Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, what steps he is taking to ensure equitable access to Mounjaro for people with bile acid malabsorption.

In the United Kingdom, medicines need to have a licence before they can be marketed, and these are granted by the Medicines and Healthcare products Regulatory Agency (MHRA). 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.

Most newly licensed medicines are then evaluated by the National Institute for Health and Care Excellence (NICE) to see if they can be recommended for routine use on the National Health Service, based on an assessment of their clinical and cost-effectiveness. Mounjaro is not currently licensed for the treatment of bile acid malabsorption and therefore has not been evaluated by NICE for routine NHS use in this indication.

Clinicians can however prescribe medicines outside their licensed indication (known as ‘off-label’ use) where they consider it to be the best treatment option for their patient, and subject to funding by the NHS locally. In the absence of NICE guidance on the use of a medicine, including where it is used off-label, NHS organisations are expected to make decisions on funding based on an assessment of the available evidence.