Sunlenca (lenacapavir) — Medica

Initial criteria

• age ≥ 18 years
• Patient is failing a current antiretroviral regimen for HIV
• Patient has resistance to two or more agents from at least three of the following classes: nucleoside reverse transcriptase inhibitor, non-nucleoside reverse transcriptase inhibitor, protease inhibitor, integrase strand transfer inhibitor
• Medication will be taken in combination with an optimized antiviral background regimen including one or more other antiretroviral agents
• Prescribed by or in consultation with a physician who specializes in the treatment of HIV infection

Reauthorization criteria

• Medication will continue to be taken in combination with an optimized antiviral background regimen including one or more other antiretroviral agents
• Patient has responded to a Sunlenca-containing regimen as determined by the prescriber (e.g., HIV RNA < 50 cells/mm3, or HIV-1 RNA ≥ 0.5 log reduction from baseline in viral load, or improvement/stabilization of CD4 T-cell count)

Approval duration

initial: 6 months; reauthorization: 1 year