Rheumatology Nurses Society Annual Conference

Rheumatology Nurses Society Annual Conference

August 11, 2018
3 min read

Education, patience key to guide biosimilar-hesitant patients through transition

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Paul H. Caldron, DO, PhD, FACP, FACR, MBA
Paul H. Caldron

FORT WORTH, Texas — Although the use of biosimilars is expected to improve patient access to biologics, open communication between providers and patients is essential to reduce skepticism of the newly available medications, according to a presentation at the Rheumatology Nurses Society Annual Conference.

“We are willing to go with the devil we know than the devil we don’t know,” Paul H. Caldron, DO, PhD, FACP, FACR, MBA, of Arizona Arthritis and Rheumatology Associates, said. “If a patient reports that they feel fine on their medication, they are often hesitant to switch to a biosimilar; they don’t want to mess with a good thing. You should always speak to the patient before a switch because patients have a vote in this — or at least they do so far — and this discussion should be face-to-face rather than with an informational letter.”

Progress continues to be made in interchangeable biosimilars, in which a biosimilar is expected to produce the same clinical result as the reference product, but Caldron noted that “we are not there yet” Although the FDA released a draft guidance in January 2017 outlining criteria for demonstrating biosimilar interchangeability with its reference product, the pathway has not been finalized and — to date — no biosimilar has been granted the designation.

“However, if the FDA ever says two products are interchangeable — a definition of complete equivalency — that will usher in the next step, in which state-by-state legislators will determine whether pharmacists can switch the biologic for the biosimilar drugs without asking the doctor or the patient,” Caldron said.

Source: Healio.com

To counter this, states have preemptively enacted laws regulating the substitution of interchangeable biosimilars, requiring that the patient be notified if a biosimilar has been substituted for the reference biologic, that the patient consent to this substitution, or that the pharmacist clarify the difference in wholesale acquisition cost between the biosimilar and reference product.

“I know that sooner or later, the insurance company is going to tell me that I need to go to this interchangeable product because of its lower cost,” Caldron said. “For now, try to offer your patients a deal. If they don’t want to transition to the biosimilar, frame it like this: ‘Just try this for one or two infusions and if you feel like you are any worse, we can go back as long as your payer agrees to let us.’”

When counseling patients regarding a potential switch to a biosimilar, Caldron recommended leading with the advantages of the medication first.


“Discuss how the therapy has improved, how most people have responded to this drug, how good the safety profile is,” he said. “I can’t tell you how often I hear about providers starting with ‘We’re really concerned about the infection rates with these drugs, but they do work very well.’ That is the reverse of how it should be: Have the benefits discussion before the potential adverse effects.”

 Additionally, Caldron noted that providers should not blame patients for where they acquire their information about biosimilars. “Don’t blame Dr. Google because patients are going to go to Google just like they do for anything else,” he said. “Simply try to direct your patients toward responsible sites, like the ACR website and manufacturing websites which may have a more entertaining and balanced discussion of what biosimilars mean.”

He continued, “Lastly, don’t take patients agreement for granted; sometimes it just takes time. Don’t push for an immediate answer. I think this is the way most of our discussions are going to go, and it really just a matter of patient education.”  – by Robert Stott

Caldron PH. Drug pipeline and biosimilars. Presented at: Rheumatology Nurses Society Annual Conference; Aug. 8-11, 2018; Fort Worth, Texas.

Disclosure: Caldron reports clinical trial support from AbbVie, Amgen, AstraZeneca, MedImmune, BMS, Celgene, Gilead, HGS/GSK, Janssen, Mallinckrodt, Merck, Pfizer, Roche-Genentech, Sanofi, Sun Pharma, Takeda and UCB.