UPMC for You Pharmacy and Therapeutics Committee Meeting October 22, 2013 meeting

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1 UPMC for You Pharmacy and Therapeutics Committee Meeting October 22, 2013 meeting 1. Call to order: The meeting was called to order at 7:05 a.m. 2. Review of the minutes: The minutes of the July and September meetings and August and October fax vote were approved by the Committee. 3. New Business: Medication Reviews Drug Class Drug Name Formulary Coverage Recommendation Antiemtic Diclegis (doxylamine/pyridoxine) with quantity limit Oral analgesic GelX Oral Gel (zinc gluconate/taurine) Alzheimer s Namenda XR (memantine) with quantity limit Gastrointestinal Suclear Bowel Prep Kit (peg 3350) May add Serotonin Reuptake Brisdelle Inhibitor (paroxetine) with quantity limit Antihypertensive Epaned (enalapril) Contraceptive Lo Minastrin Fe (norethindrone/ethinyl estradiol) Anticonvulsant Onfi suspension (clobazam) Gastrointestinal Omeprazole & Syrspend SF Alka Kit May add with quantity limit (omeprazole, SyrSpend SF Alfa) Antineoplastic Lomustine May add Antiestrogen Anticonvulsant Stimulant Opioid Dependency Tumor Necrosis Factor Inhibitor Soltamox (tamoxifen) Trokendi XR (topiramate) Zenzedi (dextroamphetamine) Zubsolv (buprenorphine/naloxone) Simponi ARIA (golimumab) with quantity limit with prior authorization

2 Drug Class Immunosuppressant Antidepressant Antidepressant Antiviral Topical Antineoplastic Antineoplastic Cardiovascular Agent Drug Name Fabior foam (tazoratene) Presera foam (emollient combination) SelRx 2.3% shampoo (selenium sulfide) Utopic 41% cream (urea) Astagraf XL (tacrolimus ER) Mirvaso (brimonidine) Brintellix (vortioxetine) Fetzima (levomilnacipran) Tivicay (dolutegravir) Valchlor (mechlorethamine) Gilotrif (afatinib) Adempas (riociguat) All voted in favor to approve the recommendations noted above. Formulary Coverage Recommendation May add New policies RX.PA HT 3 -Antagonist Step RX.PA.205 Alitretinoin (Panretin) RX.PA.206 Methoxsalen (8-MOP, Oxsorelen, Oxsorelen Ultra) RX.PA.207 Interferon alfa-n3 (Alferon N) RX.PA.208 Alosetron (Lotronex)

3 RX.PA.210 Apomorphine (Apokyn) RX.PA.213 Penicillamine (Cuprimine & Depen) RX.PA.214 Trientine Hcl (Syprine) & Zinc Acetate (Galzin) RX.PA.215 Betaine (Cystadane) RX.PA.216 Danazol RX.PA.217 Hepatitis B Products (Hepsera, Baraclude, Epivir-HBV, Intron A Pegasys, and Tyzeka) RX.PA.218 Acitretin (Soriatane) Step RX.PA.224 Budesonide ER tablet (Uceris) RX.PA.087 Certolizumab (Cimzia) 4. Updates: Policy Revisions RX.001 Formulary Decision-Making Process Updated to indicate how formulary changes are communicated to members and providers. RX.014 UPMC for You Six Prescription Per Month Limit Updated to include new drug categories added by the Department of Public Welfare that are not subject to the 6-Rx limit. The new categories include Chronic Kidney Disease, Gout, and Statins. Specific medications within these drug classes will continue to pay for members after the 6-Rx limit has been reached each month. RX.PA.035 Sodium Oxybate (Xyrem) Updated to require a specialist prescriber, use in members aged 16 years or older, submission of chart documentation and sleep studies for the requested diagnosis, and prior medication trials before approval for Xyrem can be granted. The initial authorization duration was

4 changed from 1 year to 3 months in order to verify that the member is responding to therapy before longer authorization duration is permitted. RX.PA.056 Mecasermin (Increlex) Updated to separate diagnoses and to reflect recent guideline updates for use. RX.PA.068 Intravenous and Subcutaneous Immune Globulins (IVIG & SCIG) Updated for the diagnoses of primary immunodeficiency, CIDP, multifocal motor neuropathy, dermatomyositis/polymyositis, autoimmune mucocutaneous blistering disease, parvovirus B19 infection, and allogenic hematopoietic stem cell transplant in accordance with the local coverage determination and guidelines for each diagnosis. RX.PA.073 Hyaluronic Acid Products Updated to allow for the appropriate number of fills of the requested hyaluronic acid product based upon the affected knee(s). This update was made to minimize waste and cost. RX.PA.156 Repository Corticotropin Injection (H.P. Acthar Gel) Updated to increase the number of steroid trials from one to two for all included diagnoses other than infantile spasms. In addition, a specialist prescriber will be required for requests for rheumatic disorders, dermatologic disorders, allergic states, and nephrotic syndrome. Also for nephrotic syndrome, members must be experiencing an acute exacerbation, have a trial and failure of a cytotoxic/immunosuppressive regimen, and be using a conventional systemic therapy regimen in combination with H.P. Acthar Gel. RX.PA.179 Ruxolitinib (Jakafi) Updated to lower the required baseline platelet count from >100,000 cells/mm3 to at least 50,000 cells/mm3 based upon recent study results. RX.PA.041 Granulocyte Colony-Stimulating Factors Updated to include criteria for sargramostim (Leukine). RX.PA.178 Deferasirox (Exjade) & Deferiprone (Ferriprox) Updated to include criteria for deferasirox (Exjade). RX.PA Anakinra (Kineret) Updated to shorten duration of required NSAID trial from at least 3 months to up to 2 weeks per current guideline recommendations for Systemic Juvenile Idiopathic Arthritis.

5 RX.PA.123 Canakinumab (Ilaris) Updated to shorten duration of required NSAID trial from at least 3 months to up to 2 weeks per current guideline recommendations for active systemic juvenile idiopathic. RX.PA.135 Tocilizumab (Actemra) Updated to align criteria for Systemic Juvenile Idiopathic Arthritis with the above criteria for Kineret and Ilaris, remove prior trial of anakinra (Kineret), and clarify one of the classifications for members with Systemic Juvenile Idiopathic Arthritis based on specialist review feedback. RX.PA.201 Oral Cysteamine (Cystagon & Procysbi) Updated to require relevant written documentation of laboratory and/or objective values [e.g., WBC cysteine levels, physician progress notes; or Subjective, Objective, Assessment, and Plan (SOAP note) information representing the physician s interaction with the member] as well as clinical rationale explaining why Cystagon has not produced the same clinical results as would be expected with the use of Procysbi (they are the same chemical entity). RX.PA.080 Buprenorphine/Naloxone (Suboxone, Zubsolv) & Buprenorphine (Subutex) Updated to include criteria for Zubsolv (buprenorphine/naloxone). RX.PA.098 Tetrabenazine (Xenazine) Updated to require chart documentation confirming diagnosis and criteria for requests above 50 mg per day. RX.PA.125 Ustekinumab (Stelara) Updated to include criteria for new indication of psoriatic arthritis. RX.005 Quantity Limits The table below summarizes changes to the Quantity Limits policy: Drug Quantity Limit Diabetes Medications Invokana (canagliflozin) 30 tablets per 30 days Injectables and Bio-tech Medications Procysbi (cysteamine delayed release) Signifor (pasireotide) 900 capsules per 30 days 60 ampules per 30 days

6 Drug Simponi (golimumab) Tecfidera (dimethyl fumarate) Xofigo (radium Ra 223 Dichloride) Quantity Limit 100mg: 1mL (1 syringe/autoinjector) per 28 days A quantity of 3mL (3 syringes) per 28 days is covered for the first month of treatment 60 capsules per 30 days 1 course (6 injections) per lifetime Non-steroidal Anti-inflammatory Medication (NSAID) Cambia (diclofenac oral solution) 9 packets per 30 days Ophthalmic Medications Cystaran (cysteamine) Oral Antibiotic Medications Zyvox (linezolid) Oral Chemotherapeutic Agents Mekinist (trametinib) Tafinlar (dabrafenib) Seizure Medications Onfi (clobazem) Psychiatric Medications Emsam (selegiline) Pain Medications Ergomar (ergotamine) Oral Antifungal Medications Oravig (miconazole) Diabetes Medications Insulin 4 bottles (60 ml) per 30 days 100mg/5mL suspension: 1650 ml ( ml bottles) per year 30 tablets per 30 days 120 tablets per 30 days Tablets: 60 tablets per 30 days Oral suspension: 480 ml per 30 days 30 patches per 30 days 20 tablets per 28 days 14 tablets per 14 days U-100: 5 vials per 30 days U-500: 1 vial per 30 days

7 Definitions: Must add: Drug will be added to the formulary. May add: Drug may be added to the formulary or may be non-formulary. Other drugs already on the formulary are considered equally effective from a clinical standpoint. : Drug will be non-formulary. NOTE: All recommendations are subject to DPW approval and final decision determination by UPMC for You.

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