Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, when Baxdrostat will be available on the NHS.

In the United Kingdom, medicines need to have a licence before they can be marketed. These are granted by the Medicines and Healthcare products Regulatory Agency (MHRA). Licences confirm the health condition the medicine should be used for and the recommended dosage. To get a licence, the manufacturer of the medicine has to provide evidence which shows that the medicine is safe and effective enough to be used for a specific condition and for a specific group of patients, and that they can manufacture the medicine to the required quality.

Newly licensed 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 on whether new medicines represent a clinically and cost-effective use of resources. NICE aims wherever possible to issue draft guidance on new medicines close to the time of licensing.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.

Baxdrostat has not yet been licensed by the MHRA. If the manufacturer submits a request for a marketing authorisation, NICE will appraise baxdrostat to determine whether it can be recommended for routine use on the NHS and will aim to issue guidance as close as possible to licensing.