Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what steps his Department is taking to ensure the timely approval of high-tariff drugs for use in (a) specialised commissioning and (b) repurposed treatments.

To market a medicine in the United Kingdom, a company must secure a marketing authorisation or ‘licence’ from the Medicines and Healthcare Products Regulatory Agency. Newly-licensed medicines, including licence extensions for existing medicines, are appraised by the National Institute for Health and Care Excellence (NICE) which is the independent body responsible for developing evidence-based guidance for the National Health Service in England on whether new medicines represent a clinically and cost-effective use of resources. NICE aims wherever possible to issue guidance on new medicines close to the time of licensing. The NHS in England is legally required to fund drugs recommended by NICE, usually within three months of final guidance.

NHS England may also develop a national clinical commissioning policy to confirm whether a specific treatment which has not been appraised by NICE should be routinely available to eligible patients in the NHS in England. A policy can only be developed if the medicine is used within prescribed specialised services, namely services for which NHS England is the accountable commissioner. NHS England develops clinical commissioning policies in line with published methods and eligibility criteria. National clinical policies are based on the available research evidence and may be subject to a process of funding prioritisation, depending on the cost of the treatment concerned. More information is available at the following link:

https://www.england.nhs.uk/publication/methods-national-clinical-policies/