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. 2024 Mar;78(3):644-652.
doi: 10.1002/jpn3.12153. Epub 2024 Feb 9.

Clinical outcomes and cost savings of a nonmedical switch to a biosimilar in children/young adults with inflammatory bowel disease

Megan McNicol  1 , Mahmoud Abdel-Rasoul  2   3 , Madeline G McClinchie  4 , Grant A Morris  5 , Brendan Boyle  4   6 , Jennifer L Dotson  4   6   7 , Hilary K Michel  4   6 , Ross M Maltz  4   6
Affiliations

Clinical outcomes and cost savings of a nonmedical switch to a biosimilar in children/young adults with inflammatory bowel disease

Megan McNicol et al. J Pediatr Gastroenterol Nutr. 2024 Mar.

Abstract

Objectives: The safety, efficacy, and cost savings associated with biosimilar medications are well established. However, a lack of pediatric data exists surrounding clinical outcomes when switching from an originator to a biosimilar. Our primary aim is to evaluate clinical outcomes following a nonmedical switch from the infliximab originator to a biosimilar in children and young adults with inflammatory bowel disease (IBD). Our secondary aim is to estimate cost savings associated with this switch.

Methods: A quality improvement project was implemented to establish safe switching protocols, then those patients who underwent a nonmedical switch from the infliximab originator to the biosimilar were retrospectively reviewed. Demographic data, physician global assessments (PGAs), and laboratory values were recorded 1 year pre- and post-switch. Continuation rates on the biosimilar were reported at 6 and 12 months. Cost savings were estimated using two different pricing models.

Results: Fifty-three patients underwent a nonmedical switch. Laboratory values including inflammatory markers, infliximab levels, and PGA scores remained similar when assessed pre- and post-switch. No infusion reactions or antidrug antibody development occurred. Two patients reported psoriasis-like rashes. Five patients switched back to the originator during the study period. There were 379 biosimilar infusions completed with an estimated total cost savings of $11,260 (average sales price) and $566,223 (wholesale acquisition cost).

Conclusions: Clinical remission rates, inflammatory laboratory markers, serious adverse events, infliximab levels, and antidrug antibodies remained similar after a one-time nonmedical switch to an infliximab biosimilar. Nonmedical switching to biosimilars resulted in significant cost savings.

Keywords: anti-TNF; biologic; infliximab; pediatrics; utilization.

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References

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