NICE and FDA join forces to improve medtech access

The UK’s cost effectiveness body is to work with the US regulator to speed up patient access to medtech innovations.

NICE’s Scientific Advice programme team and the FDA’s Payer Communication Taskforce are now looking at how best to help developers of medical devices, diagnostics and other medtech technologies gather the best evidence to demonstrate their product’s effectiveness.

Medtech companies currently need to convince healthcare organisations of their product’s clinical and cost effectiveness after gaining regulatory approval - but this process is far less well established than the ones for new medicines.

“In their efforts to get a product to market, companies can get caught out,” said Leeza Osipenko, head 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.”

The roles of both the Scientific Advice programme and Payer Communication Taskforce have not yet been fully detailed, however the former will likely aid medtech companies by reviewing evidence gathered and providing pre-submission advice.

“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,” added Osipenko.

NICE and the FDA’s collaboration is the latest effort to help clarify the pathway that new medtech innovations have to navigate to reach patients. In the UK, the MHRA updated its guidelines on mobile apps to help clarify medical device classification, whilst in the US, a new collaboration called Xcertia aims to improve the safety of health apps.