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MAC Meeting Minutes December 5, 2014

OFFICIAL MINUTES
Texas HIV Medication Advisory Committee Meeting
December 5, 2014


The December 5, 2014 meeting of the Texas HIV Medication Advisory Committee (MAC) was held at 4110 Guadalupe Street, Building 626 in Austin, Texas.

MAC Members in Attendance: Philip Keiser, M.D., Chair, Natalie Vanek, M.D., Vice-Chair, Mary Paul, M.D., Nancy Miertschin, M.P.H., Raul Castaneda, R.Ph., David Huse, Bruce Turner, Frank Rosas

DSHS Staff in Attendance: Shelley Lucas, Imelda Garcia, Felipe Rocha, Rachel Sanor, John Allen, Mary Richards, Heather Nagy, Lisa Cornelius, M.D., David Gross, Paul Bell

Registered Guests: Erin Smith, Mark Vane, Michelle Flores, Becky Gonzales, Sara Deppe, Jay Dee Fredericksen, Mike McBride, Januari Leo, John Carlo, Roger Grotzinger, Suzanne Erickson, Roberto Perraza, Victoria Ford, Jack McClure, Sheldon Skinner


Action and Discussion Items Covered:

  1. The meeting was called to order by Dr. Keiser at 12:03 pm, December 5, 2014.


  2. The committee reviewed and unanimously approved the February 21, 2014 meeting minutes.


  3. Imelda Garcia, Section Chief for Infectious Disease Prevention, gave a brief update on recent developments that staff has been addressing concerning a tuberculosis exposure case in El Paso that required the identification and screening of over 900 infants in addition to household members and community contacts, as well as a section wide response to the discovery of the first US Ebola virus diagnosis in Dallas. In regards to ongoing bill analysis, the Section is waiting the outcome of the recent Sunset Committee recommendation to consolidate the agencies under the enterprise umbrella within HHSC into one single agency. Registered guest Januari Leo expressed concerns that the existing advisory committees would all be disbanded and potentially reinstated by approval of a rule; Ms. Garcia stated that the topic was currently being reconsidered by the Sunset Committee, and some modifications to the report are expected to be released as early as next week.


  4. Felipe Rocha, Manager of the TB/HIV/STD Viral Hepatitis Unit, presented an update on the THMP Budget.


  5. Rachel Sanor presented ADAP/SPAP update reports detailing first time enrollment by month and program, clients served by month, monthly medication expenditures, number of prescriptions filled by month, the top ten drugs dispensed and race and gender demographics for State FY 2014. Raul Castaneda requested additional data on the numbers of clients served versus eligible to be served each month. Shelly Lucas stated that she would have Margaret Vaaler from the HIV/STD Planning and Evaluation Group give a presentation at the next meeting covering both the HIV Cascade in Texas and the unmet need statistics for Texas, with specific data pertaining to the ADAP population where applicable. Dr. Paul had some specific questions regarding the accessibility of pediatric HIV medication formulations for program recipients; John Allen explained some of the processes in place for monitoring of inventory on hand and purchasing of infrequently utilized medications, and requested that drug manufacturers contact our Program Manager when new formulations are made available to purchase. Mr. Allen also stated that he is available to work with addressing any specific formulation needs that prescribers encounter to ensure greater access to medications for all recipients. Nancy Miertschin also expressed interest in opening up discussions as to any potential ability of the THMP to assist Harris Health with dispensing partial bottle fills to the homeless population.


  6. The recommendation to add the drug cobicistat (Tybost) to the THMP formulary was approved unanimously by the Committee. Cobicistat had previously been added to the formulary as a component of the combination therapy drug Stribild, and is now being marketed as a coadministered agent with the drugs atazanavir 300mg and darunavir 800mg. Dr. Keiser explained that a combination drug containing cobicistat, atazanavir and darunavir is likely to be resented for FDA approval in the near future, and stated that the Committee is anticipating that the price associated with such an item be equivalent to the individual components rather than an increase in cost to ADAPs. Dr. Keiser also explained that the other unique component f Stribild, the integrase inhibitor elvitegravir (Vitekta), was also approved by the FDA on its own, but is not yet ready for consideration as the wholesale acquisition price (WAC) has yet to be established. Rachel Sanor stated that the ADAP task force anticipates pricing negotiations to begin with the manufacturer in early 2015.


  7. The next MAC meeting was tentatively scheduled for Friday, May 15, 2015.


  8. There was one public comment. Januari Leo with Legacy Community Health Services in Houston requested an update on the ability of the agency to begin purchasing Affordable Care Act insurance plans from the marketplace for eligible ADAP recipients, as a majority of ADAP programs are now doing for their population. Imelda Garcia stated that conversations are ongoing within the agency and recent communication with our leadership team has appeared positive, but no decisions have been made as of yet. Shelly Lucas stated that a $3.5 million Ryan White Supplemental Services Grant was received this year, and she was hopeful that the Administrative Agencies would use some of the increased funding to purchase plans on the local level while the Department continued to pursue the possibility of doing so on a statewide level. John Carlo from AIDS Arms in Dallas recommended that local programs be handled on a pilot project level, as they had found that tobacco use from recipients were leading to increased premium costs by as much as 300%. Ms. Garcia stated that such cost factors were being factored into our modeling projections, based on the known rate of tobacco use amongst Ryan White recipients


  9. The meeting was adjourned by Dr. Keiser at 1:43 pm.



Approved by:
Phillip H. Keiser, M.D. – Chairman, Texas HIV Medication Advisory Committee
Date

Last updated June 29, 2016