Extended indication Conditioning treatment prior to haematopoietic progenitor cell transplantation
Therapeutic value No judgement
Total cost 671,000.00
Registration phase Registration application pending

Product

Active substance Treosulfan
Domain Oncology and Hematology
Main indication Other hematology
Extended indication Conditioning treatment prior to haematopoietic progenitor cell transplantation
Manufacturer Medac
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
Additional remarks Alkylerend middel

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Particularity New medicine
Submission date February 2018
Expected Registration March 2019
Orphan drug Yes
Registration phase Registration application pending

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 remarks 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 remarks 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 remarks Busulfan volgens behandelschema vademecum hematologie voor een patient van 70 kg: 19 flacons, in totaal €5.883,70.

Potential total cost per year

Total cost

671,000.00

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.