Ibrutinib Medicine 09 January 2018 Extended indication Mantle cell lymphoma (MCL), 1L. Therapeutic value No judgement Total cost € 1,488,000.00 Registration phase Clinical trials Product Active substance Ibrutinib Domain Oncology and Hematology Reason of inclusion Main indication 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 Unknown Route of administration Oral Therapeutical formulation Capsule 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 Indication extension ATMP Unknown Submission date August 2019 Expected Registration May 2020 Orphan drug Yes Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Rituximab-CHOP Therapeutic value No judgement 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 € 93,000.00 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 Fabrikant; Medicijnkosten.nl Additional remarks Per capsule van 140 mg €67,61. Potential total cost per year Total cost € 1,488,000.00 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 PhIII studies in verschillende indicaties, indicatieuitbreidingen verwacht Q2 2019: Waldenstrom's macroglobulinemia (WM) icm Rituximab; Chrnosiche Lymfatische Leukemie 1L, non-fit icm obinituzumab. Voor beide indicaties prijs verwacht rond de €70.000 pppj. References Additional remarks Other information Additional remarks