Effective with date of service Jan. 27, 2023, the Medicaid and NC Health Choice programs cover lenacapavir injection, for subcutaneous use (Sunlenca) for use in the Physician Administered Drug Program (PADP) when billed with HCPCS code J3490 - Unclassified drugs.
Strength/Package Size: Injection: 463.5 mg/1.5 mL (309 mg/mL) in single-dose vials.
Indicated 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.
Recommended Dose: Initiation with one of two options followed by once every six months (26 weeks +/- 2 weeks from the date of the last injection) maintenance dosing:
Initiation Option 1
- 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)
Initiation Option 2
- Day 1: 600 mg orally (2 x 300 mg tablets)
- Day 2: 600 mg orally (2 x 300 mg tablets)
- Day 8: 300 mg orally (1 x 300 mg tablet)
- Day 15: 927 mg by subcutaneous injection (2 x 1.5 mL injections)
Maintenance: 927 mg by subcutaneous injection (2 x 1.5 mL injections) every six months (26 weeks) from the date of the last injection +/-2 weeks. See full prescribing information for further detail.
For Medicaid and NC Health Choice Billing
- The ICD-10-CM diagnosis code required for billing is: B20 - Human immunodeficiency virus (HIV) disease
- Providers must bill with HCPCS code: J3490 - Unclassified drugs
- One Medicaid and NC Health Choice unit of coverage is: 1 mg
- The maximum reimbursement rate per unit is: $22.71845
- Providers must bill 11-digit NDCs and appropriate NDC units. The NDCs are: 61958-3002-01, 61958-3004-01
- The NDC units should be reported as "UN1."
- For additional information, refer to the January 2012, Special Bulletin, National Drug Code Implementation Update
- For additional information regarding NDC claim requirements related to the PADP, refer to the PADP Clinical Coverage Policy 1B, Attachment A, H.7 on DHB's website.
- Providers shall bill their usual and customary charge for non-340B drugs.
- PADP reimburses for drugs billed for Medicaid and NC Health Choice beneficiaries by 340B participating providers who have registered with the Office of Pharmacy Affairs (OPA). Providers billing for 340B drugs shall bill the cost that is reflective of their acquisition cost. Providers shall indicate that a drug was purchased under a 340B purchasing agreement by appending the "UD" modifier on the drug detail.
- The fee schedule for the PADP is available on the NC Medicaid’s Fee Schedule & Covered Code portal.
Contact
NCTracks Call Center: 800-688-6696