The wet age-related macular degeneration (AMD) therapy market in the United States is unique in that the key approved therapies—Roche/Genentech’s Lucentis 0.5 mg and Regeneron’s Eylea—face competition from an off-label agent, Avastin (Roche/Genentech). All three therapies belong to the same drug class: vascular endothelial growth factor (VEGF) inhibitors. Although the approved therapies are effective and safe, their premium prices place a substantial burden on payers, and, hence, the drugs are subject to access and reimbursement restrictions, which, in turn, influence ophthalmologists’ prescribing decisions for wet AMD. Competition in this market is set to increase further with the expected launch of two late-phase VEGF inhibitors: Novartis’s brolucizumab (RTH-258) and Allergan’s abicipar pegol. These emerging agents may offer a dosing advantage relative to the current VEGF inhibitors, but to encourage their uptake, their developers may need to price them competitively with current therapies and use various strategies to obtain favorable market access/reimbursement conditions from managed care organizations (MCOs). Additionally, biosimilar versions of Eylea and Lucentis 0.5 mg are anticipated to launch in the United States in the coming years and may be favored by cost-sensitive payers, thereby posing further challenges to both current and emerging players in this market.

Questions Answered:

  • In light of the availability of low-priced off-label Avastin, approved anti-VEGF agents are subject to reimbursement restrictions and cost-control measures. What reimbursement restrictions and utilization controls are most commonly used for key VEGF inhibitors? Does their coverage for wet AMD differ on MCOs’ largest MA and commercial insurance plans? How do various cost-control measures affect prescribing of approved wet AMD therapies Eylea and Lucentis 0.5 mg and off-label Avastin? Is there still an opportunity for currently approved therapies to increase their patient share in wet AMD?
  • Despite the need for less-frequently dosed therapies for wet AMD, the late-phase therapies brolucizumab (RTH-258) and abicipar pegol are likely to encounter reimbursement challenges from payers if approved. At what price points would payers consider granting favorable coverage to these emerging therapies? What is the expected patient share for these therapies if placed on preferred and nonpreferred tiers? What type of pharmacoeconomic/health economic data would be most compelling to payers for a new wet AMD drug, and what type of cost-effectiveness assessment would be preferred by payers?
  • The expected U.S. launches of biosimilar versions of Eylea and Lucentis 0.5 mg could affect wet AMD market dynamics. What impact is the availability of these biosimilars likely to have on access to and reimbursement of their branded counterparts and other approved anti-VEGF agents? Are ophthalmologists willing to prescribe these therapies, and, if approved and reimbursed by payers, what is their maximum expected patient share in wet AMD?
  • Emerging wet AMD therapies that are differentiated from current products on clinical factors will most likely obtain favorable market access/reimbursement conditions from MCOs. What are the various drivers of reimbursement/formulary placement for wet AMD therapies? What are the potential areas of future opportunity in wet AMD?

Scope:

Markets covered: United States.

Methodology: Surveys of 102 ophthalmologists and 30 MCO officials (i.e., 20 pharmacy directors [PDs] and 10 medical directors [MDs]) in December 2016.

Indication coverage: Wet AMD.

Key drugs covered: Avastin, Eylea, Lucentis 0.5 mg, abicipar pegol, brolucizumab (RTH-258), squalamine, Fovista.

Key companies mentioned: Roche/Genentech, Regeneron, Allergan, Novartis, Ohr Pharmaceutical, Ophthotech.

Table of contents

  • Dry And Wet Age-Related Macular Degeneration - Access & Reimbursement - Detailed, Expanded Analysis (US)

Author(s): Himanshu Jain, M.S. Pharm

Himanshu joined the CNS / ophthalmology team at Decision Resources Group in 2016. He has authored content for psychiatry and ophthalmology (retinal / nonretinal) indications, including schizophrenia, age-related macular degeneration, diabetic retinopathy / diabetic macular edema, dry eye disease, glaucoma, and uveitis.

Himanshu has more than ten years of experience working in market research and consulting firms, and has managed multiple market assessment projects, including bottom-up forecasts, across multiple therapy areas. He holds a M.S. degree in Pharmacology and Toxicology from the National Institute of Pharmaceutical Education and Research in India and an Executive Post-Graduate Diploma in International Business from the Indian Institute of Foreign Trade.


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