Ziltivekimab Medicine 04 December 2025 Extended indication Ziltivekimab monotherapy for add-on treatment of cardiovascular event prophylaxis in adults and elderly with established atherosclerotic cardiovascular disease, chronic kidney disease and systemic inflammation. Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Ziltivekimab Domain Cardiovascular diseases Reason of inclusion New medicine (specialité) Main indication Other medication for cardiovascular diseases Extended indication Ziltivekimab monotherapy for add-on treatment of cardiovascular event prophylaxis in adults and elderly with established atherosclerotic cardiovascular disease, chronic kidney disease and systemic inflammation. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Novo Nordisk Portfolio holder Novo Nordisk Mechanism of action Interleukin inhibitor Route of administration Subcutaneous Therapeutical formulation Injection Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP Submission date September 2026 Expected Registration October 2027 Orphan drug Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Tijdslijn op basis van IHSI-inschatting. Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation In de fase 2-studies (RESCUE en RESCUE-2) is aangetoond dat ziltivekimab de ontsteking markers sterk verlaagt en in analyses de Hb-waarden bij CKD-patiënten verbetert, maar klinisch relevante eindpunten zoals vermindering van cardiovasculaire events zijn nog niet bewezen. Dit moet eind 2026 blijken uit de ZEUS-studie. Duration of treatment Frequency of administration Dosage per administration References NCT05021835 (ZEUS); Expertopinie Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Bover J. et al., BMC Nephrology, 2023; Ridker PM. et al., PMC, 2002. Additional remarks In Nederland heeft ongeveer 8 tot 9% van de volwassenen chronische nierziekte (CKD), waarvan ±60% ook atherosclerotische cardiovasculaire ziekte (ASCVD) heeft. Ongeveer de helft van deze groep vertoont daarnaast systemische inflammatie, waardoor de potentiële doelgroep enkele tienduizenden patiënten omvat. Expected cost per patient per year Cost € 13,000.00 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 Additional remarks Kosten op basis van IHSI-inschatting, afgeleid van de mediane kosten van dezelfde ATC-klasse (L04AC - interleukineremmers) geneesmiddelen in Nederland. 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