Daratumumab with lenalidomide and dexamethasone is recommended, within its marketing authorisation, as an option for untreated multiple myeloma in adults, when an autologous stem cell transplant is unsuitable. It is only recommended if the company provides it according to the commercial arrangement.
Why the committee made this recommendation
Multiple myeloma is usually first treated with lenalidomide plus dexamethasone when an autologous stem cell transplant is unsuitable. But sometimes bortezomib plus an alkylating agent (cyclophosphamide or melphalan) and a corticosteroid (dexamethasone or prednisone) might be more suitable. Daratumumab plus lenalidomide and dexamethasone is 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 compared with lenalidomide plus dexamethasone. Clinical trial evidence also shows it increases how long people live compared with lenalidomide plus dexamethasone, but by how much is uncertain. There is no direct evidence comparing daratumumab plus lenalidomide and dexamethasone with bortezomib plus an alkylating agent and a corticosteroid, but indirect comparisons suggest that it is more effective.
The most likely cost-effectiveness estimates for daratumumab plus lenalidomide and dexamethasone are within the range that NICE normally considers an acceptable use of NHS resources, so it is recommended.