• DSHS HIV/STD Program

    Post Office Box 149347, MC 1873
    Austin, Texas 78714

    Phone: 737-255-4300

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700.001

Texas HIV Medication Program Requests to Change State HIV Medication Formulary

Policy Number  700.001
Effective Date  January 8, 1996
Revision Date  April 1, 2015
Approval Authority  HIV/STD Prevention and Care Branch Manager

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

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." US Department of Health and Human Services, Health Resources and Services Administration Program Policy 97-04, states AIDS Drug Assistance Program (ADAP) funds awarded under Titles I or II of the Comprehensive AIDS Resources Emergency (CARE) Act may only be used to purchase FDA-approved medications and the devices needed to administer them.

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 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 infection 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.

 

4.3 Presentations

The Committee reserves the right to table their decision regarding adding 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 must complete form 700.001A (PDF : 103 kB). The THMP Manager will route the recommendation in memorandum form along with form 700.001A (PDF) to the Commissioner of Health for approval. The memorandum must be directed from the THMP Manager; through the Branch Manager; through the Section Director; through the Infectious Disease Prevention Section Director, through the Division of Disease Control and Prevention Assistant Commissioner; through the Chief Financial Officer, to the Commissioner.

The Commissioner will sign form 700.001A (PDF) conferring approval or rejecting the request and return the form.

 

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 form 700.001A (PDF) 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 along with form 700.001A (PDF) to the Commissioner for approval. The memorandum must be directed from the THMP Manager; through Branch Manager and the Section Director; through the Assistant Commissioner for Disease Control and Prevention; through the Chief Financial Officer; to the Commissioner.

The Commissioner will sign form 700.001A (PDF) 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 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 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 Additional Resources

File
Form 700.001A - Request to Change State HIV Medication Formulary (PDF)

 

9.0 Revision History

Date Action Section
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) -

 


 

Last updated May 21, 2021