Ensitrelvir Medicine 03 June 2025 Extended indication Ensitrelvir monotherapy for the treatment of mild and moderate COVID-19 in non-hospitalised adults and the elderly. Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Ensitrelvir Domain Infectious diseases Reason of inclusion New medicine (specialité) Main indication COVID-19 Extended indication Ensitrelvir monotherapy for the treatment of mild and moderate COVID-19 in non-hospitalised adults and the elderly. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Shionogi Portfolio holder Mechanism of action Unknown Route of administration Oral Therapeutical formulation Tablet Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP No Submission date 2025 Expected Registration January 2026 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Paxlovid Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Ensitrelvir is net als nirmatrelvir een proteaseremmer die actief is tegen SARS-CoV-2. Op dit moment is alleen Paxlovid als oraal antiviraal middel beschikbaar. Meer middelen zijn welkom. Dit middel is ook een sterke CYP3A-remmer dus bijwerkingen en interacties kunnen verwacht worden. Duration of treatment Frequency of administration Dosage per administration References NCT05305547 (SCORPIO-HR); Expertopinie Additional remarks Expected patient volume per year Patient volume < 590 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References GIPdatabank Additional remarks In 2023 waren er 590 gebruikers van Paxlovid. Expected cost per patient per year Cost References Additional remarks 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