Remimazolam Medicine 10 December 2019 Extended indication Anesthesie en sedatie (minstens 18 jaar oud) Therapeutic value No judgement Total cost € 12,500.00 Registration phase Clinical trials Product Active substance Remimazolam Domain Neurological disorders Reason of inclusion New medicine (specialité) Main indication Neurological disorders other Extended indication Anesthesie en sedatie (minstens 18 jaar oud) Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer PAION Portfolio holder Mechanism of action Receptor agonist Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Fabrikant: Paion Deutschland GmbH Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date 2020 Expected Registration 2021 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options intraveneuze anesthetica Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Verwachting is dat remimazolam met name de concurrentie zal aangaan met propofol mits het bijwerkingenprofiel gunstiger blijkt te zijn. Duration of treatment Frequency of administration Dosage per administration 50 mg References NCT03661489 Additional remarks Expected patient volume per year Patient volume < 500 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References GIP databank Additional remarks Afhankelijk van uiteindelijke plaatsbepaling zal een inschatting moeten worden gemaakt over het verwachte aantal patiënten. Vergelijkende behandeling in de studie: propofol. Hiervan waren in 2017 479 gebruikers. Inschatting: max 500 patiënten. Expected cost per patient per year Cost € 20.00 - 30.00 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 GIP databank Additional remarks Vergelijkende behandeling in de studie: propofol. prijs per patiënt per jaar in 2017 betrof 25,84 euro. Potential total cost per year Total cost € 12,500.00 Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions No Indication extensions References Additional remarks alle fase III studies hebben betrekking op anesthesie. Other information Additional remarks