Does J1961 require prior authorization?

Yes, J1961 requires prior authorization (high confidence). At least one active policy explicitly requires prior authorization.

What is the Medicare reimbursement rate for J1961?

Medicare facility rate: N/A. Non-facility rate: N/A. Work RVU: 0.00.

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`J1961`, Injection, lenacapavir (only for use as hiv treatment), 1 mg

HCPCS/CPT

Prior Authorization

Prior Auth Required

At least one active policy explicitly requires 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.'

Yeztugo continuation: 'Patient has previously received treatment with Yeztugo; 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.'

Cabenuva initial: 'Diagnosis of HIV-1 infection; and Patient has no prior virologic failures or baseline resistance to either cabotegravir or rilpivirine; and Patient is currently on a stable antiretroviral regimen; and Provider attests that patient has achieved viral suppression (HIV-1 RNA less than 50 copies per mL) for at least 3 months prior to initiation of Cabenuva; and Provider attests that patient demonstrates treatment readiness by both of the following: Patient understands the risks of missed doses of Cabenuva; and Patient has the ability to adhere to the required monthly or every 2 months injection appointments; 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.'

Cabenuva continuation: 'Patient has previously received treatment with Cabenuva; and Provider confirms that the patient has achieved and maintained viral suppression (HIV-1 RNA less than 50 copies per mL) while on Cabenuva therapy; and Dosing is in accordance with the United States Food and Drug Administration approved labeling; and 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.

12 Active Policies

ARKBLUE-LENACAPAVIR-E-G-SUNLENCA-DBAF380721, Lenacapavir (e.g., Sunlenca)

BCBSLA-00844-F301B614BD, 00844 lenacapavir (Sunlenca)

BCBSM-2171627-D85D84221F, SUNLENCA (LENACAPAVIR)

HEALTHNET_OR-HNOR-LENACAPAVIR-SUNLENCA-YEZTUGO-CP-PHAR-622-236623DEFC, Lenacapavir (Sunlenca, Yeztugo); CP.PHAR.622

BCBSOK-RX501.145, Long-Acting Injectable Antiretroviral Agents for Treatment of HIV

UMR-POL-UMR-long-acting-injectable-antiretroviral-agents, Long-Acting Injectable Antiretroviral Agents for HIV

UHC-POL-long-acting-injectable-antiretroviral-agents, Long-Acting Injectable Antiretroviral Agents for HIV

EVICORE-MEDICAL_DRUG-91D7CA2CB1CD, Sunlenca (lenacapavir) Injection

SUREST-POL-SUREST-long-acting-injectable-antiretroviral-agents, Long-Acting Injectable Antiretroviral Agents for HIV

BCBSIL-RX501.145, Long-Acting Injectable Antiretroviral Agents for Treatment of HIV

BCBSMT-RX501.145, Long-Acting Injectable Antiretroviral Agents for Treatment of HIV

BCBSNM-RX501.145, Long-Acting Injectable Antiretroviral Agents for Treatment of HIV

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J1961, Injection, lenacapavir (only for use as hiv treatment), 1 mg