Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, for what reason the NICE appraisal of (a) ivacaftor, (b) tezacaftor and (c) elexacaftor was paused; and what the new timeline is for that appraisal process.

The National Institute of Health and Care Excellence (NICE) paused its appraisal of ivacaftor, tezacaftor and elexacaftor (marketed in Europe as Kaftrio) for treating cystic fibrosis in July 2020. This followed an announcement by NHS England and NHS Improvement that National Health Service patients will be among the first in Europe to benefit from the triple therapy through an interim access deal. The deal will last for four years and allow for further data to be collected to better understand the impact for patients of this treatment.

NICE will work with the manufacturer, Vertex and the NHS on continued data collection to inform a future appraisal. New timelines for an appraisal will be confirmed in due course.