Primary Risk Drivers
Below is a snapshot of domains that materially influence the MARA Rating.
Clinical effectiveness
Empagliflozin shows moderate benefit over standard care for chronic kidney disease (CKD), with clinical trial evidence indicating that it is more effective than standard care alone. However, the main trial did not include patients with an estimated glomerular filtration rate (eGFR) below 20 ml/min/1.73 m_, and the evidence for those with eGFR between 45 and 90 ml/min/1.73 m_ is limited to indirect comparisons with dapagliflozin, which suggests similar effectiveness.
Cost effectiveness
The cost-effectiveness estimates for empagliflozin are within the range that NICE considers acceptable for Healthcare resources. Additionally, a cost comparison indicates that empagliflozin has similar costs to dapagliflozin, supporting its economic viability.
Quality of life
The document does not provide specific data on HRQoL improvements associated with empagliflozin. While it is implied that the treatment may improve patient outcomes, there is no robust evidence presented regarding significant or sustained improvements in quality of life metrics.
Supporting Domains
Safety and Adverse Effects
Empagliflozin is reported to have a safety profile similar to dapagliflozin, which is generally well-tolerated. The document indicates that adverse effects are manageable, although specific adverse event rates are not detailed.
Comparator Selection
The evidence includes indirect comparisons with dapagliflozin, but there are no direct head-to-head trials. This limits the strength of the comparator selection, as the effectiveness of empagliflozin relative to other treatments is not fully established.
Patient Population and Subgroups
The trial population does not fully represent all patients with CKD, particularly those with eGFR below 20 ml/min/1.73 m_. While the core population is covered, there are significant gaps in subgroup representation, particularly among ethnic minorities and younger patients with type 2 diabetes.
Care Pathway Integration
Empagliflozin can be integrated into existing care pathways as an add-on to standard care, which includes ACE inhibitors or ARBs. The integration requires minimal adjustments, making it a manageable addition to current treatment protocols.
Resource Use and Cost Implications
The document suggests that empagliflozin has a manageable budget impact aligned with planning, indicating that its resource use is justifiable given the expected benefits.
Evidence Quality and Robustness
The evidence base includes clinical trial data, although there are some limitations regarding the population studied and the absence of direct comparisons. Overall, the evidence is considered acceptable with some methodological concerns.
Uncertainty, Sensitivity, and Broader Impacts
While there are some uncertainties regarding the applicability of the evidence to all patient populations, the overall context supports the use of empagliflozin, particularly in light of the unmet need in CKD management.
