Primary Risk Drivers
Below is a snapshot of domains that materially influence the MARA Rating.
Clinical effectiveness
The clinical evidence from the FIDELIO-DKD trial indicates that finerenone improves kidney function and slows disease progression compared to placebo, demonstrating a moderate benefit. However, the lack of direct comparisons against SGLT2 inhibitors limits the strength of the evidence.
Cost effectiveness
The cost-effectiveness estimates for finerenone are within the acceptable range for Healthcare resources, with ICERs below £30,000 per QALY gained in various scenarios, indicating a strong economic value.
Quality of life
The evidence suggests that finerenone may lead to improvements in quality of life, particularly in managing chronic kidney disease symptoms. However, specific HRQoL data from validated instruments were not extensively detailed in the document.
Supporting Domains
Safety and Adverse Effects
Finerenone has a generally acceptable safety profile, with hyperkalaemia being the main adverse event. Most adverse events were mild and manageable, indicating good tolerability.
Comparator Selection
The document notes that finerenone was not directly compared with SGLT2 inhibitors, which are relevant comparators. This lack of direct comparison raises concerns about the robustness of the evidence.
Patient Population and Subgroups
The trial population is broadly representative of the intended patient population, with a good balance of demographics. Subgroup analyses were also considered, enhancing generalizability.
Care Pathway Integration
Finerenone can be integrated into existing care pathways with minor adjustments, primarily as an add-on to standard care, which is manageable for healthcare providers.
Resource Use and Cost Implications
The budget impact of finerenone is manageable, with potential cost savings in the long term due to improved patient outcomes and reduced progression to more severe disease states.
Evidence Quality and Robustness
The evidence is primarily based on a robust Phase 3 trial (FIDELIO-DKD), although there are some limitations regarding the generalizability of the results to the broader population.
Uncertainty, Sensitivity, and Broader Impacts
There are notable uncertainties regarding the cost-effectiveness model, particularly concerning the assumptions made about treatment effects and the lack of direct comparisons with SGLT2 inhibitors.
