Safety, Efficacy, and Savings Result From Study of Nonmedical Switching

October 26, 2020
Tony Hagen

Tony Hagen is senior managing editor for The Center for Biosimilars®.

A study of mandatory switching for patients with rheumatologic conditions led to savings without effect on safety or efficacy.

Investigators from the University of Utah said they found no additional safety or clinical risks in a study of patients who were switched from originator infliximab to infliximab biosimilars. The participating institution, University of Utah Health Plans, achieved average savings of $11,508 per patient transitioned to a biosimilar.

The study findings are significant in part because health centers often start only new patients on biosimilars, for fear of destabilizing patients who have achieved disease control with the reference drug. The result is that for patients “grandfathered” to receive the reference product, the potential savings from biosimilars are forgone.

The strength of the study prompted the Academy of Managed Care Pharmacy (AMCP) Foundation to honor lead author Tavan Parker, PharmD, with the AMCP Foundation/CVS Health Best Poster by a Resident or Fellow at the AMCP Nexus 2020 Virtual meeting on October 21, 2020.

Lack of Physician Support

Although multiple studies have demonstrated that switching patients with autoimmune disorders to an infliximab biosimilar is safe and efficacious, most physicians do not support nonmedical switching of patients who have achieved stability with the reference product Remicade because of concerns about effective management, patient mental health, and treatment safety and efficacy, the authors said, citing survey data.

Starting in February 2019, University of Utah Health Plans began switching all patients to biosimilar infliximab who were receiving Remicade originator infliximab. The primary end points were financial and clinical outcomes.

The study enrolled 63 patients (47.6% male, 52.4% female) ages 13 to 63 years. Savings calculations were based on the cost per 100 mg of the most recent Remicade infusion compared with subsequent biosimilar costs for the same patient. Patients included those with commercial (n = 42) and Medicaid coverage (n = 21), or 66.7% and 33.3%, respectively. Disease types included Crohn disease (47.6%), ulcerative colitis (17.5%), rheumatoid arthritis (12.7%), psoriatic arthritis (6.3%), and others.

A number of patients had been previously treated with other biologics, including adalimumab (29.5%) and etanercept (14.8%).

By April 2020, more than 90% of patients who began on the reference infliximab had been switched to a biosimilar. At a mean follow-up of 6.2 months, 44 (70%) of the 63 patients were on infliximab at the same or lower dose. Investigators said 9 patients had unstable or active disease before or after the switch and were given an increase in dosage or frequency of administration.

The savings for the health plan amounted to nearly $725,000, investigators said.

“Transitioning patients from the originator product to a biosimilar did not come with excess safety or clinical risks,” authors said. “The transition process included direct outreach via telephone to providers’ offices and was generally well accepted by all affected physicians.”

They said the findings suggest that the switching model could be applied to other patient populations. They recommended that in future investigations, patients be stratified by disease severity and treatment history to shed further light on the cost and cost and clinical efficacy relationship between reference infliximab and its biosimilars.

Reference

Parker T, Britton L, Willis C, et al. A retrospective analysis of the clinical and financial outcomes of converting patients from originator Remicade to an infliximab biosimilar. Presented at: AMCP Nexus 2020 Virtual; October 21, 2020.


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