Humira Biosimilars a Question Mark for Hospitals

The adoption of seven Humira (adulimumab) biosimilars that will be available in the United States starting in 2023 remain uncertain for hospitals, an executive with healthcare performance improvement company Vizient told Formulary Watch.

Steven Lucio

“There are several challenges to biosimilar adoption and utilization we have seen from our experience with medical benefit/part B biosimilars, including biosimilar and interchangeable glargine insulin. Humira is by far the biggest biosimilar yet (and likely the biggest biosimilar ever) to impact the pharmacy benefit/part D,” said Steven Lucio, Pharm.D., senior principal, pharmacy solutions for Vizient.

“Our members have expressed concern about requirements for new prior authorizations (and the workload associated with coordinating those changes), particularly given the number of anticipated competitors,” Lucio added.

From an economics level, Lucio is also concerned about whether the market will support eight to 10 competitors. “What if you start a patient on a biosimilar and that manufacturer does not capture a meaningful part of the market and chooses to leave, necessitating another change for the patient?” he said.

Lucio agreed with the concerns that the Biosimilar Forum members raised about Humira biosimilar adoption in a previous Formulary Watch article.

Much of the future of the biosimilars industry depends on whether Humira biosimilars will be placed on formularies as they become available in the U.S. market, Juliana M. Reed, executive director of the Biosimilars Forum, recently told Formulary Watch.

In addition, the Centers for Medicare and Medicaid Services will need to classify the Humira biosimilars as maintenance changes, she said. “Without this change in policy, those biosimilars will not be able to be included on formularies until 2024.”

Payer formulary decisions will complicate the work of tracking different requirements and assessing the true out-of-pocket expense of the Humira biosimilars for patients, Lucio added.

“How will biosimilars’ patient assistance program (PAP) vary?” Lucio said. “Members have told us that ensuring that PAP programs for biosimilars are at least as comparable as the originators has sometimes been challenging. They periodically find circumstances where patients would pay more for the biosimilar (thus necessitating moving the patient back to the originator and the originator’s PAP),” he said.

In Vizient’s new 2022 biosimilar survey of hospital leaders and pharmacy professionals, respondents said that payer placement, acquisition price, and interchangeability status are the top three attributes that will govern Humira biosimilars’ product selection and inclusion in a hospital’s formulary.

While the survey found that biosimilars demonstrate “significant biosimilar adoption to hospital formularies,” they are lagging in utilization in patient care, Vizient said in a news release.

The longer a biosimilar has been available, the more likely the product is to be added to an organization’s formulary, but the length of time did not necessarily translate into higher utilization. For example, 88% of respondents said they have adopted a biosimilar for Janssen’s Remicade (infliximab), and 85% said they are using it to some degree.

However, both Vizient and national purchase information reveal that the originator product retains a larger market share relative to the competing infliximab biosimilar, according to Lucio.

“Infliximab was identified by our survey respondents as the biosimilar most commonly reviewed and used to some extent. However, use of biosimilar infliximab is proportionally lower compared with the originator. Remicade (and now its unbranded counterpart) has the largest market share for the infliximab molecule,” Lucio said.

Payer demands for specific products is the top barrier to automatic therapeutic substitution, according to the Vizient survey, followed by provider acceptance, and management of the prior authorization process.

Meanwhile, 30% of those surveyed said they adopted biosimilars under provider or payer demand, 25% said they adopted them when approved by the organization’s pharmaceutical and therapeutics committee, and 22% adopted biosimilars when they are FDA-approved. At the same time, 20% reported no procedure for biosimilar adoption.