Regadenoson

Active substance
Regadenoson
Domain
Cardiovascular diseases
Reason of inclusion in Horizonscan Geneesmiddelen
Indication extension
Main indication
Other medication for cardiovascular diseases
Extended indication
Extension of Indication to include use in the measurement of fractional flow reserve (FFR) of a single coronary artery stenosis during invasive coronary angiography, when repeated FFR measurements are not anticipated.

1. Product

Proprietary name
Rapiscan
Manufacturer
GE
Mechanism of action
Receptor agonist
Route of administration
Intravenous
Therapeutical formulation
Injection
Budgetting framework
Intermural (MSZ)
Additional comments
Adenosine A2 receptor agonists

2. Registration

Registration route
Centralised (EMA)
Submission date
2018
Expected Registration
January 2019
Orphan drug
No
Registration phase
Registered
Additional comments
Positieve CHMP-opinie december 2018. Geregistreerd in januari 2019.

3. Therapeutic value

Current treatment options
adenosine
Therapeutic value
No judgement
Substantiation
Geen meerwaarde verwacht, wellicht alleen een effect te verwachten op minder pulmonale bijwerkingen.
Dosage per administration
400 microgram
References
Inschatting dosering gebaseerd op huidige EPAR.

4. Expected patient volume per year

Additional comments
In de praktijk weinig patiënten verwacht.

5. Expected cost per patient per year

Additional comments
Regadenoson injectievloeistof 80UG/ML FL 5ML, 1 injectieflacon € 74,09, dit product is echter niet vergoed in Nederland.

6. Potential total cost per year

There is currently nothing known about the possible total cost.

7. Off label use

There is currently nothing known about off label use.

8. Indication extension

There is currently nothing known about indication extensions.

9. Other information

There is currently no futher information available.