Question to the Department of Health and Social Care:

To ask Her Majesty's Government, further to the recent decision by NICE to change the way medicines and other health technologies are evaluated for use in the NHS, how "sufficient evidence" will be defined recognising that in respect of early-stage development and “true” innovation, there may be no comparator for evidential purpose.

The National Institute for Health and Care Excellence’s (NICE) updated health technology evaluation manual sets out how different types of evidence will be used to inform the evaluation and how comparators will be identified. The potential comparators used in each evaluation are set out in a scope developed through consultation with stakeholders. Decisions on the most appropriate comparator used to make recommendations are taken by expert committees guided by established practice in the National Health Service.

A copy of NICE health technology evaluations: the manual is attached.