Dabigatran etexilaat Medicine 12 June 2018 Extended indication Secondary prevention of stroke in patients with embolic stroke of unknown source (ESUS) Therapeutic value Possible equal value Total cost € 413,184.00 Registration phase Withdrawn Product Active substance Dabigatran etexilaat Domain Cardiovascular diseases Reason of inclusion Indication extension IND Main indication Antithrombotic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 Thrombin inhibitor 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trajectory Particularity Unknown ATMP Unknown Submission date Expected Registration Orphan drug No Registration phase Withdrawn Reimbursement Medicine sluice Additional remarks Aangezien de RE-SPECT ESUS trial geen superioriteit ten opzichte van aspirine kon aantonen wordt niet verwacht dat deze indicatie-uitbreiding zal worden ingediend bij de EMA. Therapeutic value Current treatment options Clopidogrel; acetylsalicylzuur + dipyridamol; acetylsalicylzuur mono-therapie Therapeutic value Possible equal value This assessment does not indicate any potential inclusion in the package. Substantiation Geen significante verbetering tov aspirine in de RESPECT-ESUS trial. Duration of treatment Frequency of administration 2 times a day Dosage per administration 150 mg References Conceptrichtlijn herseninfarct en hersenbloeding https://www.tctmd.com/news/dabigatran-trials-come-short-stroke-unknown-cause-and-cerebral-venous-thrombosis Additional remarks Expected patient volume per year Patient volume < 512 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Fabrikant; 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 (=5.120). Binnen deze patiëntenpopulatie zal er concurrentie optreden met de bestaande behandelopties. De verwachting is een marktaandeel tussen de 0-10%. Expected cost per patient per year Cost € 807.00 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 €67.96 per maand voor de 75mg, €67.21 voor de 110mg en €67.46 voor de 150mg. Potential total cost per year Total cost € 413,184.00 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