SUNLENCA (lenacapavir sodium)

SUNLENCA (lenacapavir sodium)

Self-Administration – oral tablet.

Office-Administration – subcutaneous (SC) injection.

Diagnosis considered for coverage:

• Multidrug Resistant HIV-1 Infection: Indicated in combination with other antiretroviral(s) for the treatment of HIV-1 infection in heavily treatment-experienced adults with multidrug resistant HIV-1 infection failing their current antiretroviral regimen due to resistance, intolerance, or safety considerations. 

Coverage Criteria:

For diagnosis of multidrug resistant HIV-1 Infection:

• One of the following:
  • For continuation of prior therapy; OR
  • All of the following:
    • Diagnosis of HIV-1 infection; AND
    • Both of the following:
      • Patient is heavily treatment-experienced with multidrug resistance as confirmed by a resistance assay
      • Patient is failing their current antiretroviral regimen due to one of the following:
        • Resistance
        • Intolerance
        • Safety considerations; AND
    • Patient is currently taking, or will be prescribed, an active and optimized background antiretroviral therapy regimen; AND
    • Prescribed by or in consultation with a clinician with HIV expertise.

Dosing:

• Recommended Treatment Regimen for SUNLENCA Initiation and Maintenance, Option 1 (4-pack):
  • Initiation:
    • Day 1: 927 mg by subcutaneous injection (2 x 1.5 mL injections) + 600 mg orally (2 x 300 mg tablets)
    • Day 2: 600 mg orally (2 x 300 mg tablets)
  • Maintenance:
    • Every 6 months from the last injection (26 weeks) +/-2 weeks: 927 mg by subcutaneous injection (2 x 1.5 mL injections)
• Recommended Treatment Regimen for SUNLENCA Initiation and Maintenance, Option 2 (5-pack):
  • Initiation:
    • Day 1: 600 mg orally (2 x 300 mg tablets)
    • Day 2: 600 mg orally (2 x 300 mg tablets)
    • Day 3: 300 mg orally (1 x 300 mg tablets)
    • Day 15: 927 mg by subcutaneous injection (2 x 1.5 mL injections)
  • Maintenance:
    • Every 6 months from the last injection (26 weeks) +/-2 weeks: 927 mg by subcutaneous injection (2 x 1.5 mL injections)
    • During the maintenance period, if more than 28 weeks have elapsed since the last injection and if clinically appropriate to continue SUNLENCA treatment, restart the initiation dosage regimen from Day 1, using either Option 1 or Option 2.

Coverage Duration:

• Tablets: 4 months
• SQ Injection: 1 year

Authorization is not covered for the following:

• The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information:

• SUNLENCA injection is for administration into the abdomen by a healthcare provider.

Policy Updates:

• 09/01/2023 – New program for Sunlenca approved by P&T. (P&T 08/15/2023)

References:

1. Dvory-Sobol H, Shaik N, Callebaut C, et al. Lenacapavir: a first-in-class HIV-1 capsid inhibitor. Curr Opin HIV AIDS. 2022;17(1):15-21.
2. Segal-Maurer S, DeJesus E, Stellbrink HJ, et al. Capsid inhibition with lenacapavir in multidrug-resistant HIV-1 infection. N Engl J Med. 2022;386:1793-803.
3. Sunlenca Prescribing Information. Gilead Sciences, Inc. Foster City, CA. December 2022.
4. U.S. Food and Drug Administration. (2023, February 1). FDA approves new HIV drug for adults with limited treatment options. Retrieved from https://www.fda.gov/news-events/press-announcements/fda-approves-new-hiv-drug-adults-limited-treatment-options. Accessed June 13, 2023.