Remdesivir Medicine 07 June 2022 Extended indication Treatment of paediatric patients (weighing at least 40kg) who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19 Therapeutic value No estimate possible yet Total cost Registration phase Registered Product Active substance Remdesivir Domain Infectious diseases Reason of inclusion Indication extension IND Main indication COVID-19 Extended indication Treatment of paediatric patients (weighing at least 40kg) who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19 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 RNA-replicaseremmers. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date March 2022 Expected Registration September 2022 Orphan drug No Registration phase Registered Reimbursement Medicine sluice Additional remarks Positieve CHMP opinie september 2022. Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation De winst die in klinische studies is aangetoond is minder dan verwacht en er zijn veel andere (betere) behandelopties beschikbaar. Duration of treatment Frequency of administration Dosage per administration References 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 In Nederland zal dit naar verwachting niet veel gebruikt gaan worden. Expected cost per patient per year Cost € 1,840.00 - 5,515.00 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 www.medicijnkosten.nl (Lijstprijs inclusief BTW) SmPC Veklury Additional remarks Een kuur duurt tussen de 5 en 10 dagen. Op de eerste dag wordt een dubbele dosering toegediend. For patients at high risk of progressing to severe COVID-19, including hospitalisation and not requiring supplemental oxygen, the total duration of treatment should be 3 days. 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