Ibrutinib Medicine 12 June 2018 Extended indication Extension of indication to include treatment of adult patients with Waldenström's macroglobulinaemia (WM) in combination with rituximab. Therapeutic value No judgement Total cost Registration phase Registered Product Active substance Ibrutinib Domain Oncology and Hematology Reason of inclusion Indication extension IND Main indication Multiple Myeloma Extended indication Extension of indication to include treatment of adult patients with Waldenström's macroglobulinaemia (WM) in combination with rituximab. 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. Is al geregistreerd voor deze indicatie zonder rituximab. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date December 2018 Expected Registration August 2019 Orphan drug Yes Registration phase Registered Reimbursement Medicine sluice Additional remarks Positieve CHMP-opinie in juni 2019. Aanspraak status ZN: Nee. (december 2020) Therapeutic value Current treatment options DRC and R-CP. Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation De werkgroep verwacht niet direct een plaats in eerste lijn voor deze combinatietherapie, behalve bij recidief. Er is namelijk geen standaard behandeling voor recidief MW. Dit wordt alleen bij symptomatologie behandeld. Duration of treatment Average 13 month / months Frequency of administration 1 times a day Dosage per administration 420 mg References Dimopoulos et al. N Engl J Med. 2018 Jun 21;378(25):2399-2410. Additional remarks Rituximab 375 mg/m2 intraveneus 1 maal per week gedurende 4 weken. Een tweede behandeling van 4 weken vindt plaats na een interval van 3 maanden. Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR Additional remarks Er zijn ongeveer 1.500 patiënten met MW in Nederland. 214 is het aantal diagnoses Lymfoplasmacytair lymfoom/ M Waldenström in 2016. De inschatting is dat er per jaar maar weinig patiënten voor in aanmerking zullen komen. Expected cost per patient per year Cost € 69,044.00 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; G-standaard Additional remarks Op basis van lijstprijs (per juli 2020). Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use No Indications off label use References Additional remarks Indication extension Indication extensions No Indication extensions References adisinsight Additional remarks Geen nieuwe indicatieuitbreidingen buiten de indicaties in de Horizonscan. Other information Additional remarks