HIV Pre-Exposure Prophylaxis (PrEP) — Apretude and Yeztugo
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Defines prior authorization requirements for coverage of Apretude (cabotegravir injectable) and Yeztugo (lenacapavir) for HIV pre-exposure prophylaxis (PrEP) in eligible adults and adolescents weighing ≥35 kg, including initial and reauthorization criteria and required documentation for prescribers.
Yeztugo prior authorization criteria were added to the policy.
Policy name changed to HIV PreP and criteria updated to address Descovy requirements.
Coverage Criteria for Apretude and Yeztugo (PrEP)
Initial Therapy — Approve Apretude or Yeztugo
Approve Apretude or Yeztugo if the member meets ONE of the following conditions (A or B) — Initial Criteria:
Medication samples are not accepted as evidence for testing or intolerance.
Applies prior to initiating Apretude or Yeztugo.
Applies only to Apretude when oral lead-in used.
Sequencing required before Yeztugo.
Continuation / Reauthorization
Reauthorization: All prior authorization renewals are reviewed to determine medical necessity for continuation of therapy. Authorizations may be extended based upon:
Samples do not substitute for documented prior failure/intolerance.
Dosing and Exclusions
Use outside FDA-approved dosing or non-PrEP indications is not covered.
Apretude (cabotegravir extended-release injectable) and Yeztugo (lenacapavir) are considered investigational or experimental for any uses other than HIV-1 pre-exposure prophylaxis (PrEP) and will not be covered when requested for other indications.
Use of Apretude or Yeztugo outside the manufacturer's dosing guidelines listed in FDA-approved labeling, or for indications other than PrEP, is considered investigational and is not covered.
Provider Requirements, Documentation, and Actions
Prior authorization required; initial 3-month approval, 6-month renewals
Prior authorization is required for Apretude and Yeztugo. Initial approvals are granted for 3 months; if renewal criteria are met, continuation approvals are for 6 months.
Step therapy: required 3-month trials or documented contraindication/intolerance
Step therapy requires documented trials or contraindications to preferred oral PrEP before initiating Apretude or Yeztugo: cis-gender males and transgender females must have contraindication to or intolerance after 3-month trials of both Truvada and Descovy; cis-gender females and transgender males must have contraindication to or intolerance after a 3-month trial of Truvada. For Yeztugo specifically, a trial and failure, contraindication, or intolerance to Apretude for at least 3 months is required.
- Cis-male/transgender female: documented contraindication to Truvada and Descovy or intolerance after 3-month trials of each (samples not accepted).
- Cis-female/transgender male: documented contraindication to Truvada or intolerance after a 3-month trial (samples not accepted).
- Yeztugo: trial and failure, contraindication, or intolerance to Apretude for ≥3 months (samples not accepted).
Required documentation: prescriber attestation, counseling, and chart evidence
Prescriber must attest that the member is high-risk for HIV and that medication adherence counseling was performed; chart documentation must be provided to support initiation and renewals, and a negative HIV-1 test within 30 days is required for continuation.
- Prescriber attestation: member is high-risk for HIV and adherence counseling performed.
- Chart documentation showing continued response to therapy required for renewals.
- Negative HIV-1 test within 30 days required to support continuation.
Apretude oral lead-in tolerance must be documented (30 days; no samples)
If an oral lead-in is used before injectable Apretude, provide documentation of tolerance to a 30-day Vocabria (cabotegravir) oral lead-in; medication samples are not acceptable evidence.
Yeztugo requires ≥3 months trial/failure or contraindication/intolerance to Apretude
Prior to approving Yeztugo, documentation must show a trial and failure, contraindication, or intolerance to Apretude for at least 3 months; medication samples will not be accepted to demonstrate intolerance.
Denial triggers: missing required tests, weight, sequencing, or dosing
Requests will be denied if the member does not meet initial or reauthorization criteria, including lack of a documented negative HIV-1 test prior to initiation, weight <35 kg, failure to document required contraindication/intolerance to preferred oral PrEP per step therapy, or if prescribed outside manufacturer dosing; investigational uses are not covered.
- No documented negative HIV-1 test immediately prior to initiation (with RNA confirmation if Ag/Ab negative).
- Member weight below 35 kg.
- No documentation of contraindication or intolerance per step therapy requirements (samples not accepted).
- Prescribed outside manufacturer's dosing or for investigational/experimental uses.
Billing and Procedure Codes
Key Definitions and Testing Requirements
Background
Apretude (cabotegravir extended-release injectable) and Yeztugo (lenacapavir) are FDA-recognized agents for HIV-1 pre-exposure prophylaxis (PrEP). Apretude is administered as an extended-release intramuscular injection (with an optional oral lead-in per manufacturer guidance) and Yeztugo is a capsid inhibitor with specific sequencing requirements relative to cabotegravir. Both agents must be prescribed within the manufacturer's FDA dosing guidelines to be considered for coverage.
Policy Revision History
Annual review recorded (02/2026 noted in log) and change noted to address Descovy treatment requirements.
Policy name changed to 'HIV PreP' and Yeztugo prior authorization criteria were added (sequencing requirement vs Apretude).
Yeztugo prescribing information added to references (Gilead Sciences, June 2025).
New policy created (P&T review noted in 05/2022 and subsequent additions of Apretude-specific CPT code in 08/2022).
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