Daratumumab plus bortezomib, cyclophosphamide and dexamethasone is recommended as an option for treating newly diagnosed systemic amyloid light-chain (AL) amyloidosis in adults. It is recommended only if:
daratumumab is stopped after 24 cycles of treatment, or earlier if the condition progresses, and
the company provides daratumumab according to the commercial arrangement.
This recommendation is not intended to affect treatment with daratumumab plus bortezomib, cyclophosphamide 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
Systemic AL amyloidosis is usually treated with medicines that are licensed for multiple myeloma. These include bortezomib plus cyclophosphamide and dexamethasone. Daratumumab plus bortezomib, cyclophosphamide and dexamethasone (daratumumab in combination) is the first treatment licensed for AL amyloidosis. If the condition responds to daratumumab in combination after 6 cycles, daratumumab alone is offered for up to 18 cycles, for a total of 24 cycles.
Clinical evidence suggests that daratumumab in combination increases the time until systemic AL amyloidosis gets worse compared with bortezomib plus cyclophosphamide and dexamethasone. People whose condition responds to daratumumab in combination may live longer, but this is uncertain.
The cost-effectiveness estimates for daratumumab are within the range NICE considers an acceptable use of NHS resources. So, daratumumab in combination is recommended.