Oregon Drug Use Review / Pharmacy & Therapeutics Committee Thursday, September 28, 2017, 1:00-5:00 PM Human Services Building Salem, OR 97301

Similar documents
UnitedHealthcare Pharmacy Clinical Pharmacy Programs

See Important Reminder at the end of this policy for important regulatory and legal information.

Cinryze. Cinryze (C1 esterase inhibitor [human]) Description

(y9. &i?r, JUL t Certified-Return Receipt Requested WARNING LE7TER

Children s Hospital of Philadelphia Committees for the Protection of Human Subjects Policies and Procedures. IRB Review Processes

See Important Reminder at the end of this policy for important regulatory and legal information.

Submitting Continuing Reviews and/or Amendments to the IRB

Inappropriate Testosterone Billings

Inspections, Compliance, Enforcement, and Criminal Investigations

American Boer Goat Association Conference Call Meeting November 6, 2018

Quarterly pharmacy formulary change notice

Clinical Policy: Testosterone Reference Number: AZ.CP.PHAR.02 Effective Date: Last Review Date: Line of Business: Arizona Medicaid

STATE 4H HORSE ADVISORY BOARD MEETING Saturday, February 16, 2008 Larue County Extension Office Hodgenville, KY

Pacific Northwest Ski Association A Division of USSA

Bicycle and Pedestrian Advisory Committee Agenda

M I N U T E S - Unapproved

EAST VALLEY SENIORS TENNIS LEAGUE BY-LAWS. Revised March 25, 2014 BY-LAWS

1001 West Broadway, Vancouver, BC V6H 4B1. Topical Finasteride

2016 STEP THERAPY CRITERIA

UNIVERSITY OF TENNESSEE GRADUATE SCHOOL OF MEDICINE INSTITUTIONAL REVIEW BOARD CONTINUING REVIEW AND REAPPROVAL OF RESEARCH

Androgens and Anabolic Steroids Prior Authorization with Quantity Limit - Through Preferred Topical Androgen Agent

SOP Title Review of Research: Devices for Humanitarian Uses

EMERGENCY USE 03/02/2016

INTERIM AGENDA FOR THE BOARD OF HEALTH MEETING. September 5, :00 noon

Review of Research by the Convened IRB

CONTINUING REVIEW OF APPROVED IRB PROTOCOLS

SOUTH AFRICAN RUGBY UNION - ANTI-DOPING REGULATIONS

Testosterone Topical/Buccal/Nasal

2001 REVIEW OF THE ATLANTIC STATES MARINE FISHERIES COMMISSION FISHERY MANAGEMENT PLAN FOR WEAKFISH (Cynoscion regalis)

Minutes National Officials Committee Executive Committee Mid-Year Meeting April 8-10, 2018

City of Oakland, Bicyclist & Pedestrian Advisory Commission Minutes from the July 21, 2016 meeting City Hall, Hearing Room 3

TOWN OF LAKE COWICHAN Minutes of a Regular meeting of Council Tuesday, September 25th, 2018

Policy Number: 42 Title: Investigational Devices Date of Last Revision: 06/12/2008; 07/22/2010; 05/29/2013; 05/01/2016; 10/16/2018

MINUTES City Council Regular Meeting 6:30 PM - July 17, 2018 City Hall Council Chambers, Sammamish, WA

Robert Perlstein, M.D. Medical Officer. Center for Drug Evaluation and Research. U.S. Food & Drug Administration

Valdez Fish & Game Advisory Committee January 26, 2018 Valdez Council Chambers

Forte Junior High. Cheerleader / Mascot / Manager

Testosterone Hormone Replacement Drug Class Prior Authorization Protocol

2016 USATF Race Walking Committee Annual Meeting Schedule Hilton at Walt Disney World, Orlando, FL

MEETING SUMMARY SMALL MESH MULTISPECIES COMMITTEE WHITING ADVISORY PANEL. March 13, Fairfield Inn & Suites 185 MacArthur Drive New Bedford, MA

Tuesday May, 20 th, :00 pm to 3:30 pm UW Olympic Natural Resources Center, 1455 S. Forks Ave., Forks, WA

DOCUMENTATION OF IRB DISCUSSIONS AND DECISIONS ( IRB MINUTES)

Opportunity Youth Academy 1290 Ridder Park Drive San Jose, California 95131

AMENDMENTS TO PREVIOUSLY APPROVED RESEARCH 3/01/2016

THE CITY OF TORONTO. City Clerk s Office. Minutes of the Toronto Pedestrian Committee. Meeting 3

FDA Violation 1: 1. The IRB failed to fulfill membership requirements [21 CFR ]

AA Ringette Calgary Foundation. Committee Meeting. Tuesday, April 28, In Attendance:

The Onychomycosis Market (2018 Edition) September 2018

DEPARTMENT OF WILDLIFE Law Enforcement Division 6980 Sierra Center Parkway, Ste 120 Reno, Nevada (775) Fax (775)

Investigator Manual. If you have questions about whether an activity requires IRB review, contact the IRB Office.

D) Treasurer s Report (Mike Kaytor) : Taxes are done. FOTO grant of $2500 covered Paul Wylie from last summer. 2 coaches have their 1099.

REGULAR MEETING CENTRAL HIGH BOARD OF EDUCATION CENTRAL HIGH ADMINISTRATION BLDG MAY 11, 2017, 6:00PM MILE RD MARLOW, OK 73055

FOREST GLEN GOLF & COUNTRY CLUB 18-HOLE LADIES GOLF ASSOCIATION BY-LAWS

2015 Georgia Open January 24-25, 2015

Testosterone Hormone Replacement Drug Class Prior Authorization Protocol

Fair Competition and Drug Control

Natural Hair Transplant Medical Center, Inc Dove Street, Suite #250, Newport Beach, CA Phone

CONFLICT OF INTEREST POLICY

South Calgary Wado Kai Karate

ANTI-DOPING REGULATIONS

Selection Criteria Supplement: 2019 Canoe Sprint Asia Pacific Sprint Cup Team

Reducing Breath-hold Artifacts on Abdominal MR

Notes Project Definition of Bulk Electric System

Grand National Curling Club of America, Inc. By-Laws

KIMBERTON YOUTH ATHLETIC LEAGUE Baseball Draft Rules

CYCLING AND PEDESTRIAN ADVISORY COMMITTEE THURSDAY, MARCH 16, 2017 CIVIC CENTRE CANADA ROOM MINUTES

UNIVERSITY OF TENNESSEE HEALTH SCIENCE CENTER INSTITUTIONAL REVIEW BOARD CONTINUING REVIEW OF RESEARCH

PNAHA Annual Fall Meeting September 8, 2001 Hal Homes Community Center Ellensburg, Washington

Procedure Department: HUMAN RESEARCH PROTECTIONS PROGRAM Policy Number: II.B.1

ABCD REGIONAL SERVICE COMMITTEE OF N.A. MINUTES OF FEBRUARY 6, 2016 MEETING

IRB MEETING ADMINISTRATION

OHRP Guidance on Written IRB Procedures

Shared Care Guideline For Prescribing Sustanon 250 to boys with Constitutional Delay of Growth and Puberty (CDGP)

Doping in sport relevant changes in the WADA code. Dr Chris Milne, Sports Physician Hamilton NZ

Kamloops Recreational Soccer League Bylaws

7.0 DEVIATION and EXCEPTION of a PREVIOUSLY APPROVED PROTOCOL

Oregon School Activities Association SW Parkway Avenue, Suite 1 Wilsonville, OR fax:

TESTOFEN HUMAN CLINICAL TRIAL GENCOR PACIFIC, INC. Copyright 2006 by Gencor Pacific, Inc.

THE CONSTITUTION OF THE PURDUE INTERCOLLEGIATE BOWLING CLUB. ARTICLE I Name and Governance. ARTICLE II Mission Statement

International Island Games Association The Sports and Sports By-Laws

IRB Chair Responsibilities

I. Introductions and Purpose. II. Review Procedures and Agenda. III. Selection of Chairperson. IV. Review and Adoption of 2012 Committee Minutes

Wisconsin Department of Transportation Inter-Tribal Task Force Bylaws

Alabama Soccer Association Governor s Cup

RULES. 1 st LAW COLLEGE DEHRADUN NATIONAL MOOT COURT COMPETITION AUGUST 2013

2018 Ski Jumping and Nordic Combined Sport Committee Meeting Minutes

Kerman Cal Ripken Baseball League

Forty-first Session of the Executive Council UNESCO, Paris, 24 June 1 st July 2008

SOP 5.06 Full Committee Review: Initial IRB Review

North Ryde Dockers Junior AFL Club

The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not

Beads. 4 Annual All-Star Gala FRENCH QUARTER Underwriting Opportunities AN EVENING IN THE

C O N C O R D I A R E S P A R V A E C R E S C E N T INTERNATIONAL HELIDECK REGULATORS ASSOCIATION C O D E O F R U L E S

City of Burlington Burlington Cycling Committee DRAFT MINUTES

CARSON CITY ADVISORY BOARD TO MANAGE WILDLIFE PUBLIC NOTICE

Engineering Research Council Bylaws Revised February 4, 2018

UPPER ISLAND SOCCER ASSOCIATION UISA EXECUTIVE MEETING Monday, October 3, 2016 CVUSC clubhouse, Courtenay 7:00 pm

Clinical Study Synopsis

FINASTERIDE (PROPECIA, PROSCAR) SIDE EFFECT & CONSENT FORM

U.S. ANTI-DOPING AGENCY WHEREABOUTS POLICY

Transcription:

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, September 28, 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; Walter Hardin, DO, MBA; Phil Levin, PhD; William Origer, MD; James Slater, PharmD Members Present by Phone: David Pass, MD 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; Megan Herink, PharmD, MBA Staff Present by Phone: Deanna Moretz, PharmD; Dean Haxby, PharmD Audience: *Marc Jensen, Pfizer; *Mae Kwong, Johnson & Johnson; *Anthony Wheeler, Eli Lilly; *Shawn Hansen, Novo Nordisk; *Margaret Olmon; *Stuart O Brochta, Gilead; *Steven Nemirow; *Lorren Sandt, Caring Ambassadors; *Haven Wheelock, Outside In; *BJ Cavnor; *Kent Benner, MD; Stephanie Lattig, Novo Nordisk; Sylvia Walsh; Karen Meier, Novo Nordisk; Stephanie Yamamoto; Johnson & Johnson; Amanda Shearin, BIPI; Cheryl Fletcher, AbbVie; Michael Estos, Pfizer; Jeana Colabianchi, Sunovion; Mary Kemhus, Novartis; Darlene Halverson, Novartis; Jennifer Shidler, Genzyme; Venus Holder, Eli Lilly; Lisa Boyle, WVP Health; Cory Rahn, IHN; Jennifer Svec, Med Impact; Brian Landberg, Arkvoy Diamtes; Sierra Fung, Care Oregon; Daniel Hendriekson, Care Oregon; Chris Conner, BMS; Anthony McKenzie, Western Oregon Advanced Health; Bobbi Jo Drum, BMS; Hunter Hensler, Western Oregon Advanced Health; Camille Kerr, Amgen; Heather True, Pacific University; Sarah Brattain, OSU/OHSU Intern; Stacy Eria, Family Care CCO; Mark Kantor, All Care Health; Damen, AbbVie (*) Provided verbal testimony Written testimony provided:

I. CALL TO ORDER A. The meeting was called to order at approximately 1:01 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 4-7) ACTION: Motion to approve, 2 nd, 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. Oregon State Drug Reviews 1. Updates in the Management of COPD 2. New Biologics for Treatment of Moderate to Severe Psoriasis. Dr. Sentena presented two recently published newsletters, thanked the Committee for reviewing the draft versions and solicited ideas for future newsletters. Dr. Ramirez recommended a review of the biologics and all the FDA approved indications and recommended an easy to reference chart be developed for providers. III. DUR OLD BUSINESS A. Lo-dose Quetiapine (pages 25-26) Dr. Servid presented the proposal to retire the low-dose quetiapine prior authorization (PA) criteria. ACTION: Committee deferred making recommendation to retire PA and requested staff present additional data on current utilization including age and dose at future meeting. B. Hydroxyzine HCI (pages 27-28) Dr. Servid presented the proposal to discontinue requiring PA for all formulations of of hydroxyzine HCI. C. Biologics for Autoimmune Conditions (pages 29-34) Dr. Moretz presented the proposed updates to the Biologics for Autoimmune Conditions PA andrecommendation to include new indications.

D. Antidiabetic Agents (Non-Insulin) (pages 35-74) Dr. Sentena presented the class update and proposed PA criteria with the following 1. Maintain current PA policy. 2. Add new formulations to existing PA criteria. 3. No changes to the PDL are recommended based on the new evidence. E. Antidiabetic Agents (Insulin) (pages 75-95) Dr. Sentena presented the class update and DERP summary and made the following 1. No changes are recommended to the PDL based on new evidence. 2. Remove requirement that patients must use 40 units or less per day of insulin to be candidates for an insulin pen. F. Hepatitis C Class Update (pages 96-160) Dr. Herink presented the class update and new drug evaluations and made the following 1. Expand coverage for HCV treatment with HCV stage F-2 with no requirement to be prescribed by a specialist. 2. Expand coverage for HCV treatment for all individuals with HCV co-infected with HIV. 3. Amend PA criteria to include additional extrahepatic manifestations, baseline HBV monitoring, and to allow for the re-treatment of HCV in those who have failed therapy with a NSSA inhibitor. 4. Add Fibrosure as alternative serum test in the current PA criteria and proposed 1/1/2018 PA criteria if the higher sensitivity tests are not available. ACTION: Motion to approve recommendations #3 and 4 (above) and proposed amendments to the question #7 in proposed PA criteria for results falling in a range to F1 to F2 range and modification of question #14 to explicitly state that NS5A testing is required and to document the results. 2 nd. All in favor. Approved. The Committee acknowledged the OHA will make the changes they deem necessary to comply with the MOU, however, the majority of the Committee recommended against expanding coverage for HCV treatment to stage F2, or to expand coverage for all individuals with HCV co-infected with HIV. 2 nd. Majority in favor. Approved. G. ADHD Class Update (pages 161-177) Dr. Servid presented the class update and following recommendation: 1. Maintain current PA policy. 2. Evaluate comparative costs in executive session.

VI. DRUG CLASS LITERATURE SCANS A. Literature Scans (pages 178-268) Dr. Verhulst, Dr. Engen, Dr. Sentena, and Dr. Herink presented the literature scans and following 1. Antipsychotics, Parenteral Scan (pages 178-189) 2. Growth Hormones Scan (pages 190-202) 3. Newer Antiemetics Scan (pages 203-225) 4. Pancreatic Enzymes Scan (pages 226-233) 5. Platelet Inhibitors Scan (pages 234-250) 6. Topical Steroids Scan (pages 251-259) 7. Topical Antipsoriatics Scan (pages 260-268) a. Assign coal tar preparations to antipsoriatic class as non-preferred VII. EXECUTIVE SESSION VIII. RECONVENE FOR PUBLIC RECOMMENDATIONS * After executive session A. Antidiabetic Agents (Non-Insulin) (pages 35-74) B. Antidiabetic Agents (Insulins) Class Update (pages 75-95)

. Remove PA on Lantus and Novolog pens and vials. Modify PA criteria to require trail and failure of Lantus or Novolog before approving other insulin pens. C. Hepatitis C Class Update (pages 96-160) *ACTION: Make Mavyret and Vosevi preferred. Make Harvoni non-preferred. D. ADHD Class Update (pages 161-177) *ACTION: Make dextroamphetamine-amphetamine CAP ER 24 H preferred E. Antipsychotics, Parenteral Scan (pages 178-189) F. Growth Hormones Scan (pages 190-202) *ACTION: Make Nutropin AQ preferred. Make Omnitrope non-preferred. G. Newer Antiemetics Scan (pages 203-225) H. Pancreatic Enzymes Scan (pages 226-233) I. Platelet Inhibitors Scan (pages 234-250) J. Topical Steroids Scan (pages 251-259) K. Topical Antipsoriatics Scan (pages 260-268) VIIII. ADJOURN