October 6, 2016 – The group will work with the FDA to provide medical device manufacturers an opportunity to obtain private payer input on clinical trial design.
The Duke Evidence Synthesis Group (Duke ESG) has been invited to join a new effort from the FDA’s Center for Devices and Radiological Health (CDRH) designed to provide medical device manufacturers an opportunity to obtain private payer input on clinical trial design or other plans for gathering clinical evidence needed to support positive coverage decisions. Housed within the DCRI, the Duke ESG conducts a full range of activities backed by transparent and rigorous research methods and tools to inform and improve decision-making for patients, providers, and policymakers.
Led by CDRH’s Payer Communication Task Force (PCTF), certain private payers and heath technology assessment organizations, including Duke ESG, have agreed to be listed on CDRH’s website as willing to participate in this program. Device manufacturers should follow the directions on the website to learn how to participate in this opportunity.
“This is a great opportunity for groups such as ours to give guidance to device manufacturers on trial design, to make sure they develop high-quality evidence that meets the needs of regulators and policymakers,” said Gillian D. Sanders-Schmidler, PhD (pictured), member of the DCRI and the Margolis Center for Health Policy and director of the Duke ESG. “Device trials should be designed to have a low risk of bias, be based on outcomes that are important to patients and clinicians, examine long-term outcomes, and reflect the complexity of real-world interventions.”
The PCTF website notes that “often times, the data submitted by medical device manufacturers to demonstrate safety and effectiveness to the FDA may not include data needed by payers to make coverage determinations. As a result, after FDA approval or clearance, there may be a delay in coverage, payment and use decisions that may ultimately delay patient access to medical devices.” The website says that “participation in this opportunity is voluntary for both medical device sponsors and coverage organizations. Participation will not change the evidentiary standards the FDA uses for decision-making.”
By facilitating communication between device manufacturers and payers, the PCTF hope to potentially shorten the time between FDA approval or clearance and actual coverage decisions. By communicating earlier, manufacturers may design their clinical trials to produce the data required for regulatory approval or clearance and positive coverage determinations.
Participants in the program will include “organizations that evaluate clinical evidence used to support private payer coverage decisions for medical devices (coverage organizations) that wish to provide input to medical device developers (sponsors) on clinical trial design or other plans for gathering clinical evidence needed to support positive coverage decisions,” states a Federal Register Notice announcing the initiative. Such coverage organizations include third-party commercial health insurance organizations, payer/provider organizations, health technology assessment groups and various organizations that evaluate clinical evidence and make coverage recommendations to and decisions for private payers and health plans.
Medical device manufacturers interested in this program should visit the PCTF website, select which payer/HTA(s) they would like to invite to their Pre-Submission meeting, and send an email identifying these groups to CDRHPayerCommunications@fda.hhs.gov.