Extended indication

Behandeling van relapsed/refractory CLL (chronic lymphocytic leukemia).

Therapeutic value

No judgement yet

Total cost

52,500,000.00

Registration phase

Registration application pending

Product

Active substance

Acalabrutinib

Domain

Oncology and Hematology

Reason of inclusion

New medicine (specialité)

Main indication

CLL

Extended indication

Behandeling van relapsed/refractory CLL (chronic lymphocytic leukemia).

Proprietary name

Calquence

Manufacturer

AstraZeneca

Mechanism of action

Tyrosine kinase inhibitor

Route of administration

Oral

Therapeutical formulation

Capsule

Budgetting framework

Intermural (MSZ)

Additional comments
A second-generation selective Bruton's tyrosine kinase (Btk) inhibitor

Registration

Registration route

Centralised (EMA)

Type of trajectory

Normal trajectory

Submission date

October 2019

Expected Registration

November 2020

Orphan drug

Yes

Registration phase

Registration application pending

Additional comments
De fabrikant verwacht registratie in Q4 2020.

Therapeutic value

Current treatment options

Rituximab combined with idelalisib (IdR) or bendamustine (BR); ibrutinib; venetoclax +/- rituximab; fludarabine cyclophosphamide rituximab (FCR); chlorambucil +/- rituximab

Therapeutic value

No judgement yet

Substantiation

In de ASCEND trial wordt acalabrutinib vergeleken met IdR of BR. De rol van Acalabrutinib is nog niet helemaal duidelijk. Als uit studies blijkt, dat het inderdaad net zo effectief is als ibrutinib, maar minder toxisch, dan zal het ibrutinib gaan vervangen.

Duration of treatment

Average 2 month / months

Frequency of administration

2 times a day

Dosage per administration

100 mg

References
NCT02970318 (meerdere fase 3 studies gaande)

Expected patient volume per year

Patient volume

600 - 900

Market share is generally not included unless otherwise stated.

References
Pakketadvies: ibrutinib (Imbruvica) bij eerstelijnsbehandeling chronische lymfatische leukemie (CLL) bij patiënten die geen del(17p) of TP53-mutatie hebben. Expert opinie.
Additional comments
Ieder jaar starten ongeveer 600 CLL patiënten met een eerstelijnsbehandeling. Geschat dat 900 patiënten jaarlijks behandeld worden voor een recidief of refractaire ziekte.

Expected cost per patient per year

Cost

70,000.00

References
Zie eerdere inschatting ibrutinib CLL in de horizonscan.
Additional comments
Prijs mogelijk in dezelfde range als ibrutinib: inschatting zo'n €70.000.

Potential total cost per year

Total cost

52,500,000.00

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

1L mantle cell lymphoma, R/R CLL high-risk, 1L CLL icm venetoclax en obinutuzumab

References
Astrazeneca pipeline

Other information

There is currently no futher information available.