Ibrutinib Medicine 09 January 2018 Extended indication Marginal zone lymphoma (MZL), relapsed / refractory. Therapeutic value No judgement Total cost € 13,950,000.00 Registration phase Clinical trials Product Active substance Ibrutinib Domain Oncology and Hematology Reason of inclusion Indication extension IND Main indication Lymphoma Extended indication Marginal zone lymphoma (MZL), relapsed / refractory. 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 Unknown 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 lenalidomide/rituximab/bendamustine followed by rituximab maintenance therapy. 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 Fabrikant Additional remarks Expected patient volume per year Patient volume < 150 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 Inschatting dat ongeveer 150 patiënten met MZL starten met een tweedelijns behandeling. 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 Medicijnkosten.nl Additional remarks Per capsule van 140 mg €67,61. Voor de indicatie 1e lijns Chronische lymfatische leukemie (CLL) wordt onderhandeld over een financieel arrangement en zit het geneesmiddel in de sluis. Voor deze indicatie zit ibrutinib niet in de sluis. Potential total cost per year Total cost € 13,950,000.00 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; Chronische Lymfatische Leukemie 1L, non-fit icm obinituzumab. Voor beide indicaties prijs verwacht rond de €70.000 pppj. References Additional remarks Other information Additional remarks