Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, whether his Department has plans to review NICE’s criteria for reviewing new medicines so that it ensures appropriate access to treatments by people with rare diseases.

The Department has no plans to review the National Institute for Health and Care Excellence’s (NICE) criteria for assessing medicines. NICE is an independent body and is responsible for the methods and processes it uses in the development of its guidance. NICE’s methods and processes for the assessment of drugs have been carefully developed over time through extensive engagement with stakeholders and are internationally respected. NICE continues to keep its procedures under periodic review to ensure that they remain fit for purpose.

All topics, including drugs for rare diseases, are considered through a rigorous topic selection process before formal referral to NICE to ensure that NICE guidance is appropriate and will add value. NICE assesses most significant new drugs through its technology appraisal programme and has been able to recommend a number of drugs licenced for the treatment of rare diseases for routine use on the National Health Service.