Damoctocog alfa pegol Medicine 03 December 2024 Extended indication Extension of indication to include treatment and prophylaxis of bleeding in previously treated patients ≥7 years of age with haemophilia A Therapeutic value No estimate possible yet Total cost Registration phase Registration application pending Product Active substance Damoctocog alfa pegol Domain Cardiovascular diseases Reason of inclusion Indication extension IND Main indication Hemostasis promoting medication Extended indication Extension of indication to include treatment and prophylaxis of bleeding in previously treated patients ≥7 years of age with haemophilia A Current proprietary name Already available biosimilars / generics Proprietary name Jivi Manufacturer Bayer Portfolio holder Mechanism of action Coagulant Route of administration Intravenous Therapeutical formulation Injection Budgetting framework Intermural (MSZ) Centre of expertise Hemofilie Behandel Centra Additional remarks Dit betreft de uitbreiding van de bestaande indicatie van 7 naar 12 jaar en ouder. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date November 2024 Expected Registration September 2025 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Verwachte registratie op basis van een gemiddelde doorlooptijd van 10 maanden voor een indicatieuitbreiding. 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 2 times a week Dosage per administration 40-60 IE/kg References NCT05147662 (Alfa-PROTECT); NCT01775618 (PROTECT VIII Kids) 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 No Indication extensions References Additional remarks Other information Additional remarks