Regadenoson Medicine 13 December 2018 Extended indication Extension of Indication to include use in the measurement of fractional flow reserve (FFR) during invasive coronary angiography (ICA) in patients presenting a coronary artery stenosis. Therapeutic value No judgement Total cost Registration phase Registration application pending Product Active substance Regadenoson Domain Cardiovascular diseases Reason of inclusion Indication extension IND Main indication Unknown Extended indication Extension of Indication to include use in the measurement of fractional flow reserve (FFR) during invasive coronary angiography (ICA) in patients presenting a coronary artery stenosis. Current proprietary name Already available biosimilars / generics Proprietary name Rapiscan Manufacturer GE Portfolio holder Mechanism of action Unknown Route of administration Intravenous Therapeutical formulation Injection Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Adenosine A2 receptor agonists Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date 2018 Expected Registration February 2019 Orphan drug No Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options adenosine Therapeutic value No judgement This assessment does not indicate any potential inclusion in the package. Substantiation Geen meerwaarde verwacht, wellicht alleen een effect te verwachten op minder pulmonale bijwerkingen. Duration of treatment Frequency of administration Dosage per administration 400 microgram References Inschatting dosering gebaseerd op huidige EPAR. 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 In de praktijk weinig patiënten verwacht. Expected cost per patient per year Cost References Additional remarks Regadenoson injectievloeistof 80UG/ML FL 5ML, 1 injectieflacon € 74,09, dit product is echter niet vergoed in Nederland. Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks