NICE Joins FDA Program to Shorten Time Between Device Approval and Insurer Coverage

The UK’s National Institute for Health and Care Excellence (NICE) on Wednesday announced that it would participate in the US Food and Drug Administration’s (FDA) Payer Communication Task Force (PCTF) to help speed patients’ access to the best new medical devices, diagnostics and other health-related technologies.

Early engagement should help medical technology makers to design their development programmes better to produce the data needed both to obtain regulatory approval and to persuade the payers of the value of their product.”

NICE Scientific Advice is a fee-for-service program that provides advice on a company’s proposals for evidence generation on economic and clinical effectiveness.

NICE says its involvement in this joint FDA initiative may consist of reviewing the evidence a company is gathering; providing advice in a pre-submission meeting with the other advisory bodies and commenting on the resulting company’s minutes; or producing formal written advice as a follow-up to the pre-submission meeting.

Read the full article at RAPS.

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Published on 16. December 2016 in News UK