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Zanubrutinib

Brukinsa

Extended indication Patients with Waldenström’s macroglobulinemia (WM) who have received at least one prior therapy or a
Therapeutic value Possible equal value
Registration phase Positive CHMP opinion

Product

Active substance Zanubrutinib
Domain Oncology and Hematology
Reason of inclusion New medicine (specialité)
Main indication Other hematology
Extended indication Patients with Waldenström’s macroglobulinemia (WM) who have received at least one prior therapy or as first-line treatment for patients unsuitable for chemo-immunotherapy.
Proprietary name Brukinsa
Manufacturer BeiGene
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 June 2020
Expected Registration December 2021
Orphan drug Yes
Registration phase Positive CHMP opinion
Additional remarks Positieve CHMP-opinie in september 2021.

Therapeutic value

Current treatment options Ibrutinib.
Therapeutic value Possible equal value
Substantiation De verwachting is dat zanubrutinib gelijkwaardig zal zijn ten opzichte van ibrutinib.

Expected patient volume per year

References NKR
Additional remarks Er zijn ongeveer 1.500 patiënten met MW in Nederland. 214 is het aantal diagnoses Lymfoplasmacytair lymfoom/ M Waldenström in 2016. De inschatting is dat er per jaar maar weinig patiënten voor in aanmerking zullen komen.

Expected cost per patient per year

Cost 70,000.00 - 138,000.00
References https://www.pharmacytimes.com/news/trending-news-today-beigene-sets-price-for-zanubrutinib-for-mantle-cell-lymphoma
Additional remarks In de Verenigde Staten is de lijstprijs voor zanubrutinib gesteld op $12.935 (ongeveer €11.500). Voor de behandeling van een jaar zou dat €138.000 bedragen. Zanubrutinib zal de concurrentie aan moeten gaan met ibrutinib, wat €69.839 per jaar kost. Naar verwachting zal de prijs in Europa vergelijkbaar zijn.

Potential total cost per year

There is currently nothing known about the possible total cost.

Off label use

There is currently nothing known about off label use.

Indication extension

Indication extension Yes
Indication extensions B-cell lymphoma; Waldenstrom's macroglobulinaemia.
References Adisinsight.
Additional remarks Lopende fase 3 studies.

Other information

There is currently no futher information available.