Primary Risk Drivers
Below is a snapshot of domains that materially influence the MARA Rating.
Clinical effectiveness
The clinical evidence for remdesivir indicates it can increase survival for adults needing low-flow supplemental oxygen compared to standard care, but the evidence is highly uncertain due to the changing nature of COVID-19 and the predominance of the Omicron variant. The committee noted that most evidence comes from studies conducted before the Omicron variant, leading to significant uncertainty in its effectiveness in the current context.
Cost effectiveness
The cost-effectiveness estimates for remdesivir are uncertain and depend heavily on the mortality rates and hospitalisation rates, which are variable. The committee concluded that remdesivir is likely to be cost-effective for certain high-risk groups, but overall, the ICERs are above NICE’s acceptable threshold for many populations.
Quality of life
There is limited evidence regarding the impact of remdesivir on HRQoL, particularly in children and immunocompromised populations. The committee acknowledged that while remdesivir may have some benefits, the overall impact on quality of life remains uncertain and not well documented.
Supporting Domains
Safety and Adverse Effects
Remdesivir has an acceptable safety profile with manageable adverse effects. The evidence suggests that it is well tolerated, particularly in the populations studied, although the committee noted that the safety data is less robust for children and immunocompromised individuals.
Comparator Selection
The evidence for remdesivir was compared against standard care, which has evolved over time. However, the committee noted that the comparators used in the trials may not fully reflect current clinical practice, particularly with the emergence of new variants.
Patient Population and Subgroups
The patient populations studied include adults and children, but the evidence for children is particularly limited. The committee recognized that while remdesivir is the only licensed treatment for children under 12, the small number of cases limits generalizability.
Care Pathway Integration
Remdesivir can be integrated into existing care pathways with minor adjustments. The committee noted that it fits well within the current treatment protocols for COVID-19, particularly for high-risk patients.
Resource Use and Cost Implications
The resource implications of remdesivir are significant, particularly in terms of hospitalisation costs. The committee acknowledged that while it may be cost-effective for certain populations, the overall budget impact raises concerns.
Evidence Quality and Robustness
The evidence base for remdesivir includes several studies, but there are notable gaps and uncertainties, particularly regarding its effectiveness against current variants. The committee highlighted the need for more robust data to support its use.
Uncertainty, Sensitivity, and Broader Impacts
There is considerable uncertainty surrounding the effectiveness of remdesivir in the current COVID-19 landscape, particularly with the emergence of new variants. The committee noted that this uncertainty could impact its broader applicability and acceptance.
