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Acalabrutinib

Calquence

Extended indication Acalabrutinib monotherapy for second line or later treatment of relapsed or refractory mantle cell l
Therapeutic value No estimate possible yet
Total cost 15,491,346.00
Registration phase Registration application pending

Product

Active substance Acalabrutinib
Domain Hematology
Reason of inclusion Indication extension
Main indication Aggressive non-Hodgkin’s lymphoma
Extended indication Acalabrutinib monotherapy for second line or later treatment of relapsed or refractory mantle cell lymphoma in adults and elderly
Proprietary name Calquence
Manufacturer AstraZeneca
Portfolio holder AstraZeneca
Mechanism of action Tyrosine kinase inhibitor
Route of administration Oral
Therapeutical formulation Tablet
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
ATMP No
Submission date September 2024
Expected Registration July 2025
Orphan drug Yes
Registration phase Registration application pending
Additional remarks Verwachte registratie op basis van EMA-indiening in september 2024 en een gemiddelde doorlooptijd van 10 maanden voor een indicatieuitbreiding.

Therapeutic value

Current treatment options Rituximab-CHOP of BR
Therapeutic value No estimate possible yet
Duration of treatment continuous
Frequency of administration 2 times a day
Dosage per administration 100 mg
References NCT02213926 (ACE-LY-004) (1); Wang et al. Lancet. 2017 (2).

Expected patient volume per year

Patient volume

< 247

Market share is generally not included unless otherwise stated.
References NKR 2022 (1)
Additional remarks In 2022 waren er 247 patiënten gediagnosticeerd met mantelcellymfoom (1).

Expected cost per patient per year

Cost < 62,718.00
References Z-Index 2022; ZIN pakketadvies acalabrutinib 2022
Additional remarks De apotheekinkoopprijs van acalabrutinib is €4.811,27 voor 56 tabletten met 100mg acalabrutinib (Z-Index). De aanbevolen dagelijkse dosering is 200mg (2 capsules) waarmee de kosten op €171,83 per dag komen. De kosten voor behandeling met acalabrutinib komen daarmee op €62.718 per jaar.

Potential total cost per year

Total cost

15,491,346.00

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

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.