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MAC Meeting Minutes October 26, 2018


Texas HIV Medication Advisory Committee Meeting

Meeting Minutes
October 26, 2018
12:30 p.m.

909 West 45th Street, Building 2, Room 164
Austin, Texas 78751


Table 1: Texas HIV Medication Advisory Committee (MAC) member attendance at the Friday, October 26, 2018 meeting.

MEMBER NAME

YES

NO

MEMBER NAME

YES

NO

Garcia, Fernando, M.D.

X

Rosas, Frank

X

Heresi, Gloria, M.D.

X

Tennison, Demetra

X

Keiser, Philip, M.D.

X

Turner, Bruce

X

Miertschin, Nancy, M.P.H.

X

Vanek, Natalie, M.D.

X

Moore, Clyde “Ray”

X

Rodriguez-Escobar, Yolanda, Ph.D.

X

P: Indicates participated by phone


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

Dr. Philip Keiser called the meeting to order at 12:47 pm and welcomed all in attendance. Mr. John Chacon reviewed logistical announcements and announced a presence of a quorum.


Agenda Item 3: Approval of previous meeting minutes (June 15, 2018)

Dr. Keiser asked for approval of the meeting minutes for the June 15, 2018 Texas HIV Medication Advisory Committee. Motion: Dr. Natalie Vanek motioned for approval of June 15, 2018 meeting minutes as presented. Dr. Yolanda Rodriguez-Escobar seconded the motion. Dr. Phillip Keiser asked for a verbal vote, and the motion carried unanimously with six yea’s, no nays, and no abstentions to accept the April 6, 2018 minutes.


Agenda Item 4: Action Item-Medication Advisory Committee By-Laws

Dr. Phillip Keiser led discussion regarding the edits recommended by the committee in the previous meeting and referenced handout entitled “Texas HIV Medication Advisory Committee Bylaws”. Dr. Keiser stated that all edits were approved by legal for the exception of the language in Category 8. Committee Operations and Meetings, paragraph B., subsection 2 where it read “A consumer member must be present to constitute a quorum”. Legal stated this language could not be included as the committee rule doesn’t say this and thus the committee would need a rule amendment to make this effective.

Dr. Keiser asked for approval of the Texas HIV MAC Bylaws.

Motion: Dr. Natalie Vanek motioned for approval of the Texas HIV MAC Bylaws as presented. Mr. Bruce Turner seconded the motion. Dr. Phillip Keiser asked for a verbal vote, and the motion carried unanimously with six yea’s, no nays, and no abstentions to approve the Texas HIV MAC Bylaws.

Motion: Dr. Yolanda Rodriguez-Escobar motioned to request rule to be amended for the Texas HIV MAC committee require that a consumer member be present to constitute a quorum. Mr. Bruce Turner seconded the motion. Dr. Phillip Keiser asked for a verbal vote, and the motion carried unanimously with six yea’s, no nays, and no abstentions to request rule to be amended for the Texas HIV MAC committee require that a consumer member be present to constitute a quorum.


Agenda Item 5: Texas HIV Medication Program (THMP) overview of program goals and objectives

Ms. Rachel Sanor provided an overview of the Texas HIV Medication Program goals and objectives and referenced a PowerPoint entitled “Overview Goals and Objectives – Texas HIV Medication Program”. Highlights of the overview and committee member discussion included:

  • Goal #1 is that at least 95% of persons who are retained in care for ADAP will be virally suppressed. This goal is tracked annually as a measure in the HIV/STD Prevention and Care Branch Quality Management Committee.
  • Goal #2 is to monitor the number of persons served by the HIV Medication Program. This goal is tracked monthly as a measure for the Legislative Budget Board.
  • Goal #3 is that 100% of participants are up to date with recertification and Self-Attestation. This goal is tracked monthly as a measure in the Texas HIV Medication Program Quality Management Committee.


Agenda Item 6: Discussion Item-Reports needed on goals and objectives from THMP

Dr. Phillip Keiser led the discussion on reports needed on goals and objectives from THMP. Highlights of the overview and committee member discussion included:

  • Mr. Frank Rosas asked about recommending more than just HIV medications, to which Ms. Rachel Sanor replied that we can bring information on what other states are doing and also what usage the SPAP and TIAP programs see.
  • There was discussion regarding electronic submission of applications, the current procedures using ARIES, and next steps towards an online portal.
  • Dr. Natalie Vanek asked for a report or liaison to bridge the transition from the Children’s Health Insurance Program (CHIP) to ADAP. Mr. Felipe Rocha stated that we do have existing relationships, and will find out who to speak to.
  • Dr. Phillip Keiser asked for a report of the percentage of patients retained in care, the number of patients served, number of patients up to date with self-attestations, and a financial report as has been presented in the past.
  • Dr. Natalie Vanek requested a breakdown of clients served by age, particularly age 17-24, and collect data on HIV-positive transgender patients.
  • Mr. Frank Rosas requested that the numbers for ADAP and SPAP be separated. He would also like that the ADAP Eligibility workers coordinate with the participating pharmacies.
  • Mr. Bruce Turner would like to have a report on retention. Dr. Phillip Keiser suggested merging that into Goal #3.


Agenda Item 7: Discussion Item – Creation of sub-committees

Dr. Phillip Keiser led the discussion on creation of sub-committees for the Texas HIV MAC committee. Highlights of the overview and committee member discussion included:

  • The following members agreed to serve on the three subcommittees proposed and approved:
    1. Eligibility/Enrollment Subcommittee: Mr. Frank Rosas and Dr. Yolanda Rodriguez-Escobar
    2. Data and Governance: Dr. Phillip Keiser
    3. Formulary Subcommittee: Dr. Natalie Vanek and Mr. Clyde “Ray” Moore
  • Mr. Bruce Turner felt that all Committee members should be involved in Formulary discussion.
  • Mr. Frank Rosas enquired about when attendance would be enforced and the replacement members for the empty seats. Mr. John Chacon explained that the Advisory Committee Coordination Office was now responsible for filling open appointments and prompted members to sign the Bylaws Statement agreeing to adhere to the Bylaws.
  • Dr. Natalie Vanek requested that there be set dates for the Medication Advisory Committee meetings. Dr. Keiser asked for a motion to establish subcommittees for the Texas HIV Medication Advisory Committee.

Motion: Dr. Natalie Vanek motioned to establish three subcommittees (Eligibility/Enrollment, Data/Governance, and Formulary) for the Texas HIV Medication Advisory Committee. Dr. Yolanda Rodriguez-Escobar seconded the motion. Dr. Phillip Keiser asked for a verbal vote, and the motion carried by a majority vote with five yea’s, no nays, and one abstention from Mr. Bruce Turner to establish three subcommittees for the Texas HIV Medication Advisory Committee.


Agenda Item 8: Action Item – Request from Thera Technologies for recommendation to add Trogarzo to the THMP formulary

Matthew C. Sheffield, J.D., Director of National Government Affairs representing Thera Technologies presented on Trogarzo (Ibalizumab) and referenced a detailed prescribing information handout entitled “Trogarzo Distribution System”. Highlights of the presentation and committee member discussion included:

  • Brian Rosemond, a nursing consultant with Care Services did a survey on locations that had the capacity to administer the medication, and found that 11 geographic locations could administer it, while 10 did not have the capacity.
  • Dr. Phillip Keiser clarified that if the medication was approved, the cost of the drug would come from THMP, and the cost of administration would be paid from Care Services. The local Administrative Agencies or the service provider would need to contract for the infusion capability.

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

Motion: Mr. Bruce Turner motioned to add Trogarzo to the THMP formulary as presented. Dr. Natalie Vanek seconded the motion. Dr. Phillip Keiser asked for a verbal vote, and the motion carried unanimously with six yea’s, no nays, and no abstentions to add Trogarzo to the THMP formulary


Agenda Item 9: Action Item – Request from Janssen Therapeutics for recommendation to add Symtuza to the THMP formulary

Mr. Keith J. Dunn, Medical Director representing Janssen Scientific Affairs presented on Symtuza and referenced a detailed prescribing information handout entitled “Utilization of Symtuza Components” and PowerPoint entitled “Symtuza Single-Tablet Regimen”. Ms. Erin Bruce provided additional information in support of Symtuza being added to the THMP formulary. Highlights of the presentation and committee member discussion included:

  • Ms. Rachel Sanor stated that usually a medication with components that are already on the program would be added without need to present to the Medication Advisory Committee, however this medication’s cost is approximately one and a half what the individual components cost. The other issue is the effect on the current inventory of medications on the shelves, which is approximately 9.5 months.
  • There were requests from providers for Symtuza.
  • Ms. Shelley Lucas asked about the costs to return the component meds, and if adding Symtuza would render the components obsolete. Ms. Rachel Sanor stated that different manufacturers charged different rates to return their medications, and Dr. Keiser said that it would not replace them, but would reduce utilization of the existing medications.
  • Ms. Erin Bruce from Jannsen confirmed that the pricing was confidential and that the ADAP Crisis Task Force accepted the pricing. Ms. Erin Bruce also discussed the medication returns policy for components of the new medications. However, further information was obtained from the DSHS Warehouse that indicated the stock in inventory was within acceptable levels for replacement. Dr. Keiser asked for a motion to add Symtuza to the THMP formulary. Motion: Dr. Yolanda Rodriguez-Escobar motioned to add Symtuza to the THMP formulary as presented. Mr. Bruce Turner seconded the motion. Dr. Phillip Keiser asked for a verbal vote, and the motion carried unanimously with six yea’s, no nays, and no abstentions to add Symtuza to the THMP formulary.


Agenda Item 10: 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: Ms. Tarannum Quresliv provided additional information regarding Doravirine.


Agenda Item 11: Adjournment

Dr. Phillip Keiser adjourned the meeting at 2:42 p.m.



Last updated April 28, 2021