Sodium thiosulfate (otoprotectant)
An old antidote proven in two paediatric trials to halve permanent hearing loss from cisplatin, and approved in 2022 as the first drug to prevent a chemotherapy side effect in children.
SIOPEL-6 (NEJM 2018, hepatoblastoma) and ACCL0431 (Lancet Oncol 2017) showed hearing loss reduced from ~63% to ~33% without compromising survival in localised disease (a survival signal in disseminated disease in ACCL0431 keeps use to localised tumours). Approved FDA September 2022 (ages ≥1 month), EMA 2023.
- Medicare
- Part B (clinician-administered)
Given by infusion or injection in a clinic or hospital outpatient department, so it is a Part B drug: Medicare pays 80% after the Part B deductible and the patient owes 20% coinsurance, uncapped in Original Medicare unless a Medigap policy applies. Pedmark is given after each cisplatin dose in children; almost all patients are on Medicaid/CHIP or commercial family plans.
- Commercial insurance
- covered with prior authorisation
Covered on label (paediatric localised solid tumours receiving cisplatin) with prior authorisation.
Sources: Medicare.gov: Chemotherapy · Medicare.gov: Prescription drugs (outpatient, Part B). Not medical or financial advice; verify with your plan.
- Notes
- EU-licensed 2023 to prevent cisplatin ototoxicity in children; NICE appraised it 2023-24. Check NICE.
Sources: NICE search: sodium thiosulfate (Pedmark). Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
Approvals
| Region | Year | Indication |
|---|---|---|
| US | 2022 | Reduce risk of ototoxicity from cisplatin in patients ≥1 month with localised, non-metastatic solid tumours |
| EU | 2023 | Same |
Trials
topRecruiting now (live from ClinicalTrials.gov)
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Latest papers
topQuery for this drug: (TITLE:"Sodium thiosulfate" OR ABSTRACT:"Sodium thiosulfate" OR TITLE:"otoprotectant" OR ABSTRACT:"otoprotectant" OR TITLE:"Pedmark" OR ABSTRACT:"Pedmark") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Sodium thiosulfate (otoprotectant), not a curated reading list.
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