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.
- 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.
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Andrea Witt, Ph.D.
Andrea S. Witt, Ph.D., is Director of the Central Nervous System and Ophthalmology Disorders Portfolio at Clarivate, where she oversees a team of Business Insights Analysts and Senior Directors responsible for market research encompassing Neurology, Psychiatry, Pain, and Ophthalmology.
Her interests beyond specific CNS indications included the market potential for neuroprotectants and the impact of biomarkers on CNS markets. Dr. Witt’s research, analysis, and commentaries have appeared in Barron’s, Pharmaceutical Executive, PharmaVoice, Nature Medicine, and CNBC. Dr. Witt’s previous experience includes 10 years of scientific research conducted on neurodegenerative disorders at Harvard Medical School/Brigham and Women’s Hospital, Duke University, and the University of Texas-Southwestern Medical Center, where she earned her Ph.D. degree.
Chris Lewis
Chris Lewis, Lead Healthcare Research & Data Analyst, U.S. Access and Reimbursement. Ms. Lewis oversees Clarivate’s U.S. Access & Reimbursement reports, including managing the primary research activities, reviewing content, and authoring select A&R reports on managed care trends. A Clarivate employee for 16 years, Ms. Lewis previously was a senior analyst who authored Health Plan Analysis reports and PBM profiles. She received her bachelor’s degree from California State University in Sacramento.