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MAC Meeting Minutes April 6, 2018


OFFICIAL MINUTES
Texas HIV Medication Advisory Committee Meeting
April 6, 2018


The April 6, 2018 meeting of the Texas HIV Medication Advisory Committee (MAC), was held at (4110 Guadalupe Street in the West Auditorium in Austin, Texas).  

MAC Members in Attendance: Philip Keiser, M.D.; Nancy Miertschin, M.P.H.; Mary Paul, M.D.; Natalie Vanek, M.D.; Fernando Garcia, M.D.; Yolanda Rodriguez-Escobar, Ph.D.; Demetra Tennison; Frank Rosas; Bruce Turner.

DSHS Staff in Attendance: Janna Zumbrun; Shelley Lucas; Rachel Sanor; Felipe Rocha; Christine Salinas; Janina Vazquez; Anthony Lee; Jessica Hills.

Registered Guests: Tyler Hunter; Ray Moore; Jason Craven; Harry Masters; Erin Ponce; Michelle Puyear; Toni Sparrow; Suzanne Erickson; Jeff Daniel; Joel Moerer; Jim Osburne; Matt McIntyre; Matt Sheffield; Jannell Mathis; Maricella Dumas; Jana Hermosa; Faizan Abdullah; Juanita Gutierrez; Mark Vane; Sofia Flores; 


Action and Discussion Items Covered:

  1. The meeting was called to order by Dr. Keiser at 12:45 pm. 


  2. Welcome and Introductions by Dr. Keiser. 


  3. The minutes from the January 5, 2018 meeting were unanimously approved. 


  4. Dr. Keiser directed a change in the order of the agenda. The update on Ryan White Part B was presented by Janina Vazquez, manager of the Ryan White Part B program. The eligibility definitions for Part B are being changed to align with the client's birthday and half-birthday, starting April 1. CARE shares approximately one-third of their clients with ADAP.

    There were questions on the LPAP funding from the last Advisory Committee Meeting. Natalie Vanek asked why the presentation did not show the Part A allocation, the reason being that the focus was on the Part B and CARE Services impact. Dr. Vanek stated that she would like to see it all. Nancy Miertschin stated that she would like to see how much of the total job ADAP is doing. Dr. Vanek asked about data from far west Texas. El Paso falls under the Lubbock LPAP. Ms. Vazquez stated that she will bring comparisons to the next Advisory Committee meeting.


  5. Janna Zumbrun gave an update on the Division of Laboratories and Infectious Disease Services. The Section is preparing for the Centers for Disease Control site visit. The TB, HIV, STD and Viral Hepatitis programs will be reviewed. The Section has been asked for a lot of information. The Division is busy with Legislative Appropriations Requests for the January session. There will not be any Exceptional Item requests for ADAP, as we are not expecting a shortfall this biennium.

    Bruce Turner questioned why an item on Hepatitis C medications cannot be put forward. Ms. Zumbrun answered that the Program can fund the Hepatitis C pilot without affecting funding for HIV medications, and therefore is not in a strong position to put forward a request. Dr. Keiser suggested waiting to see what the numbers are in utilization and resume the discussion later. Frank Rosas asked about the changes to the 340B pricing. Ms. Zumbrun answered that there were proposed changes from the Office of Pharmacy Affairs, but that they have been tabled for now. Rachel Sanor added that there is proposed legislation for 340B hospitals. There will be a webinar on April 11 regarding these changes, and the Committee requested that if a presentation from that webinar is available, it be forwarded to them.


  6. Felipe Rocha gave an update on the Texas HIV Medication Program
    (THMP) budget. Ms. Miertschin asked why there was a lower projection in rebates, and Dr. Keiser suggested that it would be good to break out what else the rebates are used to fund, and that this is not a revenue-negative program, which has benefits. Mr. Turner asked if the Program has been told what the Federal award will be. Ms. Vazquez stated that the Program only has a percentage, not an actual number.

    Rachel Sanor presented the AIDS Drug Assistance Program (ADAP) Update and the State Pharmacy Assistance Program (SPAP) Update. Ms. Miertschin requested the total number of clients broken down by male/female/transgender. Mr. Rosas requested a breakdown by geography. Mr. Turner asked if picking up the Part B premiums and copays has changed the total number of clients, which Ms. Sanor responded that it has a little, but open enrollment will begin in October, and that there will be more then. Dr. Keiser questioned the layout of the presentation. There was discussion regarding the number of dropped clients, particularly in the age 24 and under category. Ms. Sanor stated that the Program can look more at what these numbers mean, and that younger groups sometimes get picked up by their parents' insurance. Mr. Rocha asked about what other states do, and Ms. Lucas replied that eligibility requirements are as set by HRSA, so all of the states should be doing the same.

    Dr. Vanek motioned to develop a subcommittee to look into the age 24 and under drop rate. There was extensive discussion on how the Program can best assist vulnerable populations.

    Dr. Garcia motioned to form a subcommittee as above, which was unanimously approved. Mr. Rosas asked how it would be formed. Dr. Keiser asked THMP to determine how to proceed by the end of the month. There was further discussion regarding the Hepatitis C pilot. 


  7. Ms. Sanor presented regarding the Recertification and Self-Attestation process. The Committee discussed the process.


  8. Dr. Keiser skipped agenda items to the Comparison of State Formularies. Mr. Rosas asked about adding mental health medications to the formulary. Ms. Sanor replied that it is something ADAPs can do. This was brought up because the Committee asked what other states do. There are some concerns about warehouse capacity. THMP has the ability to do it, but it has not been requested. Ms. Lucas suggested that Mr. Rosas speak to his colleagues about making the request. Dr. Keiser stated that states with an expanded Medicaid can devote more Part B resources to ADAP, while in those states who have not expanded must cover more basic services. 


  9. The action item to add Biktarvy to the THMP formulary was discussed. Michelle Puyear presented for Gilead. After discussion, Dr. Vanek motioned to recommend the addition of Biktarvy to the THMP formulary. The Committee approved unanimously.   


  10. The action item to add Syndros (dronabinol) to the THMP formulary was discussed. Insys Therapeutics presented regarding the medication. There is not currently an ADAP Crisis Task Force negotiated price, and it has not gone through the Committee before. Dr. Garcia recommended that the Committee revisit the issue at the next meeting.


  11. Jim Osborn from Thera Technologies presented in the public comment period regarding Trogarzo. It is an anti-retroviral specifically for patients with multi-drug resistance. The FDA has approved it as an orphan drug, and there is not yet AIDS Crisis Task Force pricing. Dr. Keiser stated that it is expensive and very few people are using it, but it is good to consider. Ms. Tennison stated that there is nothing similar on the formulary.


  12. The Medication Advisory Committee Bylaws were discussed. Dr. Keiser suggested tabling the bylaws until the next meeting. There was discussion regarding the facilities available to the Committee. Dr. Keiser asked for shorter reports. Ms. Miertschin moved to table the bylaws until the next meeting, which was unanimously approved.   


  13. Dr. Mary Paul was awarded a plaque for her 18 years of service on the Medication Advisory Committee. 


  14. The next meeting was scheduled for June 15, 2018. 


  15. The meeting was adjourned at 3:34 pm.


Approved by:
Phillip H. Keiser, M.D. – Chairman, Texas HIV Medication Advisory Committee
Date: 6/18/2018



Last updated April 28, 2021