Daratumumab with bortezomib, lenalidomide and dexamethasone can be used as an option for untreated multiple myeloma in adults when an autologous stem cell transplant (ASCT) is unsuitable. Daratumumab can only be used if the company provides it according to the commercial arrangement (see section 2).
This recommendation is not intended to affect treatment with daratumumab with bortezomib, 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 healthcare professional consider it appropriate to stop.
Daratumumab with bortezomib, lenalidomide and dexamethasone must be funded in the NHS in England for the condition and population in the recommendations, if it is considered the most suitable treatment option. Daratumumab with bortezomib, lenalidomide and dexamethasone must be funded in England within 90 days of final publication of this guidance.
There is enough evidence to show that daratumumab with bortezomib, lenalidomide and dexamethasone provides benefits and value for money, so it can be used routinely across the NHS in this population.
For this evaluation, the company asked for daratumumab with bortezomib, lenalidomide and dexamethasone to be considered only for untreated multiple myeloma in adults when an ASCT is unsuitable. This does not include everyone who it is licensed for. NICE is evaluating daratumumab with bortezomib, lenalidomide and dexamethasone for untreated multiple myeloma when an autologous stem cell transplant is suitable separately.
Usual treatment for adults with untreated multiple myeloma when an ASCT is unsuitable includes:
daratumumab plus lenalidomide and dexamethasone
isatuximab plus bortezomib, lenalidomide and dexamethasone.
Daratumumab plus bortezomib, lenalidomide and dexamethasone has not been directly compared in a clinical trial with the usual treatments, but indirect comparisons suggest that it is likely to work as well as some of these.
Clinical trial evidence shows that daratumumab plus bortezomib, lenalidomide and dexamethasone increases how long people have before their condition gets worse and how long they live compared with bortezomib, lenalidomide and dexamethasone.
There are some uncertainties in the economic model. But, despite these uncertainties, the cost-effectiveness estimates are within the range that NICE considers an acceptable use of NHS resources. So, daratumumab with bortezomib, lenalidomide and dexamethasone can be used.