Expand all sections

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 Capsule
Budgetting framework Intermural (MSZ)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date 2024
Expected Registration 2024
Orphan drug Yes
Registration phase Clinical trials

Therapeutic value

Current treatment options Rituximab-CHOP
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 capsules 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.