Zanubrutinib Medicine 10 June 2020 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. Therapeutic value Possible equal value Total cost 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. Current proprietary name Already available biosimilars / generics Proprietary name Brukinsa Manufacturer BeiGene Portfolio holder Mechanism of action Tyrosine kinase inhibitor Route of administration Oral Therapeutical formulation Capsule Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date June 2020 Expected Registration December 2021 Orphan drug Yes Registration phase Positive CHMP opinion Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie in september 2021. Therapeutic value Current treatment options Ibrutinib. Therapeutic value Possible equal value This assessment does not indicate any potential inclusion in the package. Substantiation De verwachting is dat zanubrutinib gelijkwaardig zal zijn ten opzichte van ibrutinib. Duration of treatment Frequency of administration Dosage per administration References Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice 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 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. 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 Total cost Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Yes Indication extensions B-cell lymphoma; Waldenstrom's macroglobulinaemia. References Adisinsight. Additional remarks Lopende fase 3 studies. Other information Additional remarks