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1 Recommendations

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1 Recommendations

1.1 Daratumumab with lenalidomide and dexamethasone is not recommended, within its marketing authorisation, for untreated multiple myeloma in adults, when an autologous stem cell transplant is unsuitable.

1.2 This recommendation is not intended to affect treatment with daratumumab plus lenalidomide 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

Adults with multiple myeloma usually have lenalidomide plus dexamethasone as a first treatment when an autologous stem cell transplant is unsuitable. But, sometimes bortezomib plus an alkylating agent (cyclophosphamide or melphalan) and a corticosteroid (dexamethasone or prednisolone) might be more suitable. Daratumumab plus lenalidomide and dexamethasone could be an alternative first treatment when an autologous stem cell transplant is unsuitable.

Clinical trial evidence shows that daratumumab plus lenalidomide and dexamethasone increases the amount of time people have before their condition gets worse and how long they live for compared with lenalidomide plus dexamethasone. But based on the clinical trial evidence it is uncertain by how much daratumumab plus lenalidomide and dexamethasone increases how long people live for. There is no direct evidence comparing daratumumab plus lenalidomide and dexamethasone with bortezomib plus an alkylating agent and a corticosteroid, but indirect comparisons suggests that it is more effective.

The most likely cost-effectiveness estimates for daratumumab plus lenalidomide and dexamethasone are uncertain and substantially above what NICE considers to be an acceptable use of NHS resources. So, it is not recommended.