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MAC Meeting Minutes January 13, 2012

Texas HIV Medication Advisory Committee Meeting
January 13, 2012

The January 13, 2012 meeting of the Texas HIV Medication Advisory Committee (MAC) was called to order at 12:34 PM at 4100 Guadalupe, Building 636, room 1102, in Austin, Texas.

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

DSHS Staff in Attendance: Dwayne Haught, Ann Robbins, Janna Zumbrun, Adolfo Valadez, M.D., Felipe Rocha, John Allen, Mary Richards, Juanita Salinas, Nick Dauster, Karina Loyo, Dan Warr, Evelyn Shewmaker and Chris Van Deusen.

Registered Guests: Tyler Hunter, Sabrina Taylor, Dora Wheeler, Jay Fredericksen, Paul Hassell, Harold Simon, Donna Erwin, Sandra Manning, Travis Gasper, Ronnie Wallace, Linda Cantu, Haley Cormyn, Michelle Bloom, Randee Clark, Cory Bean, Mark Vane, Roger Grotzinger, Suzanne Erickson, Ray Moore, Pamela Thomas, Holly Turner, Sylvia Lopez, Victoria Ford, Januari Leo, Randall Ellis, and Jarrod Ekwurzel.

Action and Discussion Items Covered:

  1. Introduction of New Members – Bruce Turner from Houston and Frank Rojas from San Antonio were in attendance and introduced by Dr. Keiser as the new consumer members of the Committee.

  2. Approval of Previous Meeting Minutes – The meeting minutes for October 14, 2011 were approved by the Committee.

  3. MAC Member Recruitment Update – Juanita Salinas with the Texas Department of State Health Services (DSHS) said the vacant pharmacy member position on the Committee had been posted as of November 2011. Three applications had been received to date, one from Dallas and two from Houston. An internal review committee was being assembled to review the applications and make a recommendation for final approval by the Executive Commissioner of the Texas Health and Human Services Commission (HHSC). Ms. Salinas anticipates that the process should take approximately six weeks.

  4. Pharmacy Manufacturer Price Negotiations – Dwayne Haught presented an update on the negotiation process between the national AIDS Drug Assistance Program (ADAP) Crisis Task Force and the major HIV drug manufacturers. The task force met with representatives from Gilead, Bristol Myers-Squibb (BMS), Merck, ViiV, Boeringher Ingelheim, and Janssen Pharmaceuticals in Chicago on November 7-8, 2011. The negotiations proved successful on behalf of ADAPs nationwide, 13 of which had waitlists at the time negotiations were held and the remaining 44 struggling with financial issues. Additional supplemental discounts were provided by the companies in attendance, with negotiations ongoing between the task force and two other manufacturers, Genentech and Abbott. BMS also agreed to raise their financial qualification level for patient assistance to 500% of the Federal Poverty Level, bringing them in alignment with the other manufacturer programs.

  5. Complera – The Committee had previously tabled a vote on the antiretroviral combination therapy drug Complera at the last meeting (October 14, 2011), pending the outcome of additional pricing discounts between Gilead and the ADAP Crisis Task Force. Mr. Haught reported that the task force had not only negotiated an additional pricing discount for Complera, but also for other Gilead antiretroviral products such as Truvada and Atripla for ADAPs that include Complera on their formularies. The Committee voted unanimously to recommend the addition of Complera to the Texas ADAP formulary. An action memo will be forwarded to the Commissioner of Health for his final determination whether or not to add Complera to the formulary; if approved, the Texas ADAP will begin the process of securing the drug at the contractually agreed price for purchase and distribution. Tyler Hunter from Gilead confirmed that Complera would remain accessible through the patient assistance program for all current enrollees as well as additional patients during this transitional period.

  6. Budget Forecast – Dr. Valadez and Janna Zumbrun presented a current overview of the funding and budgetary projections for the Texas ADAP. As mentioned in previous budgetary discussions, many of the variables that influence budgetary decisions have come into sharper focus and are becoming constants, such as the manufacturer rebates received for drugs dispensed through the Medicare SPAP. With two quarters of data on hand for the current state fiscal year, the agency is more comfortable with predicting incoming revenue streams versus outgoing expenditures. Dr. Valadez expressed increased confidence that the potential gap in funding was decreasing thanks to the additional rebate revenue. Ms. Zumbrun said that the stock on hand in the DSHS Pharmacy Warehouse would be able to offset some of the anticipated expenditures for the upcoming fiscal year. Ann Robbins explained that the actual fiscal year funding periods for specific state and federal grants have different ending dates, which requires a constant juggling of resources in order to maximize all available funding. Dr. Valadez expressed confidence in the current projections, stating that the program is able to continue meeting the needs of the public without a waiting lists or additional eligibility restrictions. The information has been shared with the Executive Commissioner of HHSC so that his office is aware of the current fiscal status of the Texas ADAP, and we can still invoke the special provision to request additional resources from Medicaid funds later during this legislative biennium should the need arise.

  7. Utilization Report – Mr. Haught presented a series of slides showing that the ADAP served an average of 10,616 recipients and $8 million in drugs dispensed each month during FY 2012 to date, with a monthly average of 242 first-time enrollees approved for coverage.

  8. Medicaid Changes Affecting ADAP – Ms. Robbins gave an overview of impending changes to Medicaid plans in Texas. She explained that the Texas Legislature and the federal Centers for Medicare and Medicaid Services approved the Medicaid waiver which allows the transfer of most Medicaid beneficiaries to managed care status beginning on March 1, 2012. Whereas the Texas ADAP previously wrapped around the three-drug monthly drug Medicaid limit, nearly all recipients would now have unlimited prescription coverage and would no longer need to obtain additional medications through ADAP. Expenditures for the Texas ADAP might decrease slightly as a result of this change – the program dispensed roughly $1.6 million in 2010 to clients concurrently enrolled in Medicaid – but it can also make a significant impact within local communities that provide “wrap around” coverage for recipients. Ms. Robbins said that DSHS would work closely with HHSC to get the word out about these changes to recipients, providers and case managers.

  9. Rules Update – A copy of House Bill 2229 approved in the 81st Legislative Session was provided to the attendees, which lays out the specific rules and function of the Medication Advisory Committee. As a result of the law that was enacted, Ms. Robbins explained that DSHS is in the process of recommending to HHSC revised rules within the Texas Administrative Code to eliminate redundancies and retain specific details concerning the Committee that were not outlined within the law. She stated that the proposed rule changes would be presented in February 2012 to the State Health Services Council, and the revision will then be published in the Texas Register for public comment prior to actual approval by HHSC.

  10. Election of New Committee Members – By member vote, Dr. Keiser was reappointed to serve as Chair of the Medication Advisory Committee, and Dr. Vanek was elected Vice-Chair.

  11. Next Meeting Scheduled – The next MAC meeting was tentatively set for Friday, May 18, 2012.

  12. Public Comments – Randall Ellis thanked the pharmacy representatives in attendance along with the Committee members and DSHS staff for their cooperative efforts to secure lower ADAP drug pricing. He expressed concern over how we collectively approach the upcoming Legislative session to rebuild trust in terms of the reported budgetary shortfall. He also wanted to stress the need to explore ways to invest more funding in targeted testing and early treatment options to reduce the number of new HIV transmissions within the community.

  13. The meeting was adjourned by Dr. Keiser at 1:54 PM.

Last updated June 11, 2020