Diabetic Macular Edema (The Impact of Costly Market Entrants for Diabetic Macular Edema) | Physician & Payer Forum | US | 2015

How Are U.S. Ophthalmologists Incorporating Newly Approved Products into the Treatment Algorithm and How Receptive Are Payers to These Agents?

Until the U.S. 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 0.3 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 U.S. 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 U.S. 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.