Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, whether he will assess the potential merits of introducing a separate assessment process for rare disease medicines that do not meet the criteria set out by the National Institute of Health and Care Excellence for their Highly Specialised Technology route.

The Department has no plans to establish a new assessment process for the evaluation of rare disease treatments. The National Institute for Health and Care Excellence (NICE) develops guidance on most new drugs through its technology appraisal programme, and has been able to recommend a number of drugs for rare diseases for routine use on the National Health Service.

There is an established topic selection process for the technology appraisal and highly specialised technology evaluation programme that includes a public consultation and is designed to ensure that treatments are only referred for assessment by NICE where its guidance will add value. NICE periodically reviews its methods and processes to ensure that they remain fit for purpose for the NHS in England.