4D-150

No price, average sales price, wholesale acquisition cost, cost-effectiveness analysis, budget impact model, or health technology assessment has been published for 4D-150, and no published analyst price estimate was identified. The sponsor has not disclosed a price and has stated that 4D-150 would likely be priced well above a single intravitreal anti-VEGF injection, that retina clinics largely fit the Medicare Part B buy-and-bill model, and that the relatively low doses required allow pricing flexibility through favorable cost of goods sold. The sponsor estimates the 2025 global branded retinal vascular disease anti-VEGF market at $16 billion, of which about $10 billion is wet AMD and about $4 billion is diabetic macular edema, and reports that more than 600,000 United States patients receive regular anti-VEGF therapy across more than 800,000 eyes; under the Otsuka license the Asia-Pacific territory represents about 10% of the global retinal anti-VEGF market, and the sponsor retains about 85% of the commercial potential of 4D-150. Budget impact for 4D-150 therefore cannot be estimated from public data as of September 2026.

Comparator acquisition costs are documented. Medicare Part B payment limits effective July 1 to September 30, 2026, based on first-quarter 2026 ASP data, were $743.605 per 1 mg for aflibercept (J0178), $298.683 per 1 mg for aflibercept 8 mg (J0177), $803.255 per 1 mg for aflibercept-ayyh (Q5147), $32.381 per 0.1 mg for faricimab (J2777), $51.090 per 0.1 mg for ranibizumab (J2778), $359.713 per 1 mg for brolucizumab (J0179), and $74.823 per 10 mg for bevacizumab (J9035), each with 20% coinsurance. Calculated at labeled doses for neovascular AMD, these limits correspond to $1,487.21 per aflibercept 2 mg injection, $2,389.46 per aflibercept 8 mg injection, $1,942.86 per faricimab 6 mg injection, $255.45 per ranibizumab 0.5 mg injection, and $2,158.28 per brolucizumab 6 mg injection. Reported 2025 wholesale acquisition costs (WAC) per injection were $2,677.50 for aflibercept 8 mg and $2,289.65 for faricimab. In 2025, Medicare Part B spending across all indications was $2,378,138,734 for faricimab (213,777 beneficiaries), $1,537,858,049 for aflibercept 2 mg (222,280 beneficiaries), $1,140,248,051 for aflibercept 8 mg (99,161 beneficiaries), and $522,266,027 for the aflibercept biosimilar aflibercept-ayyh (80,140 beneficiaries); the nine branded and biosimilar ophthalmic anti-VEGF codes reported, which exclude bevacizumab, totaled approximately $5.67 billion. From 2014 to 2023, Medicare beneficiaries received 36,398,293 intravitreal anti-VEGF injections, and standardized Medicare reimbursement per injection fell from $1,527.37 to $1,379.54 for aflibercept and from $1,234.35 to $724.74 for ranibizumab.

Cost-effectiveness evidence exists only for comparators. Over 5 years from a United States payer perspective, faricimab dominated aflibercept 2 mg, yielding 2.80 QALYs for $52,797 versus 2.72 QALYs for $62,367 with 22.6 versus 34 injections, and had a 97% probability of being cost-effective at $100,000 per QALY; under an every-8-week faricimab regimen the incremental cost-effectiveness ratio was $162,175 per QALY. A model using 2025 wholesale acquisition costs estimated total 3-year costs for aflibercept 8 mg that were $1,978.74 lower than for faricimab in neovascular AMD, with 12.25 versus 14.80 injections. For the port delivery system with ranibizumab, the incremental cost-utility ratio versus ranibizumab injections was $75,497 per QALY at 1 year, $304,108 per QALY at 5 years, and $761,646 per QALY at 12 years, and a Medicare cost analysis found break-even at 10.8 ranibizumab, 9.3 aflibercept, or 34.5 bevacizumab injections in the first year against a 1-year port delivery system cost of $21,016. In an 11-year cost-utility analysis, aflibercept was not cost-effective compared with bevacizumab ($1,151,451 per QALY incremental), and average ophthalmic cost-utility ratios were $11,033 per QALY for bevacizumab, $44,801 per QALY for aflibercept, and $79,600 per QALY for ranibizumab.

One published United States analysis addresses the value of a one-time anti-VEGF gene therapy directly. A discounted cash flow model estimated the present value of a single treatment replacing lifelong injections at $208,420.61 versus aflibercept, $219,093.31 versus ranibizumab, and $17,379.41 versus bevacizumab, varying from $78,323.19 to $292,449.87 by age at first injection and from $148,422.91 to $388,096.81 by injection frequency; the authors argued that bevacizumab should be the base case and that reimbursement mechanisms should include contingencies for sustained efficacy. The only marketed precedent for a one-time ocular gene therapy is voretigene neparvovec, whose wholesale acquisition cost was set at $425,000 per dose or per eye in January 2018, distributed through both buy-and-bill and a direct-to-payer contracting model, with outcomes-based rebates tied to short-term efficacy at 30 to 90 days and durability at 30 months and a proposal to CMS for payments over time.