The FDA established the PCTF in 2010 to facilitate communication between device makers and payers. The agency hopes the task force will help shorten the time between when a device is approved and when it is covered under insurance plans
While device makers typically provide enough data on the safety and efficacy of their devices to earn FDA approval, payers often require additional evidence to prove the devices are both cost-effective and clinically-effective before agreeing to cover them.
Through the collaboration, NICE will help review a device maker’s evidence and share advice before the company submits the data to payers.
“Early engagement should help medical technology makers to design their development programs better to produce the data needed both to obtain regulatory approval and to persuade the payers of the value of their product,” said Leeza Osipenko, associate director of the NICE Scientific Advice program, according to RAPS.
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