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«DRUG UTILIZATION REVIEW BOARD MEETING Department of Community Health 2 Peachtree Street - 5th Floor Board Room Atlanta, Georgia 30303 March 19, 2013 ...»

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Georgia Department of

Community Health

DRUG UTILIZATION REVIEW BOARD MEETING

Department of Community Health

2 Peachtree Street - 5th Floor Board Room

Atlanta, Georgia 30303

March 19, 2013

This page intentionally left blank

DRUG UTILIZATION REVIEW BOARD MEETING

AGENDA

2 Peachtree Street - 5th Floor DCH Board Room

Atlanta, Georgia 30303

March 19, 2013 – 9:00 a.m. to 4:00 p.m.

CALL TO ORDER Laurel Ashworth, PharmD, Chair COMMENTS FROM THE DEPARTMENT Linda Wiant, PharmD, Director MINUTES FROM PREVIOUS MEETING Chair PDL MANAGEMENT Tara R. Cockerham, PharmD  Manufacturers’ Forum  New Drug Reviews  Neupro™  Prepopik™  Sklice™  Xtandi™  Therapeutic Class Review  Oral nonsteroidal antiinflammatory drugs  Supplemental Rebate Classes Review  Clinical updates  Utilization Trends Review  Drug Information Review  Drug Update Newsletter  Horizon Watch Report  Patent Expiration Report  Clinical Compass Newsletter FUTURE AGENDA ITEMS Chair CONSUMER COMMENTS SESSION Chair ADJOURNMENT OF OPEN SESSION Chair

EXECUTIVE SESSION

RECONVENING OF OPEN SESSION

 Board’s Voting on Recommendations to DCH Chair ADJOURNMENT OF MEETING Chair This page intentionally left blank Department of Community Health Drug Utilization Review Board (DURB) MINUTES Tuesday, December 11, 2012 Department of Community Health Drug Utilization Review Board (DURB) MINUTES Tuesday, December 11, 2012

MEMBERS PRESENT MEMBERS ABSENT

Laurel E. Ashworth, Pharm.D., Chair Melissa D. Carter, J.D.

Joseph R. Bona, M.D., MBA, Vice-Chair Arvind Gupta, M.D.

Paul D. Boyce, M.D.

Karen L. Carter, M.D.

Ann R. Damon, Pharm.D.

Carl Ellis, R.Ph.

Deborah W. Fincher, M.S., R.Ph.

Thomas B. Gore, M.D.

John Greeson, M.D., MBA Rondell C. Jaggers, Pharm.D.

Edwina L. Jones, Pharm.D., MBA Robyn Lorys, Pharm.D.

J. Russell May, Pharm.D.

Osgood (Drew) A. Miller, R.Ph.

Donald A. Paul, M.D.

Matthew Perri, III, R.Ph., Ph.D.

Sandra L. White, M.D., MBA, FACR Mary Virginia "Ginny" Yates, Pharm.D.

Staff Linda Wiant, Pharm.D., Pharmacy Director, Pharmacy Services Turkesia Robertson-Jones, Pharm.D., Pharmacy Operations Manager, Pharmacy Services Gilletta Gray, R.Ph., Clinical Manager, Pharmacy Services Lori Garner, MHS, MBA, R.Ph., Pharmacist, Pharmacy Services Shimary Hodges, Administrative Assistant, Pharmacy Services NorthStar HealthCare Consulting Emily Baker, Pharm.D., BCPS, MHA, MBA, President Tara R. Cockerham, Pharm.D., Clinical Programs Director Catamaran Mark Hall, MBA, PMP, Account Manager Talmahjia “Tami” Sweat, Pharm.D., Clinical Systems Product Manager Goold Health Services Steve Liles, Pharm.D., Sr. Director, Pharmacy Services Doug Martin, Pharm.D., Pharmacy Project Manager Department of Community Health Drug Utilization Review Board (DURB) MINUTES Tuesday, December 11, 2012 Call to Order The Drug Utilization Review Board (DURB/DUR Board/Board) held its fourth meeting for the calendar year on December 11, 2012. The Chair, Laurel E. Ashworth, Pharm.D., called the meeting to order at 10:01am. Board members introduced themselves.

Comments from the Department Linda Wiant, Pharm.D., Pharmacy Director, Pharmacy Services, commented on the following

items:

1. New Members – A welcome was extended to new members: Ann Damon, Pharm.D., Deborah Fincher, M.S., R.Ph, Thomas Gore, M.D, and Donald Paul, M.D.

2. Resignation – Dr. Gary Williams resigned from the Board. He was thanked for his service.

3. Georgia Society of Health-Systems Pharmacists – Rondell Jaggers, Pharm.D. was awarded Pharmacist of the Year Award.

4. Department of Community Health (DCH) – Staff members were introduced.

5. Medicaid Reform Update – Linda Wiant, Pharm.D., Pharmacy Director, Pharmacy Services, presented an overview of the Medicaid Redesign Refresh, DCH’s direction and key improvements the Department will be engaged in (see Attachment A). Questions were addressed on benchmarking and the centralized provider portal.

Minutes from the Previous Meeting Board members reviewed the minutes from the September 20, 2012 meeting. There was one correction in the ‘Minutes from Previous Meeting’ section to change the date ‘September 2012 meeting’ to ‘June 21, 2012 meeting’. A motion was made and seconded to approve the minutes with the noted correction. The motion carried unanimously to approve the minutes with corrections.

Manufacturers’ Forum Emily Baker, Pharm.D., BCPS, reviewed information regarding the Manufacturers’ Forum that was provided in the Manufacturer Information section in the DUR Board binder. A total of six (6) manufacturers participated and provided information regarding the following drugs discussed

at the December 2012 DURB meeting:

–  –  –

There were no questions or comments. The next forum is Thursday, February 7, 2013 and Tuesday, February 12, 2013 (if needed) from 9am-5pm at the NorthStar Healthcare Consulting office: 1121 Alderman Drive, Suite 112, Alpharetta, GA 30005.





Department of Community Health Drug Utilization Review Board (DURB) MINUTES Tuesday, December 11, 2012 New Drug Reviews Clinical information for the following new drugs, in the market six months or more, was presented by Dr. Baker for discussion and recommendations. The complete detailed new drug evaluation monographs are in the New Drugs for Review section of the DUR Board binder.

–  –  –

There was one question raised regarding the discontinuation rate due to neuropsychiatric side effects. Dr. Baker noted the following discontinuation rates: Confusion – Potiga (4%) vs.

Placebo ( 1%) and Psychosis/Hallucinations – Potiga (1%) vs. Placebo (0%).

Therapeutic Class Review Clinical information for the following therapeutic class was presented by Tara R. Cockerham, Pharm.D. for discussion. The complete detailed therapeutic class review was provided in the Therapeutic Class Review section of the DUR Board binder.

–  –  –

There were no questions or comments.

Clinical Utilization Reviews Clinical information for the following Clinical Utilization Review topic was presented for discussion by Dr. Cockerham. The complete detailed clinical review was provided in the Clinical Utilization Review section of the DUR Board binder.

–  –  –

There was a question regarding the difference in incidences with non-drospirenone agents. It was noted there were no differences with regards to hormone replacement therapy but there were with birth control therapy.

DCH Decisions DCH decisions from the September 2012 DURB meeting were provided in the DCH Decisions section of the DUR Board binder.

Department of Community Health Drug Utilization Review Board (DURB) MINUTES Tuesday, December 11, 2012 Utilization Trend Review Utilization trends for Georgia Medicaid Fee-for-Service were provided in detail in the Utilization Trends section of the DUR Board binder.

Drug Information Information from the following was provided in detail in the Drug Information section of the

DUR Board binder used for this meeting:

 Drug Update Newsletter  Horizon Watch Report  Patent Expiration Report  Clinical Compass Newsletter Future Agenda Items There were no future agenda items noted.

Acknowledgement of new DURB Chair and Vice-Chair Linda Wiant, Pharm.D., Pharmacy Director, Pharmacy Services, thanked and congratulated Dr.

Laurel Ashworth and Dr. Joseph Bona for taking over the positions of DURB Chair and ViceChair, respectively. Dr. Bona will move into the Chair position in January 2014.

Consumer Comments Session Dr. Bona conducted the Consumer Comments Session. Consumer comments were presented to

the Board from the following:

 Jeff Graham, Executive Director, Georgia Equality – preferred drug list for antiretrovirals  David Resnik, M.D., Grady Health Systems, Infectious Disease Program – HIV antiretrovirals  Harold Catner, M.D., Department of Public Health, Mercer University – prior approval of antiretrovirals  Leisha McKinley-Beach - Dr. Cockerham presented consumer comments to the Board from a letter from Leisha McKinley-Beach, The Black AIDS Institute, regarding restrictions on HIV antiretrovirals.

Upcoming Meetings

The following upcoming meetings were published in the DURB binder:

–  –  –

Disclosure Forms Disclosure forms were received and reviewed by the Department for completeness for all Board members that attended the meeting.

Dr. Donald Paul disclosed program support from a manufacturer and abstained from voting for products or classes of medications from this manufacturer.

Adjournment of Open Session The DUR Board voted to close the open meeting pursuant to the Open Meeting Act of Georgia Section 50-14-1 – 50-14-6 and pursuant to Federal Law Section 1396R-8B3D. The individuals recorded in attendance from the Department of Community Health, Goold Health Services, NorthStar HealthCare Consulting, Catamaran and pharmacy student Kamilah Rashid attended the closed session with the Board members. There was a unanimous vote to adjourn the open session and approve the closed session. The Chairman, Dr. Laurel Ashworth, adjourned the open session at approximately 11:38 am, at which time members took a break and reconvened for the executive (closed) session at 11:58 am.

Executive SessionThe executive session was held from 11:58am to 1:33pm.

Board’s Recommendations to the Department After all clinical and financial evaluations and discussions, the DUR Board reconvened in the open session, voted, and presented the Department with the following recommendations for changes to the Preferred Drug List (PDL). All motions and votes are noted in Attachment B.

–  –  –

The DUR Board recommended Preferred status with Prior Authorization for Elelyso™.

Department of Community Health Drug Utilization Review Board (DURB) MINUTES Tuesday, December 11, 2012 Hormone Modifier The DUR Board recommended Preferred status with Prior Authorization for Korlym™.

Anticonvulsant The DUR Board recommended Non-Preferred status with Prior Authorization for ™ Potiga.

–  –  –

The DUR Board recommended No Changes from the current PDL status. The DUR Board also recommended the Department report on prior authorization and utilization data at the June 6, 2013 meeting.

Conclusion At the conclusion of the executive session, the open session reconvened at 1:41pm, and the audience was invited back in to hear the Board’s recommendations submitted to the Department.

Dr. Laurel Ashworth presided over the voting and presented the recommendations from the Board to the Department.

With no other business for discussion, Laurel Ashworth, Pharm.D., Chair, adjourned the meeting at 1:45pm.

THESE MINUTES ARE HEREBY APPROVED AND ADOPTED, THIS THE _________ DAY OF _____________, 2013.

–  –  –

 Understand the Schedule  Review the Requirements Analysis Process Flow  Understand the outputs of Requirements Analysis

–  –  –

• The EDS PM who is transferring the requirement informs the EDS PM who is receiving the requirement of the transfer

• The receiving EDS PM contacts the receiving DCH Business Lead and coordinates a review time to discuss and clarify the requirement.

di t i ti t di d l if th i t

• The receiving EDS TFAL maps any system objects and/or creates any Change orders necessary to demonstrate an understanding of the requirement.

q

• The receiving DCH Business Lead determines if there are any other DCH team members that will need to be in the review session

• The functional project team, including the DCH Business Lead, DCH SME, DCH PMO, EDS PM, EDS TFAL and EDS Lead BA, review the requirement.

• The necessary clarifications are documented and the requirement with the associated documentation is printed and signed by the EDS PM, TFAL or Designee and the DCH Business Lead

• If the RAD has been delivered regardless of approval status, supplemental pages are printed and delivered to DCH for review and approval

–  –  –

• One on One sessions conducted

• Kick the Tire sessions conducted

• Requirements Validation sessions conducted

• iTRACE requirements are in a status of RAD Ready, Informational, State, interim RV Sign off or CCB/Deferred

• Requirements Analysis Documents are approved

–  –  –

Attendees Department of Community Health Linda Wiant, PharmD, Pharmacy Director, Pharmacy Services Gilletta Gray, RPh, Clinical Manager, Pharmacy Services NorthStar HealthCare Consulting Tara R. Cockerham, PharmD, Clinical Programs Director Emily Baker, PharmD, BCPS, MBA, MHA, President Dan Alday, RPh, Director, Clinical Programs & Analytics Nekia Austin, PharmD, JD, Director, Program Compliance Amy Baker, PharmD, Pharmacist Catamaran Health Solutions Talmahjia “Tami” Sweat, PharmD, Clinical Systems Product Manager Drug Summary Documents Please note that relevant, electronic materials that were provided by manufacturers were forwarded to the Drug Utilization Review Board (DURB). For the drugs presented at the Forum that were either new drugs, drugs not previously presented or existing drugs with new information since last presented, the information is highlighted below.

The manufacturers presenting at the Forum referred the audience and the readers of the materials to the prescribing information for additional information on the drug, especially in regards to safety.



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