Ibalizumab-uiyk (Trogarzo)

Trogarzo (ibalizumab-uiyk) is covered only for adults (≥18) with HIV‑1 who are heavily treatment‑experienced and failing current antiretroviral therapy with documented multiclass resistance (resistance to ≥1 agent in ≥3 antiretroviral classes) and must be used in combination with an optimized background regimen; pediatric patients, patients not failing therapy, and monotherapy use are excluded. Coverage requires prescribing by or consultation with an HIV specialist and documentation of age, HIV diagnosis, treatment failure, multiclass resistance, and an optimized regimen; initial approval is 6 months, reauthorization 12 months, and reauthorization requires virologic response (e.g., ≥0.5 log10 reduction in HIV RNA).

"The requested agent will be taken in combination with an optimized antiviral background regimen including one or more other antiretroviral agents."