The United Kingdom’s National Institute for Health and Care Excellence (NICE) rejected ibrutinib for the treatment of Waldenström macroglobulinemia, citing a lack of cost-effectiveness evidence submitted for patients in whom chemoimmunotherapy is considered unsuitable.
NICE said in a statement that it acknowledged the unmet need for treating this patient population, but it could not approve the drug based on the level of data provided.
NICE previously decided not to recommend ibrutinib for the treatment of chronic lymphocytic leukemia due to “numerous uncertainties in the evidence base and economic modeling” of the drug.
Ibrutinib has been approved for this indication in the United States since January 2015.
Source: PM Live, October 14, 2016.