Remdesivir Medicine 03 December 2024 Extended indication Veklury is indicated for the treatment of coronavirus disease 2019 (COVID‑19) in adults and paediatric patients (at least 4 weeks of age and weighing at least 3 kg). Therapeutic value No estimate possible yet Total cost € 7,400.00 Registration phase Registered Product Active substance Remdesivir Domain Infectious diseases Reason of inclusion Indication extension IND Main indication COVID-19 Extended indication Veklury is indicated for the treatment of coronavirus disease 2019 (COVID‑19) in adults and paediatric patients (at least 4 weeks of age and weighing at least 3 kg). Current proprietary name Already available biosimilars / generics Proprietary name Veklury Manufacturer Gilead Portfolio holder Mechanism of action Virus inhibitor 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 ATMP No Submission date January 2024 Expected Registration June 2025 Orphan drug No Registration phase Registered Reimbursement Medicine sluice Rejected Additional remarks Positieve CHMP-opinie in april 2025. Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Er wordt geen meerwaarde verwacht in Nederland. De internationale gemeenschap gebruikt het nog wel maar in de Nederlandse zetting is de plaatsbepaling zeer beperkt. Winst is ook niet enorm groot. Duration of treatment Frequency of administration Dosage per administration References NCT04431453 (GS-US-540-5823) Additional remarks Expected patient volume per year Patient volume < 2 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Expertopinie Additional remarks Uitbreiding naar pediatrische patiënten. Er wordt een heel klein aantal patiënten verwacht die hiervoor in aanmerking zullen komen. Afgelopen jaar is bij volwassenen het verbruik 0 geweest. Dus hooguit 1 of 2 patiënten per jaar. Expected cost per patient per year Cost € 1,800.00 - 5,600.00 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 Medicijnkosten.nl Additional remarks Een kuur duurt tussen de 5 en 10 dagen. Op de eerste dag wordt een dubbele dosering toegediend. Potential total cost per year Total cost € 7,400.00 Total cost for sluice Additional remarks Off label use Off label use Indications off label use References Additional remarks Indication extension Indication extensions Indication extensions References Additional remarks Other information Additional remarks