Rezafungin Medicine 10 June 2020 Extended indication Patients With Candidemia and/or Invasive Candidiasis Therapeutic value No estimate possible yet Total cost Registration phase Registration application pending Product Active substance Rezafungin Domain Infectious diseases Reason of inclusion New medicine (specialité) Main indication Fungal infections Extended indication Patients With Candidemia and/or Invasive Candidiasis Current proprietary name Already available biosimilars / generics Proprietary name Biafungin Manufacturer Cidara Portfolio holder Mechanism of action Enzyme inhibitor Route of administration Intravenous Therapeutical formulation Injection Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Glucan synthase inhibitors Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date August 2022 Expected Registration September 2023 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Caspofungin. Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Verwacht wordt dat er zeker een plek is in de poliklinische zetting. De data uit de fase 3 studie ReSTORE liet zien dat rezafungin non-inferieur is ten opzichte van caspofungin. Duration of treatment Average 3 week / weeks Frequency of administration 1 times a week Dosage per administration 200 mg References NCT03667690 Additional remarks Expected patient volume per year Patient volume 10 - 50 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Hanemaaijer et al. Ned Tijdschr Med Microbiol 2016; 24 nr. 1 Additional remarks In Europa betreft de incidentie van invasieve candidiasis ongeveer 1-11 per 100.000 inwoners. Voor Nederland zou dit ongeveer 170-1.870 gevallen betreffen. De verwachting is dat enkele tientallen patiënten daadwerkelijk in aanmerking komen. Expected cost per patient per year Cost References Additional remarks 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 Unknown Indication extensions References Additional remarks Other information Additional remarks