Expand all sections

Betrixaban

Dexxience

Extended indication Preventie van veneus thromboembolisme in acuut medisch zieke patienten.
Therapeutic value Possible equal value
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.
Proprietary name Dexxience
Route of administration Oral
Therapeutical formulation Capsule
Budgetting framework Extramural (GVS)
Additional remarks Antistollingsmiddel (Xa-remmer)

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Submission date January 2017
Orphan drug No
Registration phase Negative CHMP opinion
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
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

Expected patient volume per year

There is currently nothing known about the expected patient volume.

Expected cost per patient per year

Cost 1,200.00
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

There is currently nothing known about the possible total cost.

Off label use

Off label use Yes
Indications off label use Off-label gebruik verwacht bij minder hoog risico patiënten.

Indication extension

Indication extension 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'.

Other information

There is currently no futher information available.