Acalabrutinib

Active substance

Acalabrutinib

Domain

Oncology and Hematology

Reason of inclusion in Horizonscan Geneesmiddelen

New medicine (specialité)

Main indication

CLL

Extended indication
1L CLL in combinatie met obinutuzumab

1. Product

Proprietary name

Calquence

Manufacturer

AstraZeneca

Mechanism of action

Tyrosine kinase inhibitor

Route of administration

Oral

Therapeutical formulation

Capsule

Budgetting framework

Intermural (MSZ)

2. Registration

Registration route

Centralised (EMA)

Type of trajectory

Normal trajectory

Submission date

October 2019

Expected Registration

September 2020

Orphan drug

Yes

Registration phase

Registration application pending

Additional comments
De fabrikant verwacht registratie in Q4 2020.

3. Therapeutic value

Current treatment options

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

Therapeutic value

No judgement

Substantiation

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

Not found

Frequency of administration

1 times a day

Dosage per administration

100 mg

References
NCT02475681

4. Expected patient volume per year

Patient volume

< 600

Market share is generally not included unless otherwise stated.

Additional comments
Geschat wordt dat er jaarlijks zo'n 600 patiënten in de 1e lijn behandeld worden.

5. Expected cost per patient per year

Cost

70,000

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

6. Potential total cost per year

Total cost

42,000,000

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.

7. Off label use

There is currently nothing known about off label use.

8. 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

9. Other information

There is currently no futher information available.