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New HTA Decisions in France
March 2021
Drug name
SARCLISA® (isatuximab)
Company
Sanofi-Aventis France
Decision date
18/11/2020
Therapeutic area
Cancer
Therapeutic sub area
Blood and bone marrow cancers
Official notice date
15/01/2021
Reimbursement %
Decision (SMR)
Important
Decision (ASMR)
Minor improvement (IV)
Indication
SARCLISA® is indicated, in combination with pomalidomide and dexamethasone, for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two previous treatments (including lenalidomide and a proteasome inhibitor), and whose disease has progressed during the last treatment.
Decision Type
New technology assessment
Summary
The opinion of the committee is favourable to the reimbursement of SARCLISA®, in combination with pomalidomide and dexamethasone, for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two previous treatments (including lenalidomide and a proteasome inhibitor) and whose disease has progressed during the last treatment. SARCLISA® provides an improvement in minor benefit (ASMR IV) compared to the combination IMNOVID (pomalidomide) plus dexamethasone in the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two previous treatments including lenalidomide and a proteasome inhibitor and whose disease has progressed during the last treatment, considering : • the demonstration of the superiority of the addition of SARCLISA® to IMNOVID® (pomalidomide) plus dexamethasone compared to the combination of IMNOVID® (pomalidomide) plus dexamethasone, in terms of progression-free survival, and; • the tolerance profile, consistent with that known for anti-CD38 antibodies, marked in particular by infections and febrile neutropenia, but; • the lack of demonstration to date of a benefit in terms of overall survival in two interim analyses pending the final analysis of overall survival, and; • the lack of demonstrated impact on quality of life.