Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, for what reason NHS England has not approved abiraterone for use in high-risk, non-metastatic prostate cancer.

Abiraterone is licensed by the Medicines and Healthcare products Regulatory Agency for use in the treatment of high-risk hormone-sensitive metastatic prostate cancer. The National Institute for Health and Care Excellence (NICE) has published final draft guidance on 30 October and has been able to recommend abiraterone (originator and generics) for treating newly diagnosed high-risk hormone-sensitive metastatic prostate cancer. NICE reviewed its guidance to determine whether to recommend abiraterone for use in this indication following the patent expiry for the medicine.

Abiraterone is not licensed for use in the treatment of high-risk, non-metastatic hormone-sensitive prostate cancer, and as such, it has not been evaluated by NICE through its technology appraisal programme. NICE makes recommendations for the National Health Service in England on the vast majority of new medicines and significant licence indications for existing medicines but does not evaluate medicines that are used outside their marketing authorisations, also known as “off-label”.

Funding decisions for off-label medicines are the responsibility of NHS commissioners who are required to make decisions on the basis of the available evidence. For cancer medicines, NHS England is the responsible commissioner and has an established mechanism to make funding decisions on medicines that are not evaluated by NICE through its clinical prioritisation process. NHS England considered abiraterone as an off-label treatment for hormone-sensitive, non-metastatic prostate cancer through its clinical policy development process in 2024/25. Through this process, NHS England confirmed that there was sufficient supporting evidence to support the routine commissioning of abiraterone in this indication and it was ranked as the top priority for routine commissioning.

However, NHS England has not been able to identify the necessary recurrent funding to support the commissioning of abiraterone, or any other treatments within the prioritisation round. This position in being kept under review and will be progressed as soon as recurrent funding is identified.

This position takes into account the need to ensure the affordability of introducing any new routine commissioning policies, alongside maintaining existing services for patients, and meeting their legal requirement to fund all NICE approved drugs. Abiraterone for the treatment of high-risk, hormone sensitive, non-metastatic prostate cancer remains the top priority for routine commissioning.