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Acalabrutinib

Calquence

Extended indication

Mantle cell lymphoma (MCL), 1L.
Therapeutic value

No estimate possible yet
Total cost

13,923,396.00
Registration phase

Clinical trials

Product

Active substance

Acalabrutinib
Domain

Hematology
Reason of inclusion

Indication extension
Main indication

Aggressive non-Hodgkin’s lymphoma
Extended indication

Mantle cell lymphoma (MCL), 1L.
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

2024
Expected Registration

2025
Orphan drug

Yes
Registration phase

Clinical trials
Additional remarks 
indiening gepland H2 2024 en registratie gepland H2 2025

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

100mg
References 
NCT02972840 (ECHO)

Expected patient volume per year

Patient volume

< 222

Market share is generally not included unless otherwise stated.
References 
IKNL
Additional remarks 
Incidentie betreft in totaal 222 patiënten in 2020 voor Mantle Cell Lymphoma (MCL).

Expected cost per patient per year

Cost

62,718.00
References 
Z-Index 2022; ZIN pakketadvies acalabrutinib 2022
Additional remarks 
De apotheekinkoopprijs (AIP) van acalabrutinib is €4.811,27 voor 56 tabletten met 100 gram 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

13,923,396.00

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

Indication extension

Yes
Indication extensions

Zie andere indicatie op de Horizonscan Geneesmiddelen. Daarnaast ook in fase 3: Relapsed or refractory chronic lymphocytic leukaemia (CLL) in high-risk patients
References 
SPS UK

Other information

There is currently no futher information available.