1.1 Daratumumab plus bortezomib plus dexamethasone is recommended for use within the Cancer Drugs Fund as an option for treating relapsed multiple myeloma in people who have had 1 previous treatment. It is recommended only if the conditions in the managed access agreement for daratumumab plus bortezomib plus dexamethasone are followed.
1.2 This recommendation is not intended to affect treatment with daratumumab plus bortezomib plus 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
Currently, treatment options for multiple myeloma include bortezomib or carfilzomib (both with dexamethasone) if a person has had thalidomide as the first treatment. For those who have had bortezomib first, carfilzomib is not a treatment option and retreatment with bortezomib is becoming routine.
Clinical trial results show that, as a second treatment, daratumumab plus bortezomib plus dexamethasone improves how long people live for before the disease gets worse when compared with bortezomib plus dexamethasone. The results also suggest that people who have daratumumab plus bortezomib plus dexamethasone live longer. However, how much longer they live in total is unclear because there are no long-term trial data. The benefits of daratumumab plus bortezomib plus dexamethasone compared with carfilzomib plus dexamethasone are unclear because they haven't been compared directly in a trial.
The estimates of cost effectiveness presented by the company and evidence review group differ greatly. These differences depend mostly on the estimates of how much longer people will live if they have daratumumab plus bortezomib plus dexamethasone rather than bortezomib plus dexamethasone. If the company's estimates are confirmed by extra trial data, there is potential for daratumumab plus bortezomib plus dexamethasone to be cost effective. Therefore it is recommended for use in the Cancer Drugs Fund while extra data on long-term survival are collected.