EXCITE International, a not-for-profit collaborative focused on fixing unacceptable market adoption problems for innovative non-drug medical technologies, is pleased to announce that it has become a member of the U.S. Food and Drug Administration's (FDA) Early Payor Feedback Program (EPFP). With this membership, EXCITE becomes an additional resource for companies who wish to speak with payors, health professionals and industry experts through an Early Technology Review (ETR) in preparation for a clinical trial.
“The FDA has led the way in urging companies to think beyond regulatory clearance, and to engage early with payors, as well,” says Dr. Leslie Levin, Chief Executive Officer & Scientific Officer of EXCITE International. “EXCITE International is privileged to join the Early Payor Feedback Program and sees this as consistent with of our efforts in pioneering this approach since 2012."
The EPFP, which has been set up by the Center for Devices and Radiological Health (CDRH), is a voluntary opportunity for medical device sponsors to obtain payor input. It facilitates communication between payors and device manufacturers, which can shorten the time between FDA approval and coverage decisions. This aligns with EXCITE International’s approach, wherein a global collaboration of key stakeholders works together in the premarket space to speed market adoption, improve patient outcomes, and drive health system efficiencies.
“The FDA values the insight provided by organizations like EXCITE who are part of the Early Payor Feedback Program. Early engagement with these stakeholders during the planning phase of medical device clinical trials can help accelerate patient access to safe, effective and innovative medical devices,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health.
At present, it can take several years for medical technologies to receive FDA approval, with follow-up payor coverage by no means certain. The poor visibility into payor considerations can introduce additional risk to a company’s go-to-market strategy. Manufacturers that participate in early discussions with payors regarding evidentiary needs can position themselves to address coverage-related issues, thus de-risking reimbursement models and securing viable long-term revenue streams.
About EXCITE International
EXCITE International is a not-for-profit that designs customized clinical trial protocols with input from international payors, members of the scientific community, and other relevant key stakeholders. This collaborative approach ensures that evidence relevant to key decision makers in the post-market space is identified and collected cohesively in the pre-market space. World-class methodological centers work closely with global clinical trial sites to implement this inclusive protocol to collect, analyze, and synthesize data for adoption purposes. For EXCITE International, the benchmark for success is adoption.