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The Great Debate on Biosimilars Boils Down to Cost and Access


“If the patient doesn’t have better access, you don’t need a biosimilar," argues Roy Fleischmann, MD.

At this week’s American College of Rheumatology 2017 Annual Meeting in San Diego, California, “The Great Debate: Biosimilars…to Switch, or Not to Switch? That Is the Question” was among the most highly anticipated events of the conference. With Jonathan Kay, MD arguing in favor of switching patients to biosimilars and Roy Fleischmann, MD, arguing against, the debate seemed primed to be a discussion of the growing body of evidence concerning the safety and efficacy of switching patients to biosimilar therapies.

Kay opened the debate with just such a discussion: he reviewed the definition of biosimilars, explained the development process for these drugs, broadly outlined the findings of NOR-SWITCH and other key studies on biosimilar switching, and discussed the so-called “nocebo” effect in explaining why some studies show patients switching back to originator drugs after having moved to biosimilars. Kay closed by saying that any risk associated with a switch to a biosimilar should be weighed against potential benefits for all patients; biosimilars should decrease the cost of treatment, introduce market competition, and create access for patients who need biologic therapy.

However, Fleischmann took a different and compelling approach on the question of whether to switch patients to biosimilars. While he did make some forays against Kay’s interpretation of clinical data—saying “Nocebo’s a word that comes up when you don’t get what you want to see…[do] you want to call it nocebo, or you want to call it the data?”—Fleischmann’s primary focus was on the cost savings promised by biosimilars, but that have not yet been delivered in the US marketplace.

“If it isn’t considerably cheaper to the patient and society, there is no value in using a biosimilar. This is where I start: cost,” he said. “My opinions are based on the realities of our current knowledge of biosimilars and the medical system in the United states, good or bad,” Fleischmann said, displaying a vast map of the United States on a slide as he spoke to drive home his point. While the European experience has demonstrated cost savings with biosimilars, single-payer systems have the opportunity to drive hard bargains with drug makers. “You get a 70% price reduction, you have hit the reason for the biosimilar.”

However, said Fleischmann, “We have a unique system in the US which governs the choice of medications. It’s called the rebate system, and it’s a very sad system.” He went on to explain that insurance plans typically contract with pharmacy benefit managers (PBMs)—a “majority [of which are] owned by large hedge funds”—to negotiate drug prices with pharma. Meanwhile, “The patient, me—you—is charged full price. This is widespread throughout the United States.” Fleischmann added, citing an article published in The Center for Biosimilars®, that 58% of health plans do not reimburse for biosimilar infliximab, forcing patients to receive (and pay their copays on) the higher-cost reference drug.

The problem of high costs and stifled competition will only get worse, Fleischmann indicated, referencing AbbVie’s recent settlement with Amgen over Humira. The deal, which allows Amgen to begin marketing its product in the United States in 2023, “…suggests that the industry’s long-standing strategy of using patents to ward off cheaper competition for brand-name drugs is extending into the era of biosimilars. AbbVie will grant patent licenses for the sale of the biosimilar,” he pointed out, “So when is Humira going to be cheaper?...What about the patient?”

“I live in the US, I don’t get any benefit [from biosimilars], my government doesn’t get any benefit,” concluded Fleischmann. The only side of the biosimilar equation currently achieving a benefit, he indicated, is the payer. “If the patient doesn’t have better access, you don’t need a biosimilar.”

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