Primary Risk Drivers
Below is a snapshot of domains that materially influence the MARA Rating.
Clinical effectiveness
The evidence from two Phase 3 randomized controlled trials (YOSEMITE and RHINE) indicates that faricimab is moderately effective, showing similar clinical effectiveness to aflibercept, which is a standard treatment for diabetic macular oedema. However, the evidence is somewhat limited due to uncertainties in subgroup analyses and the lack of long-term data beyond 100 weeks.
Cost effectiveness
The cost comparison suggests that faricimab is likely to be cost-saving or have similar costs compared to aflibercept and ranibizumab, particularly if fewer injections are needed. The committee concluded that the total costs associated with faricimab are similar or lower than those of the comparators, supporting its cost-effectiveness.
Quality of life
The document does not provide specific data on HRQoL improvements associated with faricimab. While it mentions similar effectiveness to existing treatments, there is no evidence of significant or sustained improvements in quality of life metrics.
Supporting Domains
Safety and Adverse Effects
The clinical evidence indicates that faricimab has a similar safety profile to aflibercept and ranibizumab, with comparable adverse events reported in the trials. This suggests an acceptable safety profile, although some concerns remain regarding the long-term safety data.
Comparator Selection
The comparators selected for the trials (aflibercept and ranibizumab) are appropriate and recommended by NICE for treating diabetic macular oedema. The committee confirmed that these are the standard treatments against which faricimab was evaluated.
Patient Population and Subgroups
The trials included a representative population of adults with diabetic macular oedema, although there were some limitations in subgroup analyses. The core population is well covered, supporting the generalizability of the findings.
Care Pathway Integration
Faricimab can be integrated into existing treatment pathways with minor adjustments, as it is an anti-VEGF injection like aflibercept and ranibizumab. The committee noted that it fits well within current clinical practices.
Resource Use and Cost Implications
The document indicates that faricimab may lead to fewer injections and monitoring visits, which could reduce overall resource use. However, the committee acknowledged that in practice, the dosing regimen may be similar to existing treatments, leading to a justifiable cost burden.
Evidence Quality and Robustness
The evidence is derived from two Phase 3 RCTs, which are robust in design. However, there are some concerns regarding the subgroup analyses and the need for further long-term data, which introduces some uncertainty.
Uncertainty, Sensitivity, and Broader Impacts
While there are some uncertainties regarding long-term outcomes and subgroup analyses, the overall context of unmet need for diabetic macular oedema treatments supports a favorable assessment. The committee did not identify significant negative externalities.
