MAC Meeting Minutes January 18, 2019

Texas HIV Medication Advisory Committee Meeting

Meeting Minutes
January 18, 2019
12:30 p.m.

Brown Heatly Building, Public Hearing Room
4900 N. Lamar Blvd.
Austin, Texas 78751
 

Table 1: Texas HIV Medication Advisory Committee (MAC) member attendance at the Friday, January 18, 2019 meeting

Agenda Item 1 & 2: Call to Order/Welcome and Introductions

Dr. Philip Keiser called the meeting to order at 12:41 pm and welcomed all in attendance. Mr. John Chacon reviewed logistical announcements, conducted a roll call and announced a presence of a quorum.

Agenda Item 3: Approval of previous meeting minutes (October 26, 2018)

Dr. Keiser asked for approval of the meeting minutes for the October 26, 2018 Texas HIV Medication Advisory Committee.

Motion: Mr. Bruce Turner motioned for approval of October 26, 2018 meeting minutes as presented. Dr. Natalie Vanek seconded the motion. Dr. Phillip Keiser asked for a verbal vote, and the motion carried unanimously with eight yeas’, no nays, and no abstentions to accept the October 26, 2018 minutes

Agenda Item 4: Discussion Item – Meeting of Governance and Data Subcommittee

Highlights of the discussion and committee member discussion included:

• Dr. Phillip Keiser reported on the charge for the Governance and Data Sub-committee:
  • make recommendations on how MAC is run
  • address items that are not covered in by-laws – could look at revising by-laws as they pertain to election of officers
  • establish process for re-election of MAC officers and determine terms and succession of officers
  • provide input on who is selected for appointment to the MAC
  • encourage MAC members to participate in sub-committees
  • address MAC membership demographics to align membership to match the current epidemic for committee continuity
  • all sub-committee membership is open to MAC members as well as community/client/consumer input
  • non-MAC sub-committee members will need to be approved by the MAC chair
• MAC members that confirmed their interest in serving on the Governance and Data sub-committee: Dr. Natalie Vanek, Clyde Moore, Bruce Turner
• Discussion on MAC representation:
  • Rachel Sanor reported that a current process is underway for recruitment of new MAC Members and Pharmacist position – application deadline is March 1st
  • Comments from Committee on future membership of the MAC:
    • Bruce Turner commented that representation from West Texas is needed
    • Dr. Fernando Garcia commented that membership from each region in the state should be considered
    • Frank Rosas expressed a need to have more exposure for the MAC Committee throughout the state
    • Dr. Natalie Vanek commented that the ability to call in for meetings makes participation more accessible for members 

Agenda Item 5: Discussion Item – Formation and Structure of Subcommittees

Dr. Phillip Keiser led discussion regarding formation and structure of subcommittees. Highlights of the discussion and committee member discussion included:

• Sub-committee charge:
  • have a mission statement (scope of work for each committee)
  • should have MAC members but cannot have a quorum – no official MAC business can be discussed
  • can include community members with relevant expertise but they will have to be approved by MAC Chair
  • per MAC by-laws sub-committees to elect a chair/vice-chair
  • committees to bring back recommendations to the MAC
• Sub-committees formed:
  • Governance and Data – Dr. Phillip Keiser
  • Formulary – Dr. Nancy Vanek
  • Eligibility – Frank Rosas
• Goals for April MAC meeting
  • clear governance plan and election/succession of officers
  • sub-committees to meet before April and report back on election of officers for each sub-committee

Agenda Item 6: Action Item – Request from Merck & Co., Inc. for recommendation to add Delstrigo to the THMP formulary

Ms. Tarannum Quresliv, Medical Science Liaison representing Merck & Co., Inc. presented on Delstrigo and referenced a detailed prescribing information handout entitled “Delstrigo” and PowerPoint entitled “Delstrigo and Pifeltro”. Highlights of the presentation and committee member discussion included:

• Indications for both: part of HIV regimen for medication naïve patients
• 1 pill once a day without food
• No registered data from other countries in human studies
• Comments from committee
  • Pricing is considered less than favorable (per ADAP Crisis Task Force)
  • Better version of Atripla – good alternative with less resistance and fewer side effects
  • Not a ground-breaking/progressive drug
  • Uptake/use would probably not be significant
  • Texas cannot negotiate a separate price with Merck (use ADAP Crisis Task Force)
  • Adding the drug would not be cost prohibitive
  • If consumer would benefit from this drug should include in the formulary

Dr. Keiser asked for a motion to add Delstrigo to the THMP formulary.

Motion: Mr. Bruce Turner motioned to have Delstrigo go to Formulary Subcommittee for further evaluation before adding to the THMP formulary. Mr. Frank Rosas seconded the motion. Dr. Phillip Keiser asked for a verbal vote, and the motion carried with five yea’s, two nays, and one abstention to have Delstrigo go to Formulary Subcommittee for further evaluation before adding to the THMP formulary.

Agenda Item 7: Action Item – Request from Merck & Co., Inc. for recommendation to add Pifeltro to the THMP formulary

Ms. Tarannum Quresliv, Medical Science Liaison representing Merck & Co., Inc. presented on Pifeltro and referenced a detailed prescribing information handout entitled “Pifeltro” and PowerPoint entitled “Delstrigo and Pifeltro”. Highlights of the presentation and committee member discussion included:

• Committee Comments:
  • Pifeltro is good option as a stand-alone drug
  • Both Pifeltro and Delstrigo approved by ADAP Crisis Task Force but not in line with other medications approved

Dr. Keiser asked for a motion to add Pifeltro to the THMP formulary.

Motion: Mr. Bruce Turner motioned to have Pifeltro go to Formulary Subcommittee for further evaluation before adding to the THMP formulary. Mr. Frank Rosas seconded the motion. Dr. Phillip Keiser asked for a verbal vote, and the motion carried with six yea’s, two nays, and no abstentions to have Pifeltro go to Formulary Subcommittee for further evaluation before adding to the THMP formulary.

Agenda Item 8: Action Item – Schedule Next Meeting/Public Comment 

Dr. Phillip Keiser led the discussion on scheduling next meeting and referenced the Calendar handout. Highlights of the committee member discussion included:

• Next meeting April 5th
  • Dr. Heresi is not available
• Committee members agreed on the future Texas HIV MAC meeting dates of Friday, July 19, 2019 and Friday, October 18, 2019. ACCO and Program Area will look at Friday, April 5, 2019 or Friday, May 3, 2019 as alternative dates based on webcast facility availability and ACCO facilitator availability.
• Committee comments on data component of meeting:
  • Dr. Phillip Keiser stated:
    • Sub-committees to review and determine what information would be relevant to MAC to help meeting efficiency
    • Sub-committees may request specific data to review
  • Committee comments on minimum data reports:
    • eligibility data – enrolled, dropped, timeline for approval
    • brief financial report
    • top 10 utilization drug report
    • demographics
• Frank Rosas inquired about any pending legislation that would be relevant for the MAC and reminded participants that HIV Advocacy Day is March 20th
  • Imelda Garcia, Commissioner, commented:
    • HB1 and SB1 – both give THMP ability to carry forward rebate dollars across the biennium
    • No monetary reductions indicated for THMP
    • Preliminary bills have been filed – will bring update to next meeting
  • Phillip Keiser, Chair, reminded members they can advocate as a personal citizen but not as a MAC committee member

No Public Comment was offered during this agenda item.

Agenda Item 9: Adjournment 

Dr. Phillip Keiser adjourned the meeting at 2:05 p.m.

Below is the link to the archived video of the January 18, 2019 Texas HIV Medication Advisory Committee meeting. (To view and listen to the entirety of the meeting click on the link below)

January 18, 2019 Texas HIV Medication Advisory Committee meeting