NICE Explains Limited Grounds for Appealing Device Decisions

Devicemakers appealing a final appraisal determination by the UK’s National Institute for Health and Clinical Excellence (NICE) are limited to three basic arguments for an appeal, according to a draft guidance. The agency will only consider appeals on the grounds that it acted unfairly in accordance with its published procedures, that it formulated guidance that cannot be reasonably justified in light of submitted evidence or that it exceeded its powers as a public body, NICE says in the draft guidance on its technology appraisal appeal process posted on its website last month.
Devices & Diagnostics Letter