Reslizumab (1) – Cinqaero®
Bronchial asthma
Characteristics
| Start date | 15.01.2017 – Marketing authorisation: 16.08.2016 |
|---|---|
| Resolution | 06.07.2017 |
| Limitation date | 31.07.2020 limitation repealed |
| INN | Reslizumab |
| Brand name | Cinqaero® |
| Pharm. company | Teva GmbH |
| G-BA Procedure ID | D-271 |
| ATC code | R03DX08 Other systemic drugs for obstructive airway diseases (R03DX) |
| ICD-10 codes (AIS) | J45.0, J45.1, J45.8, J45.9Other and unspecified asthma |
| Alpha-ID codes (AIS) | I16367Bronchial asthma, I5235Predominantly allergic bronchial asthma, I5238Non-allergic bronchial asthma, I5245Mixed form of bronchial asthma |
| DDD | 7.1 mg P |
| Therapeutic area | Respiratory system diseases Asthma |
| Reason for procedure | Initial assessment |
| Specialty | Combination therapy |
| Therapeutic indication of the resolution |
|---|
|
CINQAERO is indicated as add-on therapy in adult patients with severe eosinophilic asthma inadequately controlled despite high-dose inhaled corticosteroids plus another medicinal product for maintenance treatment. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| a) | Adjunctive therapy for patients with severe eosinophilic asthma who are not treated with oral corticosteroids or are treated only in the context of acute exacerbations | Patient-specific therapy escalation: (high-dose inhaled corticosteroids and long-acting bronchodilators (LABA) with tiotropium and, if necessary, oral corticosteroids) or, in the case of IgE-mediated pathogenesis of asthma, possibly omalizumab in addition or (if necessary, high-dose inhaled corticosteroids and long-acting bronchodilators (LABA) with oral corticosteroids) |
| b) | Adjunctive therapy for patients with severe eosinophilic asthma who are also regularly treated with oral corticosteroids beyond the treatment of acute exacerbations: | Patient-specific therapy escalation: (High-dose inhaled corticosteroids and long-acting |
Studies and Results
|
No. of studies
(best subpopulation) |
2 (Studien 3082, 3083) |
|---|---|
|
Study design
(best subpopulation) |
H2H vs. ACT |
|
Meta analysis
(best subpopulation) |
yes |
| Reason for dividing into subpopulations (G-BA) | Other |
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.
Associated procedures
| Reslizumab (1) | Cinqaero® | Teva GmbH | Bronchial asthma | 4,800–12,000 | 50% Hint for minor additional benefit |
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