Reason for request

New indication

New indication.

Favourable opinion for reimbursement for diagnostic use as a pharmacological stress agent during the measurement of fractional flow reserve (FFR) of a single coronary artery stenosis during invasive coronary angiography, when repeated FFR measurements are not anticipated.

What therapeutic improvement?

No clinical added value in the diagnostic strategy for FFR measurement including adenosine used off-label.

Role in the diagnostic pathway?

The patients concerned by FFR measurement are only those suspected of having stable coronary-artery disease in the event of multi-vessel or intermediate lesions for which previous investigations have not provided useful information or could not be performed.

To induce hyperaemia in the patient in the context of measurement of FFR, although it does not have an MA in this indication, adenosine is the reference product for this investigation, recommended by the European Society of Cardiology when non-invasive methods are contraindicated, not available or do not enable a diagnosis to be reached.

Role of the medicinal product in the care pathway

RAPISCAN (regadenoson) is a diagnostic option in the same way as products containing adenosine (although off-label) for diagnostic use as a pharmacological stress agent during the measurement of fractional flow reserve (FFR) of a single coronary artery stenosis during invasive coronary angiography, when repeated FFR measurements are not anticipated.


Clinical Benefit

Low

The clinical benefit of RAPISCAN (regadenoson) is low in the MA indication.


Clinical Added Value

no clinical added value

Considering:

  • the correlation observed (0.97 ± 0.03) for fractional flow reserve (FFR) measurements compared to adenosine in a meta-analysis,
  • the relevance of the correlation of FFR as an endpoint, since this is a diagnostic investigation that guides the treatment of patients,
  • the absence of data indicating a superior efficacy of RAPISCAN (regadenoson) compared to adenosine,
  • the uncertainty with respect to safety given that hyperaemia may be prolonged with RAPISCAN (regadenoson) for up to 10 minutes,
  • the medical need already partially met by adenosine, used off-label,

the Transparency Committee considers that RAPISCAN (regadenoson) provides no clinical added value (CAV V) in the diagnostic strategy for FFR measurement including adenosine used off-label.


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