Dalbavancine Medicine 03 December 2024 Extended indication Extension of indication to include the treatment of acute bacterial skin and skin structure infections (ABSSSI) in paediatric patients from birth, including paediatric patients aged less than 3 months with suspected or confirmed sepsis associated with skin and subcutaneous tissue infections Therapeutic value No estimate possible yet Total cost Registration phase Registration application pending Product Active substance Dalbavancine Domain Infectious diseases Reason of inclusion Indication extension IND Main indication Bacterial infections Extended indication Extension of indication to include the treatment of acute bacterial skin and skin structure infections (ABSSSI) in paediatric patients from birth, including paediatric patients aged less than 3 months with suspected or confirmed sepsis associated with skin and subcutaneous tissue infections Current proprietary name Already available biosimilars / generics Proprietary name Xydalba Manufacturer Abbvie Portfolio holder Mechanism of action Unknown Route of administration Intravenous Therapeutical formulation Powder for solution for infusion Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date September 2024 Expected Registration July 2025 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Verwachte registratie op basis van EMA-indiening in september 2024 en een gemiddelde doorlooptijd van 10 maanden voor een indicatieuitbreiding. Therapeutic value Current treatment options Tedizolid, linezolid 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 22.5 mg/kg (maximum 1500 mg) References NCT02814916 (DUR001-306) Additional remarks 22,5mg/kg (maximum 1.500mg) on Day 1. Dalbavancin was administered intravenously over 30 (± 5) minutes. Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Horizonscan Geneesmiddelen dalbavancine (1). Additional remarks Het patiëntvolume ouder dan 3 maanden is eerder geschat op maximaal 100 (1). Het patiëntvolume dat in aanmerking komt voor deze indicatieuitbreiding naar baby's jonger dan 3 maanden zal gering zijn. Expected cost per patient per year Cost € < 760.00 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 Additional remarks Xydalba, 500mg poeder voor oplossing voor infusie per injectieflacon: €828,40 (inclusief BTW). Voor een toediening voor een baby zal een flacon nodig zijn €760 (exclusief BTW). 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