Primary Risk Drivers
Below is a snapshot of domains that materially influence the MARA Rating.
Clinical effectiveness
The evidence indicates that faricimab is likely to work as well as aflibercept for patients who have not previously received anti-VEGF treatment. However, the evidence for its effectiveness in patients who have previously been treated with anti-VEGF is limited, which prevents a higher rating.
Cost effectiveness
Faricimab is suggested to have similar costs and overall health benefits compared to aflibercept, which supports its recommendation as a cost-effective option under NICE’s cost comparison methods.
Quality of life
There is no specific data provided on HRQoL improvements associated with faricimab. The recommendation is based on cost comparison and clinical effectiveness rather than direct evidence of quality of life benefits.
Supporting Domains
Safety and Adverse Effects
The document does not highlight significant safety concerns, indicating that faricimab has an acceptable safety profile comparable to existing treatments. However, specific adverse effects are not detailed.
Comparator Selection
Faricimab is compared to aflibercept, which is an appropriate and relevant standard of care for the target population, ensuring the comparison is valid.
Patient Population and Subgroups
The patient population for faricimab is well-defined, focusing on adults with visual impairment due to macular oedema after retinal vein occlusion. However, there is limited evidence for those who have previously received anti-VEGF treatment.
Care Pathway Integration
Faricimab can be integrated into existing treatment pathways for macular oedema, requiring only minor adjustments in practice, as it is an anti-VEGF treatment similar to those already in use.
Resource Use and Cost Implications
The implementation of faricimab is expected to be manageable within existing budgets, especially given the commercial arrangement that provides it at a discount.
Evidence Quality and Robustness
The evidence base includes clinical trial data suggesting comparable efficacy to aflibercept, but there are gaps in evidence for certain subpopulations, which affects the robustness of the conclusions.
Uncertainty, Sensitivity, and Broader Impacts
While there are some uncertainties regarding the effectiveness in previously treated patients, the overall context supports the use of faricimab, addressing a significant unmet need in the treatment of macular oedema.