Form 1402, Value-Based Agreement Concept

Instructions

Updated: 11/2021

Purpose

For drug manufacturers to propose value-based agreements.

Procedure

When to Prepare or Update

Drug manufacturers submit the form for HHSC to consider the value-based agreement(s). HHSC will schedule meetings to discuss the value-based concept with manufacturers or their representatives after a complete concept has been submitted and has passed a 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. The 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. The primary way the concept would improve the health of the Texas Medicaid population.
   6. Any major safety issues or important cautionary statements.
   7. The 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. HHSC will not accept concepts 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. HHSC will not accept concepts 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. HHSC will not accept concepts 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. HHSC will not accept concepts 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. HHSC will not accept concepts 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. HHSC will not accept concepts with incomplete or missing information.

Transmittal

The Vendor Drug Program will notify the manufacturer by 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 or a request for a meeting.

Email:

vdp-cad@hhsc.state.tx.us

Mail:

Vendor Drug Program (Mail Code 2250)
Attn: Value-based Concepts
Texas Health and Human Services
701 W. 51st St.
Austin, TX 78751

Questions

Refer comments or questions about this form to vdp-cad@hhsc.state.tx.us.