Extended indication Extension of Indication to include use in the measurement of fractional flow reserve (FFR) of a sing
Therapeutic value No judgement
Registration phase Registered

Product

Active substance Regadenoson
Domain Cardiovascular diseases
Reason of inclusion 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.
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

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.

Therapeutic value

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

Expected patient volume per year

Additional comments In de praktijk weinig patiënten verwacht.

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.

Potential total cost per year

There is currently nothing known about the possible total cost.

Off label use

There is currently nothing known about off label use.

Indication extension

There is currently nothing known about indication extensions.

Other information

There is currently no futher information available.