Sipavibart: Licensing
The question
To ask the Secretary of State for Health and Social Care, whether he has had discussions with the National Institute for Health and Care Excellence on the licensing process for the drug sipavibart.
Answered by Karin Smyth
Department officials regularly discuss a range of topics with the National Institute for Health and Care Excellence (NICE), including progress with specific appraisals, such as for sipavibart.
The NICE started its appraisal of the medicine sipavibart for preventing COVID-19, ahead of the Medicines and Healthcare products Regulatory Agency’s (MHRA) decision on whether it should be licensed in the United Kingdom, with the aim of publishing guidance as soon as possible, if a licence was granted. At present, the NICE appraisal is suspended as AstraZeneca has been unable to provide an evidence submission as planned. The NICE is currently awaiting notification from AstraZeneca on when it can make a submission, and will update stakeholders in due course.
If sipavibart is recommended as clinically and cost effective by the NICE, the National Health Service in England will be legally required to fund sipavibart for eligible patients in line with the NICE’s recommendations, normally within three months of final guidance being published.
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