Ibalizumab-uiyk (Trogarzo®)

Trogarzo (ibalizumab‑uiyk) is covered only for heavily treatment‑experienced adults (≥18) with multidrug‑resistant HIV‑1 who are failing their current antiretroviral regimen and must be used in combination with an optimized background regimen — use in patients <18, those not failing therapy, without documented multiclass resistance, or as monotherapy is excluded. Approval requires documented resistance to ≥1 agent in ≥3 antiretroviral classes, prescription by or consultation with an HIV specialist, initial authorization for 6 months (reauthorization 12 months) with evidence of virologic response (e.g., ≥0.5 log10 HIV‑1 RNA reduction), and dosing consistent with a 2,000 mg IV loading dose then 800 mg every 2 weeks.

"Initial authorization indication: Individual is 18 years of age or older."

Sign up to see full coverage criteria, indications, and limitations.