NICE is unable to make a recommendation about the use in the NHS of daratumumab with bortezomib, melphalan and prednisone for untreated multiple myeloma when stem cell transplant is unsuitable. This is because Janssen has confirmed that it does not intend to make an evidence submission for the appraisal. Janssen considers that the technology is unlikely to be a cost-effective use of NHS resources.
If NHS organisations wish to consider daratumumab with bortezomib, melphalan and prednisone for this indication, 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.