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.