Section 8(6) of the National Institute for Health and Care Excellence (Constitution and Functions) and the Health and Social Care Information Centre (Functions) Regulations 2013 requires integrated care boards, NHS England and, with respect to their public health functions, local authorities to comply with the recommendations in this evaluation within 90 days of its date of publication.
Section 4f of The Innovative Medicines Fund Principles states that a discretionary source of early funding (from the overall Innovative Medicines Fund budget) is available for certain medicines recommended by NICE. In this instance, interim funding has been agreed for leniolisib. Interim funding is available from 28 March 2025 and will end 90 days after positive final guidance is published (or 30 days in the case of drugs with an Early Access to Medicines Scheme designation or cost comparison evaluation), at which point funding will switch to routine commissioning budgets.
The Welsh ministers have issued directions to the NHS in Wales on implementing NICE highly specialised technologies guidance. When a NICE highly specialised technologies guidance recommends the use of a drug or treatment, or other technology, the NHS in Wales must usually provide funding and resources for it within 60 days of the first publication of the final draft guidance.
When NICE recommends a treatment 'as an option', the NHS must make sure it is available within the period set out in the paragraphs above. This means that, if a patient has activated phosphoinositide 3‑kinase delta syndrome (APDS) and the healthcare professional responsible for their care thinks that leniolisib is the right treatment, it should be available for use, in line with NICE's recommendations.