Rezafungin Medicine 10 June 2020 Extended indication Rezzayo is indicated for the treatment of invasive candidiasis in adults. Therapeutic value Possible benefit in ease of use Total cost Registration phase Registered Product Active substance Rezafungin Domain Infectious diseases Reason of inclusion New medicine (specialité) Main indication Fungal infections Extended indication Rezzayo is indicated for the treatment of invasive candidiasis in adults. 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 No Submission date August 2022 Expected Registration December 2023 Orphan drug No Registration phase Registered Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie oktober 2023 Therapeutic value Current treatment options Caspofungin. Therapeutic value Possible benefit in ease of use 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. De toediening van eenmaal per week biedt een voordeel in toedienginsgemak 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 tot 11 per 100.000 inwoners. Voor Nederland zou dit ongeveer 170 tot 1.870 gevallen betreffen. De verwachting is dat enkele tientallen patiënten daadwerkelijk in aanmerking komen. Expected cost per patient per year Cost References Drugs.com Additional remarks De prijs in de Verenigde Staten voor Rezzayo intraveneus poeder voor injectie 200 mg bedragen ongeveer $ 2.063 voor een voorraad van 1 poeder voor injectie. De Nederlandse prijs zal lager zijn dan in de Verenigde Staten. 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