Article

A Biosimilars Roadmap: Understanding Payer Perceptions

This article was originally published on pharmexec.com

Headlined by the launch of nine biosimilars for Humira (adalimumab), the biosimilars market landscape in the US has undergone a significant shift in the last 18 months.

The rapid pace of progress—including the emergence of pharmacy-benefit biosimilars—reflects the investment in this space and the growth forecasted over the next half-decade, when the market could reach more than $100 billion.¹

Driven by a robust pipeline of products in preclinical and clinical development, the biosimilars market is poised to continue its upward growth trajectory and expand into new therapeutic areas; however, challenges remain. The adoption of adalimumab biosimilars, thus far, remains low and underscores some of the challenges biosimilar manufacturers face when launching these products. In order to capitalize on the promise of biosimilars, stakeholders across the healthcare ecosystem—including payers, healthcare providers, and regulators—need to work together to stay ahead of approvals and foster an environment that enables increased access to biosimilars.

Tasmina Hydery, PharmD, Associate Director,
Market Access and Healthcare Consulting,
Cencora

Coverage and Formulary Management Trends

Decisions related to formulary coverage will play a significant role in unlocking access to biosimilars. Recent announcements from healthcare decision-makers could pave a path toward greater uptake of biosimilars.

To gain a deeper understanding of how organizations are covering and adopting biosimilars in their formulary management and benefit design planning, a team of experts at Cencora conducted a survey through its Managed Care Network,² a proprietary research panel of more than 160 healthcare executives, medical and pharmacy directors, and managed care experts. The research, which was presented at Asembia’s AXS24 Summit,³ revealed:

More than half of payers (58%) begin planning for coverage and contracting of biosimilars under patent litigation at the time of regulatory approval. Nearly 25% start that process even prior to the FDA’s approval.
When asked whether their organization’s standard formulary prefers biosimilars over the reference product, more than half of payers (56%) responded that “some” biosimilars are preferred—a nearly 20% increase from the previous year.
In situations where there are multiple biosimilars to a reference product, more than half of payers said they would add two biosimilars to its formulary. Another 36% said they would add three or more.
Payers use a variety of resources to monitor and review the biosimilars drug pipeline, including pre-approval information (38%) and manufacturer contacts and materials (35%).

Engage Payers Early—And Consistently

While the findings suggest payers are likely to embrace biosimilars, the takeaways also underscore the importance for biosimilar manufacturers to engage payers earlier in the process—prior to regulatory approval.

By engaging payers early and sharing pre-approval information, manufacturers can start to communicate the value of their product. For example, companies can leverage formulary decision-type tools and secure online platforms to share evidence-basedproduct-based information, including clinical evidence and health economic information.

In addition to the consistent communication, manufacturers need to develop a robust pricing strategy. In today’s increasingly competitive biosimilar market, pharma companies are deploying new strategies—such as dual-pricing—to help secure access on formularies and drive market share.

According to our research, payers identified net price (93%) and wholesale acquisition cost price (74%) as the most impactful factors when considering to contract with a particular biosimilar manufacturer. Given the implications of the decision, it’s essential to have all the pertinent information—including an understanding of the current market landscape—prior to establishing the pricing strategy.

Looking Ahead

While more widespread adoption of biosimilars has been slowed by several challenges, it’s clear these products offer the potential to deliver cost savings across the healthcare system. Since the launch of the first biosimilar in 2015, biosimilars have generated nearly $24 billion in savings.⁴The impact is particularly pronounced in the oncology space, where biosimilar competition cut spending growth for oncology drugs by nearly half. ⁵

But tremendous opportunity exists to increase their impact. The Office of Inspector General recently issued a report⁶ acknowledging that while biosimilar competition has already led to lower costs for the Medicare Part B program and enrollees, the increased use of more affordable biosimilars—or the implementation of different payment policies—would result in even lower Part B and enrollee spending.

As biosimilar manufacturers face new challenges, including pressures brought by the Inflation Reduction Act, it’s increasingly important to prioritize early planning and develop robust evidence generation, communication, and market access strategies. For example, manufacturers should look to leverage real-world evidence on effectiveness and switching studies to help them overcome barriers to the adoption of pharmacy-benefit biosimilars. Continued education for prescribers and payers, along with streamlined regulatory processes, will further facilitate the integration of biosimilars into the healthcare system.

As competition increases and market dynamics evolve, stakeholders across the healthcare system need to work together to foster an environment which supports access to these products.