Question to the Department of Health and Social Care:

To ask Her Majesty's Government, further to the publication by NICE of NICE healthy technology evaluations: the manual on 22 January, how they plan to define “sufficient evidence” while recognising that in early-stage development and “true” innovation there may not be a comparator for evidential purpose.

There is no plan to define sufficient evidence. Decisions on whether there is sufficient evidence to recommend a technology as clinically and cost effective are taken by the National Institute for Health and Care Excellence (NICE) in line with its established methods and processes and through consultation with interested parties.

Where there is uncertainty, NICE is able to recommend the most promising new cancer medicines for use through the Cancer Drugs Fund, which supports patient access while further information is collected on effectiveness to inform a future decision on routine funding. NICE and NHS England and NHS Improvement have recently consulted on proposals to create an Innovative Medicines Fund that will extend the Cancer Drugs Fund model to non-cancer drugs.