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NICE Appraisal Consultation Document (ACD) on the use of ibrutinib for relapsed or refractory Chronic Lymphocytic Leukaemia (CLL)

High Wycombe, 2 March 2016:  Janssen is extremely disappointed with the NICE Appraisal Consultation Document (ACD)1 published today which states that NICE does not intend to recommend Imbruvica® (Ibrutinib) for the treatment of adult patients with relapsed or refractory Chronic Lymphocytic Leukaemia (CLL) who are not suitable for chemo-immunotherapy.

This draft recommendation from NICE for ibrutinib sits in stark contrast to the recommendations of 48 countries globally which have opted to fund or reimburse the medicine including 27 European countries, most recently in Greece.2 In England, ibrutinib is currently available on the Cancer Drugs Fund (CDF) for use in adult patients with relapsed or refractory chronic lymphocytic leukaemia (CLL) and is the most requested drug for CLL on the fund3 - demonstrating the huge clinical demand.

This is a draft decision from NICE and an ongoing consultative process will now begin. Janssen will be actively participating in this process to ensure a solution can be found so that eligible patients can continue to access ibrutinib.

In February 2014, the U.S. Food and Drug Administration (FDA) granted ibrutinib accelerated approval for the treatment of CLL based on the results of a clinical study of previously treated patients.4 It has received three oncology breakthrough therapy designations from the FDA.5

Ibrutinib was granted a UK license on the basis of phase II clinical trial data.6,7 Further phase III data demonstrated a significantly improved survival benefit.8 Encouragingly for people living with CLL, the ibrutinib trials are still ongoing because patients continue to survive on treatment. Unfortunately, however, the current NICE process views ongoing studies as “uncertain” and thus disadvantages innovative medicines that keep people alive longer.

Mark Hicken, Managing Director of Janssen UK, said: “At Janssen, our first priority is to patients and so we are extremely disappointed with the preliminary recommendation from NICE not to recommend ibrutinib for adult patients with CLL, who have limited treatment options.

“There is very high clinical demand for this innovative medicine, so this decision is yet another example of how the current NICE appraisal process is not fit-for-purpose in responding to the needs of cancer patients and the healthcare professionals who treat them. This is a worrying sign for people living in England and is, unfortunately, likely to be much more common under the new Cancer Drugs Fund process approved by the NHS England Board last week.

“If this decision is allowed to stand, patients in England are likely to have access to even fewer new cancer medicines in future, leading us to fall even further behind the rest of Western Europe.

“Our submission to NICE demonstrates cost-effectiveness and meets their end of life criteria and we intend to challenge this initial recommendation. We hope NICE will reconsider its position so that this important medicine can be routinely available to the patients that need it.”

Approximately one in every twenty-five people will be diagnosed with blood cancer during their lifetime.9 That equates to around 30,000 people each year being diagnosed with blood cancer in the UK;10 of these around 3,400 will have CLL11.

The public consultation has now started and interested parties may submit a response through the NICE website. The deadline for response is 23rd March, 2016.1



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