The UK’s National Institute for Health and Care Excellence (NICE) has announced its participation in the US Food and Drug Administration (FDA)’s Payer Communication Taskforce. This programme aims to accelerate US patient access to new technologies by gathering evidence of clinical effectiveness in an attempt to encourage US insurers to fund new treatments, post FDA-approval.
“To help companies overcome this hurdle, NICE’s Scientific Advice programme has joined forces with the FDA in the Payer Communication Taskforce.” explains Leeza Osipenko, head of the NICE Scientific Advice programme, in a press release. “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.”
The FDA already requires the demonstration of certain evidence before it will approve a product for commercialisation in the USA. However, many insurance companies require supplementary evidence, demonstrating the value of diagnostic tests or medical devices, before they will consider providing funds for such products.
“In their efforts to get a product to market, companies can get caught out,” explains Osipenko. “Although [companies] often do enough [evidence] 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.”
The NICE Scientific Advice programme—a fee-for-service consulting branch of the organisation—offers advice to life sciences technology companies on “evidence generation on economic and clinical effectiveness.” According to the release, NICE may review evidence, provide advice pre-FDA submission, and produce “formal, written advice.”
Companies seeking advice from the organisation are encouraged to notify both the FDA and NICE.