The National Institute for Health and Care Excellence (NICE) has issued a final appraisal determination (FAD) recommending that AbbVie’s Venclyxto® (venetoclax) is made available to NHS patients with difficult-to-treat types of chronic lymphocytic leukaemia (CLL) via the Cancer Drugs Fund (CDF), providing conditions of the managed access agreement are followed.
Venetoclax will now be available on the NHS to adult patients in England with CLL in the absence of 17p deletion or TP53 mutation who have failed both chemo‑immunotherapy and a B-cell receptor (BCR) inhibitor.
Venetoclax has also been recommended for the treatment of adult CLL patients in the presence of 17p deletion or TP53 mutation who are either unsuitable for or have failed a BCR inhibitor.2 Please see the NICE website for the eligibility criteria: https://www.nice.org.uk/guidance/gid-ta10077/documents/final-appraisal-d…. The recommendation marks the continuation of patient access across the UK, following the recent acceptance of venetoclax for use across NHS Scotland this August.
“The immediate inclusion of venetoclax in the Cancer Drugs Fund is a positive step forward for patients with CLL in England” commented David Innes, Chair of the CLL Support Association. “Access to new treatment options is vital for patients with challenging forms of CLL, who have a short life expectancy after exhausting current treatment options. We are pleased to see AbbVie and NICE working together to expedite patient access and are hopeful that this will ultimately translate into longer-term routine prescribing on the NHS, providing an essential treatment option for those living with CLL and their families.”
Venetoclax, is a first-in-class, oral, once-daily medicine that selectively inhibits the function of the BCL-2 protein, restoring the body’s ability to trigger cancer cell self-destruction.2 For those patients living with CLL requiring treatment, the majority will eventually have their disease recur,3 with one in two patients failing current treatments facing survival as short as three months.4,5 Venetoclax is being developed by AbbVie and Roche. It is jointly commercialised by AbbVie and Genentech, a member of the Roche Group, in the US and by AbbVie outside of the US.
Dr Peter Hillmen, Professor of Experimental Haematology and Honorary Consultant Haematologist at Leeds Teaching Hospitals NHS Trust, commented, “Today’s recommendation is great news for patients with CLL who have failed existing treatments, and provides clinicians with an important new treatment option. The studies that NICE has assessed to reach this positive decision represent a milestone in the management of relapsed/refractory CLL. The early clinical data is compelling, showing survival benefits for this challenging group of patients, including some who achieved complete remission. I would anticipate that collection of further data through the CDF will confirm these extremely promising early findings.”
Alice Butler, Medical Director at AbbVie, said, “We are pleased with today’s decision having worked closely with NICE, NHS England (NHSE) and the clinical and patient community to ensure that patients can gain access to venetoclax on the NHS. Working together with the NHS to collect more long-term data provides an important opportunity to understand the impact of venetoclax on the survival of patients with this difficult-to-treat type of CLL.”
- NICE Final Appraisal Determination. Venetoclax for treating chronic lymphocytic leukaemia: https://www.nice.org.uk/guidance/gid-ta10077/documents/final-appraisal-d…. Last accessed September 2017.
- VENCLYXTO summary of product characteristics: https://www.medicines.org.uk/emc/medicine/32650
- American Cancer Society. (2013) Leukemia – Chronic Lymphocytic. Available at: http://www.cancer.org/acs/groups/cid/documents/webcontent/003111-pdf.pdf. Last accessed September 2017.
- Follows G. Outcomes for UK CLL patients post ibrutinib therapy. UK CLL Forum poster presented at BSH. 2017.
- Jain PW et al. Outcomes of patients with chronic lymphocytic leukemia after discontinuing ibrutinib. Blood. 2015; 125: 2062-2067.