An alternative to
The first Humira biosimilar—
But policy watchers say it may take time to reap savings, in part because the next Humira biosimilars aren’t expected to launch until July. Savings will also depend largely on the level to which patients switch to these alternatives, as well as whether health insurers adopt policies that promote the use of these treatments.
“Biosimilars are absolutely going to drive savings, but I also think that people are going to have to be patient,” said Craig Burton, executive director of the Association for Accessible Medicine’s Biosimilars Council. It will be a “slow burn” and “take a little bit of time to evolve.”
Humira, a monoclonal antibody first approved by the Food and Drug Administration in 2002, has long remained on the market without competition. Its patent in the US expired in 2016, but the company obtained additional patents related to manufacturing and administering the drug, effectively delaying the introduction of lower-cost alternatives and making Humira the best-selling medication in the world.
Biosimilars are not exact replicas of a brand-name biologic, but are close enough that they lead to the same clinical outcomes. Out of the versions set to hit the market in 2023, one—
The introduction of Humira biosimilars means the brand-name drug will be exempt from the list of the highest-spending drugs subject to government price negotiations under the new authorities the Inflation Reduction Act recently gave to the Centers for Medicare & Medicaid Services. And AbbVie doesn’t anticipate any immediate financial hit, with CEO
Patient Uptake
More than 1.4 million patients have used Humira globally, according to AbbVie. The drug takes up a huge chunk of Medicare spending in the US, with an HHS watchdog report finding that the treatment, together with anti-inflammatory brand-name drug Enbrel, accounted for more than $5.7 billion in Part D spending in 2019.
Given the long-term success of Humira, which can cost patients up to $84,000 a year, initial uptake of the biosimilars may be limited, said Alex Brill, founder and CEO of economic policy consulting firm Matrix Global Advisors.
“When someone has a condition and the treatment for that condition brings things under control, they are naturally going to be hesitant to try an alternative, even though the alternative will be equally effective,” Brill said.
But Rena Conti, a health economist and associate professor at Boston University’s Questrom School of Business, said she believes those “brand loyal consumers and payers are rare.”
“It is common to see over the first six months or a year after a launch for consumers and payers to slowly switch over to the biosimilar or generic competitor,” Conti said.
Manufacturer Pricing
The companies behind these biosimilars also have a role to play here in the list prices they set relative to Humira’s cost, analysts say.
Biosimilars have thus far led to slower reductions in price compared to generic versions of small-molecule, non-biologic drugs, in part because those are easier to replicate. Generics have the same active ingredients as the brand-name drugs they’re based on, and can cost 20% to 70% less, according to FDA estimates.
Modest uptake of biosimilars has been “in part driven by prices” these companies set, said Inmaculada Hernandez, an associate professor at the University of California, San Diego focused on pharmaceutical pricing and clinical outcomes.
“Biosimilar manufacturers have complained that the market incentives are not good for the uptake of biosimilars,” she said. “Maybe if they had decreased the prices by 60% or 70% as we saw with the small-molecule generics, maybe they could have achieved more uptake,” Hernandez added.
Shaping Coverage
The biosimilars industry has its eyes on the pharmacy benefit managers that negotiate drug coverage on behalf of health plans. Manufacturer trade groups and policy analysts say the level of preference PBMs place on biosimilar coverage can influence whether there’s enough competition to lower prices.
“The PBMs control the access and they control it through the rebates,” said Juliana M. Reed, executive director of the Biosimilars Forum. She said if AbbVie offers greater rebates, or payments, to health plans, the PBMs may continue to favor the brand-name over biosimilar versions.
But several top PBMs have already announced commitments to include Humira biosimilars on their formularies.
“Pharmacy benefit companies are strong proponents of a functioning biosimilar market and are committed to removing barriers to patient and provider uptake,” the Pharmaceutical Care Management Association, the leading PBM trade group, said in an emailed statement.
Policy, Education
To encourage PBMs and health plans to favor these biosimilars, the CMS could “update their policies to allow immediate, mid-year formulary changes for plans to cover biosimilars instead of the brand biologic,” Burton said.
The CMS could also update its rebate sharing formula with plans “to reduce the value of the rebates to plans,” Burton said. Currently, the formula creates an incentive where plans benefit from coverage of higher-priced products because they get greater rebates, he said.
Pharmacists, PBMs, and health plans can also educate patients who rely on Humira that the “biosimilar is just as safe and effective as the brand and encourage them to use the product,” Conti said. They can also “educate physicians who are prescribing this product to choose the biosimilar.”
While the exact timing and level of savings are uncertain, policy analysts agree that the introduction of Humira alternatives is ushering in a new area of biosimilar competition.
“This is a very important step in the evolution of patient access, and also affordability,” Conti said.
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