[A21-38] Remdesivir (COVID-19) - Benefit assessment according to §35a Social Code Book V

Last updated 01.07.2021

Project no.:
A21-38

Commission:
Commission awarded on 01.04.2021 by the Federal Joint Committee (G-BA).

Report type:
Dossier assessment

Status:
Commission completed

Department/Division:
Drug Assessment

Application field:
Immune system and infections

Indication:

COVID-19 in adults and adolescents (aged 12 years and older with body weight at least 40 kg) with pneumonia requiring supplemental oxygen (low- or high-flow oxygen or other non-invasive ventilation at start of treatment)

Result of dossier assessment:

Adult patients with low-flow oxygen (LFO) at start of treatment: indication of considerable benefit.

Adolescent patients with low-flow oxygen (LFO) at start of treatment: added benefit not proven.

Patients with high-flow oxygen (HFO)/non-invasive ventilation (NIV) at start of treatment: added benefit not proven.

Note:

After completion of the assessment by IQWiG the Federal Joint Committee (G-BA) conducts a commenting procedure. This may provide supplementary information and as a result lead to a modified benefit assessment. Further information and the decision on the early benefit assessment can be found on the relevant page of the G-BA website.

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