Dupilumab (2) – Dupixent®
Bronchial asthma, ≥ 12 years
Characteristics
| Start date | 01.09.2019 – Marketing authorisation: 06.05.2019 |
|---|---|
| Resolution | 20.02.2020 |
| INN | Dupilumab |
| Brand name | Dupixent® |
| Pharm. company | Sanofi-Aventis Deutschland GmbH |
| G-BA Procedure ID | D-482 |
| 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, I5235Predominantly allergic bronchial asthma, I5238Non-allergic 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 | Bundling Combination therapy |
| Therapeutic indication of the resolution |
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Dupixent is indicated in adults and adolescents 12 years and older 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),who are inadequately controlled with high dose ICS plus another medicinal product for maintenance treatment. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| a) | Adolescents 12 to 17 years of age with severe asthma with type 2 inflammation, characterised by an elevated blood eosinophil count and/or elevated FeNO that is inadequately controlled despite high-dose inhaled corticosteroids (ICS) plus another drug used for maintenance therapy | Patient-specific therapy escalation taking into account previous therapy with selection of: high-dose ICS and LABA and LAMA or high-dose ICS and LABA and possibly LAMA and omalizumab |
| b) | Adults with severe asthma with type 2 inflammation, characterised by an elevated blood eosinophil count and/or elevated FeNO that is inadequately controlled despite high-dose inhaled corticosteroids (ICS) plus another drug used for maintenance therapy | Patientenindividuelle Therapieeskalation unter Berücksichtigung der Vortherapie und der Pathogenese des Asthmas unter Auswahl von: hochdosiertes ICS und LABA und LAMA oder hochdosiertes ICS und LABA und ggf. LAMA und Omalizumab oder hochdosiertes ICS und LABA und ggf. LAMA und Mepolizumab oder Reslizumab oder Benralizumab |
Studies and Results
|
No. of studies
(best subpopulation) |
3 (RI12544, QUEST, VENTURE) |
|---|---|
|
Study design
(best subpopulation) |
H2H vs. ACT (off-label) |
|
Meta analysis
(best subpopulation) |
no |
| Reason for dividing into subpopulations (G-BA) | Age |
- Clinical trials
- The DRI12544 trial was a randomised, double-blind, placebo-controlled Phase IIb trial involving 776 adult patients with uncontrolled moderate to severe asthma.
- The VENTURE trial is a randomised, double-blind Phase IIIstudy comparing dupilumab with placebo in 210 patients aged 12 years and over with uncontrolled severe asthma, who were receiving existing asthma treatment comprising high-dose ICS and 1 to 2 other controller medications at a stable dose, as well as regular OCS treatment.
a) Adolescents aged 12 to 17 years with severe asthma characterised by type 2 inflammation, as indicated by an elevated eosinophil count in the blood and/or elevated FeNO, which is inadequately controlled despite high-dose inhaled corticosteroids (ICS) plus one further medicinal product used for maintenance therapy
- An additional benefit is not proven.
- Overall, very little data was submitted for the benefit assessment from adolescent patients with inadequately controlled severe asthma with type 2 inflammation.
- There are therefore no relevant data available for the benefit assessment to evaluate the additional benefit of dupilumab as an add-on maintenance therapy in adolescents aged 12 to 17 years with inadequately controlled severe asthma with type 2 inflammation, who are already receiving high-dose ICS and at least one other medicinal product as maintenance therapy, compared with the appropriate comparator therapy.
- Overall, an additional benefit is not proven.
b) Adults with severe asthma with type 2 inflammation, characterised by an elevated eosinophil count in the blood and/or elevated FeNO, which is inadequately controlled despite high-dose inhaled corticosteroids (ICS) plus one further medicinal product used for maintenance therapy
- An additional benefit is not proven.
- The results of the VENTURE study, as well as the results from the patient populations of the DRI12544 and QUEST studies relevant to the benefit assessment, cannot be taken into account for the benefit assessment due to the high level of uncertainty regarding the implementation of the appropriate comparator therapy.
- Overall, therefore, an additional benefit is not proven.
Courtesy translation only, please refer to the German original.
Associated procedures
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