Biosimilars were touted as a tool for payers to gain savings in specialty markets, but a recent survey by Avalere of the top 25 payers in the U.S. (about 189 million covered lives) using publicly available coverage policies found that biosimilars are commonly subject to step-through polices, including those that require the patient to “fail” first on a branded product, and only then will the payer cover a biosimilar of that same branded product (i.e., the biosimilar’s reference product). Policies like this may be why although the Congressional Budget Office (CBO) originally estimated a 10-year decrease in federal spending of $5.9 billion attributable to “follow on biologics”/biosimilars in 2009, it is estimated the actual savings have only been 8 percent of that amount (approximately $241 million). So what market access issues do biosimilars face in the U.S., and where could we go from here?
A recently published literature review of biosimilar switching studies drew some pushback in the form of a letter to the editor. Though this letter may seem, on the surface, another frustrating bump in the road, it raises several new, important lines of inquiry for biosimilar makers and stakeholders to explore in future publications.
Biosimilars were touted as a payer’s tool to gain savings in specialty markets, but a recent survey by Avalere of the top 25 payers in the U.S. (about 189 million covered lives) using publicly available coverage policies found that biosimilars are commonly subject to step through polices, including those that require the patient to “fail” first on a branded product, and only then will the payer cover a biosimilar of that same branded product (i.e., the biosimilar’s reference product). Policies like this may be why although the Congressional Budget Office (CBO) originally estimated a 10-year decrease in federal spending of $5.9 billion attributable to “follow on biologics”/biosimilars in 2009, it is estimated the actual savings have only been 8 percent of that amount (approximately $241 million).
I’ve heard it said that innovation in the biosimilar world extends beyond the actual scientific and technical development of the product; innovation also applies to the act of changing and shaping regulations and perspectives. This year’s conference really emphasized the specific tasks being carried out by members of biosimilar companies, patient advocacy groups, payers, and research organizations to change and advance perspectives.
The U.S. Supreme Court recently issued two decisions related to inter partes review (IPR). This article will briefly introduce IPR, discuss the Supreme Court’s decisions, explain how these decisions may impact IPR and biosimilar companies, and suggest how biosimilar companies should respond.
While Amgen’s report shares payers’ broad considerations about biosimilars and the impact they’d have, Avalere’s report digs more deeply into the available data from payers to show just how biosimilars are stacking up. And, frankly speaking, I found some of the information quite concerning.
This article provides insights and several solutions for biosimilar companies to engage local politicians and patients in a manner that is mutually beneficial.
A U.S. House-passed version of the Continuing Resolution (CR) threatened to remove an integral tool for biosimilar reimbursement under Medicare Part B. Though this tool (pass-through status) will remain for biosimilars, this ultimately raises questions about the importance of pass-through status and how eliminating it could impact the industry as a whole.
A critical mechanism in the U.S. constitutional framework is often overlooked in a larger public affairs strategy — the right of a state to govern itself in most aspects. This article conveys the importance of shifting resources from the federal campaign efforts to a more local effort to ensure biosimilar success.
In the second of this two-part article, McKesson Specialty Health's Omar Hafez and Pete Perron discuss how to approach the complex financial landscape in the clinic and help incentivize clinics to use biosimilars.
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