Favourable opinion for reimbursement in “the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior therapies, including an immunomodulatory agent (IMiD), a proteasome inhibitor (PI) and an anti-CD38 antibody and have demonstrated disease progression on the last therapy”.
Clinical Benefit
Substantial
The Committee deems that the clinical benefit of ABECMA (idecabtagene vicleucel) is substantial in the MA indication.
Clinical Added Value
minor
Considering:
demonstration in an open-label, randomised phase 3 study of the superiority of ABECMA (idecabtagene vicleucel) compared to the investigator’s choice treatment, from five different regimens, in terms of:
progression-free survival assessed by an independent review committee according to IMWG criteria: HR = 0.49 [95% CI: 0.38-0.65], with a median of 13.3 months (min-max: 11.8-16.1) in the ABECMA (idecabtagene vicleucel) group, and 4.4 months (min-max: 3.4-5.9) in the investigator’s choice treatment group, i.e. a point estimate of the absolute difference of 8.9 months;
the overall response rate assessed by an independent review committee according to IMWG criteria: OR = 3.5 [95% CI: 2.1-5.9];
and despite:
the open-label implementation of the study, having led to possible assessment biases, particularly in terms of assessment of treatment decisions;
the fact that patients from the investigator’s choice treatment group could receive a previously administered treatment (except the last treatment received);
the lack of clinical relevance of the overall response rate in this context, particularly given the lack of evidence of its transposability to overall survival time or improvement of quality of life;
the lack of evidence, as the dossier currently stands, of an impact on overall survival, in an advanced disease with an unfavourable prognosis;
the absence of any formal conclusion that can be drawn based on the quality-of-life findings;
the safety profile marked, in particular, by significant toxicity;
the Committee deems that ABECMA (idecabtagene vicleucel)provides a minor clinical added value (CAV IV) in the current care pathway, which includes the relevant comparators.
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