NICE Terminates Appraisals for Daratumumab with Lenalidomide and Dexamethasone, Bortezomib in Relapsed Multiple Myeloma, and Ibrutinib for Untreated CLL

NICE unable to make recommendations for the use in the NHS

On 5 July 2017, the NICE announced that it has terminated appraisals for daratumumab with lenalidomide and dexamethasone for treating relapsed or refractory multiple myeloma, bortezomib for treating multiple myeloma after second or subsequent relapse, and ibrutinib for untreated chronic lymphocytic leukaemia (CLL) without a 17p deletion or TP53 mutation.

The NICE is unable to make a recommendation about the use in the NHS of daratumumab, with lenalidomide and dexamethasone (Technology appraisal [TA454]), for treating relapsed or refractory multiple myeloma because no evidence submission was received from Janssen-Cilag. The company has confirmed that it does not intend to make a submission. A technology appraisal of daratumumab with bortezomib and dexamethasone for this population is currently in progress.

The NICE is unable to make a recommendation about the use in the NHS of bortezomib for treating multiple myeloma after second or subsequent relapse (Technology appraisal [TA453])because no evidence submission was received from Janssen-Cilag. The company has confirmed that it does not intend to make a submission.

The NICE is unable to make a recommendation about the use in the NHS of ibrutinib for untreated CLL without a 17p deletion or TP53 mutation (Technology appraisal [TA452])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 daratumumab, with lenalidomide and dexamethasone, for treating relapsed or refractory multiple myeloma, or bortezomib for treating multiple myeloma after second or subsequent relapse, or ibrutinib for untreated CLL 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.

The NICE will review the positions at any point if the company decides that it wants to make an evidence submissions.