Until the approval of Genentech’s Lucentis in August 2012, laser photocoagulation therapy was the standard of care for diabetic macular edema (DME). Although laser therapy is still frequently used, the approval of the anti-vascular endothelial growth factor (VEGF) therapy Lucentis mg revolutionized treatment of DME; the drug was the first therapy to demonstrate the ability to not only maintain but also improve visual acuity for some patients. The DME therapy market underwent tremendous change in 2014 as the anti-VEGF Eylea and the long-acting corticosteroids Ozurdex and Iluvien were approved to treat the disease. In addition, Genentech’s anti-VEGF Avastin, which is approved for oncology indications, has commonly been compounded and used off-label for DME, and the drug currently captures the largest patient share owing to its very competitive pricing in this otherwise high-priced specialty pharmaceutical market. Eylea, in particular, has experienced strong uptake in the United States for DME as a result of its label for extended maintenance dosing frequency, highlighting the importance of dosing schedule to prescriber choice in this market, regardless of brand pricing. The future DME market may see the launch of several promising emerging therapies, including agents that offer novel mechanisms of action, different dosing profiles, and/or enhanced efficacy through adjunctive therapy. This report examines the market opportunities and challenges that current and future drug marketers will face in the evolving DME market access landscape. To better understand the DME treatment algorithm and market access environment from a physician perspective, we surveyed 100 ophthalmologists who treat DME with intravitreal anti-VEGF injections. To gain insight into factors influencing formulary inclusions/positioning and cost controls for current and emerging DME therapies, we surveyed 30 pharmacy and medical directors from managed care organizations (MCOs) that offer both commercial and Medicare Advantage plans. In addition, we assessed ophthalmologist and payer receptivity to novel DME treatments in order to identify factors that will drive or constrain these agents’ uptake.
Questions Answered in This Report:
- The majority of pharmacotherapy-treated DME patients receive one of three anti-VEGF agents: Lucentis, Eylea, or off-label Avastin. What factors drive ophthalmologists to prescribe Lucentis, Eylea, and Avastin? For what reasons do ophthalmologists prescribe one anti-VEGF agent rather than the alternatives? How do market access hurdles differentially affect physician prescribing of approved and off-label agents? What market access challenges and cost-control measures affect prescribing of each agent for patients with commercial insurance versus Medicare Advantage?
- Ozurdex and Iluvien are both corticosteroid intravitreal implants approved for DME. Since their approval in in 2014, what factors have driven uptake of Ozurdex and Iluvien, and what factors have limited prescribing of these agents? How do MCOs position the corticosteroid implants on formularies for commercial versus Medicare Advantage plans? How do ophthalmologists anticipate incorporating the corticosteroid implants into their DME treatment algorithm, and how will MCOs control access to these therapies?
- DME is a high-cost market in which price sensitivity may influence prescribing and insurance coverage of current therapies. For commercial and Medicare Advantage plans, what are the current formulary placement and tier assignments of agents used to treat DME? What types of cost controls do MCOs impose on current DME therapies? To what extent are copayments and coinsurance levied on DME treatments? What type of pharmacoeconomic/health economics outcome data would MCOs value in determining formulary status and coverage for DME agents?
- Several products in development for DME may offer unique clinical benefits compared with current DME treatments. What clinical development goals (e.g., superior efficacy over current therapies, lower risk of serious side effects) are most highly valued by ophthalmologists, and which clinical development goals, if met, will most likely earn a new DME therapy preferred formulary coverage? How do ophthalmologists and payers anticipate incorporating emerging therapies into the DME treatment landscape and onto their formularies, respectively? Compared with current clinical mainstays, what cost controls are likely to be imposed on key emerging therapies?
This U.S. Physician & Payer Forum contains insights from a survey of 100 ophthalmologists, as well as 20 pharmacy directors and 10 medical directors at MCOs. We reveal physician and payer dynamics that affect prescribing practices for the treatment of DME in the United States. In this report, we explore the use and formulary status of current DME therapies by physicians and payers, respectively. We also gauge payer and physician opinion of several late-stage emerging therapies. By understanding the attitudes and expectations of prescribers and payers toward current and emerging DME therapies, stakeholders can gain a better understanding of the complex and changing treatment and reimbursement climate for DME.
Markets covered: United States.
Primary research: Online survey of 100 ophthalmologists who currently manage at least 50 DME patients and treat at least some of their DME patients with anti-VEGF therapies; 20 MCO pharmacy directors; and 10 MCO medical directors.
Epidemiology: 2014, 2019, and 2024 diagnosed prevalent cases of DME.
Emerging therapies: Phase II: 3 drugs; Phase III: 1 drug.