NICE and FDA to collaborate in medtech access scheme

pharmafile | December 15, 2016 | News story | Medical Communications, Sales and Marketing |  FDA, NICE 

The National Institute of Health and Care Excellence (NICE) and the US Food and Drugs Administration (FDA) have announced their collaboration as NICE Scientific Advice, a fee-based consultancy service to drug and medical device developers, will participate in the FDA’s payer programme for the medtech industry.

The programme will see both organisations working closely with developers of technologies including medical devices and diagnostics to generate clinical efficacy data in order to facilitate faster access to patients by proving their effectiveness to healthcare payers.  

NICE’s consultancy service will offer a range of support to the programme including evidence review, providing advice to other advisory bodies during pre-submission meetings and also issuing formal advice as a follow-up to those meetings.

“In their efforts to get a product to market, companies can get caught out,” explained Leeza Osipenko, leader of 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,” she continued. “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.”

Matt Fellows