1 ST QUARTER 2015 UPDATE CHANGES TO THE HIGHMARK DRUG FORMULARIES

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1 February ST QUARTER 2015 UPDATE CHANGES TO THE HIGHMARK DRUG FORMULARIES Following is the 1 st Quarter 2015 update to the Highmark 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 December 2014 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 Comprehensive and Progressive Formularies A. Changes to the Highmark Comprehensive Formulary and the Highmark Comprehensive Health Care Reform Formulary B. Changes to the Highmark Progressive Formulary and the Highmark Progressive Health Care Reform 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 3. Updates to the Nonformulary Program 4. Updates to the Quantity Level Limit (QLL) Program Section II. Highmark Medicare-approved Formularies A. Changes to the Highmark Medicare-approved Incentive Formulary B. Changes to the Highmark Medicare-approved 5-Tier Closed Formulary C. Additions to the Specialty Tier D. Updates to the Pharmacy Utilization Management Programs 1. Updates to the Prior Authorization Program 2. Updates to the Managed Prescription Drug Coverage (MRxC) Program 3. Updates to the Nonformulary Program 4. Updates to the Quantity Level Limit (QLL) Program If you have any questions regarding this pharmacy communication or the Highmark formularies, please contact your Provider Relations Representative. As an added convenience, you can also search the Highmark Drug Formularies online at Camp Hill, PA 17089

2 Important Information Update Regarding Tecfidera (dimethyl fumarate) On November 25, 2014, the FDA issued a warning that a patient being treated for multiple sclerosis (MS) with Tecfidera (dimethyl fumarate) developed progressive multifocal leukoencephalopathy (PML) and then later died. This patient was not taking any medications thought to be associated with developing PML. As a result, information regarding this case has been added to the labeling for Tecfidera (dimethyl fumarate). PML is a rare but serious brain infection caused by the John Cunningham (JC) virus. This virus is common, and often harmless, but can cause PML in patients with a weakened immune system. Symptoms suggestive of PML may include progressive weakness on one side of the body or limbs, visual disturbances, changes in thinking, memory or orientation, confusion and personality changes. FDA recommendations for healthcare professionals at this time include: Inform patients taking Tecfidera (dimethyl fumarate) about the signs and symptoms suggestive of PML and to contact their physician if they develop these symptoms. Discontinue use of Tecfidera (dimethyl fumarate) in patients who develop symptoms and perform diagnostic evaluation for PML. Perform appropriate monitoring of lymphocyte counts in patients who are being treated with Tecfidera (dimethyl fumarate), according to package labeling. Highmark Formulary Update February 2015 SECTION I. Highmark Comprehensive and Progressive Formularies A. Changes to the Highmark Comprehensive Formulary and the Highmark Comprehensive Health Care Reform Formulary The Highmark Pharmacy and Therapeutics Committee reviewed the medications listed in the tables below. Please note 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 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 Comprehensive Formulary or the Highmark Comprehensive Health Care Reform Formulary online at Note: You must click the hyperlink for the Highmark Comprehensive Health Care Reform formulary. 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 maintenance products and improve the overall health of our members. Table 1: Products Added (All products added to the formulary effective immediately unless otherwise noted) Brand Name Generic Name Comments Vitekta elvitegravir For the treatment of HIV in treatment-experienced adult patients. Tybost cobicistat A boosting agent to increase exposure to antiretroviral therapy used to treat HIV. Spiriva Respimat tiotropium bromide For treatment of bronchospasm and prevention of exacerbations in patients with COPD. Invokamet canagliflozin/metformin For treatment of adult patients with Type II diabetes mellitus. Xarelto Starter Pack rivaroxaban For prevention of embolus formation in high-risk patients. Novofine Plus 32 Gauge x 1/6 Needle insulin needle (disposable) 32 gauge x 1/6 For administration of insulin. Humira Pediatric adalimumab For treatment of Crohn s disease and juvenile idiopathic arthritis in pediatric patients Effective: 12/5/2014 2

3 Brand Name Generic Name Comments Crestor rosuvastatin For treatment of dyslipidemia Effective: 1/15/2015 Sovaldi sofosbuvir For treatment of chronic Hepatitis C Virus (HCV). Effective: 2/3/2015 Harvoni ledipasvir/sofosbuvir For treatment of chronic Hepatitis C Virus (HCV) genotype 1. Effective: 2/3/2015 Viekira Pak ombitasvir/paritaprevir/rit onavir; dasabuvir For treatment of chronic Hepatitis C Virus (HCV) genotype 1. Effective: 2/3/2015 Table 2: Products Not Added * Brand Name Generic Name Preferred Alternatives Movantik naloxegol Amitiza Trulicity dulaglutide Victoza, Bydureon Auryxia ferric citrate calcium acetate Contrave naltrexone/bupropion Provider Discretion Uceris (rectal foam) budesonide hydrocortisone enema, mesalamine enema Fosrenol (solution) lanthanum carbonate calcium acetate Mitigare colchicine allopurinol Akynzeo netupitant/palonosetron Provider Discretion Esbriet pirfenidone Provider Discretion Ofev nintedanib Provider Discretion Sotylize sotalol HCl sotalol, sotalol AF Xigduo XR dapagliflozin/metformin Invokana, metformin, Invokamet Obredon hydrocodone bitartrate/guaifenesin benzonatate, Cheratussin DAC, codeine/guaifenesin Hysingla ER hydrocodone bitartrate ER morphine sulfate ER, oxymorphone ER *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. Table 3: Additions to the Specialty Tier Copay Option *Note: The specialty tier does not apply to Highmark Delaware members; see Highmark Delaware's online Provider Resource Center and access the Pharmacy/Formulary Information link for details on the formularies and formulary options that apply to Highmark Delaware members. (Effective upon completion of internal review and operationalization unless otherwise noted) Brand Name Generic Name Viekira Pak ombitasvir/paritaprevir/ritonavir; dasabuvir Harvoni ledipasvir/sofosbuvir Auryxia Fosrenol (solution) Esbriet Ofev ferric citrate lanthanum carbonate pirfenidone nintedanib B. Changes to the Highmark Progressive Formulary and the Highmark Health Care 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/Formulary Information link for details on the formularies and formulary options that apply to Highmark Delaware members. For your convenience, you may search the Highmark Progressive Formulary or the Highmark Health Care Reform Progressive Formulary online at Note: You must click the hyperlink for the appropriate formulary. 3

4 Table 1: Formulary Updates (All products added to the formulary effective immediately unless otherwise noted) Brand Name Generic Name Tier Comments/Preferred Alternatives Items listed below are preferred products Tybost cobicistat Tier 2 Preferred Brand A boosting agent to increase exposure to antiretroviral therapy used to treat HIV Spiriva Respimat tiotropium bromide Tier 2 Preferred Brand For treatment of bronchospasm and pre-vention of exacerbation in patients with COPD Invokamet canagliflozin/ metformin Tier 2 Preferred Brand For treatment of adult patients with Type II diabetes mellitus. Novofine Plus 32 Gauge x 1/6 Needle insulin needle (disposable) 32 gauge x 1/6 Tier 2 Preferred Brand For administration of insulin Humira Pediatric adalimumab Tier 3 Preferred Specialty For treatment of Crohn s disease and juvenile idiopathic arthritis in pediatric patients Effective: 12/5/2014 Sovaldi sofosbuvir For treatment of chronic Hepatitis C Virus (HCV). Tier 3 Preferred Specialty Effective: 2/3/2015 Harvoni ledipasvir/ sofosbuvir For treatment of chronic Hepatitis C Virus (HCV) Tier 3 Preferred Specialty genotype 1. Effective: 2/3/2015 Viekira Pak ombitasvir/ paritaprevir/ For treatment of chronic Hepatitis C Virus (HCV) Tier 3 Preferred Specialty ritonavir; dasabuvir genotype 1. Effective: 2/3/2015 Items listed below are non-preferred products Vitekta elvitegravir Tier 3 Non-preferred Brand Provider Discretion Movantik naloxegol Tier 3 Non-preferred Brand Amitiza Trulicity dulaglutide Tier 3 Non-preferred Brand Victoza, Bydureon Auryxia ferric citrate Tier 4 Non-preferred Specialty calcium acetate Contrave naltrexone/ bupropion Tier 3 Non-preferred Brand Provider Discretion Uceris (rectal foam) budesonide Tier 3 Non-preferred Brand hydrocortisone enema, mesalamine enema Fosrenol (solution) lanthanum carbonate Tier 4 Non-preferred Specialty calcium acetate Mitigare colchicine Tier 3 Non-preferred Brand allopurinol Akynzeo netupitant/ palonosetron Tier 3 Non-preferred Brand Provider Discretion Esbriet pirfenidone Tier 4 Non-preferred Specialty Provider Discretion Ofev nintedanib Tier 4 Non-preferred Specialty Provider Discretion Sotylize sotalol HCl Tier 3 Non-preferred Brand sotalol, sotalol AF Xigduo XR dapagliflozin/ metformin Tier 3 Non-preferred Brand Invokana, metformin, Invokamet Obredon hydrocodone bitartrate/ benzonatate, Cheratussin DAC, Tier 3 Non-preferred Brand guaifenesin codeine/guaifenesin Hysingla ER hydrocodone bitartrate ER Tier 3 Non-preferred Brand morphine sulfate ER, oxymorphone ER Xarelto Starter Pack rivaroxaban Tier 3 Non-preferred Brand For prevention of embolus formation in high-risk patients. *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 C. Updates to the Pharmacy Utilization Management Programs 4

5 1. Updates to the Prior Authorization Program Policy Name Policy Effective Date Updates and/or Approval Criteria Hepatitis C Oral Agents 12/10/2014 Addition of Harvoni (ledipasvir/sofosbuvir) to policy for patients with chronic hepatitis C infection, genotype 1, and an estimate GFR > 30 ml/min. Additionally, all direct acting agents will only covered for patients who have a documented METAVIR score of F3 or F4, and documented abstinence from alcohol and illicit drugs. Hepatitis C Oral Agents 1/19/2015 Addition of Viekira Pak (ombitasvir/paritaprevir/ritonavir; dasabuvir) to the policy for patients with chronic Hepatitis C infection, genotype 1, without renal or hepatic dysfunction and a documented METAVIR score of F3 or F4. Members must also have documented abstinence from alcohol and illicit drugs. Movantik (naloxegol) When a benefit, Movantik may be covered if the following criterion is met: The member has a diagnosis of opioid-induced constipation (OIC) in adult patients with chronic non-cancer related pain. Anti-Obesity 2/16/2015 Contrave has been added to this policy. When a benefit, Contrave may be covered if the following criteria is met: The member is 18 years of age and is obese, with a documented BMI 30 kg/m2 OR The member is 18 years of age and is overweight, with a documented BMI 27 kg/m2 AND at least one weight-related comorbidity (e.g., hypertension, dyslipidemia, type 2 diabetes, obstructive sleep apnea, symptomatic osteoarthritis of lower extremities, gastroesophageal reflux, coronary heart disease). Idiopathic Pulmonary 2/16/2015 When a benefit, Esbriet or Ofev may be covered if following criteria is met: Fibrosis The medication is being prescribed by a pulmonologist. The member has a documented diagnosis of idiopathic pulmonary fibrosis (ICD , ICD-10 J84.112). The member has a baseline forced vital capacity (FVC) of at least 50% and a percent predicted diffusing capacity of the lungs of carbon monoxide (DLCO) of at least 30%. The member is not using pirfenidone and nintedanib in combination. Xtandi 12/4/2014 Docetaxel failure has been removed from the policy to align with current FDA approved indication. When a benefit, enzalutamide may be approved if following criteria are met: Enzalutamide is to be used for patients with metastatic castrationresistant prostate cancer (ICD X, ICD-10 C61). Humira 12/4/2014 New indications have been added to the policy for pediatric Crohn s disease and juvenile idiopathic arthritis. Criteria have been updated to reflect current FDA approved indications. When a benefit, adalimumab may be approved if following criteria are met: Adalimumab is to be used reducing the signs and symptoms of moderately to severely active polyarticular-course juvenile idiopathic arthritis( ICD X, ICD-10 M08.00) in patients 2 years of age and older who have had an inadequate response to one or more DMARDs OR Adalimumab is used in reducing the signs and symptoms of pediatric patients > 6 years of age with moderate to severe Crohn's disease (ICD-9 555, ICD-10 K50.X) who have not responded to treatment with either a corticosteroid or immunomodulator such as azathioprine, 6- mercaptopurine, or methotrexate or monotherapy with Remicade 5

6 Policy Name Policy Effective Date Updates and/or Approval Criteria Otezla 12/4/2014 Plaque psoriasis, with approval criteria, has been added as an indication to the policy. When a benefit, Otezla may be approved if all of the following criteria are met: 1. Apremilast is to be used for the treatment of moderate to severe psoriasis (ICD , ICD-10 L40.X) in patients AND 2. The member has had an adequate trial or has experienced an intolerance to Humira and Enbrel, both of which are biologic agents indicated for the treatment of psoriasis 3. Maintenance dose does not exceed 30 mg twice daily. Stelara Approval criteria have been added to the policy to ensure use of the 90 mg dose in the appropriate population. Approval Criteria: When a benefit, Stelara may be approved when all of the following criteria are met: 1. Stelara is to be used for the treatment of moderate to severe plaque psoriasis (ICD , ICD-10 L40.X) in adult patients (> 18 years) who have previously received systemic therapy (e.g. methotrexate, cyclosporine) or phototherapy AND 2. The member has had an adequate trial or has experienced an intolerance to Humira, a biologic product indicated for the treatment of psoriasis OR 3. Stelara is to be used for the treatment of psoriatic arthritis ( ICD , ICD-10 L40.52) AND The member has failed to respond to, is intolerant of, or has a medical contraindication to one or more nonbiologic DMARDs AND 4. The member has had an adequate trial or has experienced intolerance to both preferred biologic products, Enbrel and Humira, indicated for the treatment of psoriatic arthritis. AND 5. Documentation of member weight and prescribed Stelara dose Dosing: Psoriasis For patients weighing 100 kg (220 lbs), the recommended dose is 45 mg initially and 4 weeks later, followed by 45 mg every 12 weeks. For patients weighing >100 kg (220 lbs), the recommended dose is 90 mg initially and 4 weeks later, followed by 90 mg every 12 weeks. Psoriatic Arthritis The recommended dose is 45 mg initially and 4 weeks later, followed by 45 mg every 12 weeks. For patients with co-existent moderate-to-severe plaque psoriasis weighing >100 kg (220 lbs), the recommended dose is 90 mg initially and 4 weeks later, followed by 90 mg every 12 weeks. 2. Updates to the Managed Prescription Drug Coverage (MRxC) Program Policy Effective Policy Name Date Updates and Automatic Approval Criteria* Extended Release Opioid Management - Commercial Only 2/16/2015 Hysingla ER has been added to this policy. A maximum of 30 tablets will be dispensed per month without an authorization. For claims exceeding this amount, a prior authorization will be required. Extended Release Opioid Management Commercial Only MS Contin, Kadian, Avinza, Duragesic, levorphanol tartrate, Nucynta ER Dolophine and methadone have been added to this policy. Maximum quantities are based on dosing frequency for each individual agent. For claims exceeding the amount, a prior authorization will be required. 6

7 Therapy for Gout 2/16/2015 When a benefit, Mitigare may be covered if the following criterion is met: Mitigare (colchicine) is to be used for prophylaxis of gout attacks (ICD X, ICD-10 M10-X) following an adequate trial of allopurinol or other accepted gout treatment. Immediate Release Opioid Management Commercial Only Dilaudid, hydromorphone, Demerol, meperidine, morphine sulfate, codeine sulfate and Nucynta have been added to this policy. Maximum quantities are based on dosing frequency for each individual agent. For claims exceeding the amount, a prior authorization will be required. *Standard prior authorization criteria will apply for members who do not meet the automatic approval criteria. 3. Updates to the Nonformulary Program Policy Name Policy Effective Date Updates and/or Approval Criteria Lack of Clinical Efficacy Addition of Jublia and Kerydin to this policy. Jublia and Kerydin will not be covered for members with the closed formulary due to a lack of significant efficacy in clinical trials. 4. Updates to the Quantity Level Limit Program Drug Name Up to 34-Day Supply Limit (retail) 35- to 90-Day Supply Limit (retail or mail) Viekira Pak 112 tablets 336 tablets Harvoni 28 tablets 84 tablets Sovaldi 28 tablets 84 tablets Olysio 28 capsules 84 capsules Akynzeo 1 capsule 1 capsule Belsomra 34 tablets 90 tablets Esbriet 306 capsules 810 capsules Ofev 68 capsules 180 capsules Mitigare 68 capsules 180 capsules Sivextro (tablets only) 6 tablets 6 tablets All effective dates are tentative and subject to delay, pending internal review. SECTION II. Highmark Medicare-approved Formularies A. Changes to the Highmark Medicare-approved 5-Tier Incentive Formulary The Highmark Pharmacy and Therapeutics Committee reviewed the medications listed in the following tables. For your convenience, you can search the Highmark Medicare-approved Formularies online at: Table 1: Preferred Products (Effective immediately, pending CMS approval and upon completion of internal review and operationalization, unless otherwise noted) Brand Name Generic Name Alternatives/Comments Tybost cobicistat A boosting agent to increase exposure to antiretroviral therapy used to treat HIV. Spiriva Respimat tiotropium bromide For treatment of bronchospasm and prevention of exacerbations in patients with COPD. Trumenba meningococcal group B vaccine For prevention of group B meningococcal meningitis. Invokamet canagliflozin/metformin For treatment of adult patients with Type II diabetes mellitus. Effective: 12/1/2014 Xarelto Starter Pack rivaroxaban For prevention of embolus formation in high-risk patients. Novofine Plus 32 Gauge x 1/6 Needle insulin needle (disposable) 32 gauge x 1/6 For administration of insulin. 7

8 Table 2: Non-Preferred Products (Effective immediately pending CMS approval and upon completion of internal review and operationalization, unless otherwise noted) Brand Name Generic Name Alternatives/Comments Movantik naloxegol Amitiza Trulicity dulaglutide Victoza, Bydureon Uceris (rectal foam) budesonide hydrocortisone enema, mesalamine enema Mitigare colchicine allopurinol Akynzeo netupitant/palonosetron Provider Discretion Sotylize sotalol HCl sotalol, sotalol AF Xigduo XR dapagliflozin/metformin Invokana, metformin, Invokamet Hysingla ER hydrocodone bitartrate ER morphine sulfate ER, oxymorphone ER B. Changes to the Highmark Medicare-approved 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-approved Formularies online at: Note: You must click the hyperlink to access the 5-Tier Closed Formulary. Table 1: Preferred Products (Effective immediately pending CMS approval and upon completion of internal review and operationalization, unless otherwise noted) Brand Name Generic Name Alternatives/Comments Tybost cobicistat A boosting agent to increase exposure to antiretroviral therapy used to treat HIV. Spiriva Respimat tiotropium bromide For treatment of bronchospasm and prevention of exacerbations in patients with COPD. Trumenba meningococcal group B vaccine For prevention of group B meningococcal meningitis. Xarelto Starter Pack rivaroxaban For prevention of embolus formation in high-risk patients. Invokamet canagliflozin/metformin For treatment of adult patients with Type II diabetes mellitus. Effective: 12/1/2014 Novofine Plus 32 Gauge x 1/6 Needle insulin needle (disposable) 32 gauge x 1/6 For administration of insulin. Table 2: Non-Preferred Products (Effective immediately pending CMS approval and upon completion of internal review and operationalization) Brand Name Generic Name Preferred Alternatives/Comments Movantik naloxegol Amitiza Akynzeo netupitant/palonosetron Provider Discretion Sotylize sotalol HCl sotalol, sotalol AF Hysingla ER hydrocodone bitartrate ER morphine sulfate ER, oxymorphone ER Table 3: Products Not Added * (Effective immediately pending CMS approval and upon completion of internal review and operationalization) Brand Name Generic Name Preferred Alternatives/Comments Trulicity dulaglutide Victoza, Bydureon Uceris (rectal foam) budesonide hydrocortisone enema, mesalamine enema Mitigare colchicine allopurinol Xigduo XR dapagliflozin/metformin Invokana, metformin 8

9 *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. C. Additions to the Specialty Tier (Effective immediately pending CMS approval and upon completion of internal review and operationalization) Brand Name Generic Name Viekira Pak ombitasvir/paritaprevir/ritonavir; dasabuvir Harvoni ledipasvir/sofosbuvir Keytruda pembrolizumab Kabiven and Perikabiven amino acids; electrolytes; dextrose; lipid Auryxia ferric citrate Vitekta elvitegravir Fosrenol (solution) lanthanum carbonate Iluvien fluocinolone intravitreal injection Esbriet pirfenidone Ofev nintedanib Lemtrada alemtuzumab HyQvia IVIG 10% with recombinant hyaluronidase D. Updates to the Pharmacy Utilization Management Programs 1. Updates to the Prior Authorization Program Policy Name Policy Effective Date Updates and Approval Criteria Hepatitis C Oral Agents Addition of Harvoni (ledipasvir/sofosbuvir) and Viekira Pak to policy with criteria for use consistent with guidelines and prescribing information. Movantik (naloxegol) When a benefit, Movantik may be covered if the following criterion is met: Member has a diagnosis of opioid-induced constipation (OIC) in adult patients with chronic non-cancer related pain. Idiopathic Pulmonary Fibrosis Keytruda (pembrolizumab) When a benefit, Esbriet or Ofev may be covered when the following criteria are met: The medication is being prescribed by a pulmonologist. The member has a documented diagnosis of idiopathic pulmonary fibrosis (ICD , ICD-10 J84.112). The member has a baseline forced vital capacity (FVC) of at least 50% and a percent predicted diffusing capacity of the lungs of carbon monoxide (DLCO) of at least 30%. The member is not using pirfenidone and nintedanib in combination. When a benefit, pembrolizumab may be approved when the following criterion is met: Pembrolizumab (Keytruda) is to be used for the treatment of unresectable or metastatic melanoma (ICD , ICD-10 C43-44) and disease progression following ipilimumab (Yervoy) and, if BRAF V600 mutation positive, a BRAF inhibitor. Xtandi 12/4/2014 Docetaxel failure has been removed from the policy to align with current FDA approved indication. When a benefit, enzalutamide may be approved when the following criteria are met: Enzalutamide is to be used for patients with metastatic castrationresistant prostate cancer (ICD X, ICD-10 C61). Humira 12/4/2014 New indications have been added to the policy for pediatric Crohn s disease and juvenile idiopathic arthritis. Criteria have been updated to reflect current FDA approved indications. 9

10 Policy Name Policy Effective Date Updates and Approval Criteria When a benefit, adalimumab may be approved if following criteria are met: Adalimumab is to be used reducing the signs and symptoms of moderately to severely active polyarticular-course juvenile idiopathic arthritis( ICD X, ICD-10 M08.00) in patients 2 years of age and older who have had an inadequate response to one or more DMARDs OR Adalimumab is to be used in reducing the signs and symptoms of pediatric patients > 6 years of age with moderate to severe Crohn's disease( ICD-9 555, ICD-10 K50.X) who have not responded to treatment with either a corticosteroid or immunomodulator such as azathioprine, 6-mercaptopurine, or methotrexate or monotherapy with Remicade Otezla 12/4/2014 Plaque psoriasis, with approval criteria, has been added as an indication to the policy. Administrative Prior Authorization for Part D Plans IG for Medicare Part D Only Reduction of authorization period to 12 months When a benefit, Otezla may be approved if all of the following criteria are met: 4. Apremilast is to be used for the treatment of moderate to severe psoriasis (ICD , ICD-10 L40.X) in patients AND 5. The member has had an adequate trial or has experienced an intolerance to Humira and Enbrel, both of which are biologic agents indicated for the treatment of psoriasis 6. Maintenance dose does not exceed 30 mg twice daily. Diagnosis codes for primary immunodeficiency have been added to the policy. Immune Globulins (IG) - Covered under Part B when administered in the home to a member with a diagnosis of primary immunodeficiency disease (PID). Applies to ICD-9 diagnosis codes , , , , and OR ICD-10- CM codes D80.0, D80.5, D81.0, D81.1, D81.2, D81.6, D81.7, D81.89, D81.9, D82.0, D83.0, D83.2, D83.8, or D83.9 if only an unspecified diagnosis is necessary. IG provided in the home for a diagnosis other than PID may be covered under the Part D benefit. Diagnosis codes for primary immunodeficiency have been added to the policy. If a physician determines that the administration of IG in the patient s home is medically appropriate with a diagnosis of PID, coverage for IG is provided in the home setting under the member s Part B benefit. Part B coverage for PID applies to ICD-9 diagnosis codes , , , , and OR ICD-10-CM codes D80.0, D80.5, D81.0, D81.1, D81.2, D81.6, D81.7, D81.89, D81.9, D82.0, D83.0, D83.2, D83.8, or D83.9 if only an unspecified diagnosis is necessary. IG provided in the home for a diagnosis other than PID may be covered under the Part D benefit according to afore-mentioned criteria. Payment is limited to that for the IG itself and does not cover items and services related to administration of the product. Administration and related Home Infusion Therapy services are reimbursed as a health service benefit. 12/4/2014 Per CMS guidance, authorization duration was reduced to 12 months for 26 prior authorization policies. The affected policies are listed in the "Authorization Duration Reduced to 12 Months" table below. 2. Updates to the Managed Prescription Drug Coverage (MRxC) Program Policy Name Policy Effective Date Updates and Automatic Approval Criteria* Extended Release Opioid Management - Commercial Only Hysingla ER has been added to this policy. A maximum of 30 tablets will be dispensed per month without an authorization. For claims exceeding this amount, a prior authorization will be required. Leukotriene Modifiers 1/1/2015 Singulair (montelukast) has been removed from this policy and no longer requires prior authorization. 10

11 Policy Name Policy Effective Date Updates and Automatic Approval Criteria* Namenda XR 12/4/2014 When a benefit, Namenda and Namenda XR may be approved if members meet the following criteria: Namenda or Namenda XR is being used for an FDA-approved or medically-accepted indication as defined by the Centers for Medicare & Medicaid Services (CMS). Reduction of authorization period to 12 months 12/4/2014 Per CMS guidance, authorization duration was reduced to 12 months for 4 managed prescription drug coverage policies. Affected policies are listed in the "Authorization Duration Reduced to 12 Months" table below. 3. Updates to the Nonformulary Program Policy Name Policy Effective Date Updates and/or Approval Criteria General Nonformulary Request Criteria Addition of definitions regarding supporting statements, adequate therapeutic trial. Addition of criteria requiring the prescriber to submit a supporting statement with the nonformulary request. Addition of provision for prevention of interruption of therapy for patients stable on a nonformulary protected class drug, as defined by CMS. Tiering Exception Addition of definitions regarding supporting statements, adequate therapeutic trial. Addition of criteria requiring the prescriber to submit a supporting statement with the tiering exception request. Addition of criteria clarifying that medications requested will only be compared against the immediate lower preferred tier. Requests for tiering exceptions will be approved when below criteria 1, 2, and 3 along with 4 or 5: 1. The medication requested is being used to treat a medically accepted indication. 2. There is at least 1 agent in the immediate lower preferred tier to review against the requested higher cost-share medication available for the treatment of the member s condition. 1. Tier 4 agents can only be reviewed against Tier 3 agents 2. Tier 2 agents can only be reviewed against Tier 1 agents 3. The prescribing physician or other prescriber provides an explicit oral or written supporting statement that the preferred drug(s) for the treatment of the enrollee's conditions 1. Would not be as effective for the enrollee as the requested drug OR 2. Would have adverse effects for the enrollee 4. The member had an adequate trial and/or failed three preferred agents on the immediate lower tier within the same therapeutic class (when alternatives are available), or category (when alternatives are not available in the same class) OR 5. The member had an adequate trial and/or failed all preferred alternatives if less than 3 are present on the immediate lower tier. Authorization Duration Reduced to 12 Months (effective 1/1/2015) Program Policy Name Program Policy Name PA Acthar HP PA Korlym (mifepristone) PA Afinitor (everolimus) Medicare Only PA MAP Kinase Inhibitors PA Aubagio (teriflunomide) PA Myalept (metreleptin) PA Bosulif (bosutinib) PA Miscellaneous Immunomodulators MRxC Buprenorphine (non-opioid dependence use) MRxC Selective Serotonin-Norepinephrine Reuptake Inhibitors PA Cometriq (cabozantinib) PA Provigil (modafinil) & Nuvigil (armodafinil) Medicare Only PA EGFR Tyrosine Kinase Inhibitors PA Savella (milnacipran) 11

12 PA Forteo (teriparatide) PA Signifor (pasireotide) Medicare Only PA Gattex (teduglutide) PA Simponi (golimumab) Medicare Only PA Growth Hormone Medicare Only PA Stivarga (regorafenib) MRxC High Risk Medications in the Elderly PA Sylvant (siltuximab) Medicare Only PA Homozygous Familial Hypercholesterolemia PA Testosterone (Androgens) Medicare Only PA Horizant (gabapentin enacarbil) PA Urea Cycle Disorder Medications PA IG for Medicare Part D Only MRxC Viibryd (vilazodone) and Brintellix (vortioxetine) PA Immediate Release Fentanyl Citrate Medicare Only PA Xeljanz (tofacitinib) Medicare Only 4. Updates to the Quantity Level Limit Program ** Drug Name Up to 34-Day Supply Limit (retail)* 35- to 90-Day Supply Limit (retail or mail)* Viekira Pak 112 tablets 336 tablets Harvoni 28 tablets 84 tablets Sovaldi 28 tablets 84 tablets Olysio 28 capsules 84 capsules Esbriet 306 capsules 810 capsules Ofev 68 capsules 180 capsules Mitigare 68 capsules 180 capsules Sivextro (tablets only) 6 tablets 6 tablets * Unless noted. **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, operationalization, or CMS approval. Highmark Blue Shield is an independent licensee of the Blue Cross and Blue Shield Association. Blue Shield and the Shield symbol are registered service marks of the Blue Cross and Blue Shield Association. Highmark is a registered mark of Highmark Inc. Highmark Senior Resources, Inc., a subsidiary of Highmark Inc., has a contract with the Federal government to administer Medicare Prescription Drug Coverage in the states of Pennsylvania and West Virginia. NaviNet is a registered trademark of NaviNet, Inc., which is an independent company that provides a secure, web-based portal between providers and health care insurance companies. 12

SASKATCHEWAN FORMULARY BULLETIN Update to the 62nd Edition of the Saskatchewan Formulary

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