Imbruvica, developed by Janssen for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia who are unsuitable to receive chemo-immunotherapy, has been rejected by UK’s National Institute of Health and Care Excellence.
The Burton’s tyrosine kinase inhibitor ibrutinib (Imbruvica) developed by Janssen for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) who are unsuitable to receive chemo-immunotherapy, has been rejected by UK’s cost-regulator, the National Institute of Health and Care Excellence (NICE).
Ibrutinib is currently available through UK’s Cancer Drug Fund, which provides financial assistance to cover some of the drugs that are rejected by NICE. According to Mark Hicken, managing director, Janssen UK, it is the most requested drug on the fund, which proves the clinical demand for ibrutinib.
“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,” said Hicken in a statement.
A report by PharmaTimes states that NICE has highlighted uncertainties in Janssen’s submission as being the reason for their doubts on whether ibrutinib would be cost effective for the National Health Service (NHS), UK’s publicly-funded healthcare system. The cost of a year’s course of ibrutinib treatment is £55,954.50, but the company has agreed on a patient access scheme with the department of health under which it would provide the drug at a simple discount to its list price.
This may not be the final word on the drug by NICE, rather a stop-gap to secure discount deals with drug manufacturers. Roche pharmaceuticals, for instance, first saw its drug Gazyvaro rejected by NICE, only to be approved in a few months following price negotiations.
According to a statement released by the company, there is hope that these draft guidelines could be overturned through a continued negotiation with NICE to ensure eligible patients continue to find access to ibrutinib.
“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,” said Hicken.
A recent study in the Journal of Oncology Practice estimated the annual cost of ibrutinib at $118,000 per patient in the United States.