Janssen is “extremely disappointed” with the second Appraisal Consultation Document (ACD) published today, according to a statement from the company.
NICE is not recommending Imbruvica® (ibrutinib) for the treatment of adult patients with relapsed or refractory Chronic Lymphocytic Leukaemia (CLL) without a 17p deletion or TP53 mutation who are not suitable for chemo-immunotherapy. Additionally, for the high-risk 17p deletion patients, the NICE appraisal committee is minded not to recommend ibrutinib as an option for treating CLL in adults with a 17p deletion or TP53 mutation.
In the statement, the company said: “This recommendation means that once again, the UK lags well behind other European countries that have already opted to fund or reimburse the medicine for a patient population who have very few treatment options. In England, ibrutinib remains available on the Cancer Drugs Fund (CDF) for use in adult patients with relapsed or refractory CLL and continues to be the most requested drug for CLL on the fund[ii] – demonstrating high clinical and patient demand.”
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 in February 2014. It has received three oncology breakthrough therapy designations from the FDA.
Ibrutinib was granted a UK license on the basis of phase II clinical trial data. Further phase III data demonstrated a significantly improved survival benefit. The ibrutinib trials are still however ongoing because patients continue to survive on treatment. Further data was provided by Janssen following the first ACD in March 2016, but NICE considers the data from these ongoing studies to be “uncertain”, requiring full clarity on the duration of treatment to be established; and as a consequence, penalising innovative medicines, such as ibrutinib, that keep people alive longer.
Mark Hicken, Managing Director of Janssen UK, said: “At Janssen, our first priority is to ensure our medicines reach the patients who need them. There is very high clinical and patient demand for ibrutinib and we consider this latest draft decision from NICE to be very disappointing for patients with CLL, who currently have very limited treatment options. What is even more concerning is that, without changes to the way NICE appraises cancer medicines, such decisions are likely to become commonplace, under the new Cancer Drugs Fund or ‘Managed Access Fund’ process; resulting in patients receiving access to even fewer innovative cancer medicines in the future.
“This is a draft decision from NICE and the consultative process will continue. Janssen is committed to actively participating in this process to discuss how patients can continue to access this innovative medicine”.