MAC Meeting Minutes July 19, 2019

Texas HIV Medication Advisory Committee Meeting

Meeting Minutes
July 19, 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, July 19, 2019 meeting

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

Dr. Philip Keiser called the meeting to order at 12:23 pm and welcomed all in attendance. Ms. Sallie Allen reviewed logistical announcements, conducted a roll call and announced a presence of a quorum.

Dr. Keiser requested that the committee hear the informational agenda items first and then continue with the agenda items that require a vote.

Agenda Item 4: Discussion Item – LIDS Update/Legislative Update

Dr. Keiser introduced Ms. Imelda Garcia and she provided the committee with an update. Highlights of the discussion and committee member discussion included:

• Imelda Garcia, Associate Commissioner of Laboratory and Infectious Diseases Section, provided a legislative and program update:
  • New Rider 24, which is specifically about vendor drug rebates for the HIV program and codifies the federal guidance in prioritizing the use of General Revenue funds and rebates prior to using federal funds.
  • There was a recent visit by the Centers for Disease Control and Prevention(CDC). Dr. Redfield, CDC Director, visited Austin and spoke with the DSHS Commissioner, the HIV Program Management Team, and five area local health department directors that receive direct Ryan White Part A funds. Dr. Redfield was accompanied by federal partners from HRSA, CDC, and Office of Secretary of Health. The visit highlighted President’s Plan to End HIV by 2030. There was a productive dialogue around challenges and opportunities for Texas. For a detailed review of this topic, click on the weblink provided at the end of the minutes.
  • There was discussion regarding a bill that would grant HIV medication on Medicaid a protected status. That bill was assigned to HHS and protects in that they are not allowed to have a prior authorization for HIV medications. They do not currently have prior authorization for HIV medications so it didn’t change anything. Moving forward they will not be able to require prior authorizations. 

Agenda Item 5: Discussion Item – Budget Update

Ms. Shelly Lucas advised there was no budget update available.

Agenda Item 6: Discussion Item – THMP Update

Ms. Rachel Sanor, THMP Manager, DSHS, provided a data report. Highlights of the report discussion included:

• THMP Demographic Fact Sheet:
  • Data demographic breakdown for March 1 – May 31, 2019
    • A request was made that the information be updated to include percentages
  • Top 10 ADAP Medications
  • Top 10 Medications for TIAP/SPAP
• Medication Utilization Trends of Epivir and Tivicay.

Agenda Item 7: Presentation on Dovato prescribing information

Dr. Keiser introduced Ms. Samantha Sam, PharmD, Medical Science Liaison, representing Viiv Healthcare. She provided a detailed prescribing information handout and presented on Dovato.

Agenda Item 3: Approval of previous meeting minutes (April 5, 2019)

Dr. Keiser asked for approval of the meeting minutes for the April 5, 2019 Texas HIV Medication Advisory Committee.

Motion: Dr. Natalie Vanek motioned for approval of April 5, 2019 meeting minutes. Mr. Bruce Turner seconded the motion. Dr. Phillip Keiser asked for a verbal vote, and the motion carried unanimously with seven yeas’, no nays, and no abstentions to accept the April 5, 2019 minutes.

Agenda Item 8: Discussion Item, Action Item – Sub-Committee Reports (Governance/Data, Eligibility and Formulary) 

Dr. Vanek provided highlights of the Formulary sub-committee discussion and evaluations of Dovato and Hepatitis B and Hepatitis C medications and committee member discussion included:

• Medications for recommendation for approval:
  • HIV medication: Dovato was recommended for approval by the Formulary sub-committee.
  • Hepatitis B medications: Tenofovir alafenamide, also known as Vemlidy, and Entecavir, also known as Baraclude were both recommended for approval by the Formulary sub-committee.

Dr. Keiser proceeded to Agenda Item 9: Action Item – Addition of three medications -Vote Required and asked for motions to add Dovato, Tenofovir alafenamide and Entecavir medications to the THMP formulary.

Motion: Dr. Fernando Garcia motioned to add Dovato medication to the THMP drug formulary. Mr. Frank Rosas seconded the motion. Dr. Phillip Keiser asked for a verbal vote, and the motion carried with seven yea’s, no nays, and no abstentions.

Motion: Mr. Bruce Turner motioned to add Tenofovir alafenamide (Vemlidy) medication to the THMP drug formulary. Dr. Fernando Garcia seconded the motion. Dr. Phillip Keiser asked for a verbal vote, and the motion carried with seven yea’s, no nays, and no abstentions.

Motion: Dr. Fernando Garcia motioned to add Entecavir (Baraclude) medication to the THMP drug formulary. Mr. Ray Moore seconded the motion. Dr. Phillip Keiser asked for a verbal vote, and the motion carried with seven yea’s, no nays, and no abstentions.

Dr. Keiser returned to Agenda Item 8: Sub-Committee Reports (Formulary)

Dr. Vanek continued to provide highlights of the Formulary sub-committee discussion and evaluations of Hepatitis B and Hepatitis C medications and committee member discussion included:

• Telbivudine, Adefovir: the sub-committee sought input from prescribers and other ADAPs, and utilization did not support recommendation
• Lamivudine 100 mg: the medication is already on the formulary, therefore adding the 100 mg strength and does not require a vote.
• Hepatitis C medications: Interferons – the sub-committee tabled discussion until the next MAC meeting.
• Removal of drugs from the formulary: the sub-committee recommended to remove the medications Delavirdine and Indinavir from the THMP Formulary. Neither medication is used on the program.

Dr. Keiser proceeded to Agenda Item 10: Action Item – Removal of two medications – Vote Required and asked for a motion to remove Delavirdine and Indinavir medications from the THMP formulary.

Motion: Mr. Bruce Turner motioned to remove Delavirdine and Indinavir medications from the THMP drug formulary. Mr. Frank Rosas seconded the motion. Dr. Phillip Keiser asked for a verbal vote, and the motion carried with seven yea’s, no nays, and no abstentions. Dr. Keiser returned to Agenda Item 8: Sub-Committee Reports (Formulary) Dr. Vanek concluded providing highlights of the Formulary sub-committee discussion and committee member discussion included:

• Drug shortage of DDI/Videx: no longer available from the wholesaler and generics are all discontinued. Brand name manufacturer is phasing out inventory. THMP has sent notification to prescribing physicians and clients informing them of change.
  • There are less than 6 people on this medication from 4 providers
  • Those impacted are mother to child transmissions (on Medicaid) - they have most resistance.
• Other Top 10 Drugs (non-HIV meds) being considered by sub-committee will be shared at the next MAC meeting.

Dr. Keiser provided highlights of the Governance and Data sub-committee discussion and committee member discussion included:

• Officer elections to be held at next MAC meeting on October 18th
• The proposed procedure for election of officers was shared with the committee. The sub-committee recommends that the MAC adopt the process for election of officers. For a detailed review of the discussion regarding this topic, click on the weblink provided at the end of the minutes.

Following this discussion, Dr. Keiser proceeded to Agenda Item 11: Action Item – Officer elections process and procedure – Vote Required

Dr. Keiser asked for a motion to adopt the officer elections process template.

Motion: Mr. Bruce Turner motioned that the committee accept Option 1 (ballot vote) as the formal voting ballot process. Ms. Nancy Miertschin seconded the motion. Dr. Phillip Keiser asked for a verbal vote, and the motion carried with seven yea’s, no nays, and no abstentions.

Motion: Ms. Nancy Miertschin motioned that once the Chair is elected, the floor be reopened for additional nominations for Vice Chair. Mr. Bruce Turner seconded the motion. Dr. Phillip Keiser asked for a verbal vote, and the motion carried with seven yea’s, no nays, and no abstentions.

Dr. Keiser returned to Agenda Item 8: Sub-Committee Reports (Governance/Data) and continued the highlights of the Governance and Data sub-committee discussion. Committee member discussion included:

• The Governance and Data sub-committee discussed attendance briefly and tabled the discussion due to upcoming elections and membership renewal/expiration. Once new MAC members are installed and officer elections have been completed, the sub-committee will address attendance requirements.
• Applications for new committee members have been received. The approval process is under way.

Mr. Rosas provided highlights of the Eligibility sub-committee discussion and committee member discussion included:

• Purpose of sub-committee: will work with THMP staff to identify solutions that support streamlining the ADAP eligibility application process, will review the ease of application completion, use of technology to increase efficiency of application processing, and review bi-annual certification processes to ensure that persons living with HIV have minimal barriers to completing and submitting a timely ADAP application and will research how other states are addressing similar challenges with processing ADAP eligibility applications.
• Members of the sub-committee: Frank Rosas, Raquel Figueroa, Gary Benecke, Marcus Benoit, Laura Potter. Sub-committee members that are not also MAC members need to send letter of interest and CV to Rachel Sanor and Dr. Keiser for approval.
• What is status of an on-line portal for ADAP? THMP is currently going through the governance process to build a new on-line system. A Request for Applications (RFA)has been released to select a vendor to build system. A vendor has not been selected to date. Timeline for completion is projected to be a few years.

Agenda Item 12: Public Comment 

No public comment was provided during this agenda item.

Agenda Item 13: Action items and agenda topics for next scheduled meeting, October 18, 2019

Dr. Phillip Keiser led the discussion on the action items and agenda topics for the next meeting date, October 18, 2019.

Agenda Item 14: Adjournment

Dr. Phillip Keiser adjourned the meeting at 1:58 p.m.

Below is the link to the archived video of the July 19, 2019 Texas HIV Medication Advisory Committee meeting. (To view and listen to the entirety of the meeting click on the link below)

July 19, 2019 Texas HIV Medication Advisory Committee meeting