FDA Wants To Connect Payers And Sponsors Earlier In Device Development Process

By Jof Enriquez,
Follow me on Twitter @jofenriq

The Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA) is requesting private payer organizations and health plans that make coverage or reimbursement decisions to provide input to device sponsors during pre-submission meetings.

"Early input from payers regarding their evidentiary needs can streamline the process from FDA approval or clearance to payer coverage and improve public health by facilitating earlier access to innovative, safe, and effective medical devices," FDA states in a notice in the Federal Register. 

Typically, device sponsors conduct clinical trials to support a marketing application for FDA approval or clearance. However, the clinical evidence FDA deems sufficient for marketing the device may not always match the evidence to support payer coverage decisions. Third-party commercial health insurance organizations, payer/provider organizations, health technology assessment (HTA) groups, and other organizations can have their own criteria — including, but not limited to, data comparison to other therapies and the associated costs of those therapies — on which they base coverage or reimbursements.

Sponsors may not necessarily consider these requirements from payers early in the medical device development process. Even if the sponsors discover those requirements later, it could be difficult to collect the data retrospectively, or to conduct another trial to meet payer evidentiary requirements. These scenarios can prevent timely access by patients to FDA-approved medical devices.

In order to streamline the process from FDA clearance to payer decisions, "CDRH intends to create a mechanism for such organizations to identify themselves so medical device sponsors who would like to obtain coverage input can voluntarily contact them to participate in an FDA Pre-Submission meeting."

If both device sponsors and coverage organizations meet early in the development process, they can "initially design a clinical trial that can capture both the data necessary for FDA marketing clearance or approval and that necessary to support a positive payer coverage decision."

FDA is asking coverage organizations to come forward if they are interested in giving input to sponsors during pre-submission meetings, according to RAPS. The agency says it intends to list on the CDRH web site the coverage organizations willing to participate so that sponsors have a way to reach out to them and invite them to attend pre-submission meetings.

FDA said its proposal is based on the Parallel Review program, which allowed device makers to meet regularly with FDA and the Centers for Medicare and Medicaid Services (CMS) to ascertain the type of clinical evidence that would support approvals and decisions by each agency. The FDA claims the program cuts delays for Medicare beneficiaries to access innovative medical devices.