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Crisantaspase

Enrylaze

Extended indication Enrylaze is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of
Therapeutic value No estimate possible yet
Total cost 893,450.00
Registration phase Registered

Product

Active substance Crisantaspase
Domain Hematology
Reason of inclusion New medicine (specialité)
Main indication ALL
Extended indication Enrylaze is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukaemia (ALL) and lymphoblastic lymphoma (LBL) in adult and paediatric patients (1 month and older) who developed hypersensitivity or silent inactivation to E. coli-derived asparaginase
Proprietary name Enrylaze
Manufacturer Jazz
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
Additional remarks L-Asparaginase encapsulated inside donor-derived red blood cells.

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date April 2023
Expected Registration September 2023
Orphan drug Yes
Registration phase Registered
Additional remarks Positieve CHMP-opinie juli 2023

Therapeutic value

Therapeutic value No estimate possible yet
Dosage per administration 150 IU/kg
References NCT01518517
Additional remarks Minimaal 2 en maximaal 10 toedieningen om de 3 dagen in combinatie met standaard chemotherapie (COOPRALL).

Expected patient volume per year

Patient volume

26 - 81

Market share is generally not included unless otherwise stated.
References NKR2020; Blinatumomab
Additional remarks Er zijn jaarlijks 81 diagnoses B-ALL met specifieke cytogenetische afwijkingen. Circa 30% van de patiënten krijgt een eerste recidief. Dit komt overeen met ongeveer 26 patiënten per jaar.

Expected cost per patient per year

Cost > 16,700.00
References GIPdatabank
Additional remarks De prijs zal mogelijk vergelijkbaar zijn met andere vormen van crisantaspase die al op de markt zijn. Vergoeding per gebruiker in 2023 was €16.661,59

Potential total cost per year

Total cost

893,450.00

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

Off label use No

Indication extension

Indication extension No

Other information

There is currently no futher information available.