4 Implementation

Routine commissioning

4.1 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.

4.2 The Welsh ministers have 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 2 months of the first publication of the final appraisal determination.

4.3 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 Merkel cell carcinoma and has had 1 or more previous lines of therapy, and the doctor responsible for their care thinks that avelumab is the right treatment, it should be available for use, in line with NICE's recommendations.

Cancer Drugs Fund and a managed access agreement

4.4 When NICE recommends a treatment as an option for use within the Cancer Drugs Fund, NHS England will make it available according to the conditions in the managed access agreement. This means that, if a patient has metastatic Merkel cell carcinoma and has had no prior lines of therapy, and the doctor responsible for their care thinks that avelumab is the right treatment, it should be available for use, in line with NICE's recommendations and the Cancer Drugs Fund criteria in the managed access agreement. Further information can be found in NHS England's Appraisal and funding of cancer drugs from July 2016 (including the new Cancer Drugs Fund) – A new deal for patients, taxpayers and industry.

4.5 The Welsh ministers have issued directions to the NHS in Wales on implementing NICE technology appraisal guidance when the drug or treatment, or other technology, is approved for use within the Cancer Drugs Fund. When a NICE technology appraisal recommends the use of a drug or treatment, or other technology, for use within the Cancer Drugs Fund, the NHS in Wales must usually provide funding and resources for it within 2 months of the first publication of the final appraisal determination or agreement of a managed access agreement by the NHS in Wales, whichever is the latter.

4.6 Avelumab has been recommended according to the conditions in the managed access agreement. As part of this, NHS England and Merck have a commercial access agreement that makes avelumab available to the NHS at a reduced cost for people who have not had chemotherapy for metastatic disease. The financial terms of the agreement are commercial in confidence. Any enquiries from NHS organisations about the commercial access agreement should be directed to UKPricing@merckgroup.com.

  • National Institute for Health and Care Excellence (NICE)