NICE publish guidance to enable NHS England commissioning of Venetoclax for treating CLL; within CDF managed access agreement.

[HAIRBEAR_UK]

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 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.

england.nhs.uk/cancer/cdf/

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

[Cllcanada Top Poster CURE Hero]

Great to see this. Canada should have a recommendation by the end of November...

The Canadian use is a bit broader... but doesn't include the 17p/TP53

As monotherapy for the treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy and who have failed a B-Cell Receptor Inhibitor (BCRi)

~chris

[HAIRBEAR_UK Founder Admin in reply to Cllcanada]

Fingers crossed this time round for you all. Everything in increments!

With so many variants and different CLL incarnations, we are never going to find one silver bullet, personalised medicine and variety is a must.

Without recognised predictive prognostic factors combined with targeted therapies there will always be gaps?? I am pleased to be taking part in HARMONY workshops this month that may help change some of this in Europe?

in the meantime it is good to know that there are options available should the wheels fall of the bus!!

Nick

[scarletnoir]

Thanks for this - is the comment about Wales written by yourself, or was it in the source material? As I live there and may need access to this drug in future, I'd like to know the outcome!

[HAIRBEAR_UK Founder Admin in reply to scarletnoir]

Thanks for your message scarletnoir,

Welsh policy tends to always follow NICE, The source material in italics was written into the guidance, Which is encouraging if it is followed. What is not clear is timeline and route they will use..

We as blood cancer charities are investigating How Wales will be implementing the guidance.

Will keep everyone posted.

Nick

[scarletnoir in reply to HAIRBEAR_UK]

Thanks very much - good to know - I hope that I won't need it for a long time, though!