700.001 Texas HIV Medication Program Requests to Change State HIV Medication Formulary

Policy Number	700.001
Effective Date	January 8, 1996
Revision Date	August 12, 2024
Subject Matter Expert	THMP Group Manager
Approval Authority	HIV/STD Prevention and Care Branch Manager
Signed by	D’Andra Luna

1.0 Purpose

To set out the specific steps for processing requests for additions or deletions to the Texas HIV Medication Program's (THMP) HIV medication formulary.
 

2.0 Authority

Texas Health and Safety Code §85.061. 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 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 in its formulary and how to distribute those medications.

Anyone with questions regarding this policy should contact the HIV Care and Medications Unit Director (Unit Director) or the THMP Manager.
 

3.0 How to Request

Persons or organizations (requestors) wishing to request a change to the HIV medication formulary do so in writing. The change may be in the form of an addition or deletion to the formulary. The Food and Drug Administration (FDA) must approve the medications prior to a request for their addition to the formulary. Requestors submit written requests to the THMP Manager, Attn: MSJA, MC 1873, Texas Department of State Health Services, Post Office Box 149347, Austin, Texas 78714, or in another manner allowed by the department. The THMP Manager sends a letter to persons making written requests for formulary additions to acknowledge receipt of the request.
 

4.0 Processing Public Requests

The THMP Manager presents written formulary change requests they receive at the next scheduled meeting of the Texas HIV Medication Advisory Committee (the Committee). At that time, the Committee reviews the formulary change request(s) and determines whether to include the request(s) on the agenda for the following meeting. At the Committee’s request, THMP staff may contact the requestor who submitted the formulary change request to obtain additional information.
 

4.1 Special Exceptions for HIV-Related Medications

The THMP Manager, in concurrence with the HIV/STD Section Director (Section Director), may automatically include a written request for new FDA-approved medications to treat HIV in addition to the formulary on the agenda for consideration at the next scheduled meeting of the Committee.
 

4.2 Information Packets

The THMP staff 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 for discussion at the next Committee meeting. If the requestor fails to provide the appropriate information to the Committee, the THMP Manager does not include the request in the meeting agenda.
 

4.3 Presentations

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 cannot 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 public requests to add or delete a medication from the formulary. The Committee's disposition takes the form of a recommendation. Only the Department of State Health Services (DSHS) 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, makes its recommendation(s) to the program. The Committee may:

• Recommend the addition of a medication,

• Recommend the deletion of a medication, or

• Choose not to recommend the addition or deletion of a medication.

If the Committee chooses not to 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 Committee meeting.

The THMP manager routes the Committee's final recommendation to add or delete a medication to the Commissioner for action.
 

4.5 Processing Committee Recommendations

After the Committee forwards a recommendation to the THMP Manager, the Manager routes the recommendation in memorandum form to the Commissioner for approval. The action memo includes 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 also includes an analysis of the projected utilization and impact of adding the medication for the Commissioner’s review. The Section completes this fiscal analysis with the assistance of actuarial projections. The THMP Manager directs the memorandum through the HIV Care and Medications Unit Director, through the HIV/STD Finance Manager, through the Section Director, through the Infectious Disease Prevention Division Associate Commissioner, through the Infectious Disease Medical Officer, and through the Chief Financial Officer to the Commissioner.

The Commissioner signs the memorandum, conferring approval or rejecting the request, and returns the form. Upon approval, the THMP Manager works with the HIV/STD Section Finance Manager to complete a timeline for initiating the purchase of new medications.
 

5.0 Processing Section Requests

Only the HIV Care and Medications Unit Director 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. The Section bases requests of this type on budget necessity. The completion of a detailed memorandum serves as the official request and indicates the Section did not consult the Committee. The THMP Manager will route the request in memorandum form to the Commissioner for approval. The THMP Manager directs the memorandum through the HIV Care and Medications Unit Director and the HIV/STD Section Director, through the Associate Commissioner for the Infectious Disease Prevention Division, through the Infectious Disease Medical Officer, through the Chief Financial Officer, to the Commissioner.

The Commissioner signs the memorandum, conferring approval, modifying approval, or rejecting the request, and returns the form.
 

5.1 Variations of Existing Formulary Medications

The program addresses new formulations, strengths, or packaging variations for medications currently available on the program formulary on a case-by-case basis. At the discretion of the THMP Manager, in concurrence with the Unit Director and the Section Director, the program may:

• Automatically add the new version of the medication to the program formulary if the program determines such inclusion to have either a neutral or beneficial impact on 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 if the program has concerns regarding the formulation, packaging, or increased cost of the new version of said medication.

If the program presents the new version of the formulary medication before the Committee for discussion, the Committee may:

• Recommend the addition of the new version of a formulary medication; or

• Choose not to recommend the addition of the new medication to the program formulary.

If the Committee chooses not to 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 THMP Manager automatically adds the Committee’s final recommendation to add a new version of a medication already on the program formulary to the formulary in concurrence with the Unit Director and Section Director.
 

6.0 Notification of Disposition

The Unit Director notifies the THMP Manager of the final disposition. The THMP Manager also notifies the requestor of the final disposition. The program immediately notifies the Committee of the final disposition if the request was program-generated.

The program notifies participants, providers, and HIV/STD contractors of the addition or deletion of a medication through any combination of the following methods:

• By mail;
• By fax;
• By publication as a notice in the Texas Register;
• Through the media; and
• Electronically (via email or the internet, if possible).
   

7.0 Production or Distribution Problems with Existing Formulary Medications

If the program experiences problems with obtaining a particular formulary medication due to manufacturing or distribution interruptions from the medication’s manufacturer, the program calls such problems to the attention of the Committee if the situation occurs for an extended length of time or at repeated intervals over a given period. Shortages in medication stock can pose serious barriers to participant therapy and adherence. If the program cannot consistently guarantee the availability of a given medication for eligible program participants, 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.
 

7.1 Program Reports and Response for Production or Distribution Problems and Discontinued Medications

The HIV Care and Medications Unit prepares a detailed report for approval from the Commissioner and communicates the changes with the Committee and the impacted participants. The communication informs whether the Commissioner suspended or removed the medication from the formulary.
 

8.0 Revision History

Date	Action	Section
8/12/2024	Revised for changes to Division organization, changes in statutes, and clarification of grammar.	All
12/29/2021	Revised committee recommendation and section request processing	4.5 and 5.0
9/1/2017	Changed "TB/HIV/STD Unit" to "TB/HIV/STD Section" to reflect new program designation	-
4/1/2015	Update with current job titles and processes.	All
10/7/2014	Converted format (Word to HTML)	-
	Created standalone version of form 700.001A	8.0
11/13/2002	Converted format (WordPerfect to Word)	-