Section 7 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 3 months of its date of publication.
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 routine commissioning, 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(from the overall Cancer Drugs Fund budget) from the point of marketing authorisation, or from release of positive draft guidance, whichever is later. Interim funding 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 NHS England 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.
The Welsh ministers have issued directions to the NHS in Wales on implementing NICE technology appraisal guidance. When a NICE technology appraisal 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NHS in Wales must usually provide funding and resources for it within 2 months of the first publication of the final draft guidance.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 KIT (CD117)-positive unresectable and/or KIT (CD117)-positive metastatic gastro-intestinal stromal tumours (GISTs) and the healthcare professional responsible for their care thinks that imatinib is the right treatment, it should be available for use, in line with NICE's recommendations.
All clinicians who treat people with KIT (CD117)-positive unresectable and/or KIT (CD117)-positive metastatic GIST should review their current policies and practice to take account of the guidance set out in section 1.
Local guidelines or care pathways for the care of patients with KIT (CD117)-positive unresectable and/or KIT (CD117)-positive metastatic GIST should incorporate the guidance.
To measure compliance locally with the guidance, the following criteria could be used. Further details on suggestions for audit are presented in appendix A.
For a person with KIT (CD117)-positive unresectable and/or KIT (CD117)-positive metastatic GIST, imatinib treatment at 400 mg/day is provided as first-line management for up to 12 weeks.
Imatinib therapy at 400 mg/day is continued beyond the first 12 weeks only if a person's GIST responds to treatment within 12 weeks. (Response to treatment is defined in section 1.5 and appendix B).
A person whose GIST has responded to imatinib therapy is assessed at intervals of approximately 12 weeks and imatinib therapy at 400 mg/day is continued until the GIST ceases to respond. (Response to treatment is defined in section 1.5 and appendix B).
If progressive disease develops in a person whose GIST initially responded to imatinib therapy, the dose of imatinib is not increased.
A cancer specialist with experience in the management of people with metastatic and/or unresectable GISTs supervises the use of imatinib.