The FDA published a notice on February 24, 2016 requesting whether organizations (e.g. insurers, health technology assessment organizations) that evaluate clinical evidence used to support private payer medical device coverage decisions are interested in providing input to medical device developers on clinical trial design or other evidence-gathering needed to support positive coverage decisions. If coverage organizations express interest, the FDA intends to provide a mechanism for such organizations to identify themselves so that medical device sponsors who would like to obtain coverage input can voluntarily contact them to participate in a FDA Pre-Submission meeting.
According to the FDA, early input from payers regarding their evidence 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.” For instance, sponsors that voluntarily meet with coverage organizations early in the development process may obtain information needed to:
- Initially design a clinical trial that can capture the data necessary for both FDA marketing clearance or approval and to support a positive payer coverage decision,
- Modify their pivotal study to satisfy both sets of requirements, or
- Develop other plans to collect necessary data
For more information, see https://www.gpo.gov/fdsys/pkg/FR-2016-02-24/pdf/2016-03909.pdf.