Navitoclax Medicine 07 June 2022 Extended indication In Combination With Oral Ruxolitinib (Myelofibrosis) Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Navitoclax Domain Hematology Reason of inclusion New medicine (specialité) Main indication Myeloproliferative disorders Extended indication In Combination With Oral Ruxolitinib (Myelofibrosis) Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Abbvie Portfolio holder Abbvie Mechanism of action Bcl-2 inhibitor Route of administration Oral Therapeutical formulation Tablet Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date September 2023 Expected Registration September 2024 Orphan drug Yes Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Fase 3, in combinatie met ruxolitinib (doel verkleinen van lever). Fabrikant geeft aan registratie te verwachten in september 2024. Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration Dosage per administration References NCT04472598 (TRANSFORM-1); NCT04468984 (TRANSFORM-2); Additional remarks Expected patient volume per year Patient volume 120 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References NKR; fabrikant; expert opinie. Additional remarks Er waren 166 diagnoses van myelofibrosis in 2018. De verwachting is dat de indicatie ook post ruxolitinib behandeling bevat. Van de 166 nieuw gediagnosticeerde patiënten zal uiteindelijk ~75% (125 patiënten) behandeld worden met ruxolitinib. Enkele patiënten ontvangen geen behandeling. Van deze 125 patiënten die ruxolitinib krijgen zal 80% (100 patiënten) in aanmerking komen voor een vervolg behandeling met navitoclax (fit for treatment) (2L; post ruxolitinib). Per jaar komen er 120 patiënten in aanmerking voor de behandeling met navitoclax: 100 post ruxolitinib (2L) en 20 JAKi naïve patiënten (1L). Expected cost per patient per year Cost References Additional remarks Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks