The real impact may not likely be seen until after July when additional biosimilars referencing Humira are launched.
The presence of biosimilars in the market generally creates savings in the healthcare system, putting pressure on the prices of reference products and lowering prices overall. But when it comes to the latest biosimilar to enter the market, it’s complicated.
The recent launch of Amjevita (adalimumab-atto), Amgen’s biosimilar of AbbVie’s arthritis drug Humira has been highly anticipated. It is launching with a two-tier pricing program: the first is 5% below the current Humira price and the second is 55% below the current Humira list price. Humira’s list price is $6,922 for a four-week supply — almost $90,000 annually.
The pricing model is meant to provide options for all payers, including commercial and government, as well as for private access to patients, said Renee Rayburg, RPh, vice president, specialty clinical consulting, Pharmaceutical Strategies Group (PSG). “The 5% model allows for PBMs to collect rebates that go to the payers and the 55% discount lowers the price and provides access for those in a high-deductible, consumer directed health plan,” she said in an interview with Formulary Watch.
The 55% discount off Humira was surprising, Rayburg said. “Traditionally biosimilars have come to the market 10% to 30% lower than the list price of the reference product. This is probably one of the deepest discounted prices that we’ve seen.”
This would mean, she said, that Amgen is anticipating giving rebates of at least $40,000 — the difference between Humira’s list price and the 55% discount off that price. “PBMs may go the rebate route if they think the rebates could be higher,” she said. Humira has been a top cost driver in pharmacy spend for most plans. Generating competition in a category with significant financial impact for plans is promising.
There is also value for patients as well because Amgen is offering patient assistance through the Amjevita SupportPlus Co-Pay Program with $0 copays.
This may become even more important as AbbVie is now limiting its patient copay assistance for Humira if a PBM employs co-pay accumulator or maximizer programs, which do not count such assistance toward deductibles. AbbVie has a $14,000 per calendar year maximum on its assistance for Humira, but for patients with plans that have a maximizer program, the limit is now $4,000. The use of copay accumulator and maximizer programs — mechanisms used by PBMs to reduce their spending on specialty drugs — has grown from 14% of commercially-insured patients in 2019 to 33% in 2022, according to a recent paper from IQVIA.
But the real impact of Amjevita in terms of uptake and costs for treating patients with arthritis and inflammatory conditions may be minimal. “There’s been a lot of buzz, but I don't think one product alone is going to be enough to push the market to realize the full savings that biosimilars can offer,” Rayburg said.
The biggest impact financially will likely happen after July, when additional Humira biosimilars begin to reach the market. Being first may not help Amjevita become the dominant biosimilar for several reasons, Rayburg said. Not all of the Humira biosimilars are the same; they differ in terms of characteristics. Some reference an earlier version of Humira.
In 2018, AbbVie reformulated Humira and began offering a version that was higher concentration (which reduced volume), removed the citrate buffers (which reduced burning during injection) and uses a thinner needle. According to PSG estimates, 80% of Humira utilization is the citrate-free, high concentration formulation.
Amjevita, however, is a low-concentration version biosimilar. Amgen is developing a high-concentration version of Amjevita but that is not expected to reach the market until 2024. Rayburg said this may not be an issue with new starts, but patients currently on Humira may not want to switch.
In July 2023, Boehringer Ingelheim is expected to launch the low-concentration Cyltezo. It was approved with an interchangeable designation, which may help with uptake among physicians. Organon’s Hadlima in both a low- and high-concentration will likely have an interchangeable designation after its initial launch, and Pfizer’s application for Abrilada is under consideration for an interchangeable designation. Other Humira biosimilars expected to launch later this year include Fresenius Kabi’s Idacio, Coherus BioSciences’ Yusimry, Viatris’ Hulio, and Sandoz’ Hyrimoz but none of these are expected to have such a designation.
A Cardinal Health survey of gastroenterologists, dermatologists and rheumatologists found that more than 60% would only feel comfortable prescribing an adalimumab biosimilar if it had an interchangeability designation. The survey also found that 93% of gastroenterologists said they are at least somewhat comfortable prescribing adalimumab biosimilars. Dermatologists also said they were also concerned about payers and PBM coverage.
PBM coverage for Amjevita is not likely to have an impact for current Humira patients because there will likely not be much incentive for physicians to switch their patients, Rayburg said. Several PBMs — including Optum Rx and Express Scripts — have already indicated they will include some of these biosimilars as preferred products alongside Humira. Optum Rx has said they will include Amjevita and two other biosimilars on the Select and Premium formularies. An Optum Rx spokesperson said that beginning February 1, clients can include both Amjevita list price options on the commercial formulary.
A CVS Caremark spokesperson indicated that Humira will remain preferred and Amjevita will be placed on a non-preferred brand tier. Beginning Feb. 1, it will cover Amjevita on its commercial template formularies.