Anselamimab Medicine 04 December 2025 Extended indication cardiac AL amyloidosis Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Anselamimab Domain Cardiovascular diseases Reason of inclusion New medicine (specialité) Main indication Other non-oncological hematological medications Extended indication cardiac AL amyloidosis Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Alexion Portfolio holder Alexion Mechanism of action Other Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Anti-lichtketen-geassocieerd (AL) amyloïde monoklonaal antilichaam Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP No Submission date February 2026 Expected Registration March 2027 Orphan drug Yes Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Chemotherapie en stamceltransplantatie Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Anselamimab toonde in fase-3 studie CAEL101-301 geen voordeel boven daratumumab-CyBorD bij cardiale AL-amyloïdose, maar mogelijk is er effect in geselecteerde subgroepen (MAYO IIIa), wat nog wordt onderzocht in CAEL101-302. Duration of treatment Frequency of administration Dosage per administration 1.000mg/m2 References NCT04504825 (CAEL101-301); NCT04512235 (CAEL101-302); Expertopinie Additional remarks Expected patient volume per year Patient volume 90 - 126 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References IKNL. 2019 (1); StatPearls: Cardiac Amyloidosis. 2025 (2). Additional remarks In Nederland wordt de incidentie van AL amyloïdose geschat op ongeveer 10 patiënten per miljoen inwoners per jaar (1). Dat betekent dat er jaarlijks ongeveer 180 nieuwe patiënten met AL amyloïdose worden gediagnosticeerd. Van deze groep presenteert tot wel 50 tot 70% zich met cardiale uitingen van de ziekte (2). 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 Indications off label use References Additional remarks Indication extension Indication extensions Indication extensions References Additional remarks Other information Additional remarks