Drug costs and nocebo risks: Navigating the Humira ‘biosimilar boom’ 1 year later
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A lot can change in a year. But has it?
The first Humira biosimilar hit the U.S. market a little over a year ago. Since then, a total of nine biosimilars for Humira (adalimumab, AbbVie) have launched, including two with interchangeable status.
However, despite promises of greater competition and reduced prices, it remains to be seen, now a full year from the launch of Amjevita (adalimumab-atto, Amgen) in January 2023, what impact these drugs will — or can — have on the U.S. pharmaceutical market and drug pricing system.
“We still do not know what impact will occur from so many biosimilars in the market,” Vibeke Strand, MD, MACR, FACP, a biopharmaceutical consultant and clinical rheumatologist based in Portola Valley, California, told Healio.
According to Strand, most academic centers have been “slow” to include biosimilars in their formularies.
“Most switches are mandated by insurers,” she said. “But because of the impact of pharmacy benefit managers and other parties in the middle, it is unclear whether any savings are passed on beyond what insurers receive through contracting. Consequently, it is unclear what impact they will have and whether patients really will see cost savings.”
Experts frequently use words like “unclear” and “uncertain” to describe market fluctuations associated with the shifting landscape of biologic and biosimilar medications. However, understanding the particulars of these developments could offer clues to cost, uptake and adherence to biosimilars through 2024 and beyond.
“In general, more biosimilars in the market should reduce medication costs for patients,” said Eric Roberts, PhD, MPH, a research specialist in the division of rheumatology, and member of the Rheumatology Quality and Informatics Lab, at the University of California, San Francisco. “However, we need to remember that this is a complex marketplace with many moving parts.”
If cost savings do result from the entry of more biosimilars, the impact can be felt beyond patients, according to Chiara Gasteiger, PhD, a postdoctoral scholar in the Mind & Body Lab in the department of psychology at Stanford University.
“These cost savings can be redistributed to fund other services and treatments and allow other patients to receive treatment earlier,” she said. “Biosimilars also drive innovation, which directly benefits the patient experience.”
Roberts noted that previous research in infliximab (Remicade, Janssen) has shown that while the list price of the drug’s biosimilars is lower than the bio-originator, out-of-pocket costs for patients with Medicare Part D insurance could be significantly higher.
“Although that particular coverage gap for biosimilars has been addressed, this example reminds us that the list price is but one piece of the puzzle,” he said. “We need research that quantifies the changes in out-of-pocket costs for patients, taking the complex structure of benefits in Part D into account.”
‘Above where patients come into play’
The Humira biosimilar Yusimry, (adalimumab-aqvh, Coherus) entered the U.S. market in July for $995 per carton, an 85% discount from originator Humira, according to a press release at the time from the company. Each carton contains two 40 mg/0.8 mL autoinjectors. A comparable carton from Humira at the time cost $6,922, the company said.
In addition, Coherus has partnered with the Mark Cuban Cost Plus Drug Company to sell the biosimilar at $569.27 plus dispensing and shipping fees.
“This is great news for patients,” Roberts told Healio. “Research has shown that after at least two biosimilars have been introduced to the market, overall prices for a biologic and its biosimilars tend to drop and biosimilar uptake increases. Here the introduction of lower cost biosimilar adalimumab is a necessary first step to put pressure on the market.”
However, underlying every change in the biosimilar market is the stark reality of the byzantine system of drug pricing and distribution in the United States. The net result, some experts argue, is that there is little impact on patient costs.
“All of these discounts and rebates are occurring at a level that is above where patients come into play,” John R.P. Tesser, MD, of Arizona Arthritis & Rheumatology Associates, in Phoenix, told Healio. “Many commercial patients who require these expensive medications can get access via copay card programs or programs to allay the amount of money their insurance companies might not cover for the medications.”
In short, the discounts and rebates are going to purchasers and wholesalers who are buying the drug, according to Tesser.
“At the end of this long line are patients, and it often does not matter much to them when they are getting a brand name drug for $5 or $25 a month,” he said.
For Strand, a more important issue is which biosimilars have been negotiated by pharmacy benefit managers (PBMs) — a question that speaks to the opacity of the current system.
“It is anyone’s guess as to which discounts may be passed on to patients,” she said. “We generally do not know what type of discounts are received, if any, and what arrangements PBMs have made with insurance carriers about individual biosimilars.”
To understand these arrangements, it may be helpful to look at how launch prices for biologic and biosimilar medications have changed over time.
‘Unchecked cost increases’
Upon Amjevita’s release onto the U.S. market in January 2023, Amgen established two versions of the biosimilar — one with a list price 55% below Humira and a second with a list price 5% below the originator, “with presumably a 50% rebate,” according to a research letter published in JAMA Network Open last July.
However, that letter additionally found that, although the current net price of Amjevita is lower for commercial health plans than that of the originator, it is nonetheless “more than double” what Humira cost at launch in 2003.
At launch, the lowest-cost formulation of Amjevita had a list price of $1,558, a discount of 14% compared with Humira’s 2020 net price of $1,812, but still far above Humira’s 2003 debut price of $522.
Tesser downplayed this disparity in launch cost, largely because of 20 years of time between the two debut prices.
“What they were identifying was that the biosimilar cost is currently more expensive than the originator cost,” he said. “At launch, Humira cost $13,000 or $15,000 a year. No biosimilar costs that little at the beginning today. It is worth clarifying that point.”
That said, Roberts noted that these data can serve to point out the ever-upward trajectory of drug prices over the past 2 decades.
“The Amjevita 2020 list price is lower than the 2020 Humira net price,” he said. “This is an important distinction, but it highlights the unchecked cost increases for branded drugs over time, underscoring the need to increase marketplace competition with biosimilars.”
However, in the face of this need for increased competition, only two large health care systems in the United States currently use biosimilars on a wide scale, according to Strand.
“One is the U.S. Veterans Affairs system, which remains largely opaque to us working in their clinics, except to be told which is being used, and the other is the Kaiser Permanente system,” she said.
As of March 2023, Kaiser uses Inflectra (infliximab-dyyb, Celltrion/Pfizer) for infliximab, Amjevita for adalimumab and Riabni (rituximab-arrx, Amgen) for Rituxan (rituximab, Genentech), according to Strand. She added that Kaiser initially accepted Truxima (rituximab-abbs, Teva).
“This is all with the exception of Medicare patients,” she said. “There have been relatively few switchbacks, but these occur due to patients’ trepidation; cost savings are not always passed on to patients.”
That trepidation has been another factor to arise out of the past year, as increasing numbers of rheumatology patients learn for the first time what a biosimilar is through impersonal letters informing them of a switch.
Flipping the switch
Although most clinicians understand the concepts of biosimilarity and interchangeability, explaining this to patients can be more challenging.
“Patients receive letters regarding being switched, but they do not like the letters and want more explanations,” Strand said.
To that point, another development under close watch pertains to CVS Caremark, one of the nation’s largest pharmacy benefit managers, which removed Humira from its major national commercial formularies effective April 1 in favor of biosimilar options. However, patients with Choice and Standard Opt-Out commercial formulary coverage will still have the option to be treated with the originator. According to a press release from the company, the move will “potentially save our clients more than 50% on adalimumab in 2024 than in 2022,” prior to the availability of any adalimumab biosimilars in the United States.
“It is exciting to see CVS Caremark take the opportunity to expand biosimilar uptake and reduce costs for patients,” Gasteiger said. “Decisions such as these signal a growing acceptance and confidence in the efficacy and safety of biosimilars and may encourage other health care providers, payers and institutions to consider biosimilars more favorably.”
However, like many experts, Gasteiger also has concerns. Among them: the potential for patients to demonstrate a nocebo effect in response to “new” treatment.
“Completely removing or restricting access to the originator might have some negative implications if patients develop a nocebo response,” she said. “Along with providing patient education, reverse-switching is a key strategy in managing nocebo effects. In our previous research, patients have also found it reassuring to know that the originator option is readily available if needed.”
Roberts, on the other hand, noted that CVS Caremark, a subsidiary of CVS Health, has also entered into an agreement with AbbVie to supply Cordavis, another subsidiary of CVS Health, with co-branded Humira for the second quarter of 2024. Cordavis, which works with drug manufacturers to commercialize and co-produce biosimilars for the U.S. market, has already contracted with Sandoz to commercialize and bring to market its own Humira biosimilar Hyrimoz (adalimumab-adaz) in the first quarter of 2024 under a Cordavis private label.
“Given that CVS has a relationship with Sandoz, this appears to be anticompetitive behavior,” Roberts said. “This change does not benefit patients in the same way a truly open marketplace would.”
Tesser, meanwhile, described the CVS Caremark decision as a “huge deal” that could lead to a cascade of competition in the marketplace.
He also noted that the presence of Mark Cuban’s Cost Plus Drugs company could serve to disrupt the monolithic presence of CVS Caremark, Express Scripts and OptumRx, the three PBMs that currently dominate the drug pricing market.
“The question is how much Mark Cuban’s company, and potentially others like it, will shake up the market,” Tesser said. “If he can take a big enough bite out of the market because he has patients who are willing to pay $500 a month outside of their insurance, there could be an impact.”
And then there is the question of interchangeability among biosimilars — a topic that has received no shortage of debate.
Since the July 1 debut of Cyltezo (adalimumab-adbm, Boehringer Ingelheim), the first biosimilar indicated for certain inflammatory diseases to achieve the interchangeable designation, the FDA has granted the designation to another Humira biosimilar, Abrilada (adalimumab-afzb, Pfizer). As such, these biosimilars can be substituted for Humira at the pharmacy level without the intervention or required notification of the prescribing provider — at least where state law allows.
According to Gasteiger, the list of drugs that fall under this designation is only likely to grow.
“The United States is entering its biosimilar boom, so we can expect to see more biosimilar use and more with an interchangeable designation,” she said. “It is hoped that substituting interchangeable biosimilars can further reduce costs and unnecessary administrative hurdles, enabling patients to access their medications faster.”
Gasteiger added that, looking to the future, the landscape appears to stretch far beyond simply switching from a biologic to its biosimilar.
“As the market expands, we will also see more biosimilar-to-biosimilar transitions,” she said. “This is currently an evolving area, so sharing experiences and monitoring will be helpful in guiding policies and practices.”
References:
Coherus announces industry-wide lowest list price for adalimumab biosimilar YUSIMRY (adalimumab-aqvh) launching in July 2023. https://investors.coherus.com/news-releases/news-release-details/coherus-announces-industry-wide-lowest-list-price-adalimumab. Published June 1, 2023.
Mark Cuban Cost Plus Drug company joins forces with Coherus to make YUSIMRY, a HUMIRA biosimilar, available to patients. https://investors.coherus.com/news-releases/news-release-details/mark-cuban-cost-plus-drug-company-joins-forces-coherus-make. Published June 1, 2023.
CVS Caremark accelerates biosimilars adoption through formulary changes. https://www.prnewswire.com/news-releases/cvs-caremark-accelerates-biosimilars-adoption-through-formulary-changes-302025679.html. Published Jan. 3, 2024.
Dickson SR, et al. JAMA Netw Open. 2023;doi: 10.1001/jamanetworkopen.2023.23398.
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