With the availability of multiple approved products for the treatment of diabetic macular edema (DME) in the EU5, including Bayer HealthCare’s Eylea, Novartis’s Lucentis, Allergan’s Ozurdex, and Alimera Sciences’ Iluvien, as well as the noteworthy use of off-label Avastin (Roche) in some countries, treatment decisions for DME are highly nuanced. They are affected not only by clinical considerations but also by the reimbursement environment in each country. Factoring in the anticipated availability of biosimilars of Lucentis and Eylea, as well as emerging therapies for DME, EU5 payers and prescribers must carefully balance clinical superiority with cost-effectiveness, and drug marketers must be well prepared to navigate a complex road to reimbursement.
- How do reimbursement terms for current DME therapies vary across the EU5? How do payers regulate the prescribing of premium-priced agents?
- What are payer and physician perspectives of promising but costly emerging therapies for DME, such as Allergan’s abicipar pegol, Allergo Ophthalmics’ Luminate, and Roche’s RG-7716? What strategies can drug developers use to optimize market access to their emerging DME and DR agents in the EU5?
- What key market access challenges do novel DME and diabetic retinopathy (DR) agents face? What lessons have been learned, and what market access levers can drug developers use to optimize the positioning of their products?
- How will market access barriers for branded DME agents evolve when the first biosimilars of Lucentis and Eylea are approved?
Access & Reimbursement: Provides in-depth insight regarding the impact of payer policy on physician prescribing behavior so that clients can build their market access strategy and optimize their brand positioning.
Markets covered: EU5: France, Germany, Italy, Spain, United Kingdom.
- Survey of ophthalmologists/retinal specialists across the EU5 (~50 per country).
- Interviews with 10 EU5 payers (2 per country).
Key companies: Roche, Bayer HealthCare, Alimera Sciences, Allergan, Allegro Ophthalmics, Novartis
Key drugs: Avastin, Eylea, Lucentis, Iluvien, Ozurdex, abicipar pegol, RG-7716, Luminate
- Actionable recommendations to optimize market access.
- Market access success and stumbles.
- Market access roadblocks.
- Reimbursement dynamics.
- The impact of pricing and reimbursement, policy, and coverage on prescribing.
- Market access outlook for emerging therapies.
- Diabetic Macular Edema / Diabetic Retinopathy - Access & Reimbursement - Detailed, Expanded Analysis (EU5)
Author(s): Yulia Privolnev, MA; Himanshu Jain, M.S. Pharm
Yulia Privolnev is a manager on the Global Market Access Insights team at Decision Resources Group, primarily focusing on European market access. She is responsible for monitoring, analyzing, and reporting on global market access through the production of DRG’s Global Market Access Solution (GMAS) and Access & Reimbursement products. Yulia’s specific focus is on all aspects of market access in Western and Eastern Europe, as well as external reference pricing (ERP) and managed entry agreements (MEAs) on a global scale. Yulia holds a bachelor’s degree from the University of Toronto and a master’s degree from the London School of Economics.
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.