Bringing Private Payers To The Regulatory Table: FDA Reaches Out To Insurers
This article was originally published in The Gray Sheet
The agency's device center put out a request to health insurers to make themselves available to participate in FDA pre-submission meetings so that device firms, particularly start-ups, can better understand data expectations for coverage while companies are still designing studies to support FDA approval.
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FDA wants to draw on outside expertise to help it better understand the digital-health industry and to develop its proposed Digital Health Software Precertification Program. The agency is seeking applicants for its Entrepreneur-in-Residence program in the coming months expressly for this purpose.
As sponsors push for more access to physicians, payers hope to be able to gather more pre-approval information about drugs – like they now can with devices – for budgeting and patient access.
FDA’s device center is recruiting private payers to meet with manufacturers during the pre-submission process to hasten reimbursement. But some experts believe the effort may be hobbled by a lack of common interests.