Daratumumab in combination for treating newly diagnosed systemic amyloid light-chain amyloidosis

1 Recommendations

1.1 Daratumumab plus bortezomib, cyclophosphamide and dexamethasone is not recommended, within its marketing authorisation, for treating newly diagnosed systemic amyloid light-chain (AL) amyloidosis in adults.

1.2 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 currently 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 disease responds to daratumumab in combination after 6 cycles, daratumumab alone is offered.

Clinical evidence suggests that daratumumab in combination increases the time until systemic AL amyloidosis gets worse compared with bortezomib plus cyclophosphamide and dexamethasone. However, the treatment has not been shown to increase how long people live.

All the cost-effectiveness estimates for daratumumab are in a range higher than what NICE considers an effective use of NHS resources. Therefore, daratumumab in combination is not recommended.