P&T Committee Meeting Minutes (GHP Family Business) March 18, 2014

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1 P&T Committee Meeting Minutes (GHP Family Business) March 18, 2014 Present: Bret Yarczower, MD, MBA Chair Peter Mikhail, Pharm.D., MBA Secretary Charles Baumgart, MD, MBA Keith Boell, DO Kimberly Clark, Pharm.D. Tricia Heitzman, Pharm.D. Michelle Holt-Macey, Pharm.D. via phone Kristi Juskiewicz, Pharm. D. via phone Steven Kheloussi, Pharm.D. via phone Phillip Krebs, R.EEG T. via phone Lisa Mazonkey, RPh Daniel McConnell, Pharm.D., RPh Sean Ordway, Pharm.D. Resident David Rolston, MD via phone Tricia Russell, Pharm.D. via phone William Seavey, Pharm.D. via phone Hamilton Sebastian, Pharm.D. Richard Silbert, MD - via phone Leah Smith, Pharm.D via phone Todd Sponenberg, Pharm.D., RPh Kevin Szczecina, RPh Elaine Tino, CRNP Steve Tracy, Pharm.D. Absent: Kristen Bender, Pharm.D. Beverly Blaisure, MD Fred Bloom, MD Holly Bones, Pharm.D. Jamie Dodson, RPh Jonas Pearson, MS, RPh Ray Roth, DO, MBA Kristen Scheib, Pharm. D. James Schuster, MD Michael Spishock, RPh Lori Zaleski, RPh Call To Order: Bret Yarczower called the meeting to order at 1:05 p.m., Tuesday, March 18, Review and Approval of Minutes: Bret Yarczower asked for a motion or approval to accept the January 18, 2014 minutes as written with changes noted. Lisa Mazonkey accepted the motion, and Tricia Heitzman seconded the motion. None were opposed.

2 DRUG REVIEWS: V-Go Insulin Delivery Device Sean Ordway Sean Ordway provided a review of the V-Go Insulin Delivery Device to the committee for consideration as a medical benefit. It is indicated for continuous subcutaneous infusion of 20, 30 or 40 units of insulin in one 24-hour time period and on-demand bolus dosing in 2 Unit increments (up to 36 units per one 24- hour time period) in adult patients requiring insulin. It was decided to table a decision on V-Go until a later time Opsumit (macitentan tablets) Kim Clark Kim Clark provided a review of Opsumit to the committee for consideration as a pharmacy benefit. Opsumit is an endothelin receptor antagonist (ERA) indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) to delay progression. Disease progression included: death, initiation of intravenous (IV) or subcutaneous prostanoids, or clinical worsening of PAH (decreased 6-minute walk distance, worsened PAH symptoms and need for additional PAH treatment). Opsumit also reduced hospitalization for PAH. GHP Family formulary alternatives are sildenafil, Adcirca, Letairis and Tracleer (all require prior authorization). A. Proposed Clinical Recommendations: It is recommended that Opsumit not be added to the GHP Family formulary. The following criteria should apply to requests for Opsumit: Prescription is written by a cardiologist or pulmonologist AND Medical record documentation of WHO functional class II, III, or IV pulmonary arterial hypertension AND Medical record documentation that Opsumit will be used in combination with (or therapeutic failure on, intolerance to, or contraindication to) sildenafil AND Medical record documentation of a negative pregnancy test in females of childbearing potential. Quantity Limit: one tablet per day Clinical Discussion: FDA Approved Indications, Disease State, Pharmacology, Clinical Evidence of Safety and Efficacy, Adverse Reactions, Dosing Schedule, Monitoring, Safety Profile, Patent Life, Unique Therapeutic Features, Recommendations of National Agencies and Organizations, and Special Population Precautions were discussed. Clinical Outcome: Tricia Heitzman made a motion to accept the recommendations as written. Lisa Mazonkey seconded the motion. None were opposed. Proposed Financial Recommendations: It is recommended that Opsumit not be added to the GHP Family formulary. The following prior authorization criteria should apply to requests for Opsumit: Medical record documentation that Opsumit will be used in combination with (or therapeutic failure on, intolerance to, or contraindication to) sildenafil AND Medical record documentation of therapeutic failure on, intolerance to, or contraindication to Tracleer

3 Financial Discussion: No comments or questions. Financial Outcome: Todd Sponenberg made a motion to accept the recommendations as written. Kristi Juskiewicz seconded the motion. None were opposed. B. Approved Recommendations: Opsumit will not be added to the GHP Family formulary. The following prior authorization criteria will apply to requests for Opsumit: Prescription is written by a cardiologist or pulmonologist AND Medical record documentation of WHO functional class II, III, or IV pulmonary arterial hypertension AND Medical record documentation that Opsumit will be used in combination with (or therapeutic failure on, intolerance to, or contraindication to) sildenafil AND Medical record documentation of a negative pregnancy test in females of childbearing potential AND Medical record documentation of therapeutic failure on, intolerance to, or contraindication to Tracleer Quantity Limit: one tablet per day Actemra Subcutaneous (tocilzumab) Tricia Russell Tricia Russell provided a review of Actemra Subcutaneous to the committee for consideration as a pharmacy benefit. Actemra subcutaneous (SC) injection is FDA approved to treat moderate to severe Rheumatoid Arthritis (RA) in adults who may have had inadequate response to one or more Disease Modifying Anti-Rheumatic Drugs (DMARDs). Actemra is also approved to treat Polyarticular Juvenile Idiopathic Arthritis (PJIA) and Systemic Juvenile Idiopathic Arthritis (SJIA) in patients 2 years of age and older with active disease. (The latter two conditions may only be treated by IV infusion at this time, as SC administration is not approved.) GHP Family formulary alternatives are Enbrel, Humira, Orencia, Kineret and Cimzia. All require prior authorization. A. Proposed Clinical Recommendations: It is recommended that Actemra subcutaneous not be added to the formulary for GHP Family and the following criteria should be used when reviewing: 1. Prescription written by a rheumatologist AND 2. Medical record documentation of a diagnosis of moderate to severe rheumatoid arthritis (made in accordance with the American College of Rheumatology Criteria for the Classification and Diagnosis of Rheumatoid Arthritis) AND 3. Medical record documentation of age 18 years of age AND 4. Medical record documentation of the number of swollen or tender joints prior to initiating Actemra therapy. Member must have a minimum documented joint count of: (a) Greater than four (4) swollen or tender joints based on the American College of Rheumatology 28 joint count OR (b) Greater than six (6) swollen or tender joints based on the American College of Rheumatology joint count. 5. Medical record documentation of an inadequate response to a minimum of 3 month trial of methotrexate or other DMARD if member is unable to tolerate methotrexate or methotrexate is contraindicated AND 6. Medical record documentation of an inadequate response to a minimum 3 month trial of Humira* AND Enbrel*

4 QUANTITY LIMITS: 4 syringes per 28 days AUTHORIZATION DURATION: Approval will be given for an initial duration of six (6) months. For continuation, medical record documentation of improvement in signs and symptoms of rheumatoid arthritis that must include the number of swollen or tender joints on six (6) months of Actemra is required. After the initial six (6) month approval, subsequent approvals will be for a duration of one (1) year. Reevaluation will be every one (1) year required medical record documentation of improvement in the signs and symptoms of rheumatoid arthritis and must include the number of swollen and tender joints while on Actemra therapy. Clinical Discussion: FDA Approved Indications, Disease State, Pharmacology, Clinical Evidence of Safety and Efficacy, Adverse Reactions, Dosing Schedule, Monitoring, Safety Profile, Patent Life, Unique Therapeutic Features, Recommendations of National Agencies and Organizations, and Special Population Precautions were discussed. Clinical Outcome: Kevin Szczecina made a motion to accept the recommendations as written. Dan McConnell seconded the motion. None were opposed. Proposed Financial Recommendations: It is recommended that Actemra Subcutaneous not be added to the GHP Family Formulary. Financial Discussion: No comments. Financial Outcome: Dan McConnell made a motion to accept the recommendations as written. Kevin Szczecina seconded the motion. None were opposed. B. Approved Recommendations: Actemra Subcutaneous will be non-formulary for GHP Family. The following prior authorization criteria will apply to requests for authorization: 1. Prescription written by a rheumatologist AND 2. Medical record documentation of a diagnosis of moderate to severe rheumatoid arthritis (made in accordance with the American College of Rheumatology Criteria for the Classification and Diagnosis of Rheumatoid Arthritis) AND 3. Medical record documentation of age 18 years of age AND 4. Medical record documentation of the number of swollen or tender joints prior to initiating Actemra therapy. Member must have a minimum documented joint count of: (a) Greater than four (4) swollen or tender joints based on the American College of Rheumatology 28 joint count OR (b) Greater than six (6) swollen or tender joints based on the American College of Rheumatology joint count. 5. Medical record documentation of an inadequate response to a minimum of 3 month trial of methotrexate or other DMARD if member is unable to tolerate methotrexate or methotrexate is contraindicated AND 6. Medical record documentation of an inadequate response to a minimum 3 month trial of Humira* AND Enbrel* QUANTITY LIMITS: 4 syringes per 28 days

5 AUTHORIZATION DURATION: Approval will be given for an initial duration of six (6) months. For continuation, medical record documentation of improvement in signs and symptoms of rheumatoid arthritis that must include the number of swollen or tender joints on six (6) months of Actemra is required. After the initial six (6) month approval, subsequent approvals will be for a duration of one (1) year. Reevaluation will be every one (1) year required medical record documentation of improvement in the signs and symptoms of rheumatoid arthritis and must include the number of swollen and tender joints while on Actemra therapy. Granix (tbo-filgrastim) Kimberly Clark Kimberly Clark provided a review of Granix to the committee for consideration as a medical benefit. Granix is a leukocyte growth factor indicated for reduction in the duration of severe neutropenia in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. Formulary alternatives include Neulasta and Neupogen (both require prior authorization). A. Proposed Clinical Recommendations: It is recommended that Granix be considered a medical benefit for GHP Family and the following criteria should be used when reviewing: 1. Primary Prophylaxis - the prevention of febrile neutropenia (FN) when the risk of FN due to the myelosuppressive chemotherapy regimen is 20% or greater. Those regimens include but are not limited to: TC (paclitaxel, cisplatin) MVAC (methotrexate, vinblastine, doxorubicin, cisplatin) AC (doxorubicin, cyclophosphamide, docetaxel) AT (doxorubicin, paclitaxel) TIC (paclitaxel, ifosfamide, mesna, cisplatin) VAPEC-B (vincristine, doxorubicin, prednisolone, etoposide, cyclophosphamide, bleomycin) A(N)CVB (doxorubicin or mitoxantrone, cyclophosphamide, vindesine, bleomycin) DHAP (dexamethasone, cisplatin, cytarabine) For the prevention of FN when the risk of developing FN is less than 20%, but any other risk factor listed below is present: Age 65 years or greater Poor performance status Previous history of FN Extensive prior radiation or chemotherapy treatment Poor nutritional status Open wounds or active infection Advanced cancer If approved, approval will be for 6 months. This approval duration should be added to all medications covered by policy MBP 59.0 Clinical Discussion: FDA Approved Indications, Pharmacology, Clinical Evidence of Safety and Efficacy, Adverse Reactions, Dosing Schedule, Monitoring, Safety Profile, Patent Life, Unique Therapeutic Features, Recommendations of National Agencies and Organizations, and Special Population Precautions were discussed.

6 Clinical Outcome: Todd Sponenberg made a motion to accept the recommendations as written. Dan McConnell seconded the motion. None were opposed. Proposed Financial Recommendations: It is recommended that Granix be considered a medical benefit for GHP Family. Financial Discussion: No comments. Financial Outcome: Kevin Szczecina made a motion to accept the recommendations as amended. Todd Sponenberg seconded the motion. None were opposed. B. Approved Recommendations: Granix will be a medical benefit for GHP Family. The following prior authorization criteria will apply to requests: 1. Primary Prophylaxis - the prevention of febrile neutropenia (FN) when the risk of FN due to the myelosuppressive chemotherapy regimen is 20% or greater. Those regimens include but are not limited to: TC (paclitaxel, cisplatin) MVAC (methotrexate, vinblastine, doxorubicin, cisplatin) AC (doxorubicin, cyclophosphamide, docetaxel) AT (doxorubicin, paclitaxel) TIC (paclitaxel, ifosfamide, mesna, cisplatin) VAPEC-B (vincristine, doxorubicin, prednisolone, etoposide, cyclophosphamide, bleomycin) A(N)CVB (doxorubicin or mitoxantrone, cyclophosphamide, vindesine, bleomycin) DHAP (dexamethasone, cisplatin, cytarabine) For the prevention of FN when the risk of developing FN is less than 20%, but any other risk factor listed below is present: Age 65 years or greater Poor performance status Previous history of FN Extensive prior radiation or chemotherapy treatment Poor nutritional status Open wounds or active infection Advanced cancer If approved, approval will be for 6 months. This approval duration should be added to all medications covered by policy MBP 59.0 Fycompa (perampanel) Steve Kheloussi Steve Kheloussi provided a review of Fycompa to the committee for consideration as a pharmacy benefit. Fycompa is indicated as adjunctive therapy for the treatment of partial-onset seizures with or without secondary generalized seizures in patients with epilepsy aged 12 years and older. GHP Family formulary alternatives are carbamazepine, gabapentin, lamotrigine, levetiracetam, oxcarbazepine, valproate, topiramate, phenobarbital, phenytoin, tiagabine, zonisamide, Lyrica (requires prior authorization) and Gabitril.

7 A. Proposed Clinical Recommendations: It is recommended that Fycompa not be added to the GHP Family formulary. The following criteria should apply to requests for Fycompa: Medical record documentation of a diagnosis of partial onset seizures AND Patient is at least 12 years of age AND Medical record documentation of a failure on, intolerance to, or contraindication to 3 formulary alternatives AND Fycompa is being used concomitantly with at least one other formulary AED. Quantity Limit: 1 tablet per day Clinical Discussion: FDA Approved Indications, Disease State, Pharmacology, Clinical Evidence of Safety and Efficacy, Adverse Reactions, Dosing Schedule, Monitoring, Safety Profile, Patent Life, Unique Therapeutic Features, and Special Population Precautions were discussed. Clinical Outcome: Todd Sponenberg made a motion to accept the recommendations as written. Kevin Szczecina seconded the motion. None were opposed. Proposed Financial Recommendations: It is recommended that Fycompa not be added to the GHP Family formulary. Financial Discussion: No comments or questions. Financial Outcome: Kevin Szczecina made a motion to accept the recommendations as written. Tricia Heitzman seconded the motion. None were opposed. B. Approved Recommendations: Fycompa will not be added to the GHP Family formulary. The following prior authorization criteria will apply to requests for Fycompa: Medical record documentation of a diagnosis of partial onset seizures AND Patient is at least 12 years of age AND Medical record documentation of a failure on, intolerance to, or contraindication to 3 formulary alternatives AND Fycompa is being used concomitantly with at least one other formulary AED. Quantity Limit: 1 tablet per day FAST FACTS: Tafinlar (dabrafenib) and Mekinist (trametinib) Kimberly Clark New Indication: Tafinlar Use in combination with trametinib (Mekinist) for treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test. Mekinist - Use in combination with dabrafenib (Tafinlar) for treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test. Recommendation:

8 Currently Tafinlar is non-formulary. Recommend Tafinlar remain non-formulary and the new indication is added to the GHP Family policy (1219.0F) with the following criteria for exceptions: Must be prescribed by hematologist/oncologist or dermatologist AND Medical record documentation of unresectable or metastatic melanoma with or without concomitant use of Mekinist (trametinib) AND Medical record documentation of BRAF V600E or V600K mutations as detected by an FDA-approved test AND Medical record documentation of no prior therapeutic failure with a BRAF inhibitor therapy (Zelboraf (vemurafenib) or Tafinlar (dabrafenib)) or MEK inhibitor therapy (Mekinist (trametinib)). Currently Mekinist is non-formulary. Recommend Mekinist remain non-formulary and the new indication is added to the GHP Family policy (1225.0F) with the following criteria for exceptions: Must be prescribed by hematologist/oncologist or dermatologist AND Medical record documentation of unresectable or metastatic melanoma with or without concomitant use of Tafinlar (dabrafenib) AND Medical record documentation of BRAF V600E or V600K mutations as detected by an FDA-approved test AND Medical record documentation of no prior therapeutic failure with a BRAF inhibitor therapy (Zelboraf (vemurafenib) or Tafinlar (dabrafenib)) or MEK inhibitor therapy (Mekinist (trametinib)). Tafinlar QL: 75 mg 120 capsules per 30 days 50 mg 120 capsules per 30 days Mekinist - QL: 1 mg and 2 mg 30 tablets per 30 days 0.5 mg 90 tablets per 30 days Authorization Duration: Each treatment period will be defined as 6 months. Re-review will occur every 6 months. Tafinlar or Mekinist will no longer be considered medically necessary if there is medical record documentation of disease progression Discussion: No comments or questions. Outcome: Lisa Mazonkey made a motion to accept the recommendations as written. Kevin Szczecina seconded the motion. None were opposed. Imbruvica (ibrutinib) Kimberly Clark New Indication: Imbruvica is a kinase inhibitor indicated for the treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy. Recommendations: It is recommended that based on the recent approval of Imbruvica for the treatment of patients with CLL who have failed at least one prior therapy; this indication is added to the existing policy. The criteria for requests for Imbruvica should be as follows:

9 Must be prescribed by hematologist/oncologist AND Medical record documentation of chronic lymphocytic leukemia (CLL) AND Medical record documentation of therapeutic failure on, intolerance to, or contraindication to one prior therapy QL 3 capsules per day Discussion: No questions or comments Outcome: Todd Sponenberg made a motion to accept the recommendations as amended. Kristi Juskiewicz seconded the motion. None were opposed. Isentress (raltegravir) Kimberly Clark New Indication 1 : Isentress is a human immunodeficiency virus integrase strand transfer inhibitor (HIV-1 INSTI) indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in patients 4 weeks of age and older Recommendations: There are no changes recommended at this time Discussion: No questions or comments Outcome: Todd Sponenberg made a motion to accept the recommendations as written. Kristi Juskiewicz seconded the motion. None were opposed. Cimzia (certolizumab pegol) Kimberly Clark New Indication 1 : Cimzia is a tumor necrosis factor (TNF) blocker indicated for: Treatment of adult patients with active psoriatic arthritis Treatment of adults with active ankylosing spondylitis Recommendations: It is recommended that the indications for psoriatic arthritis and ankylosing spondylitis are added to existing policies with the following prior authorization criteria: Psoriatic Arthritis Medical record documentation of a diagnosis of moderately to severely active psoriatic arthritis which must include the following: o Documentation of at least three swollen joints and at least three tender or painful joints o AND Documentation of either active psoriatic lesions or a documented history of psoriasis AND Prescription must be written by a rheumatologist AND Member must be 18 years of age AND Medical record documentation of a therapeutic failure on, intolerance to, or contraindication to Enbrel* AND Humira*

10 Approval will be given for an initial duration of six (6) months. For continuation, medical record documentation of improvement in signs and symptoms of psoriatic arthritis that must include the number of swollen or tender joints on six (6) months of Cimzia therapy is required. After the initial six (6) month approval, subsequent approvals will be for a duration of one (1) year. Reevaluation of coverage will be every one (1) year requiring medical record documentation of improvement in the signs and symptoms of psoriatic arthritis and must include the number of swollen or tender joints while on Cimzia therapy. Ankylosing Spondylitis Medical record documentation of a diagnosis of ankylosing spondylitis AND Prescription must be written by a rheumatologist AND Member must be 18 years of age AND Medical record documentation of a therapeutic failure on, intolerance to, or contraindication to Enbrel* AND Humira* Approval will be given for an initial duration of six (6) months. For continuation, medical record documentation of clinical or sustained improvement in the signs and symptoms of ankylosing spondylitis on six (6) months of Cimzia therapy. After the initial six (6) month approval, subsequent approvals will be for a duration of one (1) year requiring medical record documentation of clinical or sustained improvement in the signs and symptoms of ankylosing spondylitis while on Cimzia therapy. Discussion: No comments or questions. Outcome: Tricia Russell made a motion to accept the recommendations as written. Tricia Heitzman seconded the motion. None were opposed. MULTIPLE SCLEROSIS CLASS REVIEW: Clinical Discussion: Indications, Clinical Evidence, Adverse Reactions, Monitoring, Black Box Warnings, Contraindications, Warnings and Precautions, Drug Interactions, Patent Expiration and Exclusivity, Special Population Precautions and Recommendations of National Agencies were discussed for Aubagio, Gilenya and Tecfidera. Recommendation: Gilenya will be added to the GHP Family formulary Tecfidera will be added to the GHP Family formulary The medical policy criteria for Tysabri will be updated as follows: Existing Criteria: Has had an inadequate response to, or is unable to tolerate Copaxone and Betaseron drugs used for multiple sclerosis New Criteria: Has had an inadequate response to, or is unable to tolerate Copaxone, Betaseron, Gilenya, AND Tecfidera drugs used for multiple sclerosis The criteria for Aubagio, Avonex, Extavia and Rebif will be updated as follows:

11 Existing Criteria: Medical record documentation of therapeutic failure on, intolerance to, or contraindication to Copaxone AND Betaseron New Criteria: Medical record documentation of therapeutic failure on, intolerance to, or contraindication to Copaxone, Betaseron, Gilenya, AND Tecfidera Discussion: Todd Sponenberg voiced concern over the addition of Gilenya to the formulary due to its side effect profile. Outcome: Steve Kheloussi made a motion to accept the recommendations as written. Peter Mikhail seconded the motion. Todd Sponenberg was opposed. POLICY UPDATES: Hepatitis C Direct Acting Antivirals Policy Tricia Russell The following policy was approved by the committee following an electronic vote: POLICY: The Plan s Pharmacy Department maintains a process by which participating providers can request a prior authorization for Hepatitis C Direct Acting Antivirals that do not have drug specific criteria and are not included in the GHP Family drug formulary and for Hepatitis C Direct Acting Antivirals that do not have drug specific criteria and considered formulary, with restrictions or criteria. All medications with the exception of benefit exclusions are available for prior authorizations. Participating providers can initiate requests for a formulary exception by contacting Pharmacy Services by phone, fax or written request. Member confidentiality will be maintained as outlined in the Health Plan Administrative Policy #02, Privacy and Confidentiality. REQUIRED DEFINITIONS: 1. Attachment a supporting document that is developed and maintained by the policy writer or department requiring/authoring the policy. 2. Exhibit a supporting document developed and maintained in a department other than the department requiring/authoring the policy. 3. Devised the date the policy was implemented. 4. Revised the date of every revision to the policy, including typographical and grammatical changes. 5. Reviewed the date which documents the most recent annual review if the policy has no revisions necessary. ADDITIONAL DEFINITIONS: Formulary (Drug Formulary) products a continually updated list of medications and other related products that are developed by the Pharmacy & Therapeutics Committee, approved by the DPW and represents the current drug coverage that meets the clinical needs of the Medical Assistance population under the GHP Family benefit plan. Non-formulary products - those medications which are not included in the Formulary but are available to members through the prior authorization process. Emergency Fill - a temporary, 72 hour supply of a medication requiring prior authorization that is applicable if the medication is new for the member or is necessary to treat an emergency. Temporary Fill a temporary, 15 day supply of a medication requiring prior authorization that is applicable if the medication is a continuation of ongoing therapy for the member. PSR Pharmacy Service Representative

12 GHP Geisinger Health Plan or Plan Center of Excellence - a group of licensed physicians who have a shared facility or an entity that: Demonstrates best practices by using clinically proven health care management techniques. Has evidence of measured, favorable outcomes Encompasses a multidisciplinary team including, but not limited to, a board certified specialist, nurse educator, clinical pharmacist, psychiatrist, case management professional and social worker Has licensed, professional staff dedicated to educating patients about their ailment and its optimal management Has a board certified specialist who is actively involved in his/her discipline as evidenced through research and clinical enterprises Has the capabilities to, and has historically managed, high volumes of patients Has leadership containing board certified physicians who are actively involved in his/her discipline through clinical research initiatives and further advancement of his/her specialty Is authorized as a Center of Excellence by the Geisinger Health Plan Credentialing Committee. GENERAL INFORMATION: The Hepatitis C Direct Acting Antivirals Drug Policy will be followed in accordance with the Pennsylvania Departments of Health, Insurance and Public Welfare; and the United States Department of Labor guidelines as set forth herein. REGULATORY REQUIREMENTS: For GHP Family Members this policy will cover all requirements as dictated by the Pennsylvania Department of Health for Act 68 and 28 Pa. Code Chapter 9; Pennsylvania Department of Insurance for 31 Pa. Code Chapters 154 and 301; and the Department of Public Welfare (DPW) 55 Pa. Code 275 and 42 CFR 431 and 438 as they pertain to DPW Fair Hearing Requirements. This policy supports all applicable federal and state laws, DPW regulations and policies, Medical Assistance Bulletins, and the specifications of the HealthChoices RFP and HealthChoices Agreement. CROSS REFERENCE DOCUMENTS: GHP Family Policy 1.0F Pharmacy Part D Policy D GHP Family Policy 4.0F GHP Family Policy 204 First Level Grievance Process PROCEDURE: Coverage of Hepatitis C Medications will be restricted to those who meet the following criteria: The Hepatitis C direct acting antiviral that is prescribed does not have an existing drug policy AND The member meets FDA approved age limits AND Medical record documentation of a diagnosis of hepatitis C infection AND Medical record documentation of the member s hepatitis C genotype AND Is prescribed by a gastroenterologist, hepatologist, infectious disease specialist or transplant specialist AND Member must be evaluated and treated by a contracted Center of Excellence in Hepatitis C management AND Medical record documentation of the member receiving an FDA approved medication regimen that is inside the parameters of use approved by the Food and Drug Administration (FDA) AND Medical record documentation of receiving the following within the past 3 months: o Hepatic function panel o Complete blood count including differential o Basic metabolic panel o Baseline HCV RNA viral load AND

13 Medical record documentation of a negative pregnancy test if member is female of childbearing potential AND When concurrent peginterferon alfa therapy is indicated and prescribed, medical record documentation of a psychiatric evaluation treatment clearance within the past 6 months if there is a history of prior suicide attempt, bipolar disorder, major depressive disorder, schizophrenia, substance dependency disorders (within the past 3 years), anxiety disorders, borderline personality disorder and/or antisocial personality disorder OR for all others a mental health evaluation performed by the prescriber AND Medical record documentation of at least 6 months of abstinence from alcohol and illegal controlled substances prior to treatment; for members with a history of substance dependency, the abstinence is supported by lab testing (such as blood alcohol level [BAL] and urine drug screen [UDS]) AND Medical record documentation that member is compliant with treatment if currently being treated for substance dependency AND Medical record documentation that member received pre-treatment readiness education about hepatitis C treatment expectations by a health care provider AND Medical record documentation that member is agreeable to counseling and monitoring by representatives from GHP. Discussion: The following will be added to the policy: Medical record documentation of F3 or F4 liver fibrosis and/or compensated cirrhosis in hepatitis C genotype 1 Outcome: Todd Sponenberg made the motion to accept the recommendations as written. Daniel McConnell seconded the motion. None were opposed. Apriso Kimberly Clark (mesalamine) Recommendation: Asacol has been removed from the market. Asacol HD is still commercially available. The updated criteria are as follows: Medical record documentation of mild to moderate ulcerative colitis AND Medical record documentation of therapeutic failure on, intolerance to or contraindication to sulfasalazine and Asacol HD Discussion: No questions or comments. Outcome: Kevin Szczecina made the motion to accept the recommendations as written. Steve Kheloussi seconded the motion. None were opposed. Kineret and Orencia Kimberly Clark Recommendations: Kineret (Pharmacy, RA) Currently, the prior authorization criteria for Kineret in rheumatoid arthritis (RA) state that the member must have a therapeutic failure on, contraindication to, or intolerance to at least two TNF antagonists {etanercept (Enbrel), adalimumab (Humira), or infliximab (Remicade)]. Considering that approval of Remicade is contingent upon therapeutic failure on, contraindication to, or intolerance to Humira and

14 Enbrel, it is recommended to remove Remicade from the policy criteria and require therapeutic failure on, contraindication to, or intolerance to Humira and Enbrel. The updated prior authorization criteria are as follows: 1. Medical record documentation of a diagnosis of rheumatoid arthritis made in accordance with the American College of Rheumatology Criteria for the Classification and Diagnosis of Rheumatoid Arthritis 2. Member must be 18 years of age 3. Must be prescribed by a rheumatologist 4. Medical record documentation of an inadequate response to a minimum 4 month trial of methotrexate or other DMARD if methotrexate is contraindicated AND to separate adequate trials (12 weeks each) of Humira* AND Enbrel* 5. Medical record documentation of the number of swollen or tender joints prior to initiating anakinra therapy. Member must have a minimum documented joint count of: a. Greater than four (4) swollen or tender joints based on a 28 joint count OR b. Greater than six (6) swollen or tender joints based on a joint count Orencia (Medical, RA) Currently, the prior authorization criteria for physician administered Orencia state that the member must have a therapeutic failure on, contraindication to, or intolerance to one TNF antagonist for use in RA. A P&T review of subcutaneous Orencia indicated that it was clinically appropriate to require failure on two TNF agents prior to moving on to a non-tnf biologic for the treatment of RA. In order to align the pharmacy and medical policies, it is recommended to increase the number of TNF failures prior to approval of Orencia to two, specifically Humira* and Enbrel*. The updated prior authorization criteria are as follows: 1. Documentation of a diagnosis of RA in accordance with the American College of Rheumatology Criteria for the Classification and Diagnosis of Rheumatoid Arthritis; and 2. Member must be at least 18 years old; and 3. Must be prescribed by a rheumatologist; and 4. Documentation of inadequate response to a minimum of 4 months of methotrexate therapy AND to a separate adequate trial (defined as 12 weeks) of Humira* and Enbrel* 5. Documentation of the number of swollen or tender joints prior to initiating abatacept therapy Member must have a minimum documented joint count of (a) Greater than four (4) swollen or tender joints based on a 28 joint count; or (b) Six (6) swollen or tender joints based on a joint count. Orencia (Medical, PJIA) Currently, the prior authorization criteria for physician administered Orencia for use in polyarticular juvenile idiopathic arthritis only requires use for the appropriate diagnosis. According to the 2013 ACR Update of the Recommendations for the Treatment of Juvenile Idiopathic Arthritis 1, Orencia is one of the last line options for patients with this diagnosis. In order to ensure appropriate utilization it is recommended that the following criteria be added to the medical benefit policy for Orencia: 1. Member is at least 6 years of age AND 2. Medical record documentation of a diagnosis of moderate to severely active polyarticular juvenile idiopathic arthritis or juvenile rheumatoid arthritis with at least 5 swollen or tender joints AND 3. Must be prescribed by a rheumatologist AND 4. Medical record documentation of therapeutic failure on, intolerance to, or contraindication to Humira* and Enbrel*

15 Discussion: No questions or comments. Outcome: Todd Sponenberg made the motion to accept the recommendations as written. Kristi Juskiewicz seconded the motion. None were opposed. Vivitrol Tricia Russell (naloxone) Recommendation: Update Medical Policy MBP 51.0 as follows: Must be prescribed by an addiction specialist, and physician provided documentation of all of the following: Alcohol dependence wit therapeutic failure on, intolerance to or contraindication to a minimum of one oral treatment alternative and o Insured individual is actively participating in a comprehensive management program that includes psychosocial support and o No active alcohol intake at time of initiation of therapy and o No evidence of acute hepatitis or liver failure and o No evidence of acute opioid withdrawal and no evidence of concurrent opioid therapy and o Documentation of being opioid free for a minimum of 7 days prior to initiation of therapy with naltrexone OR Opioid dependence and o No evidence of acute hepatitis or liver failure and o No evidence of intolerability to oral naltrexone and o No evidence of acute opioid withdrawal and o No evidence of concurrent opioid therapy and o Documentation of being opioid free for a minimum of 7 days prior to initiation of therapy with naltrexone as evidenced by a negative urine drug screen for opioids and o Insured individual is actively participating in a comprehensive management program that included psychosocial support and o Documentation of an initial evaluation or scheduled appointment by a licensed Drug and Alcohol provider to determine the recommended level of care and o Documentation of referral to or enrollment in formal behavioral health counseling and/or substance abuse counseling Authorization: Initial authorization will be for a period of 6 months. Prior authorization renewals will be for 12 months and reviewed annually thereafter to determine the medical necessity for continuation of therapy. Authorization renewals will be based upon medical record documentation of : The member s disease course has stabilized or improved based upon the prescriber s assessment while on therapy A negative urine drug screen for opioids The member is actively participating in at least monthly formal behavioral health counseling, substance abuse counseling or an addiction recovery program. After a period of 1 year, less formal programs would be allowed as participation. Discussion: No questions or comments. Outcome: Dr. Bret Yarczower made the motion to accept the recommendations as written. Kristi Juskiewicz seconded the motion. None were opposed.

16 Levocarnitine Kimberly Clark Recommendation: Levocarnitine is an amino acid derivative used in the treatment of primary systemic carnitine deficiency, a disease which presents with recurrent episodes of Reye-like encephalopathy, hypoketonic hypoglycemia or cardiomyopathy. Primary systemic carnitine deficiency is characterized by low concentrations of levocarnitine plasma, red blood cells or tissues. It is recommended that levocarnitine be added to the GHP Family formulary. Discussion: No questions or comments. Outcome: Lisa Mazonkey made the motion to accept the recommendations as written. Steve Kheloussi seconded the motion. None were opposed. GAZYVA Kimberly Clark (obinutuzumab) A review of Gazyva we done in January, 2014 and the committee asked the following questions (followed by answers): What is the definition of a previously untreated patient? Patients in clinical trials appear to be truly treatment naïve. Patients included in the clinical trial were required to have previously untreated CLL required treatment (NCI criteria) Was any genetic testing conducted to determine who may respond to therapy? Subgroup analysis of progression free survival by investigator, was in general, consistent with the intent to treat population. The HRs ranged from 0.03 to In the cytogenics 17p deletion subgroup only, there was no difference between the treatment groups [HR: 0.42 (95% CI:0.15, 1.17)] with only 26 patients in this subgroup When is retreatment required? There are no clinical studies indicating if or when treatment with Gazyva would be appropriate. Recommendation: It was recommended to review Gazyva, a medical benefit, using the following criteria: Must be prescribed by a hematologist/oncologist AND Medical record documentation of previously untreated chronic lymphocytic leukemia Discussion:. No questions or comments. Outcome: Tricia Heitzman made the motion to accept the recommendations as written. Kristi Juskiewicz seconded the motion. None were opposed. XARELTO Kevin Szczecina Recommendation: A recommendation was made to remove the prior authorization requirement on Xarelto Discussion: No questions or comments. Outcome: Kim Clark made the motion to accept the recommendations as written. Dan McConnell seconded the motion. None were opposed. Caffeine Citrate Kevin Szczecina

17 Recommendation: A recommendation was made to add caffeine citrate to the formulary for members less than 2 years of age Discussion: No questions or comments. Outcome: Kim Clark made the motion to accept the recommendations as written. Todd Sponenberg seconded the motion. None were opposed. Diuril Suspension Kevin Szczecina Recommendation: A recommendation was made to add Diuril Suspension to the formulary for members less than 2 years of age. Discussion: No questions or comments. Outcome: Kim Clark made the motion to accept the recommendations as written. Dan McConnell seconded the motion. None were opposed. Sabril Kevin Szczecina Recommendation: Sabril was reviewed during January 2014 s P&T Committee meeting and it was decided to require failure on all formulary alternatives for the Refractory Complex Partial Seizures indication. This criteria was denied by DPW but the following was approved: Medical record documentation that Sabril is bring prescribed by a neurologist AND Medical record documentation that if being used for Refractory Complex Partial Seizures there is concomitant use with another seizure control medication AND Medical record documentation of therapeutic failure on, intolerance to, or contraindication to five formulary alternatives Discussion: No questions or comments. Outcome: Kristi Juskiewicz made the motion to accept the recommendations as written. Steve Kheloussi seconded the motion. None were opposed. RESULTS OF ELECTRONIC VOTE Results of electronic voting for 2014 GHP Family Formulary Voting for the 2014 GHP Family Formulary took place in February, The results were 18 votes to approve, one vote to reject. The formulary was approved as submitted. Thank you to all who responded. PRIOR AUTHORIZATION QUARTERLY AUDIT Prior authorization quarterly audit Meeting held February 18 th, No major discrepancies in coverage determinations noted. New, increased requests for high risk medications that now require a coverage determination. Continue to see high volumes for Lidoderm and Voltaren gel which may be a result of increased awareness of opioid overutilization monitoring efforts. Will continue to monitor

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