NICE is unable to make a recommendation about the use in the NHS of ibrutinib with rituximab for treating Waldenstrom's macroglobulinaemia in adults because Janssen did not provide an evidence submission. The company has confirmed that it does not intend to make a submission for the appraisal because there is unlikely to be sufficient evidence that the technology is a cost-effective use of NHS resources in this population.
If NHS organisations wish to consider ibrutinib with rituximab for treating Waldenstrom's macroglobulinaemia, 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 if the company decides that it wants to make an evidence submission.