Betrixaban Medicine 09 January 2018 Extended indication Preventie van veneus thromboembolisme in acuut medisch zieke patienten. Therapeutic value Possible equal value Total cost Registration phase Negative CHMP opinion Product Active substance Betrixaban Domain Cardiovascular diseases Reason of inclusion New medicine (specialité) Main indication Antithrombotic medications Extended indication Preventie van veneus thromboembolisme in acuut medisch zieke patienten. Current proprietary name Already available biosimilars / generics Proprietary name Dexxience Manufacturer Portfolio holder Mechanism of action Unknown Route of administration Oral Therapeutical formulation Capsule Budgetting framework Extramural (GVS) Centre of expertise Additional remarks Antistollingsmiddel (Xa-remmer) Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity Unknown ATMP Unknown Submission date January 2017 Expected Registration Orphan drug No Registration phase Negative CHMP opinion Reimbursement Medicine sluice Additional remarks Negatieve opinie CHMP maart 2018. Herbeoordeling gestart in april 2018. Negatieve opinie CHMP juli 2018. Therapeutic value Current treatment options LMWH Therapeutic value Possible equal value This assessment does not indicate any potential inclusion in the package. Substantiation Cohen et al. N Engl J Med. 2016 Aug 11;375(6):534-44. doi: 10.1056/NEJMoa1601747 Duration of treatment Average 38 day / days Frequency of administration 1 times a day Dosage per administration 80 mg References Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks Expected cost per patient per year Cost € 1,200.00 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 GoodRx.com Additional remarks Meerkosten. 30 capsules of Bevyxxa 40 mg voor $470,00 (goodRx). Patient gebruikt gemiddeld 2*38=76 pillen. 3 doosjes Bevyxxa kosten $1.410,00 (~€1.200,00) Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Yes Indications off label use References Additional remarks Indication extension Indication extensions Yes Indication extensions Uitbreiding indicatiegebied zal waarschijnlijk nog wel onderzocht worden. Er zijn studies gaande voor 'prevention of embolism after knee surgery and prevention of stroke following atrial fibrillation'. References Additional remarks Other information Additional remarks