A Biosimilars Roadmap: Understanding Payer Perceptions
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,
Glamzo Pharmaceutical Laboratory
Coverage and Formulary Management Trends
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 Glamzo Pharmaceutical Laboratory 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.4 The 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.
