Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what assessment he has made of the adequacy of the time taken by NICE to assess Givinostat.

The National Institute for Health and Care Excellence (NICE) aims wherever possible to publish recommendations on new medicines close to the point of licensing. NICE’s appraisal of givinostat has been more complex and has required additional work to ensure that it is able to make a recommendation on its use for the NHS. The timeline was extended following discussions with the company in order to facilitate a suitably comprehensive and robust submission and to incorporate a four-week targeted call for evidence from stakeholders. This call was to address specific areas where additional evidence was required to support the NICE appraisal committee to make a fully informed decision. NICE’s Appraisal Committee met to consider its recommendations on 23 October 2025. Stakeholders in the appraisal will be kept informed of the outcome and the next steps for the appraisal of givinostat as it progresses.