Overcoming Barriers to Biosimilar Adoption

The adoption of biosimilars in the US health care system has been a complex and uneven process, with a range of challenges impacting their uptake.

The potential for biosimilars to generate substantial savings has been estimated at up to $124 billion by 2025, underscoring the importance of addressing the barriers to wider adoption. | Image credit: lexiconimages - stock.adobe.com

At The Academy of Managed Care Pharmacy (AMCP) NEXUS 2024 meeting, a panel of experts discussed the current state of the biosimilars market, sharing insights on pricing trends, utilization patterns, and the critical role of health plan policies in driving greater biosimilar utilization. As the biosimilars landscape continues to evolve, understanding these key insights can help stakeholders identify strategies to overcome the obstacles and unlock the full potential of these cost-saving therapies.

Biosimilar Market Overview

The US biosimilar market has seen significant market growth within the last few years, representing a 97% compound annual growth rate since 2015, outpacing the adoption seen in Europe and other global markets. This adoption has led to notable price declines, with an average 56% discount compared with the reference product after 5 years of being on the market.

However, the uptake of biosimilars has varied across different therapeutic areas, with slower adoption observed in the immunology space, where reference products have maintained significant market share through strategies like offering unbranded versions to compete with biosimilars.

Despite these challenges, the potential for biosimilars to generate substantial savings has been estimated at up to $124 billion by 2025, underscoring the importance of addressing the barriers to wider adoption.

Market Data and Trends

The biosimilar market continued to grow, with 57 approved biosimilars and 17 reference product biologics as of June 2024. Biosimilars that have seen the fastest uptake have been in oncology, ophthalmology, and pegfilgrastim. Biosimilars with slower uptake include those in the immunology landscape, filgrastim, epoetin alfa, and insulin glargine.

Biosimilars that have seen the largest breakthrough in the market include trastuzumab with an 86% market share, bevacizumab with an 88% market share, and pegfilgrastim with an 84% market share.

Health Plan Policies on Biosimilars

A critical factor in the uneven uptake of biosimilars has been the role of health plan policies and coverage decisions.

“In 2017, 15% of policies made biosimilars the sole preferred treatment, increasing to 43% by 2023,” said Javier Gonzalez, PharmD, chief growth and commercial officer, Abarca Health. “The data also shows that the proportion of policies co-preferring biosimilars and originators has increased from 30% to 55%.”

“It really matters how health plans envision these coverage decisions [and] what coverage criteria they embed in these coverage decisions that are impacting our prescribers for the year,” said James Chambers, PharmD, MSc, PhD, professor, Center for the Evaluation of Value & Risk in Health, Tufts Medical Center.

Challenges in Biosimilar Adoption

Adalimumab is unmatched in terms to its size and scope of impact in the market. However, this comes with a few conundrums that need to be addressed. Humira became the first $20 billion drug, generating $21.2 billion in sales in 2021, making it a highly lucrative reference product. The slow uptake of adalimumab biosimilars was attributed in part to the significant rebates associated with the reference product, accounting for 30% to 40% of the specialty drug rebates in the market. The heavy reliance of rebates by payers and pharmacy benefit managers (PBMs) created a barrier in transitioning patients to lower-cost biosimilar alternatives, as it could disrupt existing rebate arrangements and guarantees.

Strategies employed by the Humira reference product manufacturer, such as introducing an unbranded version to compete with biosimilars, have also contributed to the slower biosimilar adoption in this therapy area.

Impact of CMS Policies on Biosimilars

The CMS Medicare IRA redesign for 2025 also has some unintended negative impacts on the adoption of biosimilars. The redesign still favors high-list reference products over biosimilars. For example, a high-list-price reference product with a 55% rebate had a lower net cost than a lower-list-price biosimilar with less rebate.

In this scenario, the patient's out-of-pocket costs would be the same regardless of whether they received the higher-list-price reference product or the lower-list-price biosimilar. However, the plan or payer would end up paying 28% more for the lower-list-price biosimilar option compared with the higher-list-price reference product due to the rebate dynamics. This creates a misalignment of incentives, as plans/payers may be incentivized to choose the higher-list-price reference product over the lower-cost biosimilar, contrary to the goal of promoting biosimilar adoption.

“I think there’s some opportunities for CMS to rethink and find ways that maybe can incentivize biosimilar adoption by thinking about how to pick out a greater percent share vs profit,” said Gonzalez. “Essentially, how do you change the mindset on biosimilars from the line of payers, providers, and patients, to make sure the patients get their fair share.”

Patient Perspectives on Biosimilars

From the patient perspective, the adoption of biosimilars faces significant challenges. Surveys conducted by the Patient Advocate Foundation revealed that only about a quarter of patients are even aware of what biosimilars are, and an even smaller proportion know if they are currently taking a biosimilar medication. When presented with the idea of switching to a biosimilar, patients express a mix of openness and hesitation, with around three-quarters saying they would be willing to try a biosimilar or are unsure. However, patients' primary concerns center around factors like efficacy, side effects, and cost— areas where they need reassurance and clear communication from their providers.

“We know there’s a lot of fear around switching; there’s a lot of fear around discontinued medication, going on something new, and wondering if those side effects of the efficacy will be reduced, especially if you’re taking them for a condition that is properly deteriorating,” said Rebekah Angove, PhD, executive vice president of research and evaluation, Patient Advocacy Foundation.

As the experts emphasized, centering the patient perspective and addressing their core concerns around efficacy, safety, and affordability will be essential to driving increased biosimilar utilization. Additionally, aligning health plan policies, regulatory frameworks, and financial incentives can help unlock the full potential of these lower-cost alternatives to deliver much-needed savings. While progress has been made, the road ahead remains complex. Sustained focus on these key areas can help ensure biosimilars fulfill their promise of expanding access to critical therapies and reducing the burden of health care costs.

Reference

Chambers JD, Gonzalez J, Angove R. Are patients getting a fair share of the value of biosimilars? Presented at: AMCP Nexus 2024; October 14-17, 2024; Las Vegas, NV.