The market dominance of adalimumab (Humira, AbbVie) may finally be at an end, as payor formularies make dramatic shifts in favor of biosimilars to the world’s first $20 billion drug. But what that is likely to mean for patients, and for pharmacies’ bottom line, remains to be seen, experts cautioned.

In September, United HealthGroup’s OptumRx announced that it would cut the innovator product from some of its preferred formularies beginning Jan. 1, 2025. Optum was the last of the “big three” pharmacy benefit managers (PBMs) to make the shift: CVS Caremark made a similar announcement in April, followed by Cigna/Express Scripts in August. 

Not all PBMs will be mandating across-the-board switches to a Humira biosimilar. In August, independent PBM MedImpact Healthcare Systems, Inc., announced that it would expand access to Hyrimoz and adalimumab-ryvk (Simlandi, Alvotech/Teva), approved in February 2024 as the first interchangeable Humira biosimilar, for new patients; however, existing patients could remain on Humira, and new patients who have taken one of the two biosimilars but did not see the desired results could switch to Humira. Member copay, deductible and other factors will be the same for the biosimilars and Humira based on plan benefit designs, a spokesperson said.

“We recognize that physicians with patients who are already stabilized on Humira are hesitant to shift to a biosimilar, even when they have interchangeability,” said Arpit Patel, PharmD, MedImpact’s vice president for trade relations. “Given that, we felt that the best approach to really drive the market shift would be to focus on encouraging new starts to the biosimilars, to avoid disruption. I think that we will eventually see patients on Humira move over to these lower-cost biosimilars, but that will be at the discretion of the physician.”

In addition to pricing, MedImpact selected the two biosimilars for its formulary based on factors including interchangeability, concentration and delivery mechanism, Dr. Patel said. “The earlier biosimilars didn’t necessarily check off all these boxes, so a patient might have to make a compromise such as doubling up on the dose or using a needle instead of a pen injector. We also did not want to compromise access for affordability, so we chose products that any specialty pharmacy has the ability to source.”

When a flurry of Humira biosimilars first hit the market in July 2023, payors were not immediately mandating that the originator product be taken off formularies. “We saw plan sponsors elect to keep Humira as-is on plans, likely due to manufacturer rebates and the higher list price of some of these biosimilars,” said Javon Artis, PharmD, the specialty pharmacy director at Visante. “Even as it currently stands, traditional Humira comprises something like 70% of all prescriptions nationally for adalimumab.”

Preparing for 2025

A JAMA analysis of Medicare Part D plans published in June found that approximately 98% of Part D prescription plans covered the original version of adalimumab, while only 53.4% of plans covered at least one biosimilar, including about 60 plans that paid only for biosimilars, excluding Humira. Most of the biosimilars covered had a wholesale acquisition cost close to that of the nearly $7,000 monthly list price for Humira (2024;332[1]:74-76). “Even when biosimilars were being covered, it wasn’t the low list price versions; the biosimilars cost nearly as much as Humira itself,” said lead author Matthew Klebanoff, MD, a health policy research fellow at the University of Pennsylvania, in Philadelphia.

As plan year 2025 begins, Humira’s market share will continue to erode due, in part, to vertical integration among stakeholders, Dr. Artis noted. “CVS, for example, owns the manufacturer of one of the lower-list-price biosimilars, so they … will profit from making this transition,” he said. As for how that trend might affect pricing and pharmacy margins, that is a bit more complicated.

“We are not only seeing payors offer and require patients to transition to lower-list-price biosimilars, but also in some cases the higher-list-price biosimilars,” Dr. Artis said. In such cases, “the rebates that were historically happening with the branded drug are still going to be happening, just under a different drug name—while they continue to keep the spread pricing practices shrouded.”

That may well mean even lower reimbursement to pharmacies for adalimumab agents beginning in 2025. “The PBM makes up the loss to itself by decreasing what they pay out to the pharmacy,” Dr. Artis said. “So, you have [direct and indirect remuneration] fees up front, lower list price medications, and spread pricing practices. In the first quarter of next year, we can expect overall depression in the financial reimbursement back to pharmacies dispensing these drugs.”

Dr. Artis advised health-system pharmacies to be aware that these changes are coming, and work with prescribing physicians to develop proactive strategies for transitioning patients while also understanding the financial impact from a health-system perspective. “You will need to analyze how many patients will potentially be affected by this transition, and then the resulting downward pressure on potential revenues that you’ve budgeted for the tail end of FY 2024, and certainly calendar year 2025,” he said. “It’s time to have conversations with your financial leadership team about strategies to mitigate the impact of these transitions as much as possible.”

—Gina Shaw

Originally published by our sister publication Specialty Pharmacy Continuum