Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what assessment he has made of the potential merits of increasing flexibility within NICE's Single Technology Appraisal process for medicines for rare diseases.

The Department has made no such assessment. The National Institute for Health and Care Excellence (NICE) is the independent body responsible for developing authoritative, evidence-based guidance for the NHS on whether drugs and other treatments represent an effective use of National Health Service resources.

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 NHS. NICE also operates a separate highly specialised technology evaluation programme for the assessment of very high cost drugs for the treatment of very small numbers of patients.

NICE’s methods and processes for the assessment of drugs have been carefully developed over time and are internationally respected. NICE continues to keep its procedures under periodic review to ensure that they remain effective.