Treosulfan

Active substance Treosulfan
Domain Oncology and Hematology
Reason of inclusion in Horizonscan Geneesmiddelen New medicine (specialité)
Main indication Stem cell transplants
Extended indication Treosulfan in combination with fludarabine is indicated as part of conditioning treatment prior to allogeneic haematopoietic stem cell transplantation (alloHSCT) in adult patients with malignant and non-malignant diseases, and in paediatric patients older than one month with malignant diseases.

Product

Proprietary name Trecondi
Manufacturer Medac
Mechanism of action Alkylating agent
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
Additional comments Alkylerend middel

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date February 2018
Expected Registration June 2019
Orphan drug Yes
Registration phase Registered
Additional comments Positieve CHMP-opinie december 2018. Geregistreerd in juni 2019.

Therapeutic value

Current treatment options Busulfan
Therapeutic value No judgement
Duration of treatment Average 3 day / days
Frequency of administration 1 times a day
Dosage per administration 10 g/m2
References NCT00822393
Additional comments Toedieningen op dagen -4, -3 en -2.

Expected patient volume per year

Patient volume

< 122

Market share is generally not included unless otherwise stated.

References GIPdatabank
Additional comments 122 gebruikers van busulfan in 2015.

Expected cost per patient per year

Cost 5,000.00 - 6,000.00
References Medicijnkosten.nl; Vademecum Hematologie
Additional comments Busulfan volgens behandelschema vademecum hematologie voor een patient van 70 kg: 19 flacons, in totaal €5.883,70. Inmiddels is de prijs van Treosulfan bekend: injectieflacon peoder oplossing voor infusie van 1.000MG FL: €95,68 Uitgaande van gemiddeld 3 behandeldagen en een persoon van 1,8m2 kom je uit op €5.166,73 per patiënt per jaar.

Potential total cost per year

Total cost

671,000

This amount gives an indication of the total cost. It is the result of the average expected patient volume times the average cost per patient. both per year.

Off label use

There is currently nothing known about off label use.

Indication extension

Indication extension Yes
Indication extensions Ovarian cancer, ewing sarcoma, ALL.
References Clinicaltrials.gov

Other information

There is currently no futher information available.