Sodium thiosulfate Medicine 10 June 2020 Extended indication Preventing Hearing Loss in Young Patients (1 year to 18 years old) receiving Cisplatin for Newly Diagnosed Germ Cell Tumor, Hepatoblastoma, Medulloblastoma, Neuroblastoma, Osteosarcoma, or Other Malignancy. Therapeutic value No estimate possible yet Total cost Registration phase Registration application pending Product Active substance Sodium thiosulfate Domain Oncology and Hematology Reason of inclusion New medicine (specialité) Main indication Oncology other Extended indication Preventing Hearing Loss in Young Patients (1 year to 18 years old) receiving Cisplatin for Newly Diagnosed Germ Cell Tumor, Hepatoblastoma, Medulloblastoma, Neuroblastoma, Osteosarcoma, or Other Malignancy. Current proprietary name Already available biosimilars / generics Proprietary name Pedmark Manufacturer Fennec Pharmaceuticals Portfolio holder Mechanism of action Antioxidant Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date March 2020 Expected Registration February 2022 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation De effectiviteit van sodium thiosulfaat op het voorkomen van ototoxiciteit is aangetoond middels onderzoek. Daarentegen is ook aangetoond dat sodium thiosulfaat de effectiviteit van cisplatine mogelijk teniet doet (Freyer, 2014). De algehele survival van de groep patiënten die sodium thiosulfaat is namelijk kleiner dan dat van de controle groep. Duration of treatment Frequency of administration Dosage per administration 16 g/m2 References NCT00716976, Freyer, D. (2014). The effects of sodium thiosulfate (STS) on cisplatin-induced hearing loss: A report from the Children’s Oncology Group. Journal Of Clinical Oncology, 32(15_suppl), 10017-10017. Additional remarks Dosering per toediening: 16g/m2 or 533mg per kg for patients whose therapeutic protocol administers cisplatin on a per kg basis due to young age or small body). Expected patient volume per year Patient volume < 500 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks De inschatting in de leeftijdscategorie van 1 tot 18 is dat er maximaal 500 patiënten voor in aanmerking zullen komen. Expected cost per patient per year Cost References https://dawsonjames.com/ Additional remarks In een equity onderzoek van DawsonJames securities wordt een prijs van $60.000 genoemd, ongeveer €54.000. Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions No Indication extensions References adisinsight Additional remarks Other information Additional remarks