Sunlenca (lenacapavir tablets and subcutaneous injection) — Cigna

Initial criteria

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

Reauthorization criteria

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

Approval duration

initial 6 months, renewal 1 year