The UK's National Institute for Health and Care Excellence is working alongside the US Food and Drug Administration to help speed up patient access to the latest diagnostic tests and medical devices.
The Institute said its Scientific Advice programme, a fee-based consultancy service to developers of new technologies, is linking with the FDA's Payer Communication Taskforce, which aims to facilitate communication between device manufacturers and payers.
The agencies are working closely together to help developers of medical devices, diagnostics, and similar technologies gather the best evidence to demonstrate the clinical effectiveness of their products, and thus give them the best chance of clearance and uptake post approval.
"In their efforts to get a product to market, companies can get caught out," explains 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.
"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's involvement in this joint 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, the Institute noted.