HEPV Real-World Evidence (RWE) Program

Overview

The HEPV RWE program enhances the use, acceptability, and incorporation of RWE by working with FDA, CMS and other payers, health technology assessment organizations, and others. Activities focus on:

Approaches that are scientific and methodologically rigorous for use with payers
Payer acceptance and adoption of RWE into coverage and health technology assessment evidence standards
Manufacturer awareness of RWE and capacity to develop RWE for coverage, reimbursement, and health technology assessment purposes.

The RWE Working Group

Established in 2020, the RWE Working Group oversees activities, including determining priorities, managing the work, and identifying opportunities. Jeff Farkas, Vice President of Global Health Economics, Reimbursement, and Government Affairs at Medtronic Diabetes, chairs the RWE Working Group.

“Manufacturers come together with CMS and the FDA to focus on issues that are of mutual importance to the agencies and the industry and to advance these issues in a meaningful way.”

Jeff Farkas

Chair, MDIC HEPV RWE Working Group

Vice President, Global Health Economics, Reimbursement, and Government Affairs Medtronic Diabetes

Interested in working with us?

MDIC members and representatives of relevant stakeholders, including patient advocacy groups, can participate in the HEPV RWE Working Group. Contact us to learn more:

HEPV@MDIC.org

HEPV RWE Activities

MDIC Public Forum: RWE in the Context of Payer Decision-Making

On April 20, 2021, the HEPV initiative and FDA hosted a virtual public forum on RWE in the context of payer decision-making. More than 200 participants learned about:

Collaboration between CMS and FDA on real-world data
Examples of RWE used by the FDA in regulatory decisions
The perspective of CMS and other stakeholders on RWE
Examples of the use and possible use of RWE in the development of medical technology.

Learn more:

MDIC Public Forum: RWE in the Context of Payer Decision-Making

Learn more about the HEPV initiative

How Can Medical Device Manufacturers Make Best Use Of Patient Preference Information?

MDIC Public Forum: RWE in the Context of Payer Decision-Making

Current as of June 15, 2022