Tezepelumab (1) – Tezspire®
Bronchial asthma (AB), ≥ 12 years
Characteristics
| Start date | 15.11.2022 – Marketing authorisation: 19.09.2022 |
|---|---|
| Resolution | 23.05.2023 |
| INN | Tezepelumab |
| Brand name | Tezspire® |
| Pharm. company | AstraZeneca GmbH |
| G-BA Procedure ID | D-882 |
| ATC code | R03DX11 Other systemic drugs for obstructive airway diseases (R03DX) |
| ICD-10 codes (AIS) | J45.09, J45.19, J45.89, J45.99 |
| Alpha-ID codes (AIS) | I16367Bronchial asthma, I5235Predominantly allergic bronchial asthma, I5238Non-allergic bronchial asthma, I5245Mixed form of bronchial asthma |
| Therapeutic area | Respiratory system diseases Asthma |
| Reason for procedure | Initial assessment |
| Specialty | Combination therapy |
| Therapeutic indication of the resolution |
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Tezspire is indicated as an add-on maintenance treatment in adults and adolescents 12 years of age and older with severe asthma that is inadequately controlled despite high-dose inhaled corticosteroids plus another maintenance treatment drug. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| a) | Adolescents aged 12 to 17 years with severe asthma that has become severe despite high-dose inhaled corticosteroids (ICS) plus another maintenance drug inadequately controlled despite high-dose inhaled corticosteroids (ICS) plus another maintenance drug | High-dose ICS and LABA and LAMA, or - high-dose ICS and LABA and, if applicable, LAMA and omalizumab, provided that the necessary criteria for the use of omalizumab are met, or - high-dose ICS and LABA and, if applicable, LAMA and mepolizumab or dupilumab, if the necessary criteria for the use of omalizumab are not met |
| b) | Adults with severe asthma that is inadequately controlled despite high-dose inhaled corticosteroids (ICS) plus another drug used for maintenance therapy | A patient-specific therapy escalation taking into account the previous therapy and the pathogenesis of the asthma with selection of: – high-dose ICS and LABA and LAMA or – high-dose ICS and LABA and, if applicable, LAMA and omalizumab, provided that the criteria necessary for the use of omalizumab are met, or – high-dose ICS and LABA and, if applicable, LAMA and mepolizumab or reslizumab or benralizumab or dupilumab, provided that the criteria necessary for the use of the respective antibodies are met |
Studies and Results
|
No. of studies
(best subpopulation) |
3 (NAVIGATOR, PATHWAY und DESTINATION) 0 (Data not accepted) |
|---|---|
|
Study design
(best subpopulation) |
Data not accepted (Dossier: H2H vs. non-ACT + ITC (Bucher)) |
| Reason for dividing into subpopulations (G-BA) | Age |
- Clinical trials
- The randomised, double-blind extension study DESTINATION included patients who had completed either the NAVIGATOR study (N = 827) or the SOURCE study (N = 124).
a) Adolescents aged 12 to 17 with severe asthma that is inadequately controlled despite high-dose inhaled corticosteroids (ICS) plus another medicinal product used for maintenance therapy
- The additional benefit is not proven.
- However, for the vast majority of patients in the low-biomarker populations, it remains unclear whether a trial of LAMA would have constituted an appropriate – and therefore, in accordance with the G-BA’s appropriate comparator therapy – escalation of treatment.
- The appropriate comparator therapy has not been implemented in the low-biomarker populations.
- Consequently, the results of the NAVIGATOR, PATHWAY and DESTINATION studies cannot be taken into account for the benefit assessment.
b) Adults with severe asthma that is inadequately controlled despite high-dose inhaled corticosteroids (ICS) plus an additional medicinal product used for maintenance therapy
- The additional benefit is not proven.
- However, for the vast majority of patients in the low-biomarker populations, it remains unclear whether a trial of LAMA would have constituted an appropriate comparator therapy – and therefore, in accordance with the G-BA’s standard of care, necessary – escalation of treatment.
- The appropriate comparator therapy has not been implemented in the low-biomarker populations.
- Consequently, the results of the NAVIGATOR, PATHWAY and DESTINATION studies cannot be taken into account for the benefit assessment.
- It therefore remains unclear whether treatment with dupilumab represents the appropriate, patient-specific escalation of therapy (taking prior treatment into account) for these patients.
- The appropriate comparator therapy has not been applied in the indirect comparison of tezepelumab versus dupilumab presented here.
Courtesy translation only, please refer to the German original.
Associated procedures
| Tezepelumab (2) | Tezspire® | AstraZeneca GmbH | Chronic rhinosinusitis with nasal polyps | 10,500–12,600 | 100% Hint for non-quantifiable additional benefit | |
| Tezepelumab (1) | Tezspire® | AstraZeneca GmbH | Bronchial asthma (AB), ≥ 12 years | 42,300–46,700 | 100% additional benefit not proven |
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