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01
Jun
NICE ‘uncertain’ over ibrutinib benefit

written by

Leukaemia Care, Charity

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The National Institute for Health and Care Excellence (NICE) has today issued a second set of draft guidance as part of the appraisal of new drug ibrutinib (marketed by Janssen as Imbruvica®) for the treatment of chronic lymphocytic leukaemia (CLL).

This draft guidance comes via a second appraisal consultation document (ACD), which sets out NICE’s preliminary recommendation. At this point, NICE have made the following recommendations:

“1.1 Ibrutinib is not recommended for treating chronic lymphocytic leukaemia in adults without a 17p deletion or TP53 mutation.

1.2 The appraisal committee is minded not to recommend ibrutinib as an option for treating chronic lymphocytic leukaemia in adults with a 17p deletion or TP53 mutation. The committee invites the company to submit a proposal for inclusion in the Cancer Drugs Fund.”

A copy of the draft guidance is available here.

It is important to note that this is only draft guidance and that the recommendations may change in the final guidance (expected June 2016). Additionally, any decision not to recommend ibrutinib in the final guidance would not affect patients who are currently receiving treatment with ibrutinib within the NHS, whose treatment will be continued until they and their clinician consider it appropriate to stop.

As part of their draft guidance, the committee and the economic review group (ERG) noted that the data was “immature (notably, median progression-free survival and overall survival had not been reached in the ibrutinib arm of RESONATE), which the committee acknowledged may reflect a successful treatment effect, but which led to uncertainty.” (Page 36 of 61, 4.16)

‘Successful treatment effect’ refers to the fact that median progression-free survival (PFS) and overall survival had not yet been reached in the ibrutinib arm of the RESONATE clinical trial. This means that after 30 months of follow-up, over 50% of patients are still alive and responding to treatment (compared with only 8.1 months progression-free for the comparator treatment option in the trial, ofatumumab).

Zack Pemberton-Whiteley, Head of Campaigns and Advocacy at Leukaemia CARE commented:

“We are extremely concerned that NICE considers ibrutinib to be too ‘uncertain’ to merit recommendation for NHS use, despite the fact that it has been widely recommended throughout Europe.

We are shocked by NICE’s view that the survival data is “uncertain” because median progression-free survival and overall survival has not yet been reached in the RESONATE clinical trial. Survival endpoints have not yet been reached because patients are still alive and responding to treatment. It is appalling that NICE view this as “considerable uncertainty”, rather than a significant step forward. These comments show that NICE is flawed, outdated and out of touch with what matters to patients.

We urge NICE to reconsider their recommendation to ensure that patients can continue to access ibrutinib in the future.”

For further information please contact our Campaigns and Advocacy team by email at advocacy@leukaemiacare.org.uk or call our CARE line on 08088 010444