acceptance

New Survey Finds Biosimilars Have Wide Acceptance

By Marie Rosenthal Aurora, Colo.—Nearly two-thirds of managed care stakeholders polled in a recent survey said they are covering some biosimilar products, with most of them reporting “meaningful” cost savings from the formulary strategy.

That level of acceptance and savings comes at a time when the market for biosimilars is on the upswing. Indeed, after years of slow market release, “there are now 31 biosimilar products that have been FDA approved, with 20 launches in a variety of therapeutic areas, including supportive care, oncology, inflammatory diseases, insulin products and ophthalmology products,” said Tasmina Hydery, PharmD, the assistant director of integrated technology solutions at AmerisourceBergen/Xcenda, at the AMCP Nexus 2021 meeting.

“The biosimilar landscape is on the verge of some pretty big changes with the introduction of the pharmacy benefit biosimilars [such as biosimilars of Humira] that are anticipated in the next few years,” added Jennifer Snow, MPH, the vice president of reimbursement and policy insights at AmerisourceBergen/Xcenda.

To find out how formularies were managing the changes, AmerisourceBergen/ Xcenda surveyed 51 of its managed care network advisors to see how biosimilars were being encouraged, used and covered among health plans, integrated delivery networks (IDNs) and pharmacy benefit managers (PBMs).

Of survey participants, 35% cover all of the available biosimilars and 65% said they cover some products. Most respondents said they saw cost savings after putting them on their formularies.

“Across the board, payors are seeing meaningful cost savings coming from biosimilars,” Ms. Snow said. In fact, 59% said “biosimilars provide meaningful cost-savings” to the organization; 35% said they somewhat agree, and only 6% did not think using biosimilars resulted in meaningful cost savings.

Ms. Snow questioned whether the 6% had an unreasonable expectation about how much money could be saved by using biosimilars instead of the reference products, thinking the savings would be like those seen from traditional generic medications, instead of the 20% to 30% that typically accrues from biosimilars. “We were never going to see the smallmolecule savings,” she said, adding that a 20% to 30% discount—which still would be a considerable amount compared with the cost of the reference product—was “reasonable to expect.”

It would probably come as no surprise that price and cost were primary drivers affecting decisions about designating a preferred product, Ms. Snow said. Lower price was listed by 94% as the primary influencer, followed by contracting arrangement at 75%, therapeutic area at 49%, number of indications a biosimilar has versus the reference product at 39%, physician demand at 24%, and time the biosimilar has been on the market at 22%. Patient demand amounted to only 4%.

“Two things I find really interesting [about these rankings] are the number of indications approved for the reference products being a decision point for 39%, and then also, physician demand at 24%,” said Ms. Snow, who noted that she wrote an unpublished client report in 2007 about biosimilars, which found that physician acceptance of biosimilars was a serious consideration for payors.

“Here we have it, that notion of physician demand starting to drive that preference,” she said.

Preferred Product Class

One of the best ways to encourage use and control costs is by making the biosimilars preferred products. However, just because you lead a physician to a preferred product does not mean they will prescribe it. So, how do you get them to at least consider the biosimilar? The respondents found several ways: 92% require prior authorization; 73% use step edit requirements, which require a patient to fail therapy on a lower-cost product first; 55% use tiering; 45% require patient cost sharing; 33% limit quantities; and 22% have diagnostic limitations.

“I was a little sad to see that the step edits were so high,” Ms. Snow said, “especially [for] physician-administered drugs, because that gatekeeper’s already there. I would expect that we will see these trends continue when it came to the pharmacy benefit side.”

Prescribing Considerations

There are only two interchangeable biosimilars approved—insulin glargineyfgn (Semglee, Mylan), a biosimilar to Lantus and adalimumab-adbm (Cyltezo, Boehringer Ingelheim) a biosimilar to Humira (AbbVie), which is not yet available. There was a good bit of buzz about finally having interchangeable biosimilars throughout the AMCP meeting and discussion about using a biosimilar offlabel—that is, prescribing it for an indication that the reference product has but the biosimilar does not. An interchangeable biosimilar has all the indications of the reference product and can be changed by the pharmacist rather than requiring prescriber authorization, just as a smallmolecule generic can be switched.

Ms. Snow said she was surprised by the number of organizations that would consider an off-label use for a biosimilar. Of the organizations, 55% said they would cover the biosimilar for the same indications as the reference product, including both the FDA and the non–FDA-approved indications; 24% said they would cover the biosimilar only for FDA-approved indications, and the reference product only for the remaining indications; 20% said they would cover only the FDA-approved indications; and 2% responded other (unspecified). No one said they would not cover a biosimilar.

Almost all the respondents thought biosimilars were safe and effective for treatment for both starting naive patients (96%) and for switching a patient currently on a reference product (92%). Ms. Snow said she was pleased by the latter response. “Maybe I shouldn’t have been surprised, but so much of my work with patient groups and manufacturers takes it for granted that a patient who already is on treatment should stay on that treatment because it works for them.”

Cost a Major Consideration

Cost savings was cited as the strongest factor driving biosimilar adoption, the survey found: 65% ranked it as a leading factor. Interchangeability and increased regulatory clarity about laws such as the ability to substitute a reference product with a biosimilar were second and third. Other issues were scientific clarity about safety and efficacy data, and increased understanding of biosimilars by prescribers, patients and within an organization.

When Cyltezo and other biosimilars of Humira—which will come under the pharmacy benefit instead of the medical benefit—start coming onto the market in 2023, there will be much interest in cost savings, Ms. Snow said. Of the survey respondents, 96% said they expect to see cost savings as the primary benefit of having biosimilars be classified as a pharmacy benefit.

Most of the third-party payor respondents said they wanted to see better substitution laws and real-world evidence that the biosimilar can be substituted for the reference product and still be safe and effective. Dr. Hydery said she understood that point of view, which she attributed in part to the increasing complexity of the biosimilars market. “We have products across a variety of specialties, and that means we now have more prescribers and more patients to educate,” she said. “There’s also more competition among the biosimilars; it’s not just one reference product versus one biosimilar.”

Cate Lockhart, PharmD, the executive director of the Biologics and Biosimilars Collective Intelligence Consortium, agreed that challenges remain. “Legal and regulatory hurdles still impede biosimilar adoption, and different state laws can cause confusion. So there’s still a lot of work to do to navigate these impediments,” she said. “But there’s also a lot of hope. Many people are invested in [meeting these challenges] because we want patients to get access to biosimilars.”

The coveragea of biosimilar over reference products:

Preferred On Par Nonpreferred 14% 53% 33%

a Based on a database of 535 coverage decisions, regarding nine available biosimilars, at 17 of the largest commercial health plans in the United States.

Adapted from JAMA 2020;323(19):1972-1973.

The sources reported no relevant fi nancial disclosures.

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