Tony Hagen is senior managing editor for The Center for Biosimilars®.
In a webinar this week, experts discussed the business dynamics that prevent providers from being able to choose the lowest-cost biosimilars.
Several trastuzumab biosimilars have been launched this year, and 6 FDA-approved adalimumab biosimilars are lined up for launch in 2023, but such a cornucopia of lower-cost medicine is not looked upon as favorably as might be expected.
The reason? Payer policies make it difficult for providers to use the lowest-cost biosimilars available. In a webinar hosted this week by MJH Life Sciences™, a panel of experts discussed how industry dealmaking is affecting treatment decisions and use of resources at the provider level.
FDA-approved biosimilars are not different from reference products in any clinically meaningful way, but in the business world, a payer may put a particular biosimilar on formulary because of the rebate deal it got from the manufacturer or high-pressure sales tactics used by a rival drug producer. This means that providers often have to use the biosimilar that the payer wants them to use—not the lowest-cost drug. For practices that work with multiple payers, each with different biosimilar preferences, this can be “a nightmare,” panelists said.
The Difficulty of Stocking Multiple Biosimilars
Stocking multiple biosimilar brands to satisfy the preferences of multiple payers is costly, and ensuring that payer preferences are followed requires the use of controls and staff interventions that would not ordinarily be needed for treatment decisions.
“There’s a lot of work by nurses, pharmacists, and finance people to transition to biosimilars,” said panelist Ali McBride, PharmD, MS, BCOP, FASHP, FAzPA, clinical coordinator of hematology/oncology for The University of Arizona Cancer Center in Tucson.
There’s also financial risk for a practice that uses the wrong biosimilar brand and cannot get reimbursed for it, said Kathy Oubre, MS, a panelist who serves as chief operations officer for Pontchartrain Cancer Center, which has clinic locations in Covington and Hammond, Louisiana. Her practice has implemented a signoff procedure to ensure that the preferred drug is given to a patient.
“Payers are really taking an active stand in dictating the drugs we use,” she said. Payer preferences make it difficult for a practice the size of Pontchartrain to provide biosimilars to patients. “It presents a lot of operational challenges.”
Given his druthers, McBride said, payers would not decide what biosimilars could be used. The United States would follow a European-style model in which the preferred or recommended biosimilar is the lowest-cost biosimilar available. In Denmark, for example, a biosimilar company will win a tender to provide a biosimilar for a 12-month period, after which the bidding process will reopen.
This not only lowers costs, McBride said, but also shortens the amount of time needed to transition a patient to a biosimilar. In the United States the process of getting a patient set up with a biosimilar is much more complicated on many levels. “We’re constantly working to address these pieces,” McBride said. He added that achieving of biosimilar access equality, or “parity,” across drug brands is crucial to realizing the true promise of biosimilars. “I would love to see more of a European model,” he said.
“Parity would be great,” Oubre agreed. “We believe in the science of biosimilars and the cost savings, and at the end of the day we all know that term cost toxicity, and it’s not going away.”
Kaiser Permanente and Biosimilar Uptake
Kaiser Permanente is a combination payer and medical group conglomerate that has, through its leverage, been able to achieve very high levels of biosimilar uptake, specifically by singling out a single biosimilar for coverage in different classes of medicine. “Kaiser has a unique structure,” said panelist Timothy J. Chiu, PharmD, the pharmacist evidence analyst and strategist for hematology/oncology at Kaiser Permanente. “We have tried to focus on 1 product; it reduces operational challenges,” he said.
He acknowledged that at the provider level there are complexities that affect whether patients can receive the lowest-cost biosimilar, but said that Kaiser Permanente has worked to overcome these issues.
However, the emphasis on a single biosimilar makes it simpler to achieve large-scale buy-in, he added. There’s an education component to building confidence among providers and patients that can be accomplished with a streamlined approach. “There are still a lot of misconceptions about biosimilars and people are uncomfortable about switching despite all the data,” Chiu said.
Practices attempt to discuss biosimilar choices with payers so that restrictions can be relaxed. This is not always a successful process. McBride described “a lot of pushback” from payers, and Oubre said that in her experience, “some are more receptive, some are not.”
With regard to the education component, McBride said that biosimilar education itself has to be defined. This could take many forms. For example, providers and patients would benefit from more real-world information about biosimilars as well as further studies, particularly ones that would elucidate the value of switching from originator drugs to biosimilars in order to extend the benefits of therapy. “We need more data to have this discussion,” he said.
Good pharmacovigilance will be an important way to add to this critical information pool, Chiu added.
Education could include information about oncology models of care, such as Oncology Care First, the CMS successor to the Oncology Care Model, McBride said. It’s important to know how biosimilars are going to help achieve the savings that these models are supposed to achieve, he said.
Kaiser Permanente has sought to give providers educational materials on biosimilars, and these materials have included clinical data on individual biosimilars investigated in particular settings. This has helped to achieve “buy-in,” Chiu said.
Oubre said she has not witnessed any information on biosimilars distributed by payers, and McBride said nonbranded biosimilar information would be useful.
One group that wants more information about biosimilars is employers, Oubre said. “Employers really want to know more. If something goes on formulary and a patient with breast cancer is switched and gets upset, an employer doesn’t want that.”