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