Ibrutinib

Summary

Ibrutinib is recommended by NICE

As part of the NICE single technology appraisal process, this assessment critically reviews the company’s submission related to the evidence for the clinical and cost-effectiveness of Ibrutinib for treating relapsed or refractory chronic lymphocytic leukaemia. The submission 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.  Ibrutinib alone is 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 with the discount agreed in the patient access scheme.

Contact

Clare Robertson: c.robertson@abdn.ac.uk 

Status

Completed; for further information see:

https://www.journalslibrary.nihr.ac.uk/programmes/hta/1414804/#/