Zanubrutinib Medicine 10 June 2020 Extended indication Mantelcel non-hodgkin lymfoom Waldenström's macroglobulinaemia (WM) Chronische Lymfatische Leukemie (CLL) Therapeutic value No judgement Total cost Registration phase Clinical trials Product Active substance Zanubrutinib Domain Oncology and Hematology Reason of inclusion New medicine (specialité) Main indication Aggressive non-Hodgkin’s lymphoma Extended indication Mantelcel non-hodgkin lymfoom Waldenström's macroglobulinaemia (WM) Chronische Lymfatische Leukemie (CLL) Current proprietary name Already available biosimilars / generics Proprietary name BGB-3111 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 Unknown Particularity Unknown ATMP Unknown Submission date Expected Registration Orphan drug Yes Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Zal competitief zijn met ibrutinib. Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration Dosage per administration References Additional remarks Expected patient volume per year Patient volume 27 - 79 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Pakketadvies ibrutinib Additional remarks De verwachting is dat zanubrutinib de concurrentie aan zal gaan met ibrutinib. De inschatting van het patiëntvolume in het ''pakketadvies ibrutinib'' bij patiënten met CLL betrof 27 tot 79 mogelijke patiënten die in aanmerking komen. Expected cost per patient per year Cost References Additional remarks Huidige Lijstprijs ibrutinib x Maximaal gebruik per jaar: €69.839. Dit betreft alleen Ibrutinib. Voor de indicatie 1e lijns Chronische lymfatische leukemie (CLL) wordt onderhandeld over een financieel arrangement en zit het geneesmiddel in de sluis. 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