Conversion initiative gives ‘significant’ boost to Remicade biosimilar use
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Key takeaways:
- The switch to an infliximab biosimilar was successful in 63.5% of clinically stable patients.
- Most patients who did not successfully switch cited personal preference as the reason.
An initiative to switch clinically stable patients from Remicade to a biosimilar significantly increased biosimilar use in rheumatology and gastroenterology clinics within the University of North Carolina health system, according to data.
“In talking with patients, many of them had great questions about the data available to support continued safety and efficacy when switching from an originator product to a biosimilar,” Sarah Steedman, PharmD, CPP, of the University of North Carolina (UNC) Medical Center, in Chapel Hill, told Healio. “It was then that we realized that we, and our patients, would benefit from additional clinical information adding to the existing literature on biosimilar use.”
According to Steedman and coauthor Jane Giang, PharmD, BCPS, BCGP, CPP, also of the UNC Medical Center, the health system’s rheumatology and gastroenterology clinics began an initiative in 2021 to transition patients from the originator infliximab (Remicade, Janssen) to one of two biosimilars — Renflexis (infliximab-abda, Samsung Bioepis) or Avsola (infliximab-axxq, Amgen). To compare the clinical outcomes of patients who were switched vs. those who only ever used the originator or the biosimilar, Steedman and Giang conducted a retrospective review of electronic health records.
The biosimilar conversion initiative was run out of UNC rheumatology and gastroenterology outpatient clinics. Providers selected each patient based on their clinical stability and expected openness toward a switch, then recommended a biosimilar and supported them with literature and resources. For the current analysis, the researchers evaluated how many patients stayed on each biosimilar, as well as data on adverse effects and patient attitudes.
Among of a total 180 patients included in the study, providers had deemed 85 (47.2%) as appropriate candidates for a switch, of whom 54 (63.5%) successfully switched.
According to the researchers, who published their findings in the Journal of Managed Care & Specialty Pharmacy, the most common reason among patients who did not successfully switch was patient preference (n = 11), with other reasons being they could not be reached (n = 5), insurance or cost (n = 7), intolerance (n = 6) and “unknown” (n = 2).
There was a total of 35 patient-reported adverse effects, 17 of which were attributed to an infliximab biosimilar. Transaminitis, infusion reactions, fatigue, nausea and dermatological reactions were the most commonly reported issues. These 17 adverse effects attributed to a biosimilar represented 9.4% of the total study population, the researchers wrote.
Symptoms were self-reported to have worsened among “a small proportion” of patients who switched, they added. Citing instances of only one to four biosimilar doses being delivered, the researchers wrote it was possible that, “in most cases,” patients were not adequately dosed. They additionally noted that it was challenging to discern if symptoms worsened due to the medication switch or “alternative circumstances.”
“We conclude that the effort to convert clinically stable patients to a biosimilar product resulted in a significant increase in biosimilar use within the health system,” Steedman and Giang wrote. “This is thought to have resulted in significant financial advantages both to our institution as well as patients, without sacrificing overall clinical control.”
Perspective
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The use of biologic disease-modifiers in the treatment of autoimmune diseases has revolutionized the field of rheumatology and gastroenterology. The impact of these scientific discoveries cannot be overemphasized as therapies such as infliximab have been life-altering for many people suffering from rheumatoid arthritis, psoriatic arthritis or inflammatory bowel disease.
Unfortunately, these advances come at a substantial cost to the health care system. The dawning of the age of biosimilars comes with the promise of less costly alternatives, but are they as effective as the parent molecule? And, are they as safe? Steadman and Giang report on a retrospective analysis of outcomes in 180 patients cared for at a rheumatology or gastroenterology outpatient clinic, who were switched from branded infliximab to a biosimilar.
This paper provides additional evidence that the use of biosimilar disease modifiers can be a cost-effective alternative to the use of parent-molecule drugs without loss of efficacy or safety. However, the study also demonstrates significant provider and patient biases toward preferred use of the parent molecule still exist. Ongoing education for both clinicians and patients regarding the utility of biosimilars seems appropriate.
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