Advice

following a full submission assessed under the orphan equivalent medicine process:

sodium thiosulfate (Pedmarqsi®) is accepted for use within NHSScotland.

Indication under review: for the prevention of ototoxicity induced by cisplatin chemotherapy in patients 1 month to <18 years of age with localised, non-metastatic, solid tumours.

In two randomised, open-label, phase III studies, sodium thiosulfate treatment resulted in statistically significant reductions in hearing loss induced by cisplatin chemotherapy in patients with localised, non-metastatic, solid tumours compared with best supportive care.

This advice applies only in the context of an approved NHSScotland Patient Access Scheme (PAS) arrangement delivering the cost-effectiveness results upon which the decision was based, or a PAS/ list price that is equivalent or lower.

This advice takes account of the views from a Patient and Clinician Engagement (PACE) meeting.

Medicine details

Medicine name:
sodium thiosulfate (Pedmarqsi)
SMC ID:
SMC2730
Indication:

For the prevention of ototoxicity caused by cisplatin chemotherapy in patients 1 month to < 18 years of age with localised, non-metastatic, solid tumours.

Pharmaceutical company
Norgine Ltd
BNF chapter
Ear, nose and oropharynx
Submission type
Full
Status
Accepted
Date advice published
12 May 2025