Question to the Department of Health and Social Care:
To ask the Secretary of State for Health and Social Care, pursuant to the Answer of 14 July 2025 to Question 64336 on Vamorolone, what the consequences are for (a) Integrated Care Boards and (b) NHS Trusts for not making NICE recommended medicines available within 90 days of publication of relevant guidance.
Commissioners have a statutory responsibility to make funding available for a medicine or treatment recommended by a National Institute of Health and Care Excellence (NICE) technology appraisal (TA) or highly specialised technology evaluation (HST) within the timeframe recommended in that guidance, usually within three months of the TA or HST being published.
Under the National Health Service Constitution, patients have a right to receive all medicines and treatments recommended by NICE if they and their healthcare professional think that the medicine is right for them. In practical terms, the effect of this legal obligation and the NHS constitution is that all NICE-approved treatments must be included in local formularies for use in line with the TA or HST recommendations and with no additional funding or formulary restrictions.
The only exception is if the technology is not relevant to the care provided by the organisation; for example, cancer treatments would not need to be included in the formulary of a mental health trust, and treatments for dementia would not need to be included in the formulary of a specialist children’s hospital. There is no provision to take affordability into account when adding NICE-approved medicines to local formularies.
NHS enforcement guidance relating to its statutory accountability and oversight role, under the NHS Act 2006, the 2012 Act and the 2022 Act is available at the following link:
https://www.england.nhs.uk/long-read/nhs-enforcement-guidance/
The evolving NHS operating model will strengthen capabilities and clarify roles in overseeing performance. As set out in the 10-Year Health Plan for England, we will move to a Single National Formulary (SNF) for medicines within the next two years. The SNF will play a role in driving rapid and equitable adoption of clinically and cost-effective innovations.