NICE positive for Sarclisa with pomalidomide and dexamethasone for treating relapsed and refractory – Sanofi
NICE(UK): Isatuximab plus pomalidomide and dexamethasone can be used as an option to treat relapsed and refractory multiple myeloma in adults if: i) they have had 3 previous lines of treatment, including lenalidomide and a proteasome inhibitor; ii) the condition has progressed on the last treatment; iii) daratumumab monotherapy would otherwise be offered, and the company provides it according to the commercial arrangement. This recommendation is not intended to affect treatment with isatuximab plus pomalidomide and dexamethasone that was funded with managed access before this guidance was published. If this applies, NHS England and the company have an arrangement to make sure people who started treatment during the period of managed access will continue to have isatuximab plus pomalidomide and dexamethasone until they and their NHS healthcare professional consider it appropriate to stop.
Why the committee made these recommendations:
This evaluation reviews the evidence for isatuximab plus pomalidomide and dexamethasone for treating relapsed and refractory multiple myeloma (NICE technology appraisal guidance 658). It also reviews new data collected in the NHS as part of the managed access agreement. In NICE technology appraisal guidance 658, the company asked for isatuximab plus pomalidomide and dexamethasone to be considered only after 3 lines of treatment. This does not include everyone who it is licensed for. After 3 lines of treatment, people with multiple myeloma usually have pomalidomide plus dexamethasone, or daratumumab monotherapy (alone). Clinical trial evidence shows that people on isatuximab plus pomalidomide and dexamethasone have longer before their cancer gets worse and live longer than people on pomalidomide plus dexamethasone. Evidence from people having treatment in the NHS also suggests that people on isatuximab plus pomalidomide and dexamethasone have longer before their cancer gets worse and live longer than people on daratumumab alone.
When comparing isatuximab plus pomalidomide and dexamethasone with pomalidomide plus dexamethasone, the most likely cost-effectiveness estimates are above the range that NICE considers an acceptable use of NHS resources. But when comparing isatuximab plus pomalidomide and dexamethasone with daratumumab alone, the most likely cost-effectiveness estimates are within the range NICE considers an acceptable use of NHS resources.
So, isatuximab plus pomalidomide and dexamethasone can only be used when daratumumab would otherwise be offered.
