Isavuconazole Medicine 03 December 2024 Extended indication Cresemba hard capsules are indicated in adults and paediatric patients aged 6 years and older for the treatment of invasive aspergillosis and for mucormycosis in patients for whom amphotericin B is not suitable. Therapeutic value No estimate possible yet Total cost € 3,765.00 Registration phase Registered Product Active substance Isavuconazole Domain Infectious diseases Reason of inclusion Indication extension IND Main indication Fungal infections Extended indication Cresemba hard capsules are indicated in adults and paediatric patients aged 6 years and older for the treatment of invasive aspergillosis and for mucormycosis in patients for whom amphotericin B is not suitable. Current proprietary name Already available biosimilars / generics Proprietary name Cresemba Manufacturer Basilea Portfolio holder Mechanism of action Unknown Route of administration Oral Therapeutical formulation Capsule Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date 2024 Expected Registration August 2024 Orphan drug Yes Registration phase Registered Reimbursement Medicine sluice Additional remarks Positieve CHMP opinie juni 2024 Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Dit middel wordt af en toe gegeven maar niet heel veel. Wellicht heeft het meerwaarde bij kinderen in verband met minder bijwerkingen (3). Duration of treatment Frequency of administration Dosage per administration 200 mg References IHSI Horizonscan record isavuconazole (1); NCT03816176 (2); Expertopinie (3). Additional remarks Deze indicatieuitbreiding is voor de orale variant. De aanbevolen dosering van Cresemba bij kinderen is afhankelijk van leeftijd en lichaamsgewicht, maar het maximum aan individuele laad- of dagelijkse onderhoudsdosis is 372mg (1). Expected patient volume per year Patient volume 10 - 20 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Declaratiedata. 2024 (1); Expertopinie (2). Additional remarks In 2023 waren er ongeveer 180 patiënten die Cresemba kregen voor aspergillose en mucormycose (1). De schatting is dat er 10 tot 20 kinderen in aanmerkingen komen voor deze indicatieuitbreiding (2). Expected cost per patient per year Cost € 251.00 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. References Medicijnkosten.nl, Additional remarks De gemiddelde prijs per stuk van een 100mg Cresemba capsule is €45,69 (inclusief BTW). Zes toedieningen kosten dan €251,50 (exclusief BTW). Potential total cost per year Total cost € 3,765.00 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