4D-150

No 4D-150-specific cost-effectiveness analysis, budget impact model, health technology assessment, announced price, or published analyst price estimate was identified. 4D-150 is in Phase 3 development for wet AMD. The sponsor has not disclosed a price and has said that 4D-150 would likely be priced above a single intravitreal anti-VEGF injection. The sponsor expects 4D-150 to fit the U.S. Medicare Part B buy-and-bill model used by retina clinics, cites flexible pricing enabled by low cost of goods, and describes a value proposition that aligns incentives to long-term disease control. The sponsor estimates the 2025 global branded retinal vascular disease anti-VEGF market at $16 billion, of which approximately $10 billion is wet AMD and approximately $4 billion is DME, and states that more than 600,000 U.S. patients receive regular anti-VEGF therapy across more than 800,000 eyes. Under the Otsuka license, the Asia-Pacific territory represents approximately 10% of the global retinal anti-VEGF market, and 4DMT retains rights to approximately 85% of the commercial potential of 4D-150.

One published U.S. analysis addresses the value of a one-time anti-VEGF gene therapy for nAMD. A discounted cash flow model estimated present values of $208,420.61, $219,093.31, and $17,379.41 for a one-time alternative to lifelong aflibercept, ranibizumab, and bevacizumab, respectively; values ranged 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 proposed bevacizumab as the base case and recommended reimbursement mechanisms with contingencies for sustained efficacy.

Published U.S. economic evaluations of long-acting anti-VEGF treatments report the following. Over 5 years from a U.S. payer perspective, faricimab dominated aflibercept 2 mg (US$52,797 and 2.80 QALYs versus US$62,367 and 2.72 QALYs; 22.6 versus 34 injections), with a 97% probability of cost-effectiveness at US$100,000/QALY; under a Q8W faricimab regimen the ICER was US$162,175 per QALY. A Regeneron-funded model using 2025 wholesale acquisition costs (aflibercept 8 mg 2677.50 USD and faricimab 2289.65 USD per injection) estimated total 3-year costs for aflibercept 8 mg that were 1978.74 USD lower than faricimab in nAMD (12.25 versus 14.80 injections). For the port delivery system with ranibizumab, one cost-utility analysis found an incremental cost-utility ratio of $75,497/QALY at 1 year, $304,108/QALY at 5 years, and $761,646/QALY at 12 years versus ranibizumab injections; a Medicare cost analysis found that the port delivery system with fixed 6-month refills cost $21,016 over 1 year and $89,218 over 5 years, with break-even at 10.8 ranibizumab, 9.3 aflibercept, and 34.5 bevacizumab injections in year 1. An 11-year cost-utility analysis found aflibercept not cost-effective compared with bevacizumab ($1,151,451/QALY incremental).

Medicare Part B payment limits for July to September 2026 were $743.605 per 1 mg for aflibercept (J0178), $298.683 per 1 mg for aflibercept HD (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). At labeled nAMD doses these limits correspond to $1,487.21 per aflibercept 2 mg injection, $1,606.51 per aflibercept-ayyh 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 (calculated). In 2025, Medicare Part B spending was $2,378,138,734 for Vabysmo (J2777; 213,777 beneficiaries), $1,537,858,049 for Eylea (J0178; 222,280 beneficiaries), $1,140,248,051 for Eylea HD (J0177; 99,161 beneficiaries), and $522,266,027 for the aflibercept biosimilar Pavblu (Q5147; 80,140 beneficiaries); the nine branded and biosimilar ophthalmic anti-VEGF codes listed (bevacizumab not included) totaled approximately $5.67 billion (calculated), across all indications. In 2024, Part B spending on Eylea was $2,365,369,089 (293,280 beneficiaries). From 2014 to 2023, Medicare beneficiaries received 36,398,293 intravitreal anti-VEGF injections, and standardized Medicare reimbursement per injection declined for aflibercept from $1527.37 to $1379.54.

For one-time ocular gene therapy, Spark Therapeutics set the wholesale acquisition cost of voretigene neparvovec at $425,000 per eye in January 2018 and introduced an outcomes-based rebate arrangement with short-term efficacy (30 to 90 days) and long-term durability (30 months) measures, a direct-to-payer contracting model, and a proposal to CMS for installment payments.