Remdesivir Medicine 08 June 2021 Extended indication Extension of indication to include treatment of adults with pneumonia not requiring supplemental oxygen (moderate COVID-19). Therapeutic value No estimate possible yet Total cost Registration phase Registration application pending Product Active substance Remdesivir Domain Infectious diseases Reason of inclusion Indication extension IND Main indication Viral infections other Extended indication Extension of indication to include treatment of adults with pneumonia not requiring supplemental oxygen (moderate 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 Unknown Particularity Unknown ATMP No Submission date February 2021 Expected Registration December 2021 Orphan drug No 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 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 Expected cost per patient per year Cost € < 4,500.00 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 https://icer-review.org/announcements/alternative_pricing_models_for_remdesivir/ Additional remarks In het geval van remdesivir suggereert het initiële ICER-COVID-model een prijs van ongeveer $4.500 per behandelingskuur, gebaseerd op de veronderstelling dat de mortaliteit baat heeft bij de bevindingen van de ACCT-studie met een behandelingskuur van 10 dagen. Er wordt door ICER uitgegaan van $10 productiekosten voor een behandelingskuur van 10 dagen en $5 productiekosten voor een behandelingskuur van 5 dagen (exclusief R&D). 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