Ibrutinib Medicine 09 January 2018 Extended indication Follicular lymphoma (FL), relapsed / refractory. Therapeutic value No judgement Total cost € 18,600,000.00 Registration phase Unknown Product Active substance Ibrutinib Domain Oncology and Hematology Reason of inclusion Main indication Lymphoma Extended indication Follicular lymphoma (FL), 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 Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date Expected Registration 2020 Orphan drug Yes Registration phase Unknown Reimbursement Medicine sluice Additional remarks Dit is een indicatie-uitbreiding. Therapeutic value Current treatment options 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 < 200 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 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. Potential total cost per year Total cost € 18,600,000.00 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 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