PEDMARQSI (thiosulfate de sodium) - Prevention of ototoxicity induced by cisplatin chemotherapy in patients 1 month to < 18 years of age.

Opinions on drugs - Posted on Jun 05 2025

Reason for request

Inscription

Summary of opinion

Unfavourable opinion for reimbursement in the MA indication: “Prevention of ototoxicity induced by cisplatin chemotherapy in patients 1 month to < 18 years of age with localised, non-metastatic, solid tumours.”

Clinical Benefit

Insufficient

The actual benefit provided by PEDMARQSI (sodium thiosulfate) is insufficient, within the scope of its marketing authorization indication, to justify coverage by national solidarity.