CurrentPremera BluecrossPolicy 5.01.588

PHARMACY MEDICAL POLICY 5.01.588 Pharmacologic Prevention and Treatment of HIVIAIDS

Defines medical necessity coverage criteria, benefit routing (medical vs pharmacy), authorization lengths, documentation and coding for specific HIV prevention (PrEP) and treatment drugs including Apretude, Descovy, Truvada, Rukobia, Sunlenca, and Trogarzo, with criteria for use in multidrug-resistant HIV-1 and PrEP indications.

Policy Summary

PayerPremera Bluecross

PolicyPHARMACY MEDICAL POLICY 5.01.588 Pharmacologic Prevention and Treatment of HIVIAIDS

Policy CodePolicy 5.01.588

Change TypeClarifications and removals (step therapy)

Effective DateMar 1, 2025

Next Review Date

Key ActionSubmit office visit notes containing diagnosis, relevant history, physical evaluation, and medication history to demonstrate that medical necessity criteria are met.

POLICY UPDATE CHANGES

Clarified that non-formulary exception review authorizations for all drugs listed in this policy may be approved up to 12 months.

Clarified that the medications listed in this policy are subject to the product's FDA dosage and administration prescribing information.

Removed step therapy requirement from Apretude coverage criteria.

Removed step therapy requirement from Descovy HIV PrEP coverage criteria.

Added new HCPCS codes J0752 and J0759 to match policy criteria for Lenacapavir (effective 10/01/25 noted in coding updates).

6Named drugs with coverage criteria (Apretude, Descovy, Truvada, Rukobia, Sunlenca, Trogarzo)

12 moTypical max non-formulary approval duration

3 yrsMax approval for other reviews (when criteria met)

Coverage Summary

Defines medical necessity coverage criteria, benefit routing (medical vs pharmacy), authorization lengths, documentation requirements, and coding for specific HIV prevention (PrEP) and treatment drugs including Apretude, Descovy, Truvada, Rukobia, Sunlenca, and Trogarzo.

Specifies benefit routing: Descovy, Rukobia, and Truvada are managed through the pharmacy benefit, Apretude and Trogarzo through the medical benefit, and Sunlenca through both medical and pharmacy benefits.

Authorization lengths: non-formulary exception reviews and other reviews for Rukobia, Sunlenca, and Trogarzo may be approved up to 12 months; non-formulary exception reviews for Apretude, Descovy, and Truvada may be approved up to 12 months; other reviews for Apretude, Descovy, and Truvada may be approved up to 3 years when criteria are met.

Documentation and coding: requires submission of office visit notes with diagnosis, history, physical evaluation and medication history to demonstrate medical necessity; includes HCPCS/J-codes for the listed agents (e.g., codes for lenacapavir, Truvada, Descovy, Trogarzo, ibalizumab, etc.).

Includes dose-specific and resistance documentation requirements for MDR agents (e.g., Rukobia dosing and documentation of resistance/failure to required classes; Sunlenca maintenance dose requirement).

Key thresholds and policy dates

Effective date2025-03-01

Last review2025-10-01

Policy number5.01.588

StatusCURRENT

Initial Therapy Criteria

Descovy (emtricitabine and tenofovir alafenamide) - PrEP

Descovy may be considered medically necessary for PrEP when the following are met:

PrEP use: Used for pre-exposure prophylaxis (PrEP) to reduce the risk of HIV-1 infection

Truvada (emtricitabine and tenofovir disoproxil fumarate) - PrEP

Truvada may be considered medically necessary for PrEP when ALL of the following are met:

PrEP use and documentation: Used for pre-exposure prophylaxis (PrEP) to reduce the risk of HIV-1 infection

Documentation required: Individual has tried generic emtricitabine and tenofovir disoproxil fumarate first and had an inadequate response or intolerance to generic emtricitabine and tenofovir disoproxil fumarate

Continuation Therapy / MDR Treatment Criteria

Investigational / Not Covered Uses

All other uses not outlined in this policy are considered investigational.

Investigational uses: Uses of listed drugs for conditions not specifically covered in this policy are investigational

Applicable Codes

HCPCS codes (drug administration / J-codes)HCPCS

J0738	Injection, lenacapavir, mg; FDA-approved prescription, only for use as HIV pre-exposure prophylaxis (PrEP) (not for use as treatment for HIV) (new code effective 10/01/25)
J0750	Emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg, oral, FDA-approved prescription, only for use as HIV pre-exposure prophylaxis (not for use as treatment of HIV) (Truvada)
J0751	Emtricitabine 200 mg and tenofovir alafenamide 25 mg, oral, FDA-approved prescription; only for use as HIV pre-exposure prophylaxis (not for use as treatment of HIV) (Descovy)
J0752	Oral, lenacapavir; 300 mg, FDA-approved prescription, only for use as HIV pre-exposure prophylaxis (PrEP) (not for use as treatment for HIV) (new code effective 10/01/25)
J0799	FDA-approved prescription only for use as HIV pre-exposure prophylaxis (not for use as treatment of HIV), not otherwise classified drug
J1746	Injection, ibalizumab-uiyk (Trogarzo), 10 mg
J1961	Injection, lenacapavir (Sunlenca), mg
J0739	HCPCS code previously added for Apretude (mentioned in history)
J3490	Unclassified drugs (historical; removed 03/01/25)
J3590	Unclassified biologics (historical; removed 09/01/19)

Provider Actions and Billing Notes

Prior Authorization

Authorization required and length

Non-formulary exception reviews and other reviews for Rukobia, Sunlenca, and Trogarzo may be approved up to 12 months. Non-formulary exception reviews for Apretude, Descovy, and Truvada may be approved up to 12 months; other reviews for Apretude, Descovy, and Truvada may be approved up to 3 years. Initial and reauthorization lengths vary by drug and review type.

Documentation Required

Medical record documentation

Submit office visit notes that include the diagnosis, relevant history, physical evaluation, and medication history to demonstrate that medical necessity criteria are met.

Clinical Evidence

69%HPTN 083: CAB-LA vs FTC/TDF — 69% reduction in incident HIV-1 infection

90%HPTN 084: CAB-LA vs FTC/TDF — 90% reduction in incident HIV-1 infection

53-60%BRIGHTE (Rukobia) randomized cohort: virologic response range at weeks 24-96

93%Sunlenca pooled subcutaneous arms: 93% undetectable (<50 copies/mL) by Week 28

HPTN 083 and HPTN 084 (cabotegravir long-acting injectable): trials demonstrated superiority of CAB-LA versus FTC/TDF with a 69% reduction in incident HIV-1 infection in HPTN 083 and a 90% reduction in HPTN 084.

BRIGHTE (fostemsavir/Rukobia): the phase 3 pivotal trial reported virologic response in the randomized cohort ranging approximately 53%–60% at weeks 24–96.

CAPELLA and CALIBRATE (lenacapavir/Sunlenca): pooled SC arms showed high rates of viral suppression, for example 93% undetectable (<50 copies/mL) by Week 28 in the pooled subcutaneous lenacapavir + FITAF arms; overall pooled results reported up to 94% viral suppression in relevant arms.

Background

This policy addresses FDA‑approved medications for HIV prevention (PrEP) and treatment, with a particular focus on management of multidrug‑resistant HIV where add‑on therapies may be used. It outlines when brand‑name drugs may be medically necessary for PrEP and for treatment of difficult, treatment‑experienced cases.

The policy notes that uses of the listed drugs for conditions not specifically covered are considered investigational and that the medications listed are subject to the product's FDA dosing and administration prescribing information.

The Introduction emphasizes that PrEP medications can significantly reduce the chance of acquiring HIV and that complex regimens may be required for individuals with multiple drug resistances; the policy is intended to provide specific coverage criteria for those situations.

PrEP: Pre-exposure prophylaxis to reduce the risk of acquiring HIV-1 infection.

MDR: Multidrug-resistant (MDR) HIV-1 — HIV-1 with documented resistance or treatment failure to multiple antiretroviral classes or agents, requiring use of agents for heavily treatment‑experienced individuals.

Note: Definitions are used to clarify coverage criteria for PrEP and for agents intended for multidrug‑resistant HIV‑1.

Revision History

2025-03-01material_changeLatest

Clarified that non-formulary exception review authorizations for all drugs listed in this policy may be approved up to 12 months; removed step therapy requirement from Apretude coverage criteria; removed step therapy requirement from Descovy PrEP coverage criteria.

2025-03-01clarification

Clarified that the medications listed in this policy are subject to the product's FDA dosage and administration prescribing information.

2025-10-01coding_update