Larotrectinib for treating NTRK fusion-positive solid tumours

4.1 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 a neurotrophic tyrosine receptor kinase (NTRK) fusion-positive solid tumour and the doctor responsible for their care thinks that larotrectinib 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. For larotrectinib, the necessary diagnostic testing infrastructure will need to be in place for NTRK gene fusion testing to be available and any training requirements addressed. NHS England is setting up 7 genomic laboratory hubs to do the next generation sequencing tests needed to establish if someone is eligible for larotrectinib treatment. Until the hubs are fully established, there needs to be a phased introduction of next generation sequencing for people with advanced solid tumours. Over the next 1 to 2 years, next generation sequencing will be done when standard care systemic therapies commissioned by NHS England have failed. Once testing capacity at the hubs is fully established, people will have next generation sequencing when a locally advanced or metastatic solid tumour is first diagnosed.

4.2 Chapter 2 of Appraisal and funding of cancer drugs from July 2016 (including the new Cancer Drugs Fund) – a new deal for patients, taxpayers and industry states that for those drugs with a draft recommendation for use in the Cancer Drugs Fund, interim funding will be available (from the overall Cancer Drugs Fund budget) from the point of marketing authorisation, or from release of positive draft guidance, whichever is later. Drugs that are recommended for use in the Cancer Drugs Fund will be funded in line with the terms of their managed access agreement, after the period of interim funding. The NHS England and NHS Improvement Cancer Drugs Fund list provides up-to-date information on all cancer treatments recommended by NICE since 2016. This includes whether they have received a marketing authorisation and been launched in the UK.

4.3 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 document or agreement of a managed access agreement by the NHS in Wales, whichever is the later.