Truvada (Emtricitabine and Tenofovir Disoproxil Fumarate) for HIV Prevention and Treatment
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This policy governs medical-necessity review for Truvada used in HIV pre-exposure prophylaxis and HIV treatment. It applies to providers submitting pharmacy-benefit requests; uses not outlined in the policy are considered investigational.
The 2026 update removed coverage criteria for Apretude, Descovy, Rukobia, Sunlenca, Trogarzo, and Yeztugo.
The 2026 update removed the reference to non-formulary exception reviews.
The 2026 history records removal of HCPCS codes J0738, J0739, J0750, J0751, J0752, J0799, J1746, and J1961.
The October 1, 2026 annual review removed coverage criteria for Apretude, Descovy, Rukobia, Sunlenca, Trogarzo, and Yeztugo.
The October 1, 2026 annual review removed HCPCS codes J0738, J0739, J0750, J0751, J0752, J0799, J1746, and J1961.
Medical Necessity and Coverage Scope
Truvada medical necessity
Truvada may be considered medically necessary when the following criterion is met:
Unoutlined uses
All other uses of the medications listed in this policy are considered investigational.
Such use is considered investigational.
Uses of the listed medications for conditions or indications not outlined in this policy are excluded from covered use and considered investigational.
This medical policy does not apply to Medicare Advantage. Coverage is subject to the member’s applicable benefit plan and limitations.
HCPCS Coding References
Submission and Step-Therapy Requirements
Generic Product Trial Required
Before brand-name Truvada is considered, document that the individual tried generic emtricitabine/tenofovir disoproxil fumarate and had an inadequate response or intolerance.
- Document the inadequate response or intolerance to the generic product in the medical record.
Step Through Generic Emtricitabine/Tenofovir DF
Truvada may be considered medically necessary only after the required generic emtricitabine/tenofovir disoproxil fumarate step-therapy trial has been completed and the individual has had an inadequate response or intolerance.
- Required sequence: trial generic emtricitabine/tenofovir disoproxil fumarate first, then consider brand-name Truvada when criteria are met.
Submit Clinical Records Supporting Criteria
Submit clinical records demonstrating that the medical-necessity criteria are met. Records should support the diagnosis and treatment history for the condition under review.
- Office visit notes
- Diagnosis and relevant history
- Physical evaluation
- Medication history
Unoutlined Uses Are Investigational
The medications listed in the policy are subject to the product’s FDA dosage and administration prescribing information. Uses or indications not outlined in the policy are considered investigational.
- Unoutlined uses of the listed drugs are investigational.
HIV and Antiretroviral Therapy
HIV is a lifelong infection that primarily targets and depletes CD4-positive T cells. Without effective antiretroviral therapy, HIV can progress to AIDS. Antiretroviral treatment suppresses viral replication, supports immune recovery, reduces illness and mortality, and can prevent sexual transmission when viral suppression is maintained. For people with HIV, treatment generally involves two or three medications to control the virus and help prevent resistance.
Key HIV Prevention and Disease Definitions
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