Dabigatran etexilaat Medicine 12 June 2018 Extended indication Secondary prevention of stroke in patients with embolic stroke of unknown source (ESUS) Therapeutic value No judgement Total cost € 4,239,360.00 Registration phase Clinical trials Product Active substance Dabigatran etexilaat Domain Cardiovascular diseases Reason of inclusion Main indication Antithrombotic medications Extended indication Secondary prevention of stroke in patients with embolic stroke of unknown source (ESUS) Current proprietary name Already available biosimilars / generics Proprietary name Pradaxa Manufacturer Boehringer Ingelheim Portfolio holder Mechanism of action Unknown Route of administration Oral Therapeutical formulation Capsule Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Directe trombineremmer Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Indication extension ATMP Unknown Submission date April 2019 Expected Registration February 2020 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Dit middel wordt onder voorwaarden reeds vergoed voor andere indicaties. Therapeutic value Current treatment options Acetylsalicylzuur + dipyridamol, clopidogrel, Acetylsalicylzuur (3e keus). Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration 2 times a day Dosage per administration 150 mg References Conceptrichtlijn herseninfarct en hersenbloeding Additional remarks Expected patient volume per year Patient volume < 5,120 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Hartstichting; Perera et al. Int J Stroke 2016; 11: 526–533 Additional remarks Ongeveer 32.000 mensen per jaar krijgen een herseninfarct, daarvan komt 16% in aanmerking voor behandeling van ESUS (=5120). Binnen deze patiëntenpopulatie zal er concurrentie optreden met de bestaande behandelopties. Expected cost per patient per year Cost € 828.00 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 Fabrikant; G-Standaard Additional remarks Huidige prijs bedraagt €69 per maand. Potential total cost per year Total cost € 4,239,360.00 Total cost for sluice Additional remarks Off label use Off label use No Indications off label use References Additional remarks Indication extension Indication extensions No Indication extensions References Additional remarks Other information Additional remarks