Biosimilar spending hit $2.5 billion in 2019, and that spending is projected to reach $27 billion by 2024, a 10-fold increase in just five years. Emerging patterns of utilization for oncology biosimilars are forming, and those health plans adopting an early, pro-biosimilar strategy toward oncology biosimilars could reap the rewards, with cost savings for various stakeholders, including patients, payers, and providers.
Tremendous potential for cost savings is within reach in this area, according to Rebecca Borgert, PharmD, BCOP, senior director, Oncology Clinical Strategy & Innovation; and Jim Rebello, PharmD, vice president, Formulary Strategy; both with Magellan Rx Management. Together, they offered a quick review of the different FDA approval requirements for a biosimilar versus a reference product, explaining that a reference biologic requires a great deal of comparative studies and minimal analytical data, whereas a biosimilar requires quite the opposite, with minimal comparative studies and a great deal of analytical data.
The presenters also explained that for a biosimilar to earn “interchangeability” status from the FDA, the regulator must be convinced that the biosimilar will produce the same clinical result as the reference product in any given patient. This is accomplished through switching studies, which seek to provide additional evidence that the risk of alternating between the biosimilar and the reference product is not greater than the risk of maintaining the patient on the reference product.
Despite various news headlines from 2018 that reported friction in the path to the use of biosimilars or highlighting reasons that biosimilars have failed to gain traction in the U.S. market, the use of biosimilars and their marketshare are increasing across virtually all drug categories. Currently, 29 biosimilar products have been approved by the FDA. Of those, 12 of are for autoimmune therapies, and 17 are related to either oncology or oncology support. In the oncology category, uptake has been swift. The presenters noted that only one year after launch in 2019, bevacizumab biosimilars held a 42% share of the market. Similarly, trastuzumab biosimilar marketshare stood at 38%, with rituximab at 20%.
Payers, the presenters emphasized, are the key drivers of biosimilar uptake, as they can develop formulary benefit designs and make coverage decisions that incentivize members when biosimilars are used. For example, a benefit design that includes lower cost sharing for patients prescribed a biosimilar compared with a reference product can help drive uptake. If a payer prefers biosimilars as part of its benefit design, biosimilar uptake is five-fold greater than for payers who place bevacizumab or trastuzumab biosimilars at parity with their reference agents (69% marketshare vs. 14% marketshare, respectively). When payers promote single-source biosimilar coverage, this can put pressure on hospitals and health systems. The presenters pointed out that this can result in economic challenges for the institution because of the need to stock multiple biosimilars for members with different health plans.
“Patients treated in hospital outpatient departments were 42% less likely to receive biosimilar filgrastim compared with a physician office setting,” said the presenters.
They also discussed how their organization’s medical pharmacy oncology biosimilar program increased the utilization of biosimilars, resulting in significant cost savings. Payer formulary and coverage decisions are the primary drivers of biosimilar utilization, they concluded, and said that targeted biosimilar programs designed proactively and initiated soon after product launch can yield large savings for health plans.
Borgert R, Rebello J. Emerging Patterns in the Adoption of New-to-Market Oncology Biosimilars. Presentation B11. Presented at AMCP 2021; April 12-16, 2021.