Isatuximab plus bortezomib, lenalidomide and dexamethasone can be used, within its marketing authorisation, as an option for untreated multiple myeloma in adults when an autologous stem cell transplant is unsuitable. It can only be used if the company provides it according to the commercial arrangement.
What this means in practice
Isatuximab plus bortezomib, lenalidomide and dexamethasone must be funded in the NHS in England for the condition and population in the recommendation, if it is considered the most suitable treatment option. It should be funded in England within 90 days of final publication of this guidance.
On balance, there is enough evidence to show that isatuximab plus bortezomib, lenalidomide and dexamethasone provides benefits and value for money, so it can be used routinely across the NHS in this population.
NICE has produced tools and resources to support the implementation of this guidance.
Usual treatment for untreated multiple myeloma when an autologous stem cell transplant is unsuitable is 1 of several combination treatments, most commonly daratumumab, lenalidomide and dexamethasone.
Isatuximab plus bortezomib, lenalidomide and dexamethasone has not been directly compared in a clinical trial with daratumumab, lenalidomide and dexamethasone. But the results of an indirect comparison suggest that it may increase how long people live compared with them.
The cost-effectiveness estimates for isatuximab plus bortezomib, lenalidomide and dexamethasone are within the range that NICE considers an acceptable use of NHS resources. So, it can be used.