Regadenoson (2) – Rapiscan®

Patients in whom the fractional flow reserve (FFR) of a coronary artery stenosis is measured during invasive coronary angiography using a pharmacological stress inducer, where repeated FFR measurements are not expected

• The pharmaceutical manufacturer did not submit a complete dossier by the relevant date.
• Pursuant to Section 35a(1), fifth sentence, of SGB V, this means that no assessment will be made as to whether the active ingredient regadenoson, in the therapeutic indication of FFR measurement, has any additional benefit, no additional benefit or a less benefit compared with the appropriate comparator therapy, and that the additional benefit of regadenoson in relation to the appropriate comparator therapy is deemed not proven.
• The additional benefit is deemed not proven.
• Additional benefit of the medicinal product in relation to the appropriate comparator therapy
  • The G-BA has defined pharmacological stress induction, as determined by the doctor, as the appropriate comparator therapy.

Courtesy translation only, please refer to the German original.