CurrentUnitedHealthcarePolicy 2025 P 1092-13

Selzentry (maraviroc) prior authorization

UnitedHealthcare prior authorization policy governing coverage of Selzentry (maraviroc) for treatment of CCR5‑tropic HIV‑1 in eligible members; applies to providers requesting benefit coverage under UnitedHealthcare pharmacy clinical programs.

Policy Summary

PayerUnitedHealthcare

PolicySelzentry (maraviroc) prior authorization

Policy CodePolicy 2025 P 1092-13

Change TypeFormatting and prior revisions noted

Effective DateApr 1, 2025

Next Review Date

Key ActionObtain prior authorization confirming CCR5‑tropic HIV‑1 by a highly sensitive tropism assay and document an optimized background antiretroviral regimen.

SourceLink

POLICY UPDATE CHANGES

Updated formatting without change to clinical intent.

Revised duration of authorization.

Clinical intent is to validate tropism assay testing at time of therapy initiation.

12 monthsauthorization duration

2025-04-01effective date

1/2012-1/2025P&T approval history

Coverage Criteria for Selzentry (maraviroc)

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Initial Authorization

Covered when ALL of the following are met:

Initial authorization: Patient has CCR5-tropic HIV-1 infection as confirmed by a highly sensitive tropism assay

Evidence must be provided

Initial authorization: Patient is currently taking or will be prescribed an optimized background antiretroviral therapy regimen

Initial authorization: Authorization will be issued for 12 months

State mandates and member benefit plan coverage may affect authorization

Selzentry (maraviroc) is indicated only for treatment of CCR5‑tropic HIV‑1 in adults and pediatric patients weighing at least 2 kg. The policy therefore does not recommend Selzentry for patients with dual/mixed‑ or CXCR4‑tropic HIV‑1.

Use of Selzentry for dual/mixed‑ or CXCR4‑tropic HIV‑1 is not recommended and would not meet coverage criteria under this policy; tropism testing with a highly sensitive assay is required to establish CCR5 tropism prior to therapy.

Initial Therapy

Initial therapy is covered when ALL of the following are satisfied:

Initial therapy: Confirmed CCR5-tropic HIV-1 by a highly sensitive tropism assay

Initial therapy: Patient is on or will be prescribed an optimized background antiretroviral regimen

Provider Actions and Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Selzentry (maraviroc) will be approved only when the patient has CCR5‑tropic HIV‑1 infection confirmed by a highly sensitive tropism assay and the patient is currently taking or will be prescribed an optimized background antiretroviral therapy regimen. Authorization will be issued for 12 months. State mandates, federal regulatory requirements, and the member's specific benefit plan may affect coverage.

Approved only if CCR5‑tropic HIV‑1 confirmed by a highly sensitive tropism assay
Approved only if an optimized background antiretroviral therapy regimen is planned or in place
Authorization duration: 12 months
State mandates and member benefit plan may affect coverage

Documentation Required

Required Clinical Documentation

Documentation must include evidence of CCR5‑tropic HIV‑1 as confirmed by a highly sensitive tropism assay and the planned or current optimized background antiretroviral regimen. Additional supporting documentation (previous claim/medication history, relevant diagnosis codes) may be used for initial approval or reauthorization per UnitedHealthcare automated processes.

Include tropism assay result confirming CCR5‑tropic virus
Include details of optimized background antiretroviral regimen (current or planned)
Previous claim/medication history and ICD‑10 codes may be used to support approval

Denial Risk

Triggers for Denial

Requests will be denied if documentation does not confirm CCR5‑tropic HIV‑1 by a highly sensitive tropism assay or if the request is not accompanied by an optimized background antiretroviral regimen. Other denial triggers include lack of necessary documentation, member benefit exclusions, or noncompliance with applicable state or federal mandates.

No confirmation of CCR5‑tropic HIV‑1 by a highly sensitive tropism assay
No evidence of an optimized background antiretroviral regimen (planned or current)
Missing required documentation or member benefit exclusion

Note

Not Specified / Other Provider Actions

If provider action is not specified in a request, UnitedHealthcare may rely on prior claim/medication history, diagnosis codes, and claim logic to make an authorization decision. Supply limits and program-specific utilization management rules may also apply.

Unspecified provider action may lead to review based on claims history and diagnosis codes
Supply limits and other utilization management programs may affect approval

Coding and Product Details

No specific billing codes listedmixed

No codes listed

Patient weight for pediatric use

Pediatric weight threshold>= 2 kg

ApplicabilityApplies to pediatric patients weighing at least 2 kg (per indication).

Source contextMaraviroc indicated for CCR5‑tropic HIV‑1 in adults and pediatric patients >= 2 kg.

Re-authorization / Continuation Criteria

Re-authorization

Re-authorization may be granted when ALL of the following apply or per automated processes:

Re-authorization: Authorization may be re-approved based on previous claim/medication history, diagnosis codes (ICD-10) and/or claim logic per UnitedHealthcare automated processes

Supply limits may be in place

Step Therapy

Step	Requirement
{"text":"1","status":""},{"text":"Not specified in this policy.","status":""}

Definitions

CCR5‑tropic HIV‑1 — definition and tropism assay determination

DefinitionCCR5‑tropic HIV‑1: HIV‑1 that uses the CCR5 co‑receptor for cell entry as determined by a highly sensitive tropism assay.

Required testConfirmation must be by a highly sensitive tropism assay prior to use.

Clinical implicationSelzentry is indicated only for CCR5‑tropic virus and is not recommended for dual/mixed‑ or CXCR4‑tropic HIV‑1.

Authorization linkPrior authorization requires documented CCR5 tropism by a highly sensitive assay.

Optimized background antiretroviral therapy — definition

DefinitionOptimized background antiretroviral therapy: a tailored combination of antiretroviral agents chosen to provide effective viral suppression in combination with maraviroc.

Requirement for approvalPatient must be currently taking or will be prescribed an optimized background antiretroviral regimen for prior authorization to be approved.

DocumentationPlanned or current optimized background regimen must be included in clinical documentation accompanying the request.

Background

Maraviroc (Selzentry) is a CCR5 co‑receptor antagonist indicated in combination with other antiretroviral agents for treatment of CCR5‑tropic HIV‑1 in adults and pediatric patients weighing at least 2 kg. It is not recommended for patients with dual/mixed‑ or CXCR4‑tropic virus. Prior to initiating maraviroc, tropism testing with a highly sensitive assay is required to confirm CCR5 tropism and ensure appropriate patient selection.