Dry and Wet Age-Related Macular Degeneration – Access & Reimbursement – Detailed, Expanded Analysis: Special Focus on Retinal Therapies: US Payer Management of the Medical Benefit

As part of ongoing efforts to address the rising cost of pharmaceuticals, the U.S. Centers for Medicare & Medicaid Services significantly shifted policy to allow Medicare Advantage plans to impose step therapy requirements on medically administered Part B drugs starting in 2019. This new policy presents potential challenges for manufacturers of physician-injected wet age-related macular degeneration (AMD) and diabetic macular edema (DME) therapies, such as Roche / Genentech’s Lucentis and Regeneron’s Eylea. This report explores the market access environment for current and emerging wet AMD and DME branded drugs, with a special focus on how commercial and Medicare Advantage plans manage the medical benefit of these injectable therapies.


· How do MCOs manage physician-administered retinal therapies through the medical benefit in their largest risk-based commercial and Medicare Advantage plans? Are their Medicare plans requiring step therapy as now allowed by CMS? Will they require patients to use less-expensive off-label Avastin first?

· Which therapies do surveyed MCOs prefer on their formularies and what types of utilization controls do they impose on both the pharmacy and medical benefits? How do these controls affect ophthalmologists’ choice of therapy?

· What is the potential for payer reimbursement and physician uptake of emerging therapies, including a permanent refillable implant that releases ranibizumab now in development?

Geography: United States

Primary Research: Survey of 100 ophthalmologists, survey of 39 U.S. managed care organization (MCO) pharmacy and medical directors (PDs/MDs)

Key Drugs Covered

Current therapies: Avastin, Eylea, Lucentis, Ozurdex, Iluvien

Emerging therapies: brolucizumab (Beovu), abicipar pegol, faricimab, ranibizumab port-delivery system, ONS-5010

Content Highlights: Reimbursement Landscape, Access and Prescribing, Special topic: Payer Management of the Medical Benefit, Opportunities and Challenges for Emerging Therapies


U.S. Access & Reimbursement provides in-depth insight on the impact of payer policy on prescribing behavior so that clients can build their market access strategy and optimize their brand positioning. This analysis of primary market research with physician specialists and U.S. payers helps clients stay up-to-date on restriction policies, gauge payer and prescriber attitudes toward specific therapies, identify opportunities where brands can capture patient share through market access, and maximize opportunities for emerging therapies by learning how previous brands gained favorable reimbursement or why they stumbled.

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