Increased Scrutiny by EU5 Health Authorities Will Encourage Use of Off-label Avastin and Emerging Biosimilars in the European Wet Age-Related Macular Degeneration Market

BURLINGTON, Mass., Nov. 4, 2014 /PRNewswire/ -- Decision Resources Group finds that the cost-constrained health authorities in the EU5 (France, Germany, Italy, Spain, and the United Kingdom) are increasingly scrutinizing the cost to the healthcare system of anti-vascular endothelial growth factor (VEGF) agents labeled for wet age-related macular degeneration (AMD). In fact, legislation has recently been enacted in France and Italy to allow for off-label use of Roche's Avastin, which is priced significantly lower than other anti-VEGF drugs when compounded for ophthalmic administration. The majority of surveyed retinal specialists in these markets anticipate these legislative decrees to at least moderately increase their prescribing of Avastin for wet AMD.

Other key findings from the European Physician & Payer Forum report entitled The Anti-VEGF Era and Beyond in Wet AMD: The Impact of Clinical Attributes and Market Access Status on Current and Future Prescribing Decisions Among Retinal Specialists in the EU5: 

• Impact of biosimilar anti-VEGF therapies: Among surveyed EU5 retinal specialists, 31 to 48 percent suggest that they would administer biosimilar ranibizumab (Novartis's Lucentis) to their treatment-naive wet AMD patients if the drug has clinical trial safety data, a lower out-of-pocket cost, and health authorities' support to prescribe a biosimilar ahead of the brand. Interviewed payers expect that retinal specialists would be encouraged to prescribe an approved biosimilar ranibizumab first line.
• Most-effective market access levers: Interviewed EU5 payers suggest that demonstration of superior head-to-head efficacy versus Lucentis will position emerging therapies favorably to gain formulary placement, and possibly first-line treatment status.

Comments from Decision Resources Group Senior Director Virginia Schobel, M.Sc.:

• "Our research suggests that decision-making at the regional or institutional level often dictates use of wet AMD drugs in the EU5 markets. With surveyed retinal specialists emphasizing that regional formulary variations will continue to impact patient access to wet AMD therapies through 2018, developers will need to prove a drug's cost-benefit as part of regional pricing and reimbursement negotiations, and to preferably provide the drug through a patient access scheme."
• "Cost-effectiveness data for emerging wet AMD therapies will be crucial for favorable reimbursement status in the cost-conscious EU5 market. While visual acuity improvements will be  mandatory for market entry, products in development—including Fovista (Novartis), squalamine (Ohr Pharmaceutical), abicipar pegol (Allergan/Molecular Partners), and sonepcizumab (Lpath)—can differentiate on superior efficacy among refractory patients or by reducing overall treatment burden compared to standards of care."

Additional Resources:

On December 3, 2014, Decision Resources Group will present a webinar based on this report entitled Optimizing EU5 Market Access for Wet AMD Therapies: Insights from Retinal Specialists and Payers.  For more information, please contact Christopher Comfort at [email protected].

About Decision Resources Group
Decision Resources Group offers best-in-class, high-value information and insights on critical issues within the healthcare industry. Clients rely on this analysis and data to make informed decisions. Find out more at www.DecisionResourcesGroup.com.

All company, brand, or product names contained in this document may be trademarks or registered trademarks of their respective holders.

For more information, contact:

Decision Resources Group
Christopher Comfort
781-993-2597 
[email protected]

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SOURCE Decision Resources Group

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