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 comments
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 comments
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.