Daratumumab with bortezomib and dexamethasone for previously treated multiple myeloma

1.1 Daratumumab with bortezomib and dexamethasone is recommended as an option for treating multiple myeloma in adults, only if they have had just 1 previous line of treatment and:

1.2 This recommendation is not intended to affect treatment with daratumumab with bortezomib and dexamethasone that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop.

Why the committee made these recommendations

This evaluation reviews the evidence for daratumumab with bortezomib and dexamethasone from NICE technology appraisal guidance 573. It also reviews new data collected as part of the managed access agreement.

The company proposed daratumumab with bortezomib and dexamethasone as a second-line treatment, which is narrower than its marketing authorisation. Second‑line treatments for multiple myeloma include:

Clinical trial evidence shows that daratumumab with bortezomib and dexamethasone decreases the risk of dying and the chance of myeloma returning or getting worse compared with bortezomib with dexamethasone. There is no direct evidence comparing it with carfilzomib with dexamethasone. An indirect comparison suggests that it decreases the risk of the myeloma returning or getting worse compared with carfilzomib with dexamethasone. No evidence was provided for a comparison with the lenalidomide treatments.

The most likely cost-effectiveness estimates for daratumumab with bortezomib and dexamethasone are below what NICE considers an acceptable use of NHS resources. Because no comparison was done with lenalidomide treatments, daratumumab with bortezomib and dexamethasone is only recommended for people who cannot have lenalidomide as a second treatment. This includes people who had lenalidomide as their first treatment, or when lenalidomide is unsuitable as a second‑line treatment.