The aim of this project, which was commissioned by NICE through the NIHR HTA Programme as part of the NICE’s Single Technology Appraisal process, was to review the evidence for the clinical and cost-effectiveness of Ibrutinib for treating relapsed or refractory chronic lymphocytic leukaemia. The clinical evidence submitted by the company (Janssen) responsible for manufacturing Ibrutinib (Imbruvica) focused on the results of a single large multicentre randomised controlled trial comparing Ibrutinib with ofatumumab in patients with chronic lymphocytic leukaemia, who have received at least one prior treatment. The submission also presented data from four non randomised and non-controlled studies of Ibrutinib. The Aberdeen HTA Group acted as the Evidence Review Group (ERG) for the project and provided an independent critique of the clinical and cost-effectiveness evidence submitted by the company.

After taking into consideration the company submission and the findings of the ERG’s critique, NICE released clinical guidance (TA429, January 2017). Ibrutinib alone is currently recommended within its marketing authorisation as an option for treating chronic lymphocytic leukaemia in adults: who have had at least 1 prior therapy or who have a 17p deletion or TP53 mutation, and in whom chemoimmunotherapy is unsuitable and only when the company provides Ibrutinib in line with the commercial access agreement with NHS England.


Clare Robertson: 




Cummins, E, Culligan, D, Cooper, D, Fraser, C, Robertson, C, Ramsay, CR. Ibrutinib for treating relapsed or refractory chronic lymphocytic leukaemia Evidence Review Group report in support of the NICE STA Programme. University of Aberdeen: Health Services Research Unit; 2016. URL