NICE approves venetoclax for treating chronic lymphocytic leukaemia patients

NICE use the Cancer Drugs Fund to grant access to venetoclax for treating chronic lymphocytic leukaemia patients.

Today the National Institute for Health and Care Excellence (NICE) published the Final Appraisal Determination (FAD) recommending venetoclax (Venclyxto) be made available to treat chronic lymphocytic leukaemia (CLL). Access has been granted via the Cancer Drugs fund, through a managed access program. This enables accelerated access to the treatment by CLL patients and their doctors whilst additional data is collected.

NICE recommendations

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.

The complete Guidance FAD document, committee papers and managed access agreement can be accessed here.

When a treatment is approved for use within the Cancer Drugs Fund, NHS England make it available according to the conditions in the managed access agreement. If a patient has chronic lymphocytic leukaemia and their doctor thinks that venetoclax is the right treatment, it can now be accessed in line with the above recommendations.

Venetoclax is anticipated to remain available through the CDF during the data collection period until December 2020 and during a subsequent appraisal, while the final guidance is reviewed. A final decision is expected in early 2021.

Nick York, a CLL patient working as Campaigns and Advocacy Officer at Leukaemia Care commented:

“Patients unsuitable for, or who have failed treatment with a B-cell receptor inhibitor (BCRi) have few remaining options, a poor quality of life and very limited survival prospects.

Leukaemia Care welcome NICE’s decision to make this important treatment available to patients who have run out of options. We have been receiving very promising reports from UK patients treated with venetoclax over the past few years, that they are able to function with improved quality of life and live well again.

We are pleased that NICE have aligned with NHS Scotland’s previous recommendation and we very much hope that this new managed access route secures continued access to this promising treatment for England and Wales patients for years to come.

Clinical trials involving venetoclax in combination with other agents for use in other CLL populations are now also maturing. This treatment may soon be appraised again by NICE and other NHS appraisal bodies for use in these different groups and combinations. We are potentially on the cusp of a significant step change in how CLL is managed and treated into the future. Today’s decision offers the CLL community much hope for our future.”

For further information, please contact our Campaigns and Advocacy team. They are available Monday to Friday from 9:00am – 5:30pm. If you would like to contact them, you can:

  • Call our office line on 01905 755977
  • Send them an email
  • Call the helpline, free of charge on 08088 010 444 anytime. They will pass your enquiry onto the Campaigns and Advocacy team.

For more information on chronic lymphocytic leukaemia (CLL), please click here.

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