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Vabysmo / faricimab for treating visual impairment caused by macular oedema after retinal vein occlusion

As of September 2024, MARA’s assessment finds Vabysmo / Faricimab’s reimbursement risk concentrated in quality of life, with cost effectiveness 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 cost effectiveness carries weight because that domain asks whether the price asked stands in a defensible relationship to the benefit delivered — the core of most European reimbursement decisions.

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 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.

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

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

Does the safety profile hold up for payers? — 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.

Was the drug compared against what payers expect? — 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.

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

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

Are the wider system costs understood? — 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.

Would the evidence survive payer scrutiny? — 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.

How exposed is the case to uncertainty? — 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.

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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