Measurement of Serum Antibodies to Selected Biologic Agents

This policy addresses measurement of serum drug concentrations and anti‑drug antibodies to selected biologic agents (infliximab, adalimumab, vedolizumab, ustekinumab) for therapeutic drug monitoring to guide dosing or switching in adults and children with inflammatory conditions such as rheumatoid, psoriatic and juvenile idiopathic arthritis, inflammatory bowel disease (Crohn’s and ulcerative colitis), ankylosing spondylitis, and plaque psoriasis. Major limitations include variable and assay‑dependent performance with drug interference, limited validation and pediatric data, many tests offered as laboratory‑developed tests (LDTs) under CLIA, and a determination that ADA measurement is experimental/investigational and not covered in specified contexts.

"Rheumatoid arthritis"

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