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Faricimab / vabysmo for treating wet age-related macular degeneration

As of June 2022, MARA’s assessment finds Faricimab / Vabysmo’s reimbursement risk concentrated in quality of life, with comparator selection a strength; the current MARA Rating and full rationale are available in the report.

The assessment also weighs clinical effectiveness: how much additional benefit the drug demonstrated over the care patients already receive — the first question every payer asks. The strength recorded in comparator selection carries weight because that domain asks whether the drug was tested against the treatment payers actually fund today; a benefit shown against the wrong comparator carries little weight in a reimbursement decision.

Ophthalmology

This rating sits within MARA’s Ophthalmology coverage, alongside 10 other independently assessed treatments in the same area.

What payers will ask

Is the clinical benefit the kind payers reward? — 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.

Does the economic case hold at the expected price? — 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.

Is there quality-of-life evidence payers weigh? — 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.

Does the safety profile hold up for payers? — 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.

Was the drug compared against what payers expect? — 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+.

Is the population defined the way payers need it? — 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.

Does the drug fit how care is delivered and paid for? — 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+.

Are the wider system costs understood? — 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.

Would the evidence survive payer scrutiny? — 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+.

How exposed is the case to uncertainty? — 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++.

Be alerted when this rating changes:

Sample two-page MARA Rating report for the fictional drug Samplinib: the rating with its decision record, and the ten graded payer questions with the reasoning behind each
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