Setrusumab Medicine 04 June 2024 Extended indication Osteogenesis imperfecta Therapeutic value No estimate possible yet Total cost € 156,000,000.00 Registration phase Clinical trials Product Active substance Setrusumab Domain Metabolism and Endocrinology Reason of inclusion New medicine (specialité) Main indication Other metabolism and Endocrinology Extended indication Osteogenesis imperfecta Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Mereo Portfolio holder Mechanism of action Other, see general comments Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Werkingsmechanisme: SOST protein inhibitor, setrusumab is een volledig gehumaniseerd monoklonaal antilichaam dat is ontworpen om sclerostine te remmen. Registration Registration route Centralised (EMA) Type of trajectory Particularity ATMP No Submission date August 2026 Expected Registration September 2027 Orphan drug Yes Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Primary completion date maart 2025. 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 Duration of treatment Frequency of administration 1 times a month Dosage per administration References Fase 2/3 Orbit studie (NCT05125809) Additional remarks Expected patient volume per year Patient volume < 1,200 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References www.oivereniging.nl (1) Additional remarks Van iedere 15.000 tot 20.000 personen heeft er één OI, dus in Nederland zijn er 800 tot 1.200 mensen met OI. Per jaar worden hier 10 tot 15 kinderen met OI geboren. OI komt bij mannen en vrouwen evenveel voor. (1) Expected cost per patient per year Cost € < 130,000.00 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 IHSI High Impact Report. 2025. Additional remarks Er wordt geschat dat setrusumab $150.000 per patiënt per jaar kan gaan kosten. Dit is omgerekend ongeveer €130.000. Potential total cost per year Total cost € 156,000,000.00 Total cost for sluice Additional remarks Off label use Off label use Indications off label use References Additional remarks Indication extension Indication extensions No Indication extensions References Adis Insight Additional remarks Other information Additional remarks