Trogarzo® (ibalizumab-uiyk injection)

Covered: Trogarzo is covered only for adults (≥18) with HIV‑1 who are heavily treatment‑experienced and failing current antiretroviral therapy with documented resistance to ≥1 drug in at least three antiviral classes; excluded are pediatric patients (<18), those not failing therapy, patients without multi‑class resistance, and use as monotherapy or without specialist oversight. Key requirements: must be prescribed by or in consultation with an HIV specialist, used with an optimized background regimen, initial approval up to 6 months (re‑auth up to 12 months) with documentation of age, treatment failure, genotype/phenotype resistance reports, treatment plan and labeled dosing (2000 mg IV load, then 800 mg IV q2 weeks), and demonstrated virologic response on reauthorization (e.g., ≥0.5 log10 HIV‑1 RNA reduction).

"Initial authorization requirement: Trogarzo is prescribed by or in consultation with a physician who specializes in the treatment of HIV infection."