Remdesivir Medicine 08 June 2021 Extended indication Extension of indication to include adults who do not require invasive mechanical ventilation at start of treatment. • In adolescents (aged 12 to less than 18 years and weighing at least 40 kg) with pneumonia requiring supplemental oxygen (low- or high-flow oxygen or other non-invasive ventilation at start of treatment). Therapeutic value Possibly no place in the treatment regimen Total cost Registration phase Registered Product Active substance Remdesivir Domain Infectious diseases Reason of inclusion Indication extension IND Main indication COVID-19 Extended indication Extension of indication to include adults who do not require invasive mechanical ventilation at start of treatment. • In adolescents (aged 12 to less than 18 years and weighing at least 40 kg) with pneumonia requiring supplemental oxygen (low- or high-flow oxygen or other non-invasive ventilation at start of treatment). 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 Unknown Particularity Unknown ATMP No Submission date February 2021 Expected Registration February 2022 Orphan drug No Registration phase Registered Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Therapeutic value Possibly no place in the treatment regimen This assessment does not indicate any potential inclusion in the package. Substantiation De resultaten vallen tegen. Er zullen waarschijnlijk andere geneesmiddelen ingezet worden voor deze indicatie. 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 Zie opmerkingen bij therapeutische waarde, verwachting: geen plaats in de behandeling en daarom geen patiënten verwacht die hiervoor in aanmerking zullen komen. 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