commercial and HCR

Best Date Policy revised to include another agent, Relafen DS (nabumetone). Policy approval criteria include a diagnosis of osteoarthritis or rheumatoid arthritis (RA) and a failure or intolerance to three formulary oral generic non-steroidal anti-inflammatory drugs (NSAIDs), one of which must be generic nabumetone.

Non-Preferred Benign Prostatic Hyperplasia Therapy – Healthcare Reform

1/1/2020 Policy revised to include brand Cialis 5 mg (tadalafil) as a target requiring a step through 1 alpha blocker, 1 alpha reductase inhibitor, and generic tadalafil.

Non-Preferred Sodium-Glucose Co-Transporter 2 Inhibitors – Commercial and Healthcare Reform

Best Date Policy revised to include a trial and failure of a metformin containing product for the approval criteria and the automatic approval criteria. Policy revised to include reauthorization criteria to ensure the member requires additional therapy. Policy updated with recent indications for cardiovascular benefit.

Non-Preferred Statins – Healthcare Reform Essential Formulary

Best Date Policy revised for rosuvastatin to require trial and failure of 1 preferred generic statin.

Nuedexta (dextromethorphan-quinidine) – Commercial and Healthcare Reform

12/8/2019 Policy revised to change authorization duration from lifetime to 12 months, and add reauthorization criteria.

Opioid Management – Commercial and Healthcare Reform

1/1/2020 Policy revised to incorporate safety rule modification of short acting opioid 3-day supply limitation for first time pediatric users. Policy approval criteria for additional days of therapy of this safety rule update will include cancer diagnosis, hospice, end-of-life care, or palliative care. In addition, policy criteria will also include approval for demonstration of chronic pain management or severe pain treatment strategy following trial of non-opioid therapy, state prescription drug monitoring program review and parent/guardian education. Butrans and Belbuca (buprenorphine) added to listing of Extended Release Opioid examples, information added to background: CDC recommends

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Policy Name Policy

Effective Date

Updates and Automatic Approval Criteria

when starting opioid therapy, IR opioids should be used instead of ER/LA opioids.

Qbrelis and Epaned – Commercial and Healthcare Reform

12/8/2019 Policy revised for Qbrelis (lisinopril oral solution) and Epaned (enalapril oral solution) to require trial and failure of enalapril or lisinopril tablets as they can be crushed. Reauthorization added attesting positive clinical response.

Ryvent (carbinoxamine) 6 mg – Healthcare Reform

1/1/2020 Policy revised to include brand Ryvent (carbinoxamine maleate) as a target in addition to generic carbinoxamine. Policy also updated to reflect the effective start date as 1/1/2020.

Topical Acne Medications – Commercial

Best Date Policy revised to include Aklief (trifarotene) and Amzeeq (minocycline).

Topical Acne Medications – Healthcare Reform

Best Date Policy revised for Topical Acne Medications to add Aklief (trifarotene) and Amzeeq (minocycline) and to list specific try and fail alternatives such as adapalene, clindamycin, clindamycin/benzoyl peroxide, erythromycin, tretinoin, and sulfacetamide. Reauthorization criteria expanded to include prescriber attestation that member's acne requires additional courses of treatment.

Topical Psoriasis Treatments – Healthcare Reform

1/1/2020 New policy created to ensure appropriate use of topical Dovonex, Sorilux, and Vectical (calictriol) for the treatment of plaque psoriasis. Policy requires a step through a preferred topical corticosteroid and through generic topical calciptriene.

Vimovo (naproxen, esomeprazole) – Commercial, Commercial NSF, and Healthcare Reform

1/1/2020 Policy revised to add a limitation of coverage that Vimovo (naproxen/esomeprazole) will not be approved to increase patient adherence or convenience and removed automatic approval criteria.

Xeloda (capecitabine) – Commercial

12/8/2019 Policy revised to update FDA-approved indications as listed in package insert; criteria updated with FDA-approved indications for Xeloda (capecitabine).

Xhance (fluticasone propionate) – Commercial and Healthcare Reform

11/25/2019 Policy revised to add reauthorization criteria attesting the member has experienced positive clinical response to therapy.

For policies that require step therapy, an exception may be made for Commercial and HCR members enrolled in a West Virginia plan. For additional details, refer to pharmacy policy bulletin J-513 (West Virginia – Step Therapy Override Exception). All effective dates are tentative and subject to delay pending internal review or approval. Standard prior authorization criteria will apply for members who do not meet the automatic approval criteria.

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3. Quantity Level Limit (QLL) Programs* (Effective immediately upon completion of internal review and implementation, unless otherwise noted.)

Table 1. Quantity Level Limits – Quantity per Duration for Commercial and Healthcare Reform Plans

Drug Name Retail Edit Limit Mail Edit Limit Bonsity (teriparatide) 1 pen per 28 days 3 pens per 84 days Fasenra (benralizumab) autoinjector 1 pen per 56 days 1 pen per 56 days Hadlima (adalimumab-bwwd) 2 prefilled syringes or

autoinjectors per 28 days 6 prefilled syringes or autoinjectors per 84 days

Ingrezza (valbenazine) initiation pack 1 pack per year 1 pack per year pretomanid 270 tablets per 365 days 270 tablets per 365 days Reyvow (lasmiditan) 50 mg 4 tablets per 30 days 12 tablets per 90 days Reyvow (lasmiditan) 100 mg 8 tablets per 30 days 24 tablets per 90 days Trikafta (elexacaftor/ivacaftor/texacaftor) 1 carton per 28 days 3 cartons per 84 days

Table 2. Quantity Level Limits – Quantity per Dispensing Event – Commercial and Healthcare Reform Plans

Drug Name Retail Edit Limit Mail Edit Limit Baqsimi (glucagon) nasal spray 2 bottles 2 bottles Gvoke (glucagon) 2 syringes 2 syringes Riomet ER (metformin) oral solution 2 bottles 4 bottles

Quantity per dispensing event limits the quantity of medication that can be dispensed per each fill. If the submitted day supply on a claim is 34 days or less, the retail limit will apply. If the submitted day supply on a claim is greater than 34 days, the mail limit will apply.

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Table 3. Maximum Daily Quantity Limits – Commercial and Healthcare Reform Plans

Drug Name Daily Limit Accrufer (ferric maltol) 2 capsules per day Alunbrig (brigatinib) 30 mg tablets 4 tablets per day Bosulif (bosutinib) 100 mg tablets 3 tablets per day Harvoni (ledipasvir/sofosbuvir) oral pellets 1 packet per day Hemady (dexamethasone) 2 tablets per day Ibsrela (tenapanor) 2 tablets per day Iclusig (ponatinib) 15 mg 1 tablet per day Idhifa (enasidenib) 50 mg tablets 1 tablet per day Imbruvica (ibrutinib) 140 mg capsules 3 capsules per day Ingrezza (valbenazine) 40 mg 1 capsule per day Inlyta (axitinib) 1 mg tablets 6 tablets per day Inrebic (fedratinib) 4 capsules per day Jakafi (ruxolitinib) 2 tablets per day Northera (droxidopa) 100 mg 3 capsules per day Northera (droxidopa) 200 mg and 300 m 6 capsules per day Nourianz (istradefylline) 1 tablet per day Ozobax (baclofen) 80 mL per day pretomanid 1 tablet per day Promacta (eltrombopag) 12.5 mg and 25 mg tablets 1 tablet per day Promacta (eltrombopag) 50 mg and 75 mg tablets 2 tablets per day Promacta (eltrombopag) powder in packet 1 packet per day Rinvoq (upadacitinib) 1 tablet per day Rozlytrek (entrectinib) 20 mg capsules 3 capsules per day Rozlytrek (entrectinib) 100 mg capsules 5 capsules per day Rybelsus (semaglutide) 1 tablet per day Secuado (asenapine) 1 patch per day Sovaldi (sofosbuvir) oral pellets 1 packet per day Tarceva (erlotinib) 25 mg tablets 2 tablets per day Targretin 75 mg capsules 4 capsules per day Venclexta (venetoclax) 100 mg tablets 6 tablets per day Venclexta (venetoclax) 50 mg tablets 2 tablets per day Wakix (pitolisant) 4 tablets per day Xenleta (lefamulin) oral 2 tablets per day

Members can receive up to the maximum day supply according to their benefits, but the daily limit must not be exceeded for each individual day. Requests for coverage of select medications exceeding the defined quantity level limits may be submitted for clinical review. Maximum-day supply on certain medications may vary depending on member’s benefit design.

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SECTION II. Highmark Medicare Part D Formularies A. Changes to the Highmark Medicare Part D 5-Tier Incentive Formulary

The Highmark Pharmacy and Therapeutics Committee has reviewed the medications listed in the tables below. For your convenience, you can search the Highmark Medicare Part D Formularies online at: Performance Formulary: https://client.formularynavigator.com/Search.aspx?siteCode=1349658900 Venture Formulary: https://client.formularynavigator.com/Search.aspx?siteCode=1347236614 Incentive Formulary: https://client.formularynavigator.com/Search.aspx?siteCode=1344627998 Table 1. Preferred Products* (Effective immediately pending CMS approval and upon completion of internal review and implementation.)

Brand Name Generic Name Comments Baqsimi nasal spray glucagon Provider discretion Gvoke glucagon Provider discretion Jynneos smallpox and monkeypox

vaccine Provider discretion

Table 2. Non-Preferred Products

(Effective immediately pending Centers for Medicare and Medicaid Services (CMS) approval and upon completion of internal review and implementation.)

Brand Name Generic Name Preferred Alternatives Angiomax RTU bivalirudin Heparin pretomanid pretomanid Isoniazid tablet, Levofloxacin Hemihydrate tablet Riomet ER oral solution metformin Metformin HCL ER tablet, extended release 24

hour (Dose ID: 613) Ibsrela tenapanor Amitiza, Linzess Rybelsus semaglutide Ozempic, Victoza Hemady dexamethasone dexamethasone tablet Quzyttir injection cetirizine cetirizine oral solution, hydroxyzine Aklief trifaotene tretinoin cream, tretinoin gel (gram) 0.01%,

0.025% Reyvow lasmiditan sumatriptan succinate tablet, zolmitriptan tablet,

rizatriptan tablet Amzeeq topical foam minocycline clindamycin phosphate gel (gram), clindamycin

phosphate solution non-oral, erythromycin solution non-oral

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B. Changes to the Highmark Medicare Part D 5-Tier Closed Formulary The Highmark Pharmacy and Therapeutics Committee has reviewed the medications listed in the tables below. For your convenience, you can search the Highmark Medicare Part D Formularies online at: Performance Formulary: https://client.formularynavigator.com/Search.aspx?siteCode=1349658900 Venture Formulary: https://client.formularynavigator.com/Search.aspx?siteCode=1347236614 Incentive Formulary: https://client.formularynavigator.com/Search.aspx?siteCode=1344627998

Table 1. Preferred Products (Effective immediately pending CMS approval and upon completion of internal review and implementation.)

Brand Name Generic Name Comments Baqsimi nasal spray glucagon Provider discretion Gvoke glucagon Provider discretion Jynneos smallpox and monkeypox

vaccine Provider discretion

Table 2. Non-Preferred Products (Effective immediately pending CMS approval and upon completion of internal review and implementation.)

Brand Name Generic Name Preferred Alternatives Angiomax RTU bivalirudin Heparin Riomet ER oral solution metformin Metformin HCL ER tablet, extended release 24

hour (Dose ID: 613) Rybelsus semaglutide Ozempic, Victoza Reyvow lasmiditan sumatriptan succinate tablet, rizatriptan tablet,

zolmitriptan tablet* *Applies to Venture and Incentive formularies only.

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Table 3. Products Not Added* (Effective immediately pending CMS approval and upon completion of internal review and implementation.)

Brand Name Generic Name Preferred Alternatives Ruxience rituximab-pvvr Provider discretion pretomanid pretomanid Isoniazid tablet, Levofloxacin Hemihydrate tablet Ibsrela tenapanor Amitiza, Linzess Riomet ER oral solution** metformin Metformin HCL ER tablet, extended release 24

hour (Dose ID: 613) Ozobax baclofen baclofen 10 mg tablet, baclofen 20 mg tablet Hemady dexamethasone dexamethasone tablet Quzyttir injection cetirizine cetirizine oral solution, hydroxyzine Aklief trifaotene tretinoin cream, tretinoin gel (gram) 0.01%,

0.025% Amzeeq topical foam minocycline clindamycin phosphate gel (gram), clindamycin

phosphate solution non-oral, erythromycin solution non-oral

*Physicians may request coverage of these products using the Prescription Drug Medication Request Form, which can be accessed online in Highmark's Provider Resource Center. Under Forms, select Miscellaneous Forms, and select the form titled Request for Non-Formulary Drug Coverage. **Applies to Performance formulary only. C. Additions to the Specialty Tier (Effective immediately pending CMS approval and upon completion of internal review and implementation.)

Brand Name Generic Name Rozlytrek entrectinib Rinvoq upadacitinib Inrebic fedratinib Xenleta oral lefamulin Xenleta IV lefamulin Nourianz istradefylline Harvoni oral pellets ledipasvir/sofosbuvir Sovaldi oral pellets sofosbuvir Ozobax baclofen Fasenra autoinjector benralizumab Bonsity teriparatide Beovu brolucizumab-dbll Scenesse afemelanotide Secuado asenapine Trikafta elexacaftor/ivacaftor/texacaftor

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D. Updates to the Pharmacy Utilization Management Programs 1. Prior Authorization Program

Policy Name Policy

Effective Date*

Updates and/or Approval Criteria

2020 Cystic Fibrosis Inhaled Medications – Medicare

1/1/2020 Policy revised to add Kitabis Pak (tobramycin inhalation solution) as a drug product.

Administrative Prior Authorization for Medicare

1/1/2020 Policy revised to remove promethazine-phenylephrine to align with CMS guidance.

Androgen Receptor Inhibitors – Medicare

TBD New policy created to ensure appropriate use of the androgen receptor inhibitors Nubeqa (darolutamide) for the treatment of non-metastatic castration-resistant prostate cancer (CRPC), Erleada (apalutamide) for the treatment of non-metastatic CRPC and metastatic castration-sensitive prostate cancer, and Xtandi (enzalutamide) for the treatment of CRPC. Criteria requires Nubeqa and Erleada be used in combination with a gonadotropin releasing hormone analog or bilateral orchiectomy.

Anti-EGFR and HER2 Kinase Inhibitors – Medicare

10/14/2019 Policy revised for Nerlynx (neratinib) to remove criteria for Hormone Receptor (HR)-positive status to align with FDA-approved indication.

Aubagio (teriflunomide) – Medicare

1/1/2020 Policy revised for Coverage Year 2020 to extend the coverage duration of Aubagio (teriflunomide) from 2 years to 5 years.

Chronic Inflammatory Diseases – Medicare

TBD Policy revised to add Rinvoq (upadacitinib) for rheumatoid arthritis and Taltz's (ixekizumab) expanded indication for ankylosing spondylitis, Stelara (ustekinumab) expanded indication

Darzalex (daratumumab) – Medicare

TBD Policy revised to add FDA expanded indication for Darzalex (daratumumab) use in combination with bortezomib, thalidomide, and dexamethasone in newly diagnosed patients who are eligible for autologous stem cell transplant.

Daytrana (methylphenidate patch) – Medicare

1/1/2020 Policy revised to require trial, failure, or intolerance to 2 of the following: methylphenidate, atomoxetine, or dextroamphetamine/amphetamine

Desoxyn (methamphetamine) – Medicare

1/1/2020 New policy created for Desoxyn (methamphetamine) to ensure appropriate use in attention deficit hyperactivity disorder (ADHD) with trial, failure, or intolerance to 2 of the following: methylphenidate, atomoxetine, or dextroamphetamine/amphetamine

Epidiolex (cannabidiol solution) – Medicare

1/1/2020 Policy revised for Coverage Year (CY) 2020 for Dravet Syndrome: two standard of care medications were added as part of the coverage approval criteria for Epidiolex (cannabidiol) per CY 2020 filing.

Erleada (apalutamide) – Medicare

TBD Policy terminated to be combined into new policy Androgen Receptor Inhibitors - Medicare

Evekeo (amphetamine sulfate) – Medicare

1/1/2020 New policy created for Evekeo (amphetamine sulfate) for narcolepsy supported by baseline data of excessive daytime

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Policy Name Policy

Effective Date*

Updates and/or Approval Criteria

sleepiness, one of the following: cerebrospinal fluid hypocretin-1, multiple sleep latency tests, or polysomnography and multiple sleep latency test, and trial and failure of 2 generic stimulants. Diagnosis of attention deficit hyperactivity disorder and trial and failure of 2 generic stimulants. Obesity excluded from coverage.

Gilenya (fingolimod) – Medicare

1/1/2020 Policy revised to ensure all forms of multiple sclerosis are included in criteria and expand authorization duration to 5 years.

Hemady (dexamethasone) – Medicare

TBD New policy created for Hemady (dexamethasone) to ensure appropriate use in adults with Multiple Myeloma in combination with other anti-myeloma agents who have tried generic dexamethasone.

Hepatitis C Oral Agents – Medicare

TBD Policy revised to include criteria for Harvoni (ledipasvir/sofosbuvir) and Sovaldi (sofosbuvir) oral pellet formulations in the treatment of patients 3 years of age and older with chronic HCV. Policy revised to include updated treatment duration of Mavyret (glecaprevir/pibrentasvir) for patients with chronic HCV with compensated cirrhosis.

Hepatitis C Oral Agents – Medicare

1/1/2020 Policy revised to include criteria for Harvoni (ledipasvir/sofosbuvir) and Sovaldi (sofosbuvir) oral pellet formulations in the treatment of patients 3 years of age and older with chronic HCV. Policy revised to include updated treatment duration of Mavyret (glecaprevir/pibrentasvir) for patients with chronic HCV with compensated cirrhosis.

High Risk Medications in the Elderly – Medicare

1/1/2020 Policy revised to remove digoxin and nitrofurantoin. CMS feedback required removing prior authorization and adding quantity limitations.

Ibsrela (tenapanor) – Medicare

TBD New policy created for Ibsrela (tenapanor) to ensure appropriate use in adults with IBS-C in adults and trial and failure of Amitiza (lubiprostone) and Linzess (linaclotide).

Interleukin (IL)-5 Antagonists – Medicare

Best Date Policy revised to include Nucala's (mepolizumab) expanded indication for severe asthma in patients 6 years of age or older.

Interleukin-1β blockers – Medicare

TBD Policy revised to include age restrictions (12 and older for Arcalyst [rilonacept] and 4 and over for Illaris [canakinumab]), updated references

Intravitreal Injections – Medicare

1/1/2020 New policy created for Beovu (brolucizumab-dbll), Eylea (afibercept), Lucentis (ranibixumab) and Macugen (pegaptanib) to confirm diagnosis and if member has diagnosis of neovascular (wet) age-related macular degeneration the member has failed Avastin (bevacizumab).

JAK Inhibitors – Medicare 1/1/2020 Policy revised for Jakafi (ruxolitinib) and Inrebic (fedratinib) to expand risk factors for risk status stratification. New criteria created for Inrebic to ensure intermediate-2 or high risk primary or secondary myelofibrosis in adults and baseline platelet count for new starts to therapy.

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Policy Name Policy

Effective Date*

Updates and/or Approval Criteria

Lidoderm (lidocaine patch) – Medicare

1/1/2020 Policy revised to change category from MRxC to Prior Authorization, add approval criteria for diabetic peripheral neuropathy, removed automatic approval criteria, some administrative changes made, and references updated.

Nourianz (istradefylline) – Medicare

12/1/2019 New policy created to ensure appropriate use of Nourianz (istradefylline) as an adjunct to levodopa/carbidopa for Parkinson's disease "off" episodes in patients who have tried and failed selegiline and entacapone.

NTRK Inhibitors – Medicare 12/1/2019 Policy revised to include criteria for Rozlytrek (entrectinib) in the treatment of solid tumors with neurotrophic tyrosine receptor kinase (NTRK) gene fusion and ROS1-mutated non-small cell lung cancer (NSCLC).

Ofev (nintedanib) and Esbriet (pirfenidone) – Medicare

12/1/2019 Policy revised to include criteria for Ofev's (nintedanib) expanded systemic sclerosis-associated interstitial lung disease indication including member's diagnosis and appropriate baseline pulmonary function tests and renamed policy as medications are no longer only indicated for idiopathic pulmonary fibrosis.

Orilissa (elagolix) – Medicare

TBD Policy revised to remove requirement of the member receiving a 150 mg dose once daily for reauthorization of Orilissa (elagolix).

Orkambi (lumacaftor/ivacaftor) – Medicare

TBD Policy revised to remove the member's inability to swallow for the Orkambi (lumacaftor/ivacaftor) granules as the tablets can be crushed for administration.

Ozobax (baclofen) – Medicare

TBD New policy created for Ozobax (baclofen) to ensure appropriate use in patients with spasticity due to multiple sclerosis, spinal cord injury, or spinal cord disease who are unable to swallow tablets or have tried generic baclofen tablets.

Parathyroid Hormone Analogs – Medicare

1/1/2020 Policy revised to include Bonsity (teriparatide) to require appropriate diagnosis and risk of fracture, trial and failure of a bisphosphonate, and cumulative dose does not exceed 24 months.

Parathyroid Hormone Analogs – Medicare

1/1/2020 Policy revised to include Bonsity (teriparatide) to require appropriate diagnosis and risk of fracture, trial and failure of a bisphosphonate, if postmenopausal female with high risk of fracture trial and failure of Tymlos, and cumulative dose does not exceed 24 months.

PARP Kinase Inhibitors – Medicare

1/1/2020 Policy revised to add FDA expanded indication for Zejula (niraparib) in advanced ovarian, fallopian tube, or primary peritoneal cancer in adults.

PARP Kinase Inhibitors – Medicare

1/1/2020 Policy revised to add FDA expanded indication for Zejula (niraparib) in advanced ovarian, fallopian tube, or primary peritoneal cancer in adults; and to add age limitation of 18 years of age or older to Lynparza (olaparib) (for ovarian cancer), Rubraca (rucaparib), and Talzenna (talazoparib).

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Policy Name Policy

Effective Date*

Updates and/or Approval Criteria

Pretomanid – Medicare TBD New policy created for Pretomanid (pretomanid) to ensure appropriate use for extensively drug resistant (XDR), treatment-intolerant or nonresponsive multidrug-resistant tuberculosis in patients who have tried and failed first-line medications.

Programmed Death Receptor Therapies – Medicare

TBD Policy revised to include expanded indication for Keytruda (pembrolizumab) for the treatment of endometrial carcinoma.

Provigil (modafinil) and Nuvigil (armodafinil) – Medicare

1/1/2020 Policy revised for Provigil (modafinil) & Nuvigil (armodafinil) for narcolepsy to include baseline data of excessive daytime sleepiness. For narcolepsy, obstructive sleep apnea, shift-work sleep disorder, and multiple sclerosis fatigue trial and failure of generic modafinil. Multiple sclerosis fatigue only covered for Provigil (modafinil).

Pulmonary Hypertension – Medicare

1/1/2020 Policy revised for Pulmonary Hypertension by requiring step therapy through generic tadalafil if requesting Adcirca or generic ambrisentan if requesting Letairis.

Rybelsus (semaglutide) – Medicare

TBD New policy created for Rybelsus (semaglutide) to ensure appropriate use in patients with type 2 diabetes mellitus who have experienced therapeutic failure, contraindication, or intolerance to a metformin-containing product or are taking Rybelsus (semaglutide) in addition to a metformin-containing product.

Scenesse (afamelanotide) – Medicare

TBD New policy created for Scenesse (afamelanotide) in adults with erythropoietic protoporphyria. Reauthorization attesting increase from baseline in time spent outdoors in sunlight with no pain.

Tecfidera (dimethyl fumarate) – Medicare

1/1/2020 Policy revised to update authorization duration from 1 year to 5 years.

Thrombopoiesis Stimulating Agents – Medicare

TBD Policy revised for Nplate (romiplostim) to include expanded indication of immune thrombocytopenia.

Trikafta (elexacaftor/ ivacaftor/tezacaftor) – Medicare

TBD Policy revised to include Trikafta (elexacaftor/tezacaftor/ ivacaftor) and criteria for age, diagnosis of cystic fibrosis and appropriate CFTR mutation.

Turalio (pexidartinib) – Medicare

12/12/2019 New policy created to ensure appropriate use of Turalio (pexidartinib) for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not amenable to improvement with surgery.

Valchlor (mechlorethamine) – Medicare

1/1/2020 Policy revised to include new skin-directed therapy to initial and reauthorization criteria as per latest National Comprehensive Cancer Network (NCCN) 2.19 guidelines.

Viibryd (vilazadone) and Trintellix (vortioxetine) – Medicare

1/1/2020 Policy revised to be classified as prior authorization instead of MRxC, include restriction to apply to new starts only, require t/f of one antidepressant for initial authorization as well as

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Policy Name Policy

Effective Date*

Updates and/or Approval Criteria

automatic approval criteria, some administrative changes made, and authorization duration changed to 5 years.

Vimpat (lacosamide) – Medicare

1/1/2020 Policy revised for Coverage Year 2020 for Vimpat (lacosamide) to be approved after the member has had inadequate response or intolerance to two other anticonvulsants.

Wakix (pitolisant) – Medicare

TBD New policy created to require a documented diagnosis of narcolepsy, documentation of baseline EDS, documented treatment failure, intolerance or contraindication to modafinil as well as one additional CNS stimulant OR wakefulness/stimulant meds are clinically inappropriate or there is a legitimate concern of illegal drug diversion.

Xtandi (enzalutamide) – Medicare

TBD Policy terminated to be combined into new policy Androgen Receptor Inhibitors – Medicare.

Xyrem (sodium oxybate) – Medicare

1/1/2020 Policy revised to require documentation that the member is 7 years of age or older.

Yosprala (aspirin/omeprazole) – Medicare

Best Date Policy revised for Yosprala (aspirin and omeprazole) to add need for secondary prevention of cardiovascular and cerebrovascular events as per filing.

ZTLido (lidocaine 1.8% topical system) – Medicare

1/1/2020 Policy revised to add approval criteria for diabetic peripheral neuropathy, some administrative changes made, and references updated.

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

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2. Managed Prescription Drug Coverage (MRxC) Program *

Policy Name Policy

Effective Date*

Updates and Automatic Approval Criteria

Brand and Extended Release Metformin – Medicare

1/1/2020 Policy revised to ensure members have tried and failed generic metformin ER and generic metformin IR for approval of Glucophage XR (metformin ER). Policy revised to ensure members have tried and failed generic metformin IR for approval of Glucophage (metformin). Policy revised to add Riomet ER (metformin ER oral suspension) to ensure members have tried and failed metformin ER (generic Glucophage XR), and to ensure appropriate utilization in members who are unable to swallow tablets containing metformin.

Duexis (ibuprofen, famotidine) – Medicare

1/1/2020 Policy revised to remove automatic authorization criteria.

Selective Serotonin-Norepinephrine Reuptake Inhibitors – Medicare

1/1/2020 Policy revised to change name from SNRI to Fetzima (levomilnacipran) (this is the only medication discussed in policy now), updated the references, changed the authorization duration to 5 years and removed desvenlafaxine references since this medication is no longer discussed in the policy, also some administrative changes.

Vimovo (naproxen, esomeprazole) – Medicare

1/1/2020 Policy revised to remove automatic authorization criteria.

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

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3. Quantity Level Limit (QLL) Program* (Effective date pending CMS approval, completion of internal review and implementation, unless otherwise noted.)

Drug Name Retail Quantity Limit

(31 days) Mail Order Quantity Limit

(90 days) Accrufer (ferric maltol) 2 capsules per day 2 capsules per day Beovu (brolucizumab-dbll) 2 vials per 56 days 4 vials per 112 days Bonsity (teriparatide) 1 pen per 28 days 3 pens per 84 days Enbrel Mini 50 mg/mL 7.84 mL per 28 days 23.52 mL per 84 days Entresto (sacubitril/valsartan) 24/26 mg 6 tablets per day 6 tablets per day Entresto (sacubitril/valsartan) 49/51 mg 3 tablets per day 3 tablets per day Hadlima (adalimumab-bwwd) 2 prefilled syringes 6 prefilled syringes Harvoni (ledipasvir/sofosbuvir) oral pellets 1 packet per day 1 packet per day Ibrance 75 mg, 100 mg, and 125 mg capsules

21 tablets per 21 days 21 tablets per 21 days

Ibsrela (tenapanor) 2 tablets per day 2 tablets per day Inrebic (fedratinib) 4 capsules per day 4 capsules per day Nourianz (istradefylline) 1 tablet per day 1 tablet per day Ozobax (baclofen) 80 mL per day 80 mL per day pretomanid 1 tablet per day 1 tablet per day Revlimid capsules 1 capsule per day 1 capsule per day Rinvoq (upadacitinib) 1 tablet per day 1 tablet per day Riomet ER (metformin) oral solution 2 bottles per dispensing event 2 bottles per dispensing event Rozlytrek (entrectinib) 20 mg capsules 3 capsules per day 3 capsules per day Rozlytrek (entrectinib) 100 mg capsules 5 capsules per day 5 capsules per day Rybelsus (semaglutide) 1 tablet per day 1 tablet per day Scenesse (afemelanotide) 6 implants per 365 days 6 implants per 365 days Secuado (asenapine) 1 patch per day 1 patch per day Sovaldi (sofosbuvir) oral pellets 1 packet per day 1 packet per day Sprycel 20 mg tablets 2 tablets per day 2 tablets per day Stivarga 40 mg tablets 84 tablets per 21 days 84 tablets per 21 days Sunosi 75 mg, 150 mg tablets 1 table per day 1 tablet per day Tarceva (erlotinib) 25 mg tablets 2 tablets per day 2 tablets per day Trikafta (elexacaftor/ivacaftor/texacaftor) 1 carton per 28 days 3 cartons per 84 days Wakix (pitolisant) 4 tablets per day 4 tablets per day Xenleta (lefamulin) oral 2 tablets per day 2 tablets per day Zelnorm 6 mg tablets 2 tablets per day 2 tablets per day

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