J0738 — Injection, lenacapavir, 1 mg, fda approved prescription, only for use as hiv pre-exposure prophylaxis (not for use as treatment for hiv)
HCPCS/CPT
Prior Authorization
No Prior Auth Required
Code is covered without prior authorization (high confidence)
Medicare Pricing
Work RVU
0.00
Facility
N/A
Non-Facility
N/A
Documentation Required
- Apretude initial: 'Used for HIV-1 pre-exposure prophylaxis (PrEP); and Patient has a negative HIV-1 test; and Provider confirms that the patient will be tested for HIV-1 infection with each subsequent injection; and Dosing is in accordance with the United States Food and Drug Administration approved labeling; and Initial authorization is for no more than 12 months.'
- Apretude continuation: 'Patient has previously received treatment with Apretude; and Patient has a negative HIV-1 test; and Provider confirms that the patient will be tested for HIV-1 infection with each subsequent injection; and Dosing is in accordance with the United States Food and Drug Administration approved labeling; and Authorization is for no more than 12 months.'
- Yeztugo initial: 'Used for HIV-1 pre-exposure prophylaxis (PrEP); and Patient has a negative HIV-1 test; and Provider confirms that the patient will be tested for HIV-1 infection with each subsequent injection; and Dosing is in accordance with the United States Food and Drug Administration approved labeling; and Initial authorization is for no more than 12 months.'
Key Coverage Criteria
- Apretude (cabotegravir): Proven to reduce the risk of sexually acquired HIV-1 infection in at-risk adults and adolescents weighing at least 35 kg. Medically necessary when used for HIV-1 pre-exposure prophylaxis (PrEP) and the additional criteria (see Documentation Requirements) are met.
- Apretude continuation: Medically necessary when patient has previously received treatment with Apretude and meets continuation criteria (see Documentation Requirements).
- Cabenuva (cabotegravir/rilpivirine): Proven for the treatment of human immunodeficiency virus type-1 (HIV-1) in patients who are virologically suppressed (HIV-1 RNA less than 50 copies per mL). Medically necessary when the additional criteria (see Documentation Requirements) are met.
- Cabenuva continuation: Medically necessary when patient has previously received Cabenuva and provider confirms patient has achieved and maintained viral suppression while on Cabenuva therapy and dosing is per FDA labeling.
- Sunlenca (lenacapavir) injection: Proven and medically necessary for the treatment of multi-drug resistant human immunodeficiency virus (HIV-1) in patients who meet all specified criteria, including provider attestation of multi-drug resistant HIV-1 and prescription of an optimized background antiretroviral regimen containing at least one agent demonstrating full viral sensitivity/susceptibility.
- Sunlenca continuation: Medically necessary when patient has previously received Sunlenca, achieved a clinically significant viral response, will continue an optimized background regimen in combination with Sunlenca, and dosing is per FDA labeling.
4 Active Policies
CIGNA-A004 — Preventive Care Services - (A004)
UHC-POL-long-acting-injectable-antiretroviral-agents — Long-Acting Injectable Antiretroviral Agents for HIV
UMR-POL-UMR-long-acting-injectable-antiretroviral-agents — Long-Acting Injectable Antiretroviral Agents for HIV
SUREST-POL-SUREST-long-acting-injectable-antiretroviral-agents — Long-Acting Injectable Antiretroviral Agents for HIV
Related Codes
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