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In 2019, the National Institute for Health and Care Excellence (NICE) carried out a technical appraisal of ▼cemiplimab for treating metastatic or locally advanced cutaneous squamous cell carcinoma.1 At that time, there was significant uncertainty of the clinical value of the drug—both with regard to its survival data and its cost-effectiveness, but NICE felt it had ‘plausible potential’ and recommended its use within the Cancer Drug Fund. This is an increasingly common practice. A managed access agreement is set up between the NHS and the pharmaceutical company with two key components, namely a data collection arrangement sets out the outcomes that need to be collected to resolve the areas of uncertainty and a commercial agreement sets out (in confidence) the price of the drug during the managed access period.2
NICE completed its 3-year review of cemiplimab and published an updated technical appraisal in June 2022.3 It approved cemiplimab on the basis that while …
Competing interests None declared. Refer to the online supplementary files to view the ICMJE form(s).
Provenance and peer review Commissioned; externally peer reviewed.
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