Sunlenca® (lenacapavir) Injection

Covered: Sunlenca (lenacapavir) injection is covered only for adults (≥18) with heavily treatment‑experienced, multidrug‑resistant HIV‑1 who are failing their current antiretroviral regimen and only for the FDA‑approved indication (non‑FDA uses excluded). Key requirements: initial approval (6 months) requires documented failure of current therapy, resistance to ≥2 agents in at least three ARV classes, use in combination with an optimized background regimen, prescribing by or in consultation with an HIV specialist, and for reauthorization demonstration of virologic response (e.g., HIV‑1 RNA <50 copies/mL or ≥0.5 log10 reduction) with maintenance dosing ~927 mg every 26 weeks.

"When requesting Sunlenca (lenacapavir) Injection, the individual requiring treatment must be diagnosed with an FDA-approved indication and meet the specific coverage guidelines and applicable safet..."