Inotuzumab ozogamicine Medicine 04 December 2025 Extended indication Extension of indication to include treatment of paediatric patients 1 year and older with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukaemia (ALL). Therapeutic value No estimate possible yet Total cost € 300,000.00 Registration phase Registration application pending Product Active substance Inotuzumab ozogamicine Domain Hematology Reason of inclusion Indication extension IND Main indication ALL Extended indication Extension of indication to include treatment of paediatric patients 1 year and older with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukaemia (ALL). Current proprietary name Already available biosimilars / generics Proprietary name Besponsa Manufacturer Pfizer Portfolio holder Mechanism of action Antibody-drug conjugate Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Yes Submission date March 2025 Expected Registration April 2026 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 ITCC-059 (WI203581); INO-Ped-ALL-1 (WI235086) Additional remarks Expected patient volume per year Patient volume < 5 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Declaratiedata Additional remarks In 2022 waren er 20 volwassen gebruikers van inotuzumab ozogamicine. Door deze indicatieuitbreiding naar een jaar en ouder zal het patiëntvolume iets toenemen. Er wordt verwacht dat er maximaal tien patiënten in aanmerking zullen komen. Expected cost per patient per year Cost € < 60,000.00 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 Declaratiedata Additional remarks Per jaar wordt er ongeveer €60.000 vergoed per gebruiker van inotuzumab ozogamicine. Potential total cost per year Total cost € 300,000.00 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