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Oregon Drug Use Review / Pharmacy & Therapeutics Committee

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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, July 26, 2018 1:00 - 5:00 PM HP Conference Room 4070 27th Ct. SE Salem, OR 97302 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. Conflict of Interest Declaration R. Citron (OSU) C. Approval of Agenda and Minutes T. Klein (Chair) D. Department Update T. Douglass (OHA) E. Legislative Update T. Douglass (OHA) F. Mental Health Clinical Advisory Group Discussion K. Shirley (MHCAG) 1:40 PM II. CONSENT AGENDA TOPICS T. Klein (Chair) A. P&T Methods B. CMS and State Annual Reports C. Quarterly Utilization Reports 1. Public Comment III. DUR ACTIVITIES 1:45 PM A. ProDUR Report R. Holsapple (DXC) B. RetroDUR Report D. Engen (OSU) C. Oregon State Drug Reviews K. Sentena (OSU) 1. A Review of Implications of FDA Expedited Approval Pathways, Including the Breakthrough Therapy Designation IV. PREFERRED DRUG LIST NEW BUSINESS 2:00 PM A. Oral Cystic Fibrosis Modulators Class Update M. Herink (OSU) 1. Class Update/Prior Authorization Criteria 2. Symdeko™ (tezacaftor/ivacaftor) New Drug Evaluation 3. Public Comment 4. Discussion of Clinical Recommendations to OHA 1 2:30 PM B. Newer Diabetes Treatments Class Update K. Sentena (OSU) 1. Class Update/Prior Authorization Criteria 2. Steglatro™ (ertugliflozin) New Drug Evaluation 3. Ozempic® (semaglutide) New Drug Evaluation 4. Public Comment 5. Discussion of Clinical Recommendations to OHA 3:00 PM BREAK 3:10 PM C. Asthma Biologics DERP Summary D. Moretz (OSU) 1. DERP Summary/Prior Authorization Criteria 2. Public Comment 3. Discussion of Clinical Recommendations to OHA 3:30 PM D. Radicava® (edaravone) New Drug Evaluation D. Engen (OSU) 1. New Drug Evaluation/Prior Authorization Criteria 2. Public Comment 3. Discussion of Clinical Recommendations to OHA 3:45 PM E. Neuropathic Pain DERP Summary D. Moretz (OSU) 1. DERP Summary/Prior Authorization Criteria 2. Public Comment 3. Discussion of Clinical Recommendations to OHA V. DUR OLD BUSINESS 4:05 PM A. Sedatives J. Page (OSU) 1. Updated Prior Authorization Criteria 2. Public Comment 3. Discussion of Clinical Recommendations to OHA 4:10 PM B. New Drug Policy S. Servid (OSU) 1. Updated Prior Authorization Criteria 2. Public Comment 3. Discussion of Clinical Recommendations to OHA 4:15 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, May 24, 2018, 1:00-5:00 PM DXC 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; Phil Levine, PhD; Walter Hardin, DO, MBA; Jim Slater, PharmD; Caryn Mickelson, PharmD; Stacy Ramirez, PharmD; Cathy Zehrung, RPh; Kelley Burnett, DO Members Present by Phone: Staff Present: Richard Holsapple, RPh; Roger Citron, RPh; Trevor Douglass, DC, MPH; Sarah Servid, PharmD; Lindsay Newton; Dee Weston; Renae Wentz, MD; Julia Page, PharmD; Jonnaliz Corbett; Deanna Moretz, PharmD; Tiffany Tsai, PharmD; Pearce Engelder, PharmD; Megan Herink, PharmD; David Engen, PharmD Staff Present by Phone: Kathy Sentena, PharmD Audience: Leo Yasinski; Rick Frees, Vertex; Vivian Chau, SMC; Bobbi Jo Drum, BMS; Teresa Blair, Ipsen; Brittany Duffy-Goche, National Psoriasis Foundation; Troy Larsen, Sage; Laura Jeffcoat, AbbVie; Maragaret Olmon, AbbVie; Kelly Nguyn, OHSU; Larry Curtis, Allergant; Julie Haynes; Mary Kemhus, Novartis; Diann Matthews; Rashid Kazerooni, Merz; Amy Burns, AllCare; Bing Bing Liany, Care Oregon; Lisa Boyle, WVP Health; Raulo Frear, Merck. (*) Provided verbal testimony Written testimony provided: I. CALL TO ORDER A. The meeting was called to order at approximately 1:02 pm. Introductions were made by Committee members and staff. No new conflict of interests were declared. B. Dr. Douglass provided a department update and legislative update. 4 ACTION: Motion to approve, 2nd, All in Favor. II. CONSENT AGENDA TOPICS A. Approval of agenda and March minutes presented by Mr. Citron. (pages 5-8) ACTION: Motion to approve, 2nd, All in Favor. B. Topical Antibiotics Class Update with Xepi™ (ozenoxacin) New Drug Evaluation (pages 9- 19) 1. Review in executive session. C. Glaucoma Class Update with Rhopressa™ (netarsudil) and Vyzulta™ (latanoprostene) New Drug Evaluations (pages 20-40) 1. Review in executive session. ACTION: Motion to approve, 2nd, All in Favor. III. DUR Old Business A. Exclusion List Dee Weston presented the exclusion list and the recommendation to remove it from the current PA guide. ACTION: Motion to approve, 2nd, All in Favor. IV. DUR Activities A. Quarterly Utilization Reports (pages 41-46) – Mr. Citron presented the quarterly report B. ProDUR Report (pages 47-50) – Mr. Holsapple presented the ProDUR report C. RetroDUR Report (pages 51-54) – Dr. Engen presented the RetroDUR report D. Oregon State Drug Reviews 1. Recently published reviews: i. What’s New with Biologic Agents for Inflammatory Disease? (pages 55-56) ii. Second Generation Antipsychotic Use in Major Depressive Disorder (pages 57-58) 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. V. PREFERRED DRUG LIST NEW BUSINESS A. Benlysta ® (belimumab) New Drug Evaluation (pages 59 - 72) 5 Dr. Moretz presented the new drug evaluation, proposed PA criteria and recommended: 1. Designate belimumab as a non-preferred agent with PA criteria. ACTION: The Committee amended the proposed PA criteria to require documentation of baseline disease severity and objective documentation of improvement in disease activity to the renewal criteria; to require treatment with current standard of care medications for systemic lupus erythematosus prior to approval of belimumab; and to require prescription by or in consultation with a specialist. Motion to approve, 2nd, All in Favor. B. Fluoroquinolone Class Update (pages 73-88) Dr. Herink presented the class update and recommended: 1. Continue to maintain at least one FQ with broad coverage of gram-negative bacteria and at least one ‘respiratory’ FQ as preferred options. 2. Evaluate comparative costs in executive session. ACTION: Motion to approve, 2nd. All in favor. Approved. C. Clostridium Difficile Drugs Class Update (pages 89-106) Dr. Moretz presented the class update and proposed PA criteria to: 1. Designate bezlotoxumab as non-preferred and subject to PA. 2. Modify fidaxomicin PA criteria to remove metronidazole as a prerequisite to fidaxomicin in patients with recurrent CDI. 3. Evaluate comparative costs in executive session. ACTION: The Committee amended the proposed PA criteria to also remove metronidazole as a prerequisite for bezlotoxumab, and to remove the question which asks if the provider will switch to a preferred agent in the fidaxomicin PA criteria. Motion to approve, 2nd. All in favor. Approved. D. Botulinum Toxins Class Update (pages 107-132) Dr. Page presented the class update with the following recommendations: 1. Update current clinical prior authorization criteria to reflect current coverage and guidelines in the OHA Prioritized List of Health Services. ACTION: Motion to approve, 2nd. All in favor. Approved. VI. DUR NEW BUSINESS A. Methadone Drug Use Evaluation (pages 133-145) Dr. Tsai presented the drug use evaluation with the following recommendations: 1. Maintain status of methadone as non-preferred on the PDL. ACTION: The Committee agreed with the recommendation to maintain methadone as non-preferred on the PMPDP. B. Gabapentin Drug Use Evaluation (pages 146-161) 6 Dr. Engelder presented the drug use evaluation with the following recommendations: 1. No changes are recommended. ACTION: The Committee agreed with the recommendation that no changes were needed.
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