Regadenoson (1) – Rapiscan®

• The active ingredient (INN) regadenoson was first placed on the market on 15 April 2011.
• On 14 October 2011, in accordance with the transitional provisions under Section 10(1) and (2) of the Medicinal Products Benefit Assessment Ordinance (AM-NutzenV), the final dossier for this active ingredient (INN) was submitted to the G-BA.

Patients undergoing myocardial perfusion imaging with pharmacological stress

• The pharmaceutical manufacturer has not submitted all the evidence required for the benefit assessment of regadenoson.
• Consequently, the additional benefit of the medicinal product compared with the appropriate comparator therapy determined by the G-BA is deemed not proven (Section 35a(1), fifth sentence, of Book V of the Social Code).
• In the present case, the bibliographic literature search required for the assessment of additional benefit is lacking.
• The purpose of the bibliographic literature search is to ensure that all available evidence relevant to answering the research question is complete, thereby enabling the G-BA determine, in a transparent manner, whether the pharmaceutical manufacturer has fulfilled its obligation under Section 4(6) of the AM-NutzenV to identify all studies relevant to the specific question of the benefit assessment.
• As the pharmaceutical manufacturer did not submit the bibliographic literature search, the completeness of the study pool cannot be assessed.
• No assessment of the additional benefit of regadenoson was carried out given the uncertainty regarding the completeness of the pool of studies.
• If a pharmaceutical manufacturer fails to submit all the evidence required for the benefit assessment of a medicinal product in accordance with Section 35a of Book V of the Social Code (SGB V), such evidence cannot be submitted at a later stage and taken into account in the ongoing assessment procedure.
• This follows from Section 35a(1), fourth sentence, of SGB V, which stipulates that, in the event of a failure to submit or the incomplete submission of the required evidence, the additional benefit of the medicinal product under assessment is deemed not proven.
• Furthermore, the evaluation of the commenting procedures did not result in any change to the appropriate comparator therapy determined by the G-BA.

Courtesy translation only, please refer to the German original.