NICE Endorses Funding for Ibrutinib in Patients With CLL

Patients who have had at least 1 prior therapy or carry a 17p deletion or TP53 mutation are now eligible to be treated with the Burton’s tyrosine kinase inhibitor ibrutinib (Imbruvica) developed by Janssen, according to the National Institutes of Health and Care Excellence (NICE), which is the agency that monitors funding for healthcare in England and Wales.

In early 2016, Janssen UK received news that NICE had rejected funding for ibrutinib, which was, at the time, being funded through UK’s Cancer Drug Fund. NICE had doubts about whether the drug—which cost £55,954.50 for a year’s course—would be cost effective. Mark Hicken, managing director of Janssen UK, had said then that the company was negotiating with NICE to demonstrate cost effectiveness and to ensure patient’s continued to have access to the drug.

Results from the RESONATE-2 trial could have swayed the decision in favor of the drug. At the 2016 annual meeting of the American Society of Hematology, Paul Barr, MD, assistant professor of medicine at the University of Rochester Wilmot Cancer Institute, reported impressive results from the trial. In a population of older treatment-naïve patients, the 24-month overall survival was 95% in the ibrutinib arm, compared with 84% for the comparator arm. Hematological functions, too, were significantly improved in patients treated with ibrutinib.

The company is now waiting to see whether NICE also clears ibrutinib for treating patients with mantle cell lymphoma and Waldenström's macroglobulinemia.