Age-Related Macular Degeneration | Access & Reimbursement | US | 2023

The age-related macular degeneration (AMD) market in the United States is unique given that market penetration of approved branded therapies—Roche / Genentech’s Lucentis, Regeneron’s Eylea, Novartis’s Beovu, Roche’s Vabysmo and Susvimo—has been hampered by the availability of Roche’s Avastin (bevacizumab), frequently compounded and prescribed off-label because of its lower price. Competition facing key brands will further intensify with the launches of Regeneron’s high-dose aflibercept, Kodiak Sciences’ tarcocimab tetrodomer (formerly KSI-301), and AbbVie / Regenxbio’s gene therapy ABBV-RGX-314. These agents potentially offer a dosing advantage over the currently available VEGF inhibitors, addressing a substantial unmet need in this market. In the United States, biosimilars of Lucentis (ranibizumab) began launching in July 2022 and biosimilars of Eylea (aflibercept) are expected to launch in 2024, making it essential to understand how these presumably lower-priced therapies could impact access to premium-priced brands.

QUESTIONS ANSWERED

• Does coverage of the key VEGF inhibitors for wet AMD differ on MCOs’ largest Medicare Advantage and commercial insurance plans? To what extent do payers’ cost-control measures impact prescribing of these approved therapies and Avastin?
• How is the availability of biosimilars of Eylea and Lucentis likely to impact access to and reimbursement of their reference brands? What impact might they have on recently-launched therapies such as Vabysmo?
• To what extent are biosimilar versions of Lucentis (Biogen / Samsung-BioEpis’s Byooviz and Coherus’s Cimerli) prescribed and reimbursed for wet AMD, if at all?
• What will be the market impact of Outlook Therapeutics’ Lytenava (ONS-5010), an ophthalmic formulation of bevacizumab, on current and emerging therapies if it launches for wet AMD?
• What is U.S. ophthalmologists’ anticipated use of Apellis’s Syfovre, launched in March 2023 for the treatment of GA secondary to AMD?
• Do ophthalmologists expect to prescribe late-phase emerging therapies to their Medicare and commercially insured wet AMD patients? How do payers expect to cover these therapies on their largest commercial and Medicare Advantage plans?

CONTENT HIGHLIGHTS

Geography: United States

Primary research: Survey of 101 U.S. ophthalmologists, survey of 30 U.S. MCO PDs / MDs

Fingertip formulary: Formulary coverage and restrictions data for wet AMD therapies and Syfovre by commercial plans covering approximately 163.6 million lives and Medicare Part D plans covering 36.7 million lives nationally.

Key drugs covered: Eylea, Lucentis, Vabysmo, Susvimo, Avastin, Byooviz, Cimerli, Avastin, high-dose aflibercept, tarcocimab tetrodomer, ABBV-RGX-314, Syfovre

Content highlights:

Reimbursement and contracting.

Access and prescribing.

Opportunities and challenges for emerging therapies.

Disease-specific special topic: the impact of aflibercept biosimilars on the wet AMD market

PRODUCT DESCRIPTION

U.S. Access & Reimbursement provides integrated brand- and disease-level insight on reimbursement dynamics and the impact of U.S. payer policy on physician prescribing behavior in the market access environment, including up-to-date analysis of drug coverage and restriction policies and payer and prescriber perspectives on key marketed drugs and receptivity to emerging therapies.