Strategies to Boost Biosimilar Adoption and Improve Patient Access

The adoption of biosimilars in the US has been a complex and often slow-moving process, with various stakeholders navigating a web of challenges. From reimbursement structures and provider education to patient engagement and policy changes, the path to widespread biosimilar utilization requires a multifaceted approach.

Researchers explore innovative approaches to overcome barriers and drive sustainable biosimilar utilization. | Image credit: leowolfert-stock.adobe.com

At AMCP Nexus 2024, industry experts Justin Bioc, PharmD, BCPS, BCGP, RPh, head of clinical pharmacy, Devoted Health, and Sophia Humphreys, PharmD, MHA, BCBBS, director of formulary management and pharmacy clinical programs, Sutter Health, discussed the current landscape, highlighting the barriers to biosimilar uptake and outlining innovative strategies to accelerate adoption and improve patient access to these cost-saving alternatives.

Evolution of Specialty Medications

The management of biologics poses significant challenges compared with small molecule medications. Biologics have a much more complex molecular structure, often consisting of large protein molecules made in living organisms. This complexity makes it extremely difficult to create identical copies, unlike the straightforward synthesis of small molecule generics.

This complexity translates to higher research and development costs, as well as challenges in ensuring biosimilars are truly comparable to the reference product. Navigating the intricate reimbursement structures and aligning incentives across payers, providers, and patients further complicates the effective management of these high-cost therapies. However, biosimilars provide the opportunity for considerable cost savings.

“If we think about all of the prescriptions that we dispense either in hospital retail or from specialty pharmacy or from physician clinics, 90% or more are generics and biosimilars,” said Humphreys. “All together, generics and biosimilars account for about 13% of the entire prescription spend, while the prescription count is more than 90%. What's really interesting is we've talked about high health care costs for many, many years, but if you think about generics and biosimilars altogether, it's only 1.2% of the entire health care spend.”

Impact of Biosimilars on Health Care Costs

The rising costs of health care, particularly driven by the increasing use of specialty medications and biologics, have placed a significant burden on the system. The total US drug spend exceeded $435 billion last year, with patient out-of-pocket costs reaching $91 billion, even with the support of manufacturer patient assistance programs.

Specialty medications now account for 54% of total drug spend, up from 46% just a few years ago. Controlling these high-cost therapies has become a top priority for health care stakeholders, as they strive to maintain high-quality care while managing budgets and ensuring patient access.

Barriers to Biosimilar Adoption

Despite the significant potential savings offered by biosimilars, their adoption has been slower than expected. The complex reimbursement structures, with average sales price (ASP)–based formulas and the impact of rebates, have created misaligned incentives across the health care system. Payers may prefer to cover the reference product due to higher rebates, even when biosimilars are available at a lower cost.

Additionally, the lack of transparency in how rebates are shared between payers, pharmacy benefit managers (PBMs), and providers has made it difficult to realize the full cost savings potential of biosimilars.

Patient and provider education has also emerged as a critical factor, as switching patients from a well-established reference product to a biosimilar can be challenging without clear communication of the benefits and safety profile.

Strategies to Promote Biosimilar Adoption

The presenters outlined several key strategies to drive increased biosimilar adoption and utilization. One critical element is the need for a systematic, collaborative approach involving all stakeholders. This includes establishing biosimilar task forces or subcommittees to proactively evaluate and promote biosimilar options.

Leveraging electronic health record tools to simplify prescribing and dispensing workflows can also help streamline the process for busy clinicians. Providing targeted education and support to specialty pharmacies is another important step, as they play a crucial role in patient-facing interactions.

“There's a philosophical question that we're often asking ourselves, which is, do we build benefits to benefit the person who's using them, or do we build benefits to make everything a little bit more affordable for everyone,” said Bioc. “Each of those things has a different strategy and a different actuarial science model that you'll be building.”

Policy Changes on Biosimilars

It is important to consider the potential impact of evolving policy changes on biosimilars. One key development is the recent CMS draft guidance on interchangeability of biosimilars. This guidance could potentially simplify the approval process for interchangeable biosimilars, potentially accelerating their market entry. However, Humphreys noted that the current requirement for switching studies has been questioned, as 9 out of 13 interchangeable biosimilars were approved without such data.

The speakers also highlighted the need for legislative support, such as the ASP plus 8% reimbursement model, to help sustain the biosimilar market.

“Biosimilars are not really changing the price; the net price is helping the business side of things, but the patient is still experiencing that really high-risk price, and you see formulary strategies with both products, but we don't know what's driving really driving the strategy,” said Bioc.

Additionally, they emphasized the importance of addressing patent litigation and management challenges that have historically limited commercial market access for some biosimilars.

As the biosimilar landscape continues to evolve, with more products entering the market and policy changes on the horizon, the key will be for all stakeholders to collaborate and implement systematic strategies to drive sustainable utilization. By aligning incentives, streamlining workflows, and providing targeted education, the health care system can unlock the full benefits of biosimilars in improving patient access and managing the rising costs of specialty medications.

“This is going to be an interesting year with the Medicare Prescription Payment Plan and the new Inflation Reduction Act provisions,” said Bioc. “These conversations are very different than the ones that we're having today, where most of our conversations were about gap planning, and now we're going to be talking about basically taking out a loan to pay for drugs throughout the year.”

Reference

Humphreys S, Bioc J. Maximizing utilization and continuity of care: Advancing adalimumab biosimilar adoption in managed care. Presented at: AMCP Nexus 2024; October 14-17, 2024; Las Vegas, NV.