5.1 Section 7(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 clinical commissioning groups, NHS England and, with respect to their public health functions, local authorities to comply with the recommendations in this appraisal within 3 months of its date of publication. Because pembrolizumab was made available in the NHS through the early access to medicines scheme, NHS England has indicated that this guidance will be implemented 30 days after final publication.
5.2 The Welsh Assembly Minister for Health and Social Services has issued directions to the NHS in Wales on implementing NICE technology appraisal guidance. When a NICE technology appraisal recommends the use of a drug or treatment, or other technology, the NHS in Wales must usually provide funding and resources for it within 3 months of the guidance being published.
5.3 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 unresectable or metastatic melanoma after progression with ipilimumab and, for BRAF V600 mutation‑positive disease, a BRAF or MEK inhibitor, and the doctor responsible for their care thinks that pembrolizumab is the right treatment, it should be available for use, in line with NICE's recommendations.
5.4 NHS England and Merck Sharp & Dohme have agreed that pembrolizumab will be available to the NHS with a commercial access agreement. The details of this commercial access agreement are confidential. Any enquiries from NHS organisations about the commercial access agreement should be directed to email@example.com.