Tecovirimat Medicine 08 December 2020 Extended indication Treatment of orthopoxvirus disease Therapeutic value No estimate possible yet Total cost Registration phase Registered Product Active substance Tecovirimat Domain Infectious diseases Reason of inclusion New medicine (specialité) Main indication Viral infections other Extended indication Treatment of orthopoxvirus disease Current proprietary name Already available biosimilars / generics Proprietary name Tecovirimat SIGA Manufacturer SIGA Technologies Portfolio holder Mechanism of action Other, see general comments Route of administration Oral Therapeutical formulation Capsule Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Dit orale middel blokkeert het virale envelopeiwit P37, zodat er geen nieuwe infectieuze virussen vanuit geïnfecteerde cellen kunnen ontsnappen. Het is geregistreerd voor volwassenen en kinderen vanaf 13kg. Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date October 2020 Expected Registration January 2022 Orphan drug Yes Registration phase Registered Reimbursement Medicine sluice Additional remarks Tecovirimat is sinds 2018 geregistreerd door de FDA voor behandeling van pokken. Positieve CHMP opinie ontvangen in november 2021 voor marketing authorisation under exceptional circumstances. Geregistreerd onder ‘exceptional circumstances’. Dit betekent dat er eigenlijk weinig informatie beschikbaar was om de registratie te wegen en de EMA de resultaten zal blijven bijhouden. Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation De verwachting is dat dit niet gebruikt zal worden in Nederland. Duration of treatment Average 14 day / days Frequency of administration Dosage per administration 600 mg References NCT02474589 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 References https://www.keionline.org/21725 Additional remarks In de Verenigde Staten wordt een prijs van $255 per dosis gevraagd. 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