US biosimilar uptake faces several barriers, including misconceptions regarding biosimilar efficacy and a misalignment of prescription incentives between payers, providers, and patients, panelists discussed.
A lack of understand of biosimilars and prescription incentives not aligning with patient needs are 2 major issues preventing mass biosimilar uptake in the United States, according to panelists during a recent webinar discussion.
The webinar, titled “What’s the Hold-Up? Overcoming Barriers to the Use of Biosimilars,”was hosted by The Center for Biosimilars® and sponsored by Samsung Bioepis. The panel discussion, moderated by Tony Hagen, senior editor at The Center for Biosimilars®, explored some of the barriers preventing biosimilar utilization and market entry as well as offered solutions to overcome them as the industry continues to grow.
Misaligned Incentives and Financial Toxicity
One way misaligned incentives manifest is when payers make and alter formulary decisions without consulting practices, which can force patients on a biologic to switch to a different version when the product they’re treated with loses formulary coverage.
Although there are cases where providers choose not to prescribe biosimilars, in others it may be due to physicians ultimately losing the ability to choose a therapy for their patients based on what is the lowest priced product or what is in the practice’s inventory, according to Madelaine Feldman, MD, FACR, president of the Coalition of State Rheumatology Organizations.
Feldman said that a major problem preventing biosimilar adoption is that savings and rebates are often not designed to save patients money, but are instead intended to increase profits for payers, who often negotiate contracts with companies to place more expensive products on formularies.
“Cost and price are 2 different things and when the middlemen talk about why we choose the lowest net costs, that actually means the highest profit. Their fiduciary responsibility is to their shareholders. It's unfortunate but it's the truth. It is not to the health care system, it is not to patients, and it is not to providers. And anything that they can do to increase their profit involves using higher price drugs because…all of the price concessions are a percentage of the list price,” explained Feldman.
The promise of savings is a major benefit to using biosimilars. However, if savings are not benefiting patients, they continue to face challenges with financial toxicity because of the high cost of health care in the United States, according to Sameer Awsare, MD, associate executive director at Permanente Medical Group.
“Some of our oncology patients are sometimes on 3 different biologics, and that is so expensive. Often, they're thinking of selling their house or thinking, ‘Should I even get treatment because I may leave nothing for my kids.’ And solving that issue for our patients is really what I wish for,” he noted.
Interchangeability and Education Concerns
Interchangeability designations are also a topic of concern for biosimilar adoptions because patients and providers may be lulled into thinking that an interchangeable biosimilar is more advanced compared with other biosimilars for the same reference product, which is a false statement, the panelists said.
“Interchangeability is interesting term. And it confuses some people, because they think, ‘Oh, well, we shouldn't be substituting these products if they're not interchangeable’,” said Ryan Haumschild, PharmD, director of pharmacy at Emory Healthcare and Winship Cancer Institute as well as an advisory board member for The Center for Biosimilars®.
Sonia Oskouei, PharmD, vice president of biosimilars at Cardinal Health and an advisory board member for The Center for Biosimilars®, added that interchangeability should be viewed as strictly a regulatory designation because the label means is that additional data has been submitted to the FDA and that the agency has approved it to be automatically substituted at the pharmacy level without requiring physician permission.
Oskoeui continued, saying that future education material also needs to be tailored based on which stakeholder or clinical space it’s directed at. “When it comes to education, we need to take a tailored approach based on the needs and the stakeholder type because today, a need and an oncology is very different than the need and endocrinology with diabetes and what's really needed in ophthalmology,” she said.
“I think you have to recognize that this is complex, and you have to work with your payer colleagues because…we need better coverage and embracing the use of biosimilars. And I think there has to be a better connection benefit the patient, as well as the plan and the health system. If all 3 pillars are met, that's where we're going to see more of a cross-functional team working together to make sure we have better uptake across organizations,” Haumschild suggested.