Ibrutinib Medicine 09 January 2018 Extended indication Mantle cell lymphoma (MCL), 1L. Therapeutic value No estimate possible yet Total cost € 1,472,944.00 Registration phase Clinical trials Product Active substance Ibrutinib Domain Oncology and Hematology Reason of inclusion Indication extension IND Main indication Aggressive non-Hodgkin’s lymphoma Extended indication Mantle cell lymphoma (MCL), 1L. Current proprietary name Already available biosimilars / generics Proprietary name Imbruvica Manufacturer Janssen Portfolio holder Mechanism of action Tyrosine kinase inhibitor Route of administration Oral Therapeutical formulation Tablet Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Proteïnekinaseremmer. Remt irreversibel Bruton’s tyrosinekinase. Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date 2022 Expected Registration December 2022 Orphan drug Yes Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Fabrikant verwacht indiening in 2022 en registratie tegen december 2022. Therapeutic value Current treatment options Rituximab-CHOP Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration 1 times a day Dosage per administration 560 mg References Additional remarks Expected patient volume per year Patient volume 16 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR; Fabrikant; Budget impact analyse van ibrutinib (Imbruvica) bij de behandeling van chronische lymfatische leukemie (patiënten zonder 17p of TP53 mutaties) Additional remarks De incidentie van MCL in Nederland was in 2015, 187 patiënten waarvan 130 patiënten ouder zijn dan 65 jaar. Ongeveer 12% van de patiënten hiervan komt in aanmerking voor deze behandeling. Het geschatte aantal patiënten komt daarmee op 12% x 130 = 16 patiënten per jaar. Expected cost per patient per year Cost € 92,059.00 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 G-standaard; fabrikant Additional remarks Lijstprijs (€63,05/tablet 140mg) x maximaal gebruik per jaar (4 tabletten/dag x 365 dagen) = €92.058 . Potential total cost per year Total cost € 1,472,944.00 Total cost for sluice Additional remarks Off label use Off label use No Indications off label use References Additional remarks Indication extension Indication extensions Yes Indication extensions Er lopen meerdere fase 3 studies in verschillende indicaties, indicatieuitbreidingen verwacht in het tweede kwartaal van 2019: Waldenstrom's macroglobulinemia (WM) in combinatie met Rituximab; Chronische Lymfatische Leukemie 1L, non-fit icm obinituzumab. Voor beide indicaties prijs verwacht rond de €70.000 per patiënt per jaar. References Additional remarks Other information Additional remarks