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Isavuconazole

Cresemba

Extended indication Cresemba hard capsules are indicated in adults and in paediatric patients from 6 years of age for th
Therapeutic value No estimate possible yet
Total cost 3,772.50
Registration phase Registered

Product

Active substance Isavuconazole
Domain Infectious diseases
Reason of inclusion Indication extension
Main indication Fungal infections
Extended indication Cresemba hard capsules are indicated in adults and in paediatric patients from 6 years of age for the treatment of invasive aspergillosis and for mucormycosis in patients for whom amphotericin B is inappropriate
Proprietary name Cresemba
Manufacturer Basilea
Route of administration Oral
Therapeutical formulation Capsule
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date 2024
Expected Registration August 2024
Orphan drug Yes
Registration phase Registered
Additional remarks Positieve CHMP opinie juni 2024

Therapeutic value

Therapeutic value No estimate possible yet
Substantiation Dit middel wordt af en toe gegeven maar niet zeer veel. Wellicht heeft het meerwaarde bij kinderen in verband met minder bijwerkingen (3).
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.
References Declaratiedata. 2024 (1); Expertopinie (2).
Additional remarks In 2023 waren er ~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 251.50
References Medicijnkosten.nl,
Additional remarks De gemiddelde prijs per stuk van een 100 mg Cresemba capsule is €45,69 (incl. BTW). Zes toedieningen kosten dan €251,50 (excl. BTW).

Potential total cost per year

Total cost

3,772.50

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

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.