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AXPAXLI (axitinib intravitreal implant)

Neovascular age-related macular degeneration

Also known as OTX-TKI
Manufacturer
Ocular Therapeutix
Last updated
309 sources

Executive summary

Budget impact of axitinib intravitreal implant

1 evidence topic · 19 sources

Summary

No price, wholesale acquisition cost, average sales price, AXPAXLI-specific cost-effectiveness analysis, budget impact model, or health technology assessment was identified, and no Institute for Clinical and Economic Review assessment of AXPAXLI or nAMD therapies was found. Budget impact therefore cannot be estimated from public data as of September 2026. The manufacturer's annual report, citing a Market Scope report, states that the exudative retinal disease market is estimated to include up to 8.3 million patients in the United States by 2030 and accounted for approximately $9.4 billion in U.S. annual estimated revenues in 2025, and that 1.7 million people in the United States and 14.8 million globally had wet AMD in 2025, with projected compound annual growth rates of 3.3% and 3.0% through 2030. The manufacturer states that its net product revenues would be significantly affected if it does not achieve the pricing and reimbursement coverage it anticipates. In August 2026, it reported that its payer team had engaged 100% of Tier 1 Medicare Advantage and commercial payers, who indicated that a label demonstrating superior durability could command premium pricing, and that approximately 80% of retina specialists surveyed (n=53) would likely use a product with the implant's profile. The company's post hoc estimate of a 72% reduction in injection burden over 60 weeks (56% including loading doses) compares the implant with a projected on-label aflibercept 2 mg regimen, not with observed practice.

Medicare Part B spending on anti-VEGF agents provides context for potential budget impact. In 2024, fee-for-service Medicare spent $3.0 billion on Eylea (including Eylea HD; 329,500 users; average $9,200 per user) and $1.9 billion on Vabysmo (173,300 users; average $11,100 per user), and in 2023, $0.6 billion on Avastin, whose indications include macular degeneration (161,500 users) and $0.5 billion on Lucentis (91,600 users). From 2014 to 2023, standardized Medicare reimbursement per injection declined from $1234.35 to $724.74 for ranibizumab and from $1527.37 to $1379.54 for aflibercept and increased from $46.76 to $300.73 for bevacizumab. Vision loss of all causes was estimated to cost the United States $134.2 billion in 2017.

Published economic evaluations of anti-VEGF agents show that results depend on drug price and injection frequency. In a 5-year U.S. payer model, faricimab was dominant over aflibercept 2 mg (US$52,797 versus US$62,367; 2.80 versus 2.72 QALYs) with 22.6 versus 34 injections, but faricimab every 8 weeks had an incremental cost-effectiveness ratio of US$162,175 per QALY; the authors concluded that treatment durability may outweigh unit price differences over time. A 3-year U.S. cost model estimated total costs 1978.74 USD lower with aflibercept 8 mg than with faricimab (12.25 versus 14.80 injections). For the ranibizumab port delivery system, a sustained-delivery option, a U.S. cost-utility analysis reported $75,497 per QALY at 1 year, $304,108 per QALY at 5 years, and $761,646 per QALY at 12 years versus ranibizumab injections, and a Medicare cost analysis estimated break-even with the port delivery system with 1 refill at 10.8 ranibizumab or 9.3 aflibercept injections. A discounted cash flow analysis valued a one-time alternative to intravitreal anti-VEGF treatment at $208,420.61, $219,093.31, and $17,379.41 relative to aflibercept, ranibizumab, and bevacizumab. In an 11-year U.S. cost-utility analysis, aflibercept was not cost-effective compared with bevacizumab ($1,151,451 per QALY), and a Medicare Part B model estimated $18 billion in savings for Medicare Part B if all patients were treated with bevacizumab.

Health technology assessments of longer-interval agents have tied price to the lowest-cost comparator. NICE found that faricimab has similar costs and overall health benefits to aflibercept or ranibizumab and recommended choosing the least expensive suitable treatment. CADTH estimated an incremental cost-effectiveness ratio of $695,839 per QALY for faricimab versus bevacizumab, estimated that a 79% price reduction would be required for cost-effectiveness relative to bevacizumab, and concluded that its cost per administration should be no more than that of the lowest-cost funded comparator. For aflibercept 8 mg, CDA-AMC stated that it should be priced no more than the lowest-cost funded anti-VEGF, and its analyses suggested that, rather than the sponsor's projected 3-year budget savings of $158,158,913, introduction would result in additional costs of $18.8 million and $21.5 million over 3 years. A U.S. budget impact analysis of brolucizumab for a health plan with 1 million enrollees estimated annual cost increases of $824,696 and $163,101 under as-needed and treat-and-extend regimens and savings of $93,068 and $94,170 under the manufacturer-recommended and real-world regimens. A UK analysis suggested durability as a relevant factor in cost-effectiveness analysis of anti-VEGF treatments when clinic capacity is limited.