Two presentations and a panel discussion at the annual meeting of the Association for Accessible Medicines (Access 2023) went over the current state of biosimilar uptake and the factors that help determine whether a biosimilar will experience good adoption rates.
Two presentations and a panel discussion at the annual meeting of the Association for Accessible Medicines (Access 2023) went over the current state of biosimilar uptake and the factors that help determine whether biosimilar will experience good adoption rates.
Doug Long, MBA, vice president of industry relations at IQVIA, and Michael Kleinrock, lead research director for the IQVIA Institute for Human Data Science, each presented data collected as part of IQVIA’s Biosimilars in the United States 2023-2027 report, showing the uptake rates of individual biosimilar classes and estimating that biosimilars could save the United States $180 billion over the next 5 years.
Kleinrock noted that there are many reasons why some biosimilar classes experience better uptake than others, including the difficulty of manufacturing the molecule, payer preferences, rebate opportunities, and physician prescribing patterns among others. Biosimilars and generics can also be used as a tactic to address global pharmaceutical challenges, such as the COVID-19 pandemic, rising inflation costs, and ongoing drug supply shortages.
“All in all, I'm pretty enthusiastic about where biosimilars can go as a sector and in terms of helping us manage sustainability in the delivery of medicine to patients," Kleinrock said. "But I think you have to remember something: Biologics are half of the spending, but they're a relatively small percentage of the volume if we take the insulins out...so, relatively few people are being affected when we talk about these high-end specialty medicines that are biologics. And access to them is an equity, diversity, and social issue that we have to think about.”
During the panel discussion, when asked what success will look like for biosimilars, especially with the emergence of the first adalimumab biosimilar on the US market, Kleinrock said that success will require biosimilar penetration across multiple stakeholders and expressed his concerns about biosimilar utilization under new policies enacted by the Inflation Reduction Act (IRA).
“Under the IRA, there’s an out-of-pocket cap for seniors, which will essentially mitigate a lot of the patient motivation in Medicare for a biosimilar because they will quickly reach their cap [using a reference product] before someone decides to save them money," he stated. "Commercial plans may have a different play. It’s going to matter which payer it is and what [their policies are.] So, maybe, success looks like good economics but looks different between commercial and Medicare plans.”
Additionally, Michelle Holm, PharmD, MPH, senior pharmacist contract portfolio manager and an assistant professor at Mayo Clinic, explained some of the issues with the average sales price (ASP) and other prescribing incentives as well as how they influence prescribing habits and biosimilar utilization.
“A lot of institutions are underwater. ASP is not stable—it continues to decrease. So, how do you, as a hospital, keep your doors open? Is ASP putting you under water? How do you not go back to the originator? Especially if you're a 340B [hospital] or not getting reimbursed?," Holm asked. "What does it look like to give physician-based practices and institutions the same price so that no one's underwater? On top of that, I think we really need to look at opportunities outside of reimbursement and what in the biosimilar space can we do to prevent drug shortages and everyone going to the same biosimilar.”
Brenda Motheral, RPh, MBA, PhD, CEO of Archimedes, dove into employer relationships with adalimumab biosimilars, payers, and the lack of transparency around rebates, saying that while employers have a better idea of how much adalimumab biosimilars can save them compared with some of the medical benefit drugs, the secrecy surrounding rebates can prevent prescriptions for biosimilars.
“If you think about the fundamental question that anybody would want to know in purchasing any good or service—what is my net price of this product?—99% of employers, and even their consultants, in this market don't know the answer to that question for the first biosimilar and they're not likely to know it for the upcoming ones….," Motheral said. "On top of that, we know the PBM [pharmacy benefit manager] strategy is to really maximize the rebate flow through the system…. I think employer education and promotion is absolutely critical in this market to broaden this awareness.”
She also recommended that employer-targeted education needs to inform employers what savings they are missing out on and offer advice on how to approach PBMs and payers about encouraging biosimilar utilization.