Acalabrutinib

Extended indication	1L CLL in combinatie met obinutuzumab
Therapeutic value	No judgement
Total cost	42,000,000.00
Registration phase	Registration application pending

Product

Active substance	Acalabrutinib
Domain	Oncology and Hematology
Reason of inclusion	New medicine (specialité)
Main indication	CLL
Extended indication	1L CLL in combinatie met obinutuzumab
Proprietary name	Calquence
Manufacturer	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	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; fludarabine cyclophosphamide rituximab (FCR); chlorambucil +/- rituximab
Therapeutic value	No judgement
Frequency of administration	1 times a day
Dosage per administration	100 mg
References	NCT02475681

Expected patient volume per year

Patient volume	< 600 Market share is generally not included unless otherwise stated.
Additional remarks	Geschat wordt dat er jaarlijks zo'n 600 patiënten in de 1e lijn behandeld worden.

Patient volume

< 600

Market share is generally not included unless otherwise stated.

Additional remarks

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

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	42,000,000.00 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.

Total cost

42,000,000.00

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	Geen andere fase III studies naar andere indicaties op dit moment, wel lopen er vele fase II studies naar verschillende indicaties.
References	AdisInsight

Other information

There is currently no futher information available.