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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.