Bioimilar adoption in the U.S. has been slower than expected, and a new report may offer clues as to why.
“The State of the US Biosimilars Market Access: Payer Perceptions of Past, Present, and Future Hurdles to Adoption,” from Trinity Partners, provides insight into U.S. payers’ perceptions of the past, present, and future state of biosimilar market access in the U.S.
As part of this report, Trinity conducted qualitative market research with N=10 medical directors at U.S. payer organizations (representing plans covering more than 100 million commercial and Medicare lives in the U.S.).
“Biosimilars were once expected to disrupt the U.S. biologic market in a major way,” says Jillian Godfrey Scaife, principal, Trinity Partners. “The industry anticipated increased competition would drive down prices for both payers and patients leading to reduced healthcare costs. This prediction has not come to fruition.”
As of December, 1, 2017, nine biosimilars were approved by the FDA but only four are available on the market, according to Godfrey Scaife. “Adoption of these biosimilars has been slower than anticipated resulting in cost savings far below initial expectations,” she says. “It will be important for healthcare executives to understand the market dynamics that caused this outcome.”
The adoption of biosimilars in the U.S. has been hindered by three main hurdles:
The lack of market access due to complex contracting dynamics. “Biosimilar pricing to date has not offered the sharp discounts payers expect, after accounting for contract discounts and nuances such as the ‘rebate trap,’ an artifact of performance-based contracting between manufacturers and payers,” says Godfrey Scaife.
She explains that payers receive rebates that increase in magnitude with certain “performance” metrics, such as how much volume or market share a product achieves within a class, for the contracted payer. “If payers encouraged switching away from the reference product to the biosimilar product, they could lose out on valuable rebates and therefore end up paying significantly more money in order to try the new biosimilar product,” she says.
- Regulatory and legal uncertainty. Biologic innovator companies have taken legal and promotional actions that have impeded biosimilar commercial success, according to Godfrey Scaife. “Innovator companies have filed lawsuits to try and delay the launch of biosimilar products,” she says. “Biologic innovator companies are also investing large amounts of money in direct-to-consumer (DTC) advertising to build patient loyalty for their biologic brands.”
- A general lack of clinical comfort with biosimilars. “Physicians are not completely comfortable with biosimilars and are interested in seeing more clinical and real-world data before they start switching their patients to biosimilar products,” Godfrey Scaife says. “If biosimilars were to attain interchangeability status, this gap in clinical comfort could be minimized.”
Understanding the key barriers to biosimilar adoption in the U.S. is the first step managed care executives can take to overcome these obstacles, according to Godfrey Scaife.
“The issues are quite complex and not easily resolved,” she says. “Managed care executives can also help educate physicians and increase their clinical comfort with biosimilars by providing more data that supports interchangeability of biosimilars with the reference product. If biosimilar manufacturers could increase physicians’ clinical comfort with biosimilars, more payers would likely be willing to adopt more aggressive policies to encourage the use of biosimilar products and help increase adoption.”