Vonicog alfa Medicine 06 June 2023 Extended indication Extension of indication to include prophylactic treatment to prevent or reduce the frequency of bleeding episodes in Pediatric and Adult Patients. 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 Extension of indication to include prophylactic treatment to prevent or reduce the frequency of bleeding episodes in Pediatric and Adult Patients. Current proprietary name Already available biosimilars / generics Proprietary name Veyvondi Manufacturer Baxalta Portfolio holder Mechanism of action Coagulant Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Recombinant Von Willebrand factor Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date March 2023 Expected Registration January 2024 Orphan drug Yes Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks 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 Dosage per administration References NCT03879135 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 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