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MAC Meeting Minutes May 18, 2012

Texas HIV Medication Advisory Committee Meeting
May 18, 2012

The May 18, 2012 meeting of the Texas HIV Medication Advisory Committee (MAC) was called to order at 12:16 PM at 909 West 45th Street, room 164, in Austin, Texas.

MAC Members in Attendance: Philip Keiser, M.D., chair, Nancy Miertschin, vice chair, Natalie Vanek, M.D., Mary Paul, M.D., Yolanda Rodriguez-Escobar, David Huse, Demetra Tennison, Frank Rosas and Bruce Turner.

DSHS Staff in Attendance: Ann Robbins, Adolfo Valadez, M.D., Nick Curry, M.D., Felipe Rocha, John Allen, Mary Richards, Kurt Wolf, Juliet Garcia, Becky Ruiz, Dan Warr, and Juanita Salinas.

Registered Guests: Tyler Hunter, Linda Simpson, Dustin Rogelstad, Jay Dee Fredericksen, Paul Hassell, Ronnie Wallace, Aaron L. Williams, Randee Clark, Sunnye Simmons, Mark Vane, Roger Grotzinger, Suzanne Erickson, Ray Moore, Holly Turner, Randall Ellis, Jarrod Ekwurzel, Vera Parker, Joey Felice and Mike McBride.

Action and Discussion Items Covered:

  1. Approval of Previous Meeting Minutes – The meeting minutes for January 13, 2012 were approved by the Committee.

  2. MAC Member Pharmacist Recruitment Update – Ann Robbins explained that the vacant pharmacy member position on the Committee has been reposted. A new round of recruitment letters were sent out to 6,500 people on the HIV/STD distribution list, as well as to the participating THMP pharmacies and the Ryan White administrative agencies. No applications had been received to date, and Ms. Robbins stated that the June 15th closing date could be extended if necessary. Juanita Salinas confirmed that the three previous applicants from last year’s initial solicitation would have to reapply with new applications.

  3. Utilization Report – Ms. Robbins presented a series of slides showing that the ADAP served 13504 THMP recipients and 1,635 SPAP recipients over the first two quarters of state fiscal year 2012. Drug expenditures for THMP recipients during those two quarters (September 2011 through February 2012) totaled $46,639,824.

  4. Treatment Guidelines – Dr. Keiser initiated a discussion regarding the updated national treatment guidelines that were issued March 29, 2012, which recommends antiretroviral therapy for all HIV-infected individuals. He explained that the Texas ADAP doesn’t have eligibility restrictions in place for minimum CD4 counts or viral load levels so he wouldn’t expect an immediate increase in enrollment levels, but the new guidelines may impact overall utilization levels at a later point. Both Dr. Keiser and Dr. Vanek reiterated that they did not wish to introduce clinical guidelines as an additional eligibility requirement. Dr. Keiser asked if the THMP staff had begun asking whether or not a patient was therapy naïve on the medical certification forms; John Allen confirmed that the forms have been updated, but the existing data software cannot be updated to record the data electronically at his time. In terms of being able to track the impact of the new guidelines on program enrollment, Ms. Robbins explained that CD4 and viral load counts are entered into the patient database at the time of enrollment, and such data can be cross-referenced with other data systems to track date of diagnosis and health status at the time of therapy initiation. Ms. Robbins explained that the upcoming integration of HIV2000 data into ARIES will increase the ease of such research efforts.

  5. Gilead’s upcoming “Quad” combination therapy drug - Dr. Keiser informed the Committee that an official FDA decision approving the new antiretroviral combination therapy drug from Gilead is expected to be released on August 27, 2012, so it would make sense to plan for the next Committee meeting in early September to discuss the merits of adding it to the THMP formulary and subsequently making a recommendation for the Commissioner.

  6. Budget Update – Dr. Valadez addressed the Committee to provide a brief high-level overview of the current preparations for the upcoming legislative session. He explained that in planning for “worst-case scenarios” the agency is taking into account multiple ongoing concerns such as the deficit issues facing Medicaid and overall state revenue, as well as the unresolved issues concerning healthcare reform and the Affordable Care Act. The agency is anticipating receipt of official instructions from the Governor’s office regarding budget cuts within different percentage ranges within a variety of scenarios. A series of hearings and video conferences are being prepared for the next two months, allowing for public input and insight into the budgetary planning process.

  7. Ms. Robbins presented a series of slides that covered the current program projections based on data through the second quarter of State Fiscal Year 2012. She explained that the program is currently on track thanks to having a sufficient supply of additional stock on hand in the DSHS Pharmacy Warehouse that will be utilized after the next fiscal year begins in September 2012. An increase in funding award revenue was not expected given the current economic and political climate, but manufacturer rebates received for drugs dispensed to Medicare SPAP recipients has been a tremendous help in reducing the severity of state ADAP budgetary shortfalls around the country. The rebates received on behalf of the Texas HIV SPAP go back into the THMP budget and are used to purchase and distribute additional medications for ADAP recipients; Ms. Robbins pointed out that current projections anticipate $17 million in rebates on behalf of the THMP during SFY 2012. Dr. Valadez cautioned that the rebates would cease if the Supreme Court strikes down the affordable care act. Dr. Keiser inquired as to the possible uses for the rebate money, in regards to possible expansion of services via additional medications on the formulary or a higher FPL level for financial eligibility. Dr. Valadez and Ms. Robbins explained that the most effective method for the Committee to provide input into this matter would be to provide a written recommendation regarding service expansion options. Dr. Vanek said that she would also like to see expansion of services taken into consideration utilizing the additional rebate money received. A motion was introduced and unanimously passed by the Committee to have DSHS staff provide additional information at the next meeting regarding how the SPAP rebate income is being utilized on behalf of the program.

  8. THMP Four-Year Rule Review – Ms. Robbins notified the Committee that the rule for the Texas HIV Medication Program as detailed in the Texas Administrative Code is currently undergoing its scheduled four-year review process. A few minor changes have been made to the existing rule overall for the sake of clarity, primarily in regards to the existing list of cost containment measures. The goal was to avoid the interpretation that the cost containment measures had to be implemented in a specific rigid sequence, thus constraining the flexibility of the program when determining the appropriate measure to undertake first under a variety of budget scenarios. Ms. Robbins stressed that no changes to eligibility requirements or revamps to the program itself were being proposed. Ms. Robbins said that the initial revision draft would be posted online at the DSHS website along with the email address for any comments regarding the rules during the initial drafting period. The rules would next be presented to the State Health Services Council, and then published within the Texas Register for an official 30-day public comment period prior to official approval by the Council at a subsequent meeting. Nancy Miertschin requested that any comments collected by the program under the initial period be consolidated in some format for presentation at the next Committee meeting.

  9. Next Meeting Scheduled – The next MAC meeting was tentatively set for Friday, September 14, 2012.

  10. Public Comments – Randall Ellis asked the Committee to look into recommending an increase to the income eligibility level for program recipients in order to expand access. He said there was good data available that can be brought before the Texas Legislature as evidence that greater access to treatment decreases overall client cost.

  11. The meeting was adjourned by Dr. Keiser at 2:03 PM.

Last updated June 11, 2020