Ibrutinib Medicine 09 January 2018 Extended indication Non-germinal center B-cell-like (non-GCB) diffuse large B-cell lymphoma (DLBCL), 1L. Therapeutic value Possible added value Total cost € 25,800,000.00 Registration phase Unknown Product Active substance Ibrutinib Domain Oncology and Hematology Reason of inclusion Main indication Lymphoma Extended indication Non-germinal center B-cell-like (non-GCB) diffuse large B-cell lymphoma (DLBCL), 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 Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date Expected Registration 2019 Orphan drug Yes Registration phase Unknown Reimbursement Medicine sluice Additional remarks Dit is een indicatie-uitbreiding. Sluis-product. Therapeutic value Current treatment options Rituximab-CHOP zonder toevoeging van ibrutinib Therapeutic value Possible added value This assessment does not indicate any potential inclusion in the package. Substantiation De resultaten van de grote fase 3 studie R-CHOP +/- ibrutinib worden in de zomer 2018 verwacht. Duration of treatment Average 24 week / weeks Frequency of administration 1 times a day Dosage per administration 560 mg References Additional remarks Behandelschema: 18-24 weken, 126-168 x 560 mg; 1 dd 560 mg elke dag tijdens R-CHOP kuur a 3 weken voor totaal 6 of 8 kuren. Duur is afhankelijk van het geven van 6 of 8 kuren. Expected patient volume per year Patient volume < 600 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR; Budget impact analyse van ibrutinib (Imbruvica) bij de behandeling van chronische lymfatische leukemie (patiënten zonder 17p of TP53 mutaties) Additional remarks Totaal aantal nieuwe DLBCL volgens NKR: 1400, hiervan zijn ongeveer 40% van het non-GCB subtype. Expected cost per patient per year Cost € < 43,000.00 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 Verwachting is zelfde prijs als voor huidige indicatie. Per capsule van 140 mg €67,61. Potential total cost per year Total cost € 25,800,000.00 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