From Clinical Trials to RWE: Defining Faricimab Value Drivers in Neovascular Age Related Macular Degeneration Through a Cost Utility Analysis

OBJECTIVES: Real-word evidence revealed that adherence and persistence to anti-Vascular Endothelial Growth Factor (anti-VEGFs) therapies among patients with Neovascular Age-related Macular Degeneration (nAMD) is suboptimal, leading to potential poor visual outcome. In TENAYA & LUCERNE clinical trials (CTs), faricimab showed its ability to extend injection intervals while achieving vision gains comparable to Standard of Care (SoC), leading to a positive Cost Utility Analysis (CUA) in CTs setting. This study aimed to evaluate the cost-utility of faricimab under potential RWE full adherence and persistence conditions vs current SoC in a real-world setting from the perspective of the Italian National Health Service (NHS).

METHODS: A 28-day cycle Markov model was used to estimate lifetime clinical outcomes and costs of nAMD patients treated with faricimab and SoC. Transition probabilities, treatment discontinuation rates, and injection frequency were derived from pivotal CTs and RADIANCE observational study for faricimab and SoC, respectively. Comparative effectiveness data were obtained from propensity score weighting analysis. Adherence and persistence from CTs were assumed for faricimab. Direct healthcare costs and (dis)utilities were collected from literature. Gross prices for drugs were used. Costs and health gains were discounted at an annual 3% rate. Probabilistic and deterministic sensitivity analyses were conducted to evaluate the uncertainty of input parameters.

RESULTS: Faricimab was associated with improved Quality Adjusted Life Year (QALY) (+1.15) compared to SoC, with additional cost of nearly 31.000€/patient. Cost increase was mainly driven by the enhanced adherence and persistence with faricimab. The Incremental Cost-Utility Ratio (ICUR) was about 27.000 € per QALY gained.

CONCLUSIONS: Faricimab, with CTs-based compliance, is a cost-effective option compared to real-world SoC for Italian nAMD patients, with a deterministic ICUR below the recently proposed thresholds for the health technology assessment. This study will also allow to further investigate real world anti-VEGFs measured appropriateness impact on CUA.