Biosimilars Present Distinct Challenges in Rheumatology Practice

In a presentation titled “Biosimilar Medicine: Changing Landscape in Health Care,” given on Monday at the 2017 American College of Rheumatology Annual Meeting in San Diego, California, J. Eugene Huffstutter MD, FACP, FACR, shared practical considerations for using biosimilars in the rheumatology clinic.

Among the potential issues that a physician could encounter with a biosimilar in practice are the following:

• Immunologic differences between therapies. “I’ve had [reactions] with the first infusion of a biologic, and I’ve had it with the 20th infusion of the same biologic,” said Huffstutter, suggesting that transitioning to a biosimilar may not, in routine practice, result in more injection-site reactions than continued treatment with a biologic would.
• Potential potency differences between drugs
• Mechanical differences related to the delivery of the therapy
• Pharmacovigilance. Huffstutter voiced concerns about the current regulatory practice of assigning a 4-letter suffix, devoid of meaning, to the name of a biosimilar, saying that the suffix “[has] got to be meaningful. We can’t remember this stuff otherwise.”
• Manufacturing differences between biosimilars and biologics

However, Huffstutter pointed out that there are other risks associated with a transition to biosimilars, some of which are not discussed as often as the above:

• Manufacturing shortages. Huffstutter pointed to the recent manufacturing difficulties faced by drug companies operating in hurricane-devastated Puerto Rico as a real-world example of the potential for shortages of drugs (though reference biologics could be impacted in the same manner).
• Political considerations. CMS could decide, Huffstutter said, to pay only for a reference biologic and to do away with its complex system of addressing biosimilars under unique J-codes. In such a scenario, clinicians would have to revert to using reference drugs.
• Coverage challenges. Pharmacy benefit managers (PBMs) and their approaches to these drugs are a true variable.
• Corporate challenges. It is unclear whether biosimilars will be worth drug makers’ financial risks in the long term, and there is no guarantee that they will continue to develop or market these drugs if the barriers to market entry prove to be too high.

Furthermore, rheumatologists have a steep learning curve ahead. Huffstutter called on rheumatologists to familiarize themselves with state laws governing substitution of interchangeable biosimilars, availability of patient support programs, insurance contracts, formulary status, and—critically—patient acceptance of biosimilars. Patients, he says, have “been left out of this whole discussion.”

But before biosimilars will achieve widespread adoption in rheumatology, the issue of cost must be addressed. Huffstutter shared many rheumatologists’ frustrations about the high cost of biologics, and was bemused by CMS’ wholesale acquisition cost that determines reimbursement for biosimilars. “[I] want CMS to tell us where they get these prices from so I can buy it from there, because it’s certainly a lot cheaper than what I can buy it for,” he said.

Instead of putting the onus for high costs on the drug manufacturers—“not only do we throw [manufacturers] under the bus, we back up and run over them again”—Huffstutter blamed PBMs, who profit from rebates provided by manufacturers in exchange for formulary placement, for potentially blocking biosimilar access. “That’s where the money is…[a manufacturer's profit] is chump change compared to what is going on [with PBMs],” said Huffstutter. “I don’t care how good a rheumatologist you are: if you can’t get a drug to a patient, you’re wasting your time.”