Mim 8 Medicine 05 December 2023 Extended indication Haemophilia A Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Mim 8 Domain Cardiovascular diseases Reason of inclusion New medicine (specialité) Main indication Other non-oncological hematological medications Extended indication Haemophilia A Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Novo Nordisk Portfolio holder Novo Nordisk Mechanism of action Coagulant Route of administration Subcutaneous Therapeutical formulation Injection Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Blood coagulation factor stimulant. Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP No Submission date August 2024 Expected Registration September 2025 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks De fabrikant geeft aan registratie in de tweede helft van 2025 te verwachten. Therapeutic value Current treatment options Emicizumab Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation De klinische studies (FRONTIER) lopen nog. Duration of treatment Frequency of administration Dosage per administration References NCT05878938 (FRONTIER 5) Additional remarks Participants will receive Mim8 PPX once-weekly dosing (QW), once every two weeks dosing (Q2W), or once-monthly dosing s.c. injection using a prefilled fixed dose DV3407-C1 pen-injector for 26 weeks. Expected patient volume per year Patient volume < 1,376 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Jaarreportage HemoNED 2021 (1). Additional remarks Er zijn 1.376 patiënten bekend met hemofilie A (1). De patientaantallen zullen vergelijkbaar zijn met emicizumab gebruikersaantallen, maar de aantallen emicizumab gebruikers zullen mogelijk gaan stijgen. Op dit moment krijgt ongeveer 50% van de populatie emicizumab in de eerste 3 jaar na introductie. Dat zal naar verwachting doorgroeien richting 100%. De registratie-indicatie is nog niet geheel duidelijk (ernstige hemofilie, matig-ernstig?). Dit bepaalt ook het uiteindelijke patiëntvolume. 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