Janssen slams NICE decision on Imbruvica
pharmafile | March 2, 2016 | News story | Research and Development, Sales and Marketing | CLL, Cancer, Cancer Drugs Fund, Janssen, Johnson & Johnson, NICE, imbruvica
Janssen, the R&D arm of pharma major Johnson & Johnson, says it is extremely disappointed following regulator NICE’s announcement that it does not intend to recommend its Imbruvica (ibrutinib) to treat chronic lymphocytic leukaemia (CLL).
Mark Hicken, managing director of Janssen UK, comments: “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.”
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 fund – demonstrating the huge clinical demand.
In February 2014, the US 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. It has received three oncology breakthrough therapy designations from the FDA.
About one in every 25 people will be diagnosed with blood cancer during their lifetime. That equates to around 30,000 people each year being diagnosed with blood cancer in the UK; of these around 3,400 will have CLL.
The public consultation has now started and interested parties may submit a response through the NICE website. The deadline for responses is March, 23.
Anjali Shukla
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