Tixagevimab / Cilgavimab (2) – Evusheld®
COVID-19, Preexposition prophylaxis, ≥ 12 years
Characteristics
| Start date | 15.05.2023 – Marketing authorisation: 25.03.2022 |
|---|---|
| Resolution | 02.11.2023 |
| INN | Tixagevimab/Cilgavimab |
| Brand name | Evusheld® |
| Pharm. company | AstraZeneca GmbH |
| G-BA Procedure ID | D-944 |
| ATC code | J06BD03 IMMUNOGLOBULINS (J06B) |
| ICD-10 codes (AIS) | Z29.1Encounter for administration of immunoglobulin, Z29.9Encounter for prophylactic measures, unspecified |
| Alpha-ID codes (AIS) | I20305Prophylactic measure, I32424Preventive immunotherapy |
| Therapeutic area | Infectious diseases COVID-19 |
| Reason for procedure | Initial assessment |
| Therapeutic indication of the resolution |
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EVUSHELD is used for the pre-exposure prophylaxis of coronavirus disease 2019 (COVID-19) in adults and adolescents aged 12 years and over with a body weight of at least 40 kg who are entitled to receive this medicinal product in accordance with Section 2 (1) of the COVID-19 Prevention Ordinance. |
| Subpopulation | Indication | Comparator |
|---|---|---|
| Adults and adolescents aged 12 years and over with a body weight of at least 40 kg for pre-exposure prophylaxis of COVID-19 | Observational waiting |
Studies and Results
|
No. of studies
(best subpopulation) |
0 (Data not accepted) |
|---|---|
|
Study design
(best subpopulation) |
Data not accepted (Dossier: H2H vs. ACT) |
- Clinical trials
- The PROVENT study (observation period November 2020 – February 2023) is a double-blind RCT comparing COVID-19 pre-exposure prophylaxis with tixagevimab/cilgavimab against placebo in adults who were unvaccinated at the start of the study and who, according to predefined inclusion criteria, are at increased risk of an inadequate immune response to vaccination or of SARS-CoV-2 infection.
Adults and adolescents aged 12 years and over weighing at least 40 kg for pre-exposure prophylaxis against COVID-19
- An additional benefit is not proven for adults and adolescents aged 12 years and over weighing at least 40 kg for pre-exposure prophylaxis against COVID-19.
- Overall, based on the study results presented, no conclusions can be drawn regarding the additional benefit of tixagevimab/cilgavimab compared with the appropriate comparator therapy in the patient population relevant to the benefit assessment, as it remains unclear whether the study patient population cited by the pharmaceutical manufacturer corresponds to the patient population relevant to the benefit assessment.
- Overall assessment
- On balance, based on the study results submitted, no conclusions can be drawn regarding the additional benefit of tixagevimab/cilgavimab compared with the appropriate comparator therapy in the patient population relevant to the benefit assessment, as it remains unclear whether the study patient population used by the pharmaceutical manufacturer corresponds to the patient population relevant to the benefit assessment. An additional benefit is therefore not proven.
Courtesy translation only, please refer to the German original.
Associated procedures
| Tixagevimab / Cilgavimab (2) | Evusheld® | AstraZeneca GmbH | COVID-19, Preexposition prophylaxis, ≥ 12 years | n.d. | 100% additional benefit not proven | |
| Tixagevimab / Cilgavimab (1) | Evusheld® | AstraZeneca GmbH | COVID-19, erhöhtes Risiko für schweren Verlauf, ≥ 12 Jahre | n.d. | 100% Hint for minor additional benefit |
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