Today The National Institute for Health and Care Excellence (NICE) have published technology appraisal guidance [TA487] nice.org.uk/guidance/ta487
No surprises this is in line with the final Appraisal Determination (FAD) last Month and our outline article here ( NICE use the Cancer Drugs Fund to grant access to venetoclax for treating chronic lymphocytic leukaemia patients.) healthunlocked.com/leukaemi....
Implementation:
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 chronic lymphocytic leukaemia and the doctor responsible for their care thinks that venetoclax 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.
Cancer Drugs Fund
November 2017 Managed Access Agreement, Venetoclax for treating chronic lymphocytic leukaemia nice.org.uk/guidance/ta487/... PDF nice.org.uk/guidance/ta487/... This outlines the purpose and process of data collection and patient eligibility criteria
Venetoclax is recommended for use within the Cancer Drugs Fund, within its marketing authorisation, as an option for treating chronic lymphocytic leukaemia; that is in adults:
•with a 17p deletion or TP53 mutation and when a B-cell receptor pathway inhibitor is unsuitable, or whose disease has progressed after a B-cell receptor pathway inhibitor or
•without a 17p deletion or TP53 mutation, and whose disease has progressed after both chemo-immunotherapy and a B-cell receptor pathway inhibitor and
•only if the conditions in the managed access agreement are followed.
5.2 The Welsh Ministers have issued directions to the NHS in Wales on implementing NICE technology appraisal guidance where the drug or treatment, or other technology is approved for use within the Cancer Drugs Fund. When a NICE technology appraisal guidance 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. We are currently investigating state of play with this in Wales!
To be continued
Nick