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

Posted 15 December 2016 By Zachary Brennan


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.

FDA’s Center for Devices & Radiological Health (CDRH) initially established the PCTF to facilitate communication between device manufacturers and payers to potentially shorten the time between FDA approval or clearance and actual coverage decisions. 

In addition to NICE, current participants on the payer side include insurers Humana and Kaiser Permanente.

“In their efforts to get a product to market, companies can get caught out,” explained Leeza Osipenko, who leads the NICE Scientific Advice programme. “To win regulatory approval in the US, companies give the FDA data on the safety and efficacy of their devices. But although they often do enough to win FDA approval, they need additional evidence to prove to the organisations who would actually pay for those devices that they are cost-effective and clinically-effective. 

“To help companies overcome this hurdle, NICE’s Scientific Advice programme has joined forces with the FDA in the Payer Communication Taskforce. 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.

Back in February, FDA also called 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.

NICE Statement

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Categories: Medical Devices, Due Diligence, Government affairs, Reimbursement, Regulatory strategy, Regulatory intelligence, News, US, Europe, CDRH, NICE

Tags: NICE, medical device insurer coverage, medical devices and approval

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