Vonicog Alfa Medicine 03 June 2025 Extended indication Vonicog alfa monotherapy for prophylactic treatment of severe type 1, type 2 or type 3 Von Willebrand's disease in infants, toddlers, children and adolescents Therapeutic value No estimate possible yet Total cost Registration phase Registration application pending Product Active substance Vonicog Alfa Domain Cardiovascular diseases Reason of inclusion Indication extension IND Main indication Hemostasis promoting medication Extended indication Vonicog alfa monotherapy for prophylactic treatment of severe type 1, type 2 or type 3 Von Willebrand's disease in infants, toddlers, children and adolescents Current proprietary name Already available biosimilars / generics Proprietary name Veyvondi Manufacturer Shire Portfolio holder Shire Mechanism of action Coagulant Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Uitsluitend in geaccrediteerde hemofiliebehandelcentra Additional remarks Recombinant Von Willebrand factor. Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP No Submission date April 2025 Expected Registration February 2026 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Meerdere uit bloedplasma bereidde von Willebrand factor concentraten: bijv: Haemate-P, Wilate, Wilfactin. Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation NCT05582993 Duration of treatment Frequency of administration Dosage per administration References Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks Expected cost per patient per year Cost € 11,000.00 - 26,000.00 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 GIPdatabank Additional remarks Op basis van declaratiedata van bestaande von Willebrand factoren zullen de kosten tussen de €11.000 en €26.000 per patiënt per jaar zitten. 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