Reslizumab (1) – Cinqaero®

a) Patients with severe eosinophilic asthma who are not treated with oral corticosteroids, or who are treated with them only during acute exacerbations

• The G-BA has based its decision on whether reslizumab offers additional benefit compared with the appropriate comparator therapy on the basis of the dossier submitted by the pharmaceutical manufacturer, the dossier assessment prepared by the IQWiG, the statements presented during the written and oral consultation procedures, and the addendum to the benefit assessment prepared by the IQWiG.
• In order to determine the extent of the additional benefit, the G-BA assessed the data justifying the identification of an additional benefit in terms of their therapeutic relevance (qualitatively), in accordance with the criteria set out in Chapter 5, Section 5(7) of the VerfO.
• The methodology proposed by the IQWiG in accordance with the General Methods was not applied in the benefit assessment of reslizumab.
• On this basis, and taking into account the comments received and the oral hearing, the G-BA has reached the following assessment:

b) Patients with severe eosinophilic asthma who are treated regularly with oral corticosteroids, even beyond the treatment of acute exacerbations

• The G-BA has based its decision on whether an additional benefit of reslizumab can be established compared with the appropriate comparator therapy based on the dossier submitted by the pharmaceutical manufacturer, the dossier assessment prepared by the IQWiG, the comments submitted during the written and oral consultation procedures, and the addendum to the benefit assessment prepared by the IQWiG.
• In order to determine the extent of the additional benefit, the G-BA assessed the data justifying the identification of an additional benefit in terms of their therapeutic relevance (qualitatively), in accordance with the criteria set out in Chapter 5, Section 5(7) of the VerfO.
• The methodology proposed by the IQWiG in accordance with the General Methods was not applied in the benefit assessment of reslizumab.
• On this basis, and taking into account the comments received and the oral hearing, the G-BA has reached the following assessment:

Courtesy translation only, please refer to the German original.