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Comparison of Reference and Biosimilar Medications for Pediatric Noninfectious Uveitis
Nita G Valikodath1, Jay Rathinavelu2, Jordan D Deaner3
1Department of Ophthalmology, University of Michigan, Kellogg Eye Center, Ann Arbor, MI.
Insights
Pediatric noninfectious uveitis patients using biosimilar infliximab experienced fewer flares and lower costs than reference infliximab. However, shorter biosimilar treatment duration may limit definitive outcome comparisons.
Area of Science:
- Ophthalmology
- Immunology
- Pharmacoeconomics
Background:
- Noninfectious uveitis (NIU) in children requires long-term management.
- Tumor necrosis factor-alpha (TNF-alpha) inhibitors are crucial for treating pediatric NIU.
- Biosimilars offer potential cost savings and expanded treatment options.
Purpose of the Study:
- To compare clinical outcomes and healthcare costs of TNF-alpha inhibitor biosimilars versus reference medications in pediatric NIU.
- To evaluate the safety and efficacy of biosimilar infliximab in a pediatric population.
Main Methods:
- Retrospective chart review of patients aged 18 or younger with pediatric NIU treated with reference or biosimilar TNF-alpha inhibitors.
- Inclusion criteria: active ocular inflammation and at least one month of follow-up between January 2013 and June 2023.
- Data collected included patient demographics, treatment duration, disease flares, and annual costs.
Main Results:
- Nineteen pediatric patients met the inclusion criteria (mean age 9.3 years).
- Patients on biosimilar infliximab showed a trend towards fewer flares per year (0.15) compared to reference infliximab (0.22).
- Biosimilar infliximab demonstrated a lower average annual cost ($40,950-$41,141) compared to reference infliximab ($42,298).
Conclusions:
- The primary driver for switching to biosimilar infliximab was insurance mandates.
- While biosimilar infliximab showed a lower cost and trended towards fewer flares, shorter treatment durations in the study limit definitive conclusions on long-term efficacy.
- Further research with longer follow-up periods is warranted to fully assess the comparative effectiveness of biosimilar TNF-alpha inhibitors in pediatric NIU.
Objective/Purpose:
Compare outcomes and costs of TNF-alpha inhibitor biosimilars to reference medications in the treatment of pediatric NIU.
Methods:
Patients 18 years old or below treated with reference or biosimilar TNF-alpha inhibitor for noninfectious uveitis and had a history of active ocular inflammation with at least 1 month of ophthalmology follow-up from January 1, 2013, to June 1, 2023, were included. Retrospective chart review was performed.
Results:
Nineteen patients met the inclusion criteria. Mean age was 9.3±4.0 years, and 47.4% (9/19) were female. Of the patients who were on infliximab at any time point in their disease course (n=9), the mean duration on infliximab was 3.6 years (42 mo). Of the patients on biosimilar infliximab (n=10), the mean duration was 0.82 years (9.8 mo). Mean flares/year was 0.22±0.3 on infliximab and 0.15±0.3 on biosimilar infliximab. The average annual cost was $42,298.97 for infliximab (n =9), $41,141 for infliximab-dyyb (n=9), and $40,950 for infliximab-axxq (n=1). Reasons for switching to biosimilar infliximab from adalimumab included a combination of insurance mandate (100%), worsening disease activity (37.5%), or other issues such as noncompliance (37.5%).
Conclusions:
The most common reason for biosimilar initiation was insurance mandate. Compared with the reference infliximab, pediatric patients had fewer number of flares per year on biosimilar infliximab, but they were also on the biosimilar for a shorter duration of time compared with the reference which may confound an accurate assessment. Biosimilar infliximab had a lower cost profile compared with reference infliximab.
