Zanubrutinib Medicine 07 June 2022 Extended indication Extension of indication to include treatment of adult patients with marginal zone lymphoma (MZL) who have received at least one-prior anti-CD20-based therapy Therapeutic value No estimate possible yet Total cost Registration phase Registration application pending Product Active substance Zanubrutinib Domain Hematology Reason of inclusion Indication extension IND Main indication CLL Extended indication Extension of indication to include treatment of adult patients with marginal zone lymphoma (MZL) who have received at least one-prior anti-CD20-based therapy 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 Unknown Particularity Unknown ATMP Unknown Submission date January 2022 Expected Registration November 2022 Orphan drug Unknown Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options PI3K delta remmers, zoals bijvoorbeeld: duvelisib en idelalisib. Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration 2 times a day Dosage per administration 160 mg References NCT03846427 (MAGNOLIA) Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Budget impact analyse van ibrutinib (Imbruvica) bij de behandeling van chronische lymfatische leukemie (patiënten zonder 17p of TP53 mutaties). Additional remarks Ongeveer 10% van de Non Hodgkin Lymfoom gevallen is een marginale zone lymfoom. In Nederland zijn er 3.000 nieuwe patiënten per jaar. Hiervan zijn dus ongeveer 300 patiënten met marginale zone lymfoom. Naar verwachting zal 50% hiervan op enig moment een tweedelijnsbehandeling ondergaan. Het patiëntvolume zal daardoor maximaal 150 patiënten bedragen. Echter worden er beperkte patiëntaantallen verwacht gezien concurrerende geneesmiddelen. Expected cost per patient per year Cost € < 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 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. Additional remarks 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 Unknown Indication extensions References Additional remarks Other information Additional remarks