The antiviral drug remdesivir (brand name: Veklury) has been the first drug targeting COVID-19, which has undergone an early benefit assessment.
It was originally developed against Ebola infections but has been made available for treating COVID-19 in May 2020. Currently, remdesivir still is the only drug that is licensed in Europe for treating COVID-19. Specifically, it is indicated for adults and adolescents with pneumonia who require additional oxygen but not yet invasive ventilation.
Initially, remdesivir was exempt from an early benefit assessment, since the costs to the SHI funds within a 12 months period were expected to be below €1 million.
The G-BA then started an early benefit assessment in April 2021, which was now completed. The G-BA differentiated between three subgroups of patients:
- Adults receiving low-flow oxygen therapy at the beginning of the study,
- Adults receiving high-flow oxygen therapy or other non-invasive ventilation at the beginning of the study, and
- Adolescents between 12 and 18 years of age.
For all three subgroups, the appropriate comparator therapy (ACT) was physician’s choice.
The full G-BA assessment of remdesivir can be found here (in German only). The English translation is expected in September 2021.
Results for subgroup 1
For subgroup 1, the meta-analyses of studies ACTT-1, GS5774-A und CAP-2 showed that more patients recovered from the COVID-19 infection when treated with remdesivir compared with the ACT. It remained unclear though whether remdesivir could also improve overall survival since the included studies had very heterogeneous results. The extent of the additional benefit was therefore minor.
The certainty was only assessed as a hint since there were several uncertainties in the data. It was unclear whether the comparator arms in the study truly reflected physician’s choice. For example, the use of corticosteroids varied greatly. In addition, these studies were conducted at the beginning of the pandemic. Therefore, their results are only partly transferable to the current healthcare situation. Now, with increased therapeutic experience, patients can generally be treated differently and better. For example, patients may receive dexamethasone, which limits the immune response.
Overall, the G-BA assigned a hint of minor additional benefit.
Results for subgroup 2
For this subgroup, data on mortality and morbidity were available from the meta-analyses of studies ACTT-1 and GS5774-A. However, it was uncertain whether the use of dexamethasone in the comparator arms in these studies reflected the ACT. Therefore, the studies were not considered for the benefit assessment.
In addition, the G-BA noted that even if the studies were accepted, the meta-analyses showed neither benefits nor disadvantages of remdesivir.
Thus, there was no additional benefit proven.
Results for subgroup 3
Adolescents were not included in any of the submitted studies. The manufacturer also didn’t submit any data allowing the transfer of the evidence from adults to adolescents.
Since there are significantly different mortality risks for COVID-19 depending on age, the results observed for adults cannot be transferred to adolescents.
Thus, there are no data available for adolescents and the additional benefit was not proven.