Dupilumab (6) – Dupixent®
Asthma bronchiale, ≥ 6 until ≤ 11 years
Characteristics
| Start date | 15.04.2022 – Marketing authorisation: 04.04.2022 |
|---|---|
| Resolution | 06.10.2022 |
| INN | Dupilumab |
| Brand name | Dupixent® |
| Pharm. company | Sanofi-Aventis Deutschland GmbH |
| G-BA Procedure ID | D-804 |
| ATC code | D11AH05 Agents for dermatitis, excluding corticosteroids (D11AH) |
| ICD-10 codes (AIS) | J45.0, J45.1, J45.8, J45.9Other and unspecified asthma |
| Alpha-ID codes (AIS) | I16367Bronchial asthma, I5222Bronchial atopic asthma, I5239Intrinsic bronchial asthma, I5245Mixed form of bronchial asthma |
| DDD | 21.4 mg P |
| Therapeutic area | Respiratory system diseases Asthma |
| Reason for procedure | New therapeutic indication |
| Specialty | Combination therapy |
| Therapeutic indication of the resolution |
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Dupixent is indicated in children 6 to 11 years old as add-on maintenance treatment for severe asthma with type 2 inflammation characterised by raised blood eosinophils and/or raised fraction of exhaled nitric oxide (FeNO), see section 5.1, who are inadequately controlled with medium to high dose inhaled corticosteroids (ICS) plus another medicinal product for maintenance treatment |
| Subpopulation | Indication | Comparator |
|---|---|---|
| Children 6 to 11 years of age with severe asthma with type 2 inflammation, characterised by an elevated blood eosinophil count and/or an elevated exhaled nitric oxide fraction (FeNO) that is inadequately controlled despite medium- to high-dose inhaled corticosteroids (ICS) plus another drug used for maintenance therapy. | A patient-specific therapy escalation taking into account the previous therapy under selection of: - high-dose ICS and LABA and, if appropriate, LAMA or - high-dose ICS and LABA and, if applicable, LAMA and omalizumab, provided that the criteria necessary for the use of omalizumab are fulfilled. |
Studies and Results
|
No. of studies
(best subpopulation) |
1 (VOYAGE) 0 (Data not accepted) |
|---|---|
|
Study design
(best subpopulation) |
Data not accepted (Dossier: H2H vs. ACT) |
Children aged 6 to 11 years with severe asthma characterised by type 2 inflammation, as indicated by an elevated eosinophil count in the blood and/or an elevated fraction of exhaled nitric oxide (FeNO), which is inadequately controlled despite treatment with medium- to high-dose inhaled corticosteroids (ICS) plus an additional medicinal product used for maintenance therapy
- For the treatment of children aged 6 to 11 years with severe asthma involving type 2 inflammation, characterised by an elevated eosinophil count in the blood and/or an elevated fraction of exhaled nitric oxide (FeNO), which is inadequately controlled despite treatment with medium- to high-dose inhaled corticosteroids (ICS) plus another medicinal product used for maintenance therapy, additional benefit is not proven.
- An additional benefit is therefore not proven.
- In the VOYAGE study, in the control arm, the inadequate treatment at the start of the study was continued unchanged throughout the study in all children, even though, in accordance with the appropriate comparator therapy determined by the G-BA, further options for treatment escalation were available.
- An escalation of the existing maintenance therapy was not permitted at the start of the study; during the course of the study, it was only possible for a small proportion of the study population after at least two severe asthma exacerbations.
- It therefore remains unclear for how many patients in the study a trial of LAMA, an increase in the ICS dose or a trial of omalizumab would have been appropriate.
- In summary, the results of the VOYAGE study cannot be taken into account for the benefit assessment due to the high level of uncertainty regarding the implementation of the appropriate comparator therapy.
Courtesy translation only, please refer to the German original.
Associated procedures
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