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Effective Date: 
4/2020

Documents

 

Instructions

Updated: 4/2020

 

Purpose

For drug manufacturers to propose value-based agreements.

Procedure

When to Prepare or Update

For consideration by Texas Health and Human Services Commission of a manufacturer’s proposed value-based agreement(s). Meetings to discuss a value-based concept with manufacturers or their representatives will be scheduled after a complete concept has been submitted to the HHSC Vendor Drug Program and passed preliminary review for feasibility.

Detailed Instructions

  1. Contact Information: Complete all sections.
  2. Summary of Concept: Complete all sections. Briefly describe the concept in lay terms. The summary is not limited to, but should include, the following:
    1. Name of the drug(s)/product(s) and condition(s) it treats.
    2. Population of patients served.
    3. Settings in which the population is treated (e.g., clinic, hospital).
    4. How patients typically use the drug(s) (clinician-administered, orally, topical) or product(s) and how often (multiple times a day, weekly, a single dose).
    5. Primary way the concept would improve the health of the Texas Medicaid population.
    6. Any major safety issues or important cautionary statements.
    7. Average cost of the drug(s)/product(s) per use.
    8. Overview of health outcomes or metrics to be monitored.
  3. Additional Information: Complete all sections and include documentation in a PDF.
    1. If FDA approved, list all indications for which it has been approved.
    2. Ensure all questions with radio button responses have been answered. Incomplete concepts will be returned to the submitter.
    3. Include all codes (national drug codes, procedure codes, etc.).
    4. Provide an answer to each question and ensure all questions with check box responses have been answered. Concepts will not be accepted with incomplete or missing information.
  4. Effectiveness: Complete all sections and include documentation in a PDF.
    1. Provide an answer to each question and ensure all requested documentation is included with the concept submission. Concepts will not be accepted with incomplete or missing information.
  5. Safety: Complete all sections and include documentation in a PDF.
    1. Ensure all questions with radio button responses have been answered.
    2. Provide an answer to each question and ensure all requested documentation is included with the concept submission. Concepts will not be accepted with incomplete or missing information.
  6. Cost: Complete all sections and include documentation in a PDF.
    1. If necessary, indicate which cost index and if the cost reflects the entire regimen or per use.
    2. Use the same cost index to compare treatment costs.
    3. Provide an answer to each question. Concepts will not be accepted with incomplete or missing information.
  7. Health Outcomes or Metrics: Complete all sections and include documentation in a PDF.
    1. Ensure all questions with radio button responses have been answered.
    2. Provide an answer to each question and ensure all requested documentation is included with the concept submission. Concepts will not be accepted with incomplete or missing information.
  8. Coverage: Complete all sections and include documentation in a PDF.
    1. Ensure all questions with radio button responses have been answered.
    2. Provide an answer to each question. Concepts will not be accepted with incomplete or missing information.

Transmittal

The Vendor Drug Program will provide notification to the email address listed in Section I when the concept has been received, if it was not accepted because of incomplete or missing information, and throughout the review process if there are questions and/or a request for a meeting.

  • Email:  vdp-contracts@hhsc.state.tx.us  
  • Mail: Vendor Drug Program (Mail Code 2250)
    Attn: Value-based Concepts
    Texas Health and Human Services
    4900 North Lamar Blvd.
    Austin, TX 78751

Questions

Email vdp-contracts@hhsc.state.tx.us.