700.001 Texas HIV Medication Program Requests to Change State HIV Medication Formulary
|January 8, 1996
|December 29, 2021
|HIV/STD Prevention and Care Branch Manager
To set out the specific steps for processing requests for additions or deletions to the Texas HIV Medication Program's (THMP) HIV medication formulary.
The Texas Administrative Code, Title 25 §98.103(a), Medication Coverage, (a) states, "The medications provided under the Texas HIV Medication Program, and the specific eligibility criteria for them shall be determined by the commissioner of health, considering the recommendations of the HIV Medication Advisory Committee." Part B of the Ryan White HIV/AIDS Treatment Extension Act of 2009 (Public Law 111-87) provides grants to U.S. states and territories through the Ryan White HIV and AIDS Program (RWHAP). The AIDS Drug Assistance Program (ADAP), is a state and territory-administered program authorized under Part B that provides FDA-approved medications to low-income people living with HIV who have limited or no health coverage from private insurance, Medicaid, or Medicare. The RWHAP legislation requires that each ADAP must cover at least one drug from each class of HIV antiretroviral medications on their ADAP formulary. Within these requirements, each ADAP decides which medications to include on its formulary and how those medications will be distributed.
Questions regarding this policy should be directed to the HIV/STD Prevention and Care Branch Manager (Branch Manager) or the THMP Manager.
3.0 How to Request
All persons or organizations (requestors) wishing to request a change to the HIV medication formulary must do so in writing. The change may be in the form of an addition or deletion to the formulary. All medications must be Food and Drug Administration (FDA) approved prior to requesting the medication be added to the formulary. Written requests should be submitted to the THMP Manager, Attn: MSJA, MC 1873, Texas Department of State Health Services, Post Office Box 149347, Austin, Texas 78714. All persons making written requests for formulary additions will receive a letter acknowledging the receipt of the request from the THMP Manager.
4.0 Processing Public Requests
All publicly-generated written formulary change requests received by the THMP Manager will be presented at the next scheduled meeting of the Texas HIV Medication Advisory Committee (the Committee). At that time, the Committee will review the formulary change request(s) and determine if the request(s) will be included on the agenda for the following meeting. The requestor who submitted the formulary change request may be contacted by the THMP staff, at the Committee’s request, to obtain additional information.
4.1 Special Exceptions for HIV-Related Medications
At the discretion of the THMP Manager, in concurrence with the TB/HIV/STD Section Director (Section Director), any publicly generated written request for new FDA-approved medications to treat HIV to be added to the formulary may be automatically included on the agenda for consideration at the next scheduled meeting of the Committee.
4.2 Information Packets
The THMP staff will send each of the Committee members a packet containing a copy of the original written request and any additional information on all FDA approved medications listed on the agenda to be discussed at the next Committee meeting. Failure of the requestor to provide the appropriate information to the Committee will result in the medication being removed from the meeting agenda.
The Committee reserves the right to table their decision regarding recommending the addition of a medication and to ask the requestor to present additional information about the medication to the Committee at the next meeting. If additional information is necessary and the requestor is unable to attend, the Committee may select a Committee member to present the information or may elect to have a colleague familiar with the requested medication make the presentation.
4.4 Advisory Committee Recommendations
The Committee should reach a conclusion on all public requests to add or delete a medication from the formulary. The Committee's disposition shall take the form of a recommendation. Only the Commissioner of Health (the Commissioner), with input from the Section Director, has the authority to grant a change to the formulary, defined as either the addition of a new medication or the deletion of an existing medication. The Committee, after reviewing and discussing the information pertaining to the medication, will make its recommendation(s) to the Program. The Committee may:
recommend the addition of a medication,
recommend the deletion of a medication, or
choose to not recommend the addition or deletion of a medication.
Should the Committee choose to not recommend the addition or deletion of a medication, the Committee may:
make a final disposition of the request, or
table the request and direct the Program Administrator to gather additional information on the medication and resubmit the request at the following meeting of the Committee.
The Committee's final recommendation to add or delete a medication will be routed by the THMP Manager to the Commissioner for action.
4.5 Processing Committee Recommendations
After the Committee forwards a recommendation to the THMP Manager, the Manager will route the recommendation in memorandum form to the Commissioner of Health for approval. The action memo will include a summary of the recommendation, including the name of the medication, the name of the pharmaceutical manufacturer supplying the medication, and criteria for using the medication. It will also include an analysis of the projected utilization and impact of adding the medication for the Commissioner’s review. This fiscal analysis will be completed with the assistance of actuarial projections. The memorandum must be directed from the THMP Manager; through the Branch Manager; through the TB/HIV/STD Finance Manager; through the Section Director, through the Laboratory and Infectious Disease Services Division Associate Commissioner; through the Infectious Disease Medical Officer; through the Chief Financial Officer, to the Commissioner.
The Commissioner will sign the memorandum, conferring approval or rejecting the request and return the form. Upon approval, the THMP Manager will work with the TB/HIV/STD Section Finance Manager to complete a timeline for initiating the purchase of new medications.
5.0 Processing Section Requests
Only the Branch Manager, or the THMP Manager in concurrence with the Section Director, may request a change to the HIV medication formulary without first seeking the recommendation of the Committee. Section requests of this type shall be based upon budget necessity. Completion of a detailed memorandum shall serve as the official request and shall indicate that the Committee was not consulted. The THMP Manager will route the request in memorandum form to the Commissioner for approval. The memorandum must be directed from the THMP Manager; through Branch Manager and the Section Director; through the Associate Commissioner for Laboratory and Infectious Disease Services Division, through the Infectious Disease Medical Officer, through the Chief Financial Officer, to the Commissioner.
The Commissioner will sign the memorandum, conferring approval or rejecting the request and return the form.
5.1 Variations of Existing Formulary Medications
New formulations, strengths, or packaging variations for medications currently available on the Program formulary shall be addressed by the Program on a case-by-case basis. At the discretion of the THMP Manager, in concurrence with the Branch Manager and the Section Director, the Program may:
automatically add the new version of the medication to the Program formulary should the Program determine such inclusion to have either a neutral or beneficial impact to the Program budget, without requiring the Commissioner’s approval, or
place the variant medication on the agenda of the next scheduled Committee meeting for discussion should the Program have concerns of any sort regarding the formulation, packaging, or increased cost of the new version of said medication.
If the new version of the formulary medication is presented before the Committee for discussion, the Committee may:
recommend the addition of the new version of a formulary medication, or
choose to not recommend the addition of the new medication to the Program formulary.
Should the Committee choose to not recommend the addition of a new version of the formulary medication, the Committee may:
make a final disposition of the request, or
table the request and direct the THMP Manager to gather any additional information deemed necessary by the Committee regarding the new variation of the formulary medication, and resubmit the request at the following meeting of the Committee.
The Committee’s final recommendation to add a new version of a medication already on the Program formulary will be automatically added to the formulary by the THMP Manager in concurrence with the Branch Manager and Section Director.
6.0 Notification of Disposition
The Branch Manager will notify the THMP Manager of the final disposition. The THMP Manager shall also notify the public requestor of the final disposition if the original request was publicly generated. The Program shall immediately notify the Committee of the final disposition if the request was Program generated.
The Program will notify clients, providers, and HIV/STD contractors of the addition or deletion of a medication through any combination of the following methods:
by publication as a notice in the Texas Register,
through the media, and
electronically (via email or the internet if possible).
7.0 Production and/or Distribution Problems with Existing Formulary Medications
Should the Program experience problems with obtaining a particular formulary medication due to manufacturing or distribution interruptions from the medication’s manufacturer, the Program will call such problems to the attention of the Committee if the situation occurs for an extended length of time or in repeated intervals over a given period. Shortages in medication stock can pose serious barriers to client therapy and adherence; should the Program be unable to consistently guarantee the availability of a given medication for eligible Program clients, the Committee reserves the right to make recommendations to delete a medication from the Program formulary or modify the requirements for obtaining that medication from the Program.
8.0 Revision History
|Revised committee recommendation and section request processing
|4.5 and 5.0
|Changed "TB/HIV/STD Unit" to "TB/HIV/STD Section" to reflect new program designation
|Update with current job titles and processes.
|Converted format (Word to HTML)
|Created standalone version of form 700.001A
|Converted format (WordPerfect to Word)