Ibalizumab-uiyk (Trogarzo®)

Covered only for adults (≥18) with HIV‑1 who are heavily treatment‑experienced and failing current ART with documented multidrug resistance (≥1 agent resistant in ≥3 antiretroviral classes) when used with an optimized background regimen; excluded for pediatric patients, patients not failing therapy, lacking resistance documentation, off‑label uses, monotherapy, or deviations from specified IV dosing. Initial approval is 6 months (reauthorization 12 months) and requires prescription by or consultation with an HIV specialist, documentation of diagnosis/age/resistance/treatment plan/dosing, and for reauthorization evidence of virologic response (e.g., ≥0.5 log10 HIV RNA reduction); dosing per label is 2000 mg IV loading then 800 mg IV every 2 weeks.

"Patient must be failing current antiretroviral regimen — not covered if patient is not failing therapy."

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