Dabigatran etexilaat

Extended indication	Secondary prevention of stroke in patients with embolic stroke of unknown source (ESUS)
Therapeutic value	No judgement yet
Total cost	409,600.00
Registration phase	Clinical trials

Product

Active substance	Dabigatran etexilaat
Domain	Cardiovascular diseases
Reason of inclusion	Indication extension
Main indication	Antithrombotic medications
Extended indication	Secondary prevention of stroke in patients with embolic stroke of unknown source (ESUS)
Proprietary name	Pradaxa
Manufacturer	Boehringer Ingelheim
Route of administration	Oral
Therapeutical formulation	Capsule
Budgetting framework	Extramural (GVS)
Additional remarks	Directe trombineremmer

Registration

Registration route	Centralised (EMA)
Type of trajectory	Normal trajectory
Submission date	February 2019
Expected Registration	December 2019
Orphan drug	No
Registration phase	Clinical trials
Additional remarks	Dit middel wordt onder voorwaarden reeds vergoed voor andere indicaties.

Therapeutic value

Current treatment options	Clopidogrel; acetylsalicylzuur + dipyridamol; acetylsalicylzuur mono-therapie
Therapeutic value	No judgement yet
Duration of treatment	continuous
Frequency of administration	2 times a day
Dosage per administration	150 mg
References	Conceptrichtlijn herseninfarct en hersenbloeding

Expected patient volume per year

Patient volume	< 512 Market share is generally not included unless otherwise stated.
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 fabrikant verwacht een marktaandeel tussen de 0-10%.

Patient volume

< 512

Market share is generally not included unless otherwise stated.

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 fabrikant verwacht een marktaandeel tussen de 0-10%.

Expected cost per patient per year

Cost	800.00
References	Fabrikant; G-Standaard
Additional remarks	Huidige prijs bedraagt €69 per maand.

Potential total cost per year

Total cost	409,600.00 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.

Total cost

409,600.00

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.

Off label use

Off label use	No

Indication extension

Indication extension	No

Other information

There is currently no futher information available.