MAC Meeting Minutes October 18, 2019

Texas HIV Medication Advisory Committee Meeting

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

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

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

MEMBER NAME	YES	NO
Adjel, Margaret	X
Alozie, Ogechika Karl, M.D.	P
Heresi, Gloria, M.D.	X
Hillard, Lionel	P
Lazarte Susana, M.D.	X
Miertschin, Nancy, M.P.H.	X
Moore, Clyde “Ray”	X
Rodriguez-Escobar, Yolanda, Ph.D.	X
Rosas, Frank	X
Tennison, Demetra		X
Vanek, Natalie, M.D. (Acting Chair)	X
Garcia, Fernando, M.D.	P
P: Indicates participated by phone

Agenda Item 1 & 2: Call to Order and Welcome

Dr. Natalie Vanek, Acting Chair, called the meeting to order at 12:38 pm and welcomed all in attendance. Dr. Vanek introduced Ms. Sallie Allen, Project Manager, Advisory Committee Coordination Office, HHSC to provide logistics and conduct roll call. 

Agenda Item 2: Logistical Announcement and Roll Call

Ms. Allen reviewed logistical announcements, conducted a roll call and announced a presence of a quorum.

Agenda Item 3: New Member Appointments – Introductions

Dr. Vanek welcomed the newly appointed members to the Committee and asked everyone to introduce themselves and provide a brief background.

Agenda Item 4: Member Recognition

Dr. Vanek introduced Mr. Felipe Rocha, MSSW Director TB/HIV/STD Section, DSHS, to recognize three members whose term had expired: Dr. Philip Keiser, Chair – 1998-2019; Dr Fernando Garcia – 2002-2019; and Mr. Bruce Turner – 2012-2019. He thanked them for their service to the Committee and extended them well wishes.

Agenda Item 5: Adoption of Election Procedures and Election of Presiding Officers (Vote Required)

Dr. Vanek introduced Mr. John Chacon, Project Manager, Advisory Committee Coordination Office, HHSC, to review and confirm the Committee’s adopted election procedures to use the ballot vote process and conduct the election of the presiding officers.

Highlights of the election included:

• John Chacon, Project Manager, Advisory Committee Coordination Office, HHSC, reviewed newly adopted MAC officer election procedures, and officer roles and responsibilities.
• Nomination for Chair received via email for Dr. Natalie Vanek, who accepted the nomination. Dr. Vanek spoke regarding her interest and ability to serve as Chair.
  • Balloting was conducted by Sallie Allen and John Chacon. Dr. Natalie Vanek was unanimously voted as Chair by all members present and those participating by phone.
• Nomination for Vice-Chair received via email for Nancy Miertschin, who accepted. Then nominations for Vice-Chair were opened for additional nominees:
  • Dr. Yolanda Rodriguez-Escobar nominated Frank Rosas, Consumer Member, who accepted.
  • Both nominees spoke regarding their interest and ability to serve as officers.
• Balloting for Vice-Chair was conducted by Sallie Allen and John Chacon.
  • The balloting resulted in a tie. Both nominees spoke further regarding their interest and ability to serve as officers.
  • A second round of balloting was conducted. Frank Rosas was elected as Vice-Chair by majority vote.

Agenda Item 6: Approval of previous meeting minutes (July 19, 2019)

Dr. Vanek introduced Ms. Allen to review and conduct a motion for approval of the meeting minutes for the July 19, 2019 Texas HIV Medication Advisory Committee. Ms. Allen asked members to review the draft minutes and requested a motion.

Motion: Mr. Frank Rosas motioned for approval of July 19, 2019 meeting minutes. Mr. Ray Moore seconded the motion. Ms. Allen called for a voice vote, and the motion carried unanimously with nine yeas’, no nays, and one abstention to accept the July 19, 2019 minutes.

Agenda Item 7: Discussion Item – Commissioners and Legislative Update 

Dr. Vanek introduced Mr. Rocha, and he provided the Committee with an update.

Highlights of the discussion included:

• The HIV/STD/TB section will be relocating their offices to north Austin in mid-2020.
• No legislative update at this time

Agenda Item 8: Discussion Item – Budget Update 

Dr. Vanek introduced Mr. Rocha, and he provided the Committee with an update.
Highlights of the discussion included:

• Mr. Felipe Rocha, Director, TB/HIV/STD Section, has been working with the budget office. Program and budget offices have had staff transitions which has impacted the program’s ability to provide accurate budget information. Program budgets are a critical part of program oversight and DSHS is mindful about providing accurate budget information.
• Budget items which are typically reported on.
• Ms. Nancy Miertschin inquired about a report that would illustrate rural vs. urban medication use (epidemiology report).
• Mr. Frank Rosas expressed the importance of having comprehensive reports (fiscal and programmatic). Dr. Natalie Vanek agreed with Mr. Rosas about the importance of the reports and recommended that the MAC receive these reports at least twice a year. The Committee also agreed that a budget orientation would be helpful.

Agenda Item 9: Discussion Item – THMP Update

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

• Data and Governance sub-committee is reviewing what data would be most helpful. The THMP Facts Sheet has been shared with the MAC.
• THMP program data, June-August 2019 was presented.
• The Top 10 Medication usage report was shared.
• ADAP applications average 14 day turn around
• New clients are typically processed within 10 days.
• Medication approval process timeline will vary.

Agenda Item 10: Presentation on Livalo and Zypitamag prescribing information

Dr. Vanek introduced Dr. Craig Sponseller, Chief Medical Officer, Kowa Pharmaceuticals. He gave a presentation and distributed a handout regarding Livalo.

Highlights of the Committee member discussion included:

• Mr. Lionel Hillard asked how the medication interacts with the transgender population that take hormones? Dr. Sponseller stated that while important information, they do not have any data to address the question.

Next, Dr. Vanek introduced Dr. Elena Fazio, PhD., Market Access and Government Affairs Specialist, Medicure, Inc. Dr. Fazio participated via a conference call. She also gave a presentation and provided a handout regarding Zypitamag.

Highlights of the Committee member discussion included:

• Mr. Lionel Hillard asked how the medication interacts with the transgender population that take hormones? Dr. Fazio reported that Medicure does not currently have any data to report for the transgender community nor do they have any trials that includes this community.
• Committee members discussed the medication. Dr. Vanek stated that the Formulary sub-committee reviewed Zypitamag calcium and Zypitamag magnesium medications. The sub-committee felt these medications were important for patients who take protease inhibitors or who have renal insufficiency and who are on statins. Sub-committee decided to table voting on medications but open to moving forward with discussing medications.
• Dr. Yolanda Rodriguez-Escobar motioned to table vote for next meeting. Additionally, she would like the Committee to consider holding pharmaceutical companies accountable to inclusivity with regard to transgender community in their trials.
• Mr. Lionel Hillard seconded the motion to table vote.
• Dr. Vanek called for a voice vote, and the motion carried unanimously with ten yeas’, no nays, and no abstentions

Agenda Item 11: Discussion Item, Action Item – Sub-committee Reports (Governance/Data, Eligibility and Formulary)

Ms. Miertschin provided highlights of the Governance and Data subcommittee discussion and Committee member discussion included:

• Currently the sub-committee is made up of Nancy Miertschin and Sylvia Moreno.
• The charge of the sub-committee is governance/operations of the MAC, officer elections, sub-committee structure.
• Officers elected today will serve from January 2020 – March 2021.

Mr. Rosas provided highlights of the Eligibility subcommittee discussion and Committee member discussion included:

• The sub-committee meets once a month.
• Mr. Rosas is the Chair and Gary Benecke is Vice-Chair, and other members are from Houston, Dallas, and El Paso.
• Summary of discussions:
  • Revised eligibility forms
  • HRAR data system

Dr. Vanek provided highlights of the Formulary subcommittee discussion and Committee member discussion included:

• The charge of the sub-committee is to review new medications needs.
• Other members: Ruston Taylor (pharmacist), Dr. Gloria Heresi, Dr. Margaret Adjei (pharmacist), and Ray Moore (consumer).

Agenda Item 12: Action Item – Addition of two medications, Livalo and Zypitamag to the THMP formulary – Vote Required

Dr. Yolanda Rodriguez-Escobar requested that pharmaceutical studies be more inclusive of all populations that use medications and capture all relevant data.

Dr. Vanek asked for a motion to table these two medication recommendations until the January 17, 2020 meeting.

Motion: Dr. Yolanda Rodriguez-Escobar, motioned to table the recommendation of these two medications to the next meeting. Mr. Lionel Hillard seconded the motion. Dr. Vanek asked for a voice vote, and the motion carried with ten yea’s, no nays, and no abstentions.

Agenda Item 13: Action Item – MAC to vote on the addition of the top ten non-HIV medications to THMP formulary – Vote Required

Medications: Lisinopril, Gabapentin, Metoprolol tartrate, Duloxetine, Sertraline, Amlodipine, Atorvastatin, Trazodone, HCTZ and Metformin.

Committee member discussion included:

• The Formulary sub-committee researched and reviewed medications based on need and utilization. This expansion is meaningful because they are non-HIV medications. These are used to treat diabetes, depression, and hyper-tension. Medications are all generic so the sub-committee does not anticipate significant impact on the budget. Medications are for 90-day prescriptions (for established patients). They reviewed the cost of medications for monthly vs. 90-day supply, and cost of dispensing fees.

Dr. Vanek asked for a motion to add the ten non-HIV medications referenced above to the THMP formulary.

Motion: Mr. Lionel Hillard motioned to add the ten non-HIV medications referenced above to the THMP drug formulary in a group vote. Mr. Ray Moore seconded the motion. Dr. Vanek asked for a voice vote, and the motion carried with ten yea’s, no nays, and no abstentions.

Agenda Item 14: Public Comment

No public comment was provided during this agenda item.

Agenda Item 15: Action items and agenda topics, for next scheduled meeting, January 17, 2020 or January 24, 2020

Dr. Vanek led the discussion on the action items and agenda topics for the next meeting date, January 17 or January 24, 2020. Highlights of the Committee member discussion included:

• Review of medications Livalo and Zypitamag.
• MAC sub-committee assignments.
• Approval of non-MAC members on sub-committees.
• Financial update.
• New member orientation will be on January 24, 2020, prior to the MAC meeting.

Agenda Item 16: Adjournment

Dr. Vanek adjourned the meeting at 3:50 pm.

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

October 18, 2019 Texas HIV Medication Advisory Committee meeting