Patients with chronic lymphocytic leukaemia (CLL) living in England and Wales are unlikely to get access to Janssen UK’s Imbruvica on the NHS after the drug was turned down by cost regulators.
The National Institute for Health and Care Excellence has published preliminary guidelines rejecting the drug’s use because uncertainties in the company’s submission have cast a shadow of doubt over whether Imbruvica (ibrutinib) is a cost-effective use of NHS resources in the this setting.
Janssen said it is “extremely disappointed” with NICE’s position which, it argues, is “in stark contrast to the recommendations of 48 countries globally which have opted to fund or reimburse the medicine including 27 European countries”.
In England, Imbruvica is currently available through the Cancer Drugs Fund for use in adult patients with relapsed or refractory CLL and, according to the firm, “is the most requested drug for CLL on the fund - demonstrating the huge clinical demand”.
“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,” said Mark Hicken, Janssen UK’s managing director. “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”.
The firm said it would challenge the recommendation arguing that, if it 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”.
The cost of a year’s course of Imbruvica treatment is £55,954.50 (excluding VAT), but the company has agreed a patients access scheme with the Department of health under which it would provide the drug at a simple discount to its list price.