Imbruvica faces preliminary NICE rejection for CLL

Janssen's CLL drug Imbruvica has been rejected by the UK's NICE in preliminary guidance over concerns regarding cost effectiveness.

The National Institute for Health and Care Excellence's (NICE) initial appraisal document stated that Imbruvica (ibrutinib) is not recommended in two specific forms of chronic lymphocytic leukaemia (CLL): people who have had at least one prior therapy and people with a 17p genetic mutation or TP53 mutation in whom chemo-immunotherapy is unsuitable.

The recommendations are based, in part, on uncertain results from the recent RESONATE trial investigating the use of Imbruvica versus Novartis' Arzerra (ofatumumab) in previously treated CLL patients, although some median analyses found Imbruvica improved progression-free and overall survival.

However, the biggest concern is over the cost of the drug. Imbruvica has a list price of £51.10 per tablet (excluding VAT), with a year's course costing around £56,000. However, Janssen had agreed an undisclosed price with the Department of Health.

Janssen expressed disappointment, remarking that the decision "sits in stark contrast to the recommendations of 48 countries globally which have opted to fund or reimburse the medicine including 27 European countries."

Mark Hicken, UK managing director of Janssen, focused on NICE's appraisal process, describing it as "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 CDF [Cancer Drugs Fund] process approved by the NHS England board last week."

The sentiment was echoed by Head of Campaigns and Advocacy at Leukaemia CARE, Zack Pemberton-Whitely: "[the preliminary recommendation] demonstrates the numerous flaws in NICE's methodology when dealing with uncertainty."

Cancer Drugs Fund uncertainty

Imbruvica is still available via the Cancer Drugs Fund (CDF) and remains its most requested CLL drug. However, the upcoming restructuring of the Fund, due to come into effect on 1 July, suggests the potential for even more bad news for Imbruvica.

Its initial acceptance onto the CDF took time, with rival Arzerra the first to be given the nod in November 2014. A year later it was saved from de-listing from the CDF for Mantle Cell Lymphoma, alongside Takeda's Adcetris, Roche's Avastin and Kadcyla, and Janssen's own Caelyx.

NICE's preliminary verdict is open for comment until 23 March. The full approval document can be accessed here.