Favourable opinion for reimbursement in the indication “in combination with bortezomib, lenalidomide, and dexamethasone, for the first-line treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant”.
Clinical Benefit
Low
The clinical benefit of SARCLISA (isatuximab) is low in the MA indication.
Clinical Added Value
no clinical added value
Considering:
an increase in progression-free survival, with HR = 0.60 (CI98.5% [0.41; 0.88]) relative to a comparator (VRd protocol) that was accepted at the time of study implementation but was no longer a reference treatment on the date of the assessment, this having been the case since 31 August 2018 when the marketing authorisation for DARZALEX (daratumumab) was issued for this indication (established superiority versus a protocol with no anti-CD38);
the lack of evidence of a benefit in terms of overall survival;
the absence of formal evidence of an improvement in quality of life (exploratory endpoint);
the safety profile of the IsaVRd protocol compared to the VRd protocol, marked by excess grade 3 or more AEs (91.6% versus 84.0%) and serious AEs (70.7% versus 67.4%);
the impossibility of positioning this protocol compared to daratumumab-containing protocols,
the Committee deems that SARCLISA (isatuximab) provides no clinical added value (CAV V) in the current care pathway for the first-line treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.
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