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Acalabrutinib

Calquence

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 remarks 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 remarks 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 remarks 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 remarks 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.