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Oregon Drug Use Review / Pharmacy & Therapeutics Committee © Copyright 2012 Oregon State University. All Rights Reserved Drug Use Research & Management Program OHA Division of Medical Assistance Programs 500 Summer Street NE, E35; Salem, OR 97301-1079 Phone 503-947-5220 | Fax 503-947-1119 Oregon Drug Use Review / Pharmacy & Therapeutics Committee Thursday, January 25, 2018 1:00 - 5:00 PM Barbara Roberts Human Services Building 500 Summer St. NE Salem, OR 97301 MEETING AGENDA NOTE: Any agenda items discussed by the DUR/P&T Committee may result in changes to utilization control recommendations to the OHA. Timing, sequence and inclusion of agenda items presented to the Committee may change at the discretion of the OHA, P&T Committee and staff. The DUR/P&T Committee functions as the Rules Advisory Committee to the Oregon Health Plan for adoption into Oregon Administrative Rules 410-121-0030 & 410-121-0040 as required by 414.325(9). I. CALL TO ORDER 1:00 PM A. Roll Call & Introductions R. Citron (OSU) B. Roles and Responsibilities of Committee Members T. Douglass (OHA) C. Conflict of Interest Declaration R. Citron (OSU) D. Election of Chair & Vice Chair R. Citron (OSU) E. Department and Legislative Update T. Douglass (OHA) F. Approval of Agenda and Minutes II. CONSENT AGENDA TOPICS R. Citron (OSU) 1:25 PM A. Noctiva® (desmopressin) Abbreviated Drug Review B. Drugs for Asthma and COPD Literature Scan 1. Public Comment III. DUR NEW BUSINESS 1:30 PM A. Hepatitis C Direct-Acting Antivirals Policy Discussion R. Citron (OSU) 1. Prior Authorization Criteria A. Seaman (OHSU) 2. Treatment of Hepatitis C in People who Inject Drugs 3. Public Comment 4. Discussion of Clinical Recommendations to OHA IV. PREFERRED DRUG LIST NEW BUSINESS 2:05 PM A. Biologics for Autoimmune Conditions Class Update J. Page (OSU) 1. Class Update/Prior Authorization Criteria 2. Kevzara® (sarilumab) New Drug Evaluation 1 3. Tremfya® (guselkumab) New Drug Evaluation 4. Prior Authorization Criteria 5. Public Comment 6. Discussion of Clinical Recommendations to OHA 2:35 PM B. Vesicular Monoamine Transporter 2 Inhibitors Class Review K. Sentena (OSU) 1. Class Review/Prior Authorization Criteria 2. Public Comment 3. Discussion of Clinical Recommendations to OHA 2:55 PM BREAK 3:10 PM C. Oral First and Second Generation Antipsychotics Class Update S. Servid (OSU) 1. Class Update/Safety Edits 2. Public Comment 3. Discussion of Clinical Recommendations to OHA 3:30 PM D. PCSK-9 Inhibitors Class Update M. Herink (OSU) 1. Class Update/Prior Authorization Criteria 2. Public Comment 3. Discussion of Clinical Recommendations to OHA V. DUR ACTIVITIES 3:50 PM A. Quarterly Utilization Reports R. Citron (OSU) B. ProDUR Report R. Holsapple (DXC) C. RetroDUR Report R. Citron (OSU) D. Oregon State Drug Reviews K. Sentena (OSU) 1. Recently Published Reviews a. Marketing Claims of Newer Drugs and the Evidence 2. Future Topic Recommendations 4:00 PM VI. EXECUTIVE SESSION 4:50 PM VII. RECONVENE for PUBLIC RECOMMENDATIONS VIII. ADJOURN 2 Drug Use Research & Management Program OHA Health Systems Division 500 Summer Street NE, E35; Salem, OR 97301-1079 Phone 503-947-5220 | Fax 503-947-1119 Oregon Pharmacy and Therapeutics Committee – Appointed members Name Title Profession Location Term Expiration William Origer, M.D. Physician Residency Faculty Albany December 2020 Caryn Mickelson, Pharm.D. Pharmacist Pharmacy Director Coos Bay December 2020 Tracy Klein, Ph.D., F.N.P. Public Nurse Practitioner Portland December 2020 James Slater, Pharm.D. Pharmacist Pharmacy Director Beaverton December 2020 Kelley Burnett, D.O. Physician Pediatric Medical Director Grants Pass December 2019 Dave Pass, M.D. Physician Medical Director West Linn December 2019 Stacy Ramirez, Pharm.D. Pharmacist Community Pharmacist Corvallis December 2019 Cathy Zehrung, R.Ph. Pharmacist Pharmacy Manager Silverton December 2018 Phil Levine, Ph.D. Public Retired Lake Oswego December 2018 Rich Clark, M.D., M.P.H. Physician Anesthesiologist Salem December 2018 Walter Hardin, D.O., M.B.A. Physician Medical Director Hillsboro December 2018 Oregon Pharmacy and Therapeutics Committee Appointments Last updated 12/5/2017 3 Drug Use Research & Management Program OHA Health Systems Division 500 Summer Street NE, E35; Salem, OR 97301-1079 Phone 503-947-5220 | Fax 503-947-1119 Oregon Drug Use Review / Pharmacy & Therapeutics Committee Thursday, November 30, 2017, 1:00-5:00 PM Human Services Building Salem, OR 97301 MEETING MINUTES NOTE: Any agenda items discussed by the DUR/P&T Committee may result in changes to utilization control recommendations to the OHA. Timing, sequence and inclusion of agenda items presented to the Committee may change at the discretion of the OHA, P&T Committee and staff. The DUR/P&T Committee functions as the Rules Advisory Committee to the Oregon Health Plan for adoption into Oregon Administrative Rules 410-121-0030 & 410-121- 0040 as required by 414.325(9). Members Present: Tracy Klein, PhD, FNP; Caryn Mickelson, PharmD; Cathy Zehrung, RPh; Stacy Ramirez, PharmD; Kelley Burnett, DO; Phil Levin, PhD; William Origer, MD; James Slater, PharmD; Rich Clark, MD, MPH; Walter Hardin, DO, MBA Members Present by Phone: Staff Present: Richard Holsapple, RPh; Roger Citron, RPh; Dee Weston; Sarah Servid, PharmD; Lindsay Newton; Dave Engen, PharmD, CGP; Kathy Sentena, PharmD; Kim Wentz, MD; Julia Verhulst, PharmD; Deanna Moretz, PharmD Staff Present by Phone: Dean Haxby, PharmD Audience: *Margaret Olmon, AbbVie; Jeana Colabianchi, Sunovion; *Mary Kemhus, Novartis; Jennifer Shidler, Genzyme; Lisa Boyle, WVP Health; Bobbi Jo Drum, BMS; Karen Jackson, Trividia; Russ Rahmidah, PTC Therapeutics; Tera Gardol, PTC Therapeutics; Jeremy Guard, Alexion; Bill McDougall; Braden Purke; Chris Johnson, Spark; Diann Matthews, Merz; Nicolas Nguyen, Sunovion; Bill Francis; Rick Frees, Vertex; Joe Schreck, Allergan; Mike Donabedia, Sarepta; *Niren Shah, PTC Therapeutics; *Stan Cohan, Providence Hospital; *Lynda Finch, BioGen; Todd Hudson, PTC Therapeutics; *Kelley Maynard, Little Hercules; *Paul Cosgrove; Maiceya Gonzalez, Salud Pharmacy; Gregg Gittus, Alkermes; Tim McFerron, Alkermes; *Christine Curry, Genetech; David Barhoum, Genetech; Darren Coffman, HERC; Holly Bourgeois, OSU; *Meganne Leach, OHSU; Patrick Moty, Horizon Pharma; Joe Glassmire, Portola; *Andrea Dumont, Portola; Amy Burns, AllCare Health; (*) Provided verbal testimony Written testimony provided: Kyle Pinion, MSAA; PTC Therapeutics 4 I. CALL TO ORDER A. The meeting was called to order at approximately 1:05 pm. Introductions were made by Committee members and staff. B. Mr. Citron reported there were no new conflicts of interest to declare. C. Approval of agenda and July minutes presented by Mr. Citron. (pages 5-9) ACTION: Motion to approve, 2nd, All in Favor. II. DUR ACTIVITIES A. Quarterly Utilization Reports – Mr. Citron presented the Quarterly Utilization report. B. ProDUR Report – Mr. Holsapple presented the ProDUR report. C. RetroDUR Report – Dr. Engen presented the RetroDUR report D. RetroDUR Project Proposals - Dr. Engen presented the proposals. E. Oregon State Drug Reviews 1. Recently published reviews i. Tramadol and Codeine Use in Pediatrics ii. Oral Anticoagulation Update 2. Future Topic Recommendations Dr. Sentena presented two recently published newsletters, thanked the Committee for reviewing the draft versions and solicited ideas for future newsletters. F. Provider Education Opportunities 1. Proton Pump Inhibitors Dr. Sentena presented a draft of the Proton Pump Inhibitor provider education proposal. III. P&T Operating Procedures Update A. Operating Procedures Update-Presented by Mr. Citron and Dr. Servid 1. Consent Agenda 2. New Drug Policy 3. Biosimilar Policy 4. Public Comment 5. Discussion of Recommendations to OHA The Committee approved the specific items regarding consent agenda, biosimilar policy and the new drug policy after amending the proposed PA criteria to a $5,000 per claim or per month threshold instead of $10,000 and to require FDA approved dosing. ACTION: Motion to approve, 2nd. Majority in favor, one opposed. Approved. The proposed changes to the operating procedures and evidence grading methods was deferred for future study and a P&T subcommittee was requested to be convened to meet and bring edits back to January meeting. 5 IV. DUR OLD BUSINESS A. Drugs for Duchenne Muscular Dystrophy (pages 45 - 46) Dr. Servid presented the proposal of updating the PA criteria to: 1. Require that the requested treatment is funded by the OHP for that condition. ACTION: Amend PA criteria to include link to the HERC prioritized list. Motion to approve, 2nd. All in favor. Approved. B. Antiemetics (pages 47-49) Dr. Sentena presented the proposal to update the PA criteria to: 1. Eliminate quantity limits for all drugs in the class except for dronabinol. ACTION: Motion to approve, 2nd. All in favor. Approved. C. Low-Dose Quetiapine (pages 50-54) Dr. Servid presented the proposal to modify the safety edit to: 1. Apply to only patients with a daily dose of 50 mg or less. ACTION: Motion to approve, 2nd. All in favor. Approved. V. DUR NEW BUSINESS A. Pediatric Antipsychotic Drug Use Evaluation (pages 55 - 85) Dr. Servid presented the drug use evaluation and recommendation to: 1. Develop a RetroDUR program that provides new start patients access to care coordination and referral for expert consultation. ACTION: Motion to approve, 2nd. All in favor. Approved. VI. PREFERRED DRUG LIST NEW BUSINESS A. Bevyxxa (betrixaban) New Drug Evaluation (pages 86-93) Dr. Sentena presented the new drug evaluation, with the recommendation to: 1. Maintain betrixaban as a non-preferred drug in the anticoagulant PDL class 2. Subject betrixaban to the non-preferred drug prior authorization (PA) criteria. ACTION: Motion to approve, 2nd. All in favor. Approved. 6 B. Multiple Sclerosis Class Update (pages 94-129) Dr. Moretz presented the class update, with the recommendation to: 1. Apply clinical prior authorization (PA) criteria to ocrelizumab for both physician administered and point of sale pharmacy claims and limit use to: • Funded MS conditions • History of inadequate response to at least 2 disease modifying agents (DMA) approved for MS; and • Prescribed by a neurologist. 2.
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