Icosapent ethyl Medicine 10 June 2020 Extended indication Indicated to reduce cardiovascular risk as an adjunct to statin therapy Therapeutic value Possible added value Total cost Registration phase Registration application pending Product Active substance Icosapent ethyl Domain Cardiovascular diseases Reason of inclusion New medicine (specialité) Main indication Other medication for cardiovascular diseases Extended indication Indicated to reduce cardiovascular risk as an adjunct to statin therapy Current proprietary name Already available biosimilars / generics Proprietary name Vascepa Manufacturer Amarin Portfolio holder Mechanism of action Enzyme inhibitor Route of administration Oral Therapeutical formulation Capsule Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Phospholipase A2 remmer Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date December 2019 Expected Registration January 2021 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options Omega-3-vetzuren Therapeutic value Possible added value This assessment does not indicate any potential inclusion in the package. Substantiation In de Reduce-it studie werden positieve resultaten behaald, namelijk een reductie van 4.8% in cardiovasculaire events ten op zichte van placebo (17.2% vs 22%). In de secundaire preventie setting en de hoog risico primaire preventie setting wordt een redelijk grote impact verwacht van icosapent ethyl. Duration of treatment Frequency of administration 1 times a day Dosage per administration 4 g References NCT01492361 Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References GIPdatabank Additional remarks In 2018 waren er ruim 2 miljoen gebruikers van cholesterolverlagers. In de studie waren alleen patiënten met verhoogde triglyceriden >1.52 mmol/L (later verhoogd tot 2.26 mmmol/L) en LDLC 1.06-2.6 mmol/L in patiënten >45 jaar en HVZ of >50 jaar en DM met 1 extra HVZ risicofactor. Het is nog niet bekend of de fabrikant zich vasthoudt aan deze criteria bij de registratie. Er wordt verwacht dat 25% - 50% van de patiënten met statine therapie baat zal hebben bij deze behandeling. Het is lastig in te schatten hoe groot deze groep daadwerkelijk zal zijn maar is mogelijk aanzienlijk. Expected cost per patient per year Cost References Medicijnkosten.nl 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