NICE is unable to make a recommendation about the use in the NHS of ibrutinib for untreated chronic lymphocytic leukaemia without a 17p deletion or TP53 mutation because no evidence submission was received from Janssen–Cilag. The company has confirmed that it does not intend to make a submission.
If NHS organisations wish to consider ibrutinib for untreated chronic lymphocytic leukaemia without a 17p deletion or TP53 mutation, they should follow the advice on rational local decision-making in the NHS Constitution for England and the NHS Commissioning Board and Clinical Commissioning Groups (Responsibilities and Standing Rules) Regulations 2012. This outlines the approach that should be taken when there is no NICE guidance.
NICE will review the position at any point if the company decides that it wants to make an evidence submission.