Ibrutinib Medicine 09 January 2018 Extended indication Follicular lymphoma (FL), relapsed / refractory. Therapeutic value No judgement Total cost € 18,411,800.00 Registration phase Clinical trials Product Active substance Ibrutinib Domain Oncology and Hematology Reason of inclusion Indication extension IND Main indication Indolent non-Hodgkin’s 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 Tyrosine kinase inhibitor 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 2021 Expected Registration April 2022 Orphan drug Yes Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Fabrikant verwacht registratie in Q2 2022 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 < 200 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 In 2015 kregen in Nederland 436 patiënten de diagnose FL. Behandelopties bij patiënten met FL zijn onder andere radiotherapie en chemotherapie, hiermee wordt bij ongeveer 50% van de patiënten langdurige ziektevrije overleving bereikt. De inschatting is dat er ongeveer 200 patiënten met FL starten met een tweedelijnsbehandeling. 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 Additional remarks Op basis van lijstprijs (per mei 2020). Potential total cost per year Total cost € 18,411,800.00 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 per patiënt per jaar.. References Additional remarks Other information Additional remarks