Primary Risk Drivers
Below is a snapshot of domains that materially influence the MARA Rating.
Clinical effectiveness
The clinical evidence from two Phase 3 randomized controlled trials (TENAYA and LUCERNE) indicates that faricimab is moderately effective compared to aflibercept, with a mean change in best corrected visual acuity showing a difference of 0.4 letters. While this suggests a benefit, the margin of improvement is modest, thus justifying a rating of A.
Cost effectiveness
The cost comparison indicates that faricimab is likely to be cost-saving or have similar costs compared to aflibercept and ranibizumab. The committee acknowledged that the total cost associated with faricimab is similar or lower, supporting a rating of A for marginal cost-effectiveness.
Quality of life
The document does not provide specific data on HRQoL outcomes related to faricimab. While it mentions similar effectiveness to existing treatments, the absence of detailed patient-reported outcomes or validated tools leads to a rating of B++ due to minimal or mixed impact.
Supporting Domains
Safety and Adverse Effects
The evidence suggests that faricimab has a similar safety profile to aflibercept and ranibizumab, with similar adverse events reported. This acceptable safety profile, with no significant concerns raised, justifies a rating of A.
Comparator Selection
The comparators selected (aflibercept and ranibizumab) are appropriate and recommended by NICE for the same condition. The committee concluded that these are suitable comparators, leading to a rating of A+.
Patient Population and Subgroups
The trials included a representative population of adults with wet age-related macular degeneration, and the criteria for treatment align with those for existing therapies. This moderate representativeness supports a rating of A.
Care Pathway Integration
Faricimab can be integrated into existing treatment pathways with minor adjustments, as it is an anti-VEGF injection similar to aflibercept and ranibizumab. This manageable integration supports a rating of A+.
Resource Use and Cost Implications
The document indicates that faricimab may reduce the number of injections and monitoring visits, suggesting a favorable resource use profile. This potential for cost savings aligns with a rating of A.
Evidence Quality and Robustness
The evidence is derived from two Phase 3 RCTs with a substantial sample size (1,329 adults), indicating strong robustness. Minor limitations were noted, but overall, the evidence quality supports a rating of A+.
Uncertainty, Sensitivity, and Broader Impacts
There is some uncertainty regarding the long-term efficacy and the number of injections needed beyond the initial treatment period. This uncertainty, while manageable, leads to a rating of B++.
