By SHEILA FRAME
FDA Commissioner Scott Gottlieb has said biosimilars are “key to promoting access and reducing health care costs. And it’s a key to advancing public health.” While the Administration works to reduce barriers to bringing biosimilars to market, payers and providers can help increase adoption of biosimilars in clinical practice and ensure cost savings.
Organizations such as the American College of Rheumatology and the American Society of Clinical Oncology have issued educational documents to help guide providers in incorporating biosimilars into treatment plans, where appropriate. Yet, many doctors remain hesitant to prescribe them due to concerns about safety, efficacy, immunogenicity, effects of switching to a new biosimilar and the economic value to patients.
Biosimilars are developed in a similar way as existing biologics and have the same safety, efficacy, and quality profiles, but are more competitively priced to ensure more patients have access to these important medicines and that the system can afford them. A ten-year growing body of real-world use in the EU shows biosimilar medicines increase usage of biologic medicines, while matching their reference biologics in terms of safety, efficacy and quality.
Switching between a biologic and a biosimilar has also proven to be safe in several studies. New data recently presented at the American College of Rheumatology Annual Meeting further reinforces the safety profile of biosimilars. In addition, a review of 90 studies that enrolled 14,225 unique individuals found that a great majority of the studies had unchanged risk of immunogenicity-related safety concerns or diminished efficacy after switching from a reference biologic to a biosimilar medicine. No new safety or efficacy concerns have been detected in more than 10 years and 700 million patient days of experience with biosimilar medicines.
Contracting arrangements with reference product manufacturers that limit competition and step edit policies that do not make sense for two products that have the same safety, efficacy and quality profiles, are making it difficult for patients to access these important medicines. By adopting utilization management controls and benefit design changes that favor biosimilars, payers can play an important role in increasing adoption of biosimilars, increasing patient access and lowering costs for the overburdened U.S. health system.
A 5-year budget impact model looking at a hypothetical health plan with 1 million members being presented at the Academy of Managed Care Pharmacy Annual meeting this week shows that $ 6 million could be saved by one health plan alone if an etanercept biosimilar was able to enter the marketplace. An early adopter of biosimilars, Yale New Haven Health System reports their switch to Zarxio® will lead to 20 percent in savings, which could equate to $ 400,000 per year –real world proof that biosimilars can make a big difference. According to a RAND Corps report released last year, biosimilars could save the U.S. health system $ 54 billion over the next decade.
There is clear evidence to support biosimilars and a competitive biologics marketplace. However, biosimilars must be covered, prescribed and used if patients and healthcare systems are to realize their full promise. We believe we have a social responsibility to ensure biosimilar success.
Sheila Frame, Vice President and Head Sandoz Biopharmaceuticals, North America, is responsible for the development and commercialization of the biosimilar medicines portfolio in the US and Canada.