We are extremely disappointed with the preliminary decision by the National Institute for Health and Care Excellence (NICE) not to recommend Imbruvica® (Ibrutinib) for treating chronic lymphocytic leukaemia (CLL) patients who have had at least one prior therapy or, for people with 17p deletion or TP53 mutation and for whom chemo-immunotherapy is unsuitable.
CLL patients have historically had limited access to effective and innovative treatments. If this decision is not reversed following the next consultation process, the health of CLL patients could be seriously affected.
Because patients are responding well and living longer in the clinical trials of this new treatment, median survival data is uncertain and that has led NICE to be unsure whether the clinical benefits of the drug justify the cost to the NHS. We hope that NICE will indeed agree to review this decision as we are deeply concerned that this could mean that patients will have access to even fewer effective new cancer medicines in the future.
We therefore urge NICE to continue their discussions with Janssen to allow them to come to a decision that will be welcomed by CLL patients in the UK.
CLLSA Chair 2 March 2016
Further information and reading:
This draft guidance is set out in the Appraisal Consultation Document available here
It is important to note that this is draft guidance and not a final decision, a consultation process involving NICE, Janssen, clinical groups, patient organizations (CLLSA being one) and individuals will now begin. It is hoped that this will collectively provide NICE with the information required to overturn this to a Final Appraisal Decision that recommends this treatment for CLL patients.
Leukaemia Care - Ibrutinib receives draft “no” from NICE . A good summary overview here
Janssen statement in response to the NICE Appraisal Consultation Document (ACD) on the use of Imbruvica® (Ibrutinib) here
NICE consultation documents and details here