Posted 23 February 2016
By Michael Mezher
The US Food and Drug Administration (FDA) is calling on private health insurers and other payer groups that use clinical data to inform coverage decisions to participate in medical device pre-submission meetings to facilitate timelier access to new devices.
The agency believes that including coverage organizations, such as private insurers and health technology assessment (HTA) bodies, early on will allow those organizations to discuss clinical trial design and evidence gathering with sponsors before clinical trials begin.
The issue, FDA says, is that medical device development occurs in a "sequential manner," where sponsors design and carry out clinical trials, often with input from FDA on the data necessary to support marketing approval.
However, the evidence to support FDA approval of a device doesn't always match the data that a payer needs to make coverage decisions.
"While some clinical evidence developed in a pivotal clinical trial undertaken to support FDA approval or clearance could support payer coverage decisions, outcome endpoints needed by payers, such as comparison to other therapies and the associated costs of those therapies, are often not fully collected," FDA said in a notice published to the Federal Register Tuesday.
In those cases, a sponsor would either need to perform additional analyses or conduct new studies to gather the data needed by a payer, creating a delay between approval and access to a device by patients.
To remedy the situation, FDA is asking coverage organizations to come forward if they are interested in giving input to sponsors during pre-submission meetings. The agency says it intends to publish a list of coverage organizations that have expressed willingness to participate so device sponsors have a way to reach out to them to solicit their participation in pre-submission meetings.
By meeting with coverage organizations early in the development process, FDA says sponsors will be better able to tailor their clinical development programs to meeting both FDA and payer needs.
FDA also clarifies that participation in pre-submission meetings will be voluntary for both sponsors and the coverage organizations who express interest in the program.
FDA says it developed its plan using lessons learned from its parallel review pilot program, a joint effort by the agency and the Centers for Medicare and Medicaid Services (CMS) that began in 2011 to "streamline the decision making process" for Medicare coverage after a device is approved.
The agency's current proposal would mirror the parallel review pilot program by creating a similar mechanism for sponsors to get input from private coverage organizations that make similar decisions to cover patients in their networks.