CurrentUnitedHealthcarePolicy N/A

Prior Authorization Selzentry (maraviroc) for CCR5-tropic HIV-1

This document is a UnitedHealthcare prior authorization form and approval criteria for maraviroc (Selzentry) used to treat CCR5-tropic HIV-1; it defines required documentation, testing, dosing considerations and approval duration for pharmacy benefit reviewers and prescribing providers.

Policy Summary

PayerUnitedHealthcare

PolicyPrior Authorization Selzentry (maraviroc) for CCR5-tropic HIV-1

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionProvider must complete and sign the Selzentry prior authorization form and attach required documentation including tropism assay, CD4, viral load, resistance testing (as applicable), and weight verification for pediatric patients.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

CCR5HIV-1 tropism required

3Current lab results needed (treatment-experienced)

1 yrMaximum PA approval duration

Approval Criteria for Selzentry (maraviroc)

Approval Criteria (general)

Selzentry (maraviroc) may be approved when ALL of the following are met:

ALL of the following

Tropism result
- Tropism testing has been performed and a copy of the assay report is attached
  If tropism testing has NOT been performed, the request must be denied
- Tropism assay demonstrates CCR5-tropic HIV-1
  FDA-approved indication is CCR5-tropic HIV-1
- Requests for patients with dual/mixed or CXCR4-tropic HIV-1 are not recommended
  Efficacy not demonstrated for dual/mixed or CXCR4-tropic

Policy Summary

PayerUnitedHealthcare

PolicyPrior Authorization Selzentry (maraviroc) for CCR5-tropic HIV-1

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date

Next Review Date

SourceLink

On This Page

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Patient type and required labs

- Current (within 6 months) CD4 count attached
- Current (within 6 months) viral load attached
- Current (within 6 months) resistance testing attached
- Current (within 6 months) CD4 count attached
- Current (within 6 months) viral load attached
- Resistance testing may be omitted for treatment-naïve patients

Pediatric-specific requirement (if applicable)

For pediatric patients, weight verification is included in the submission to ensure appropriate weight-based dosing

Provider has included medication history / claims profile or medical records for review

Prescriber has completed PA form in full including signature and contact information

Incomplete forms may be returned

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Dosing considerations and drug interactions

Dose adjustment must be considered based on co-administered drugs (maraviroc is a CYP3A and P-gp substrate). Prescribed dose should match interaction context:

ALL of the following

With strong CYP3A inhibitors (with or without CYP3A inducers) including most protease inhibitors (except tipranavir/ritonavir) and delavirdine: prescribe 150 mg twice daily
With NRTIs, tipranavir/ritonavir, nevirapine, and other drugs that are not strong CYP3A inhibitors or CYP3A inducers: prescribe 300 mg twice daily
With CYP3A inducers including efavirenz (without a strong CYP3A inhibitor): prescribe 600 mg twice daily

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Denial conditions

Requests must be denied if any of the following apply:

ANY of the following

Tropism testing has not been performed
Tropism assay does not demonstrate CCR5-tropic HIV-1 (i.e., dual/mixed or CXCR4-tropic)
Required current lab results are not submitted (see lab requirements above)

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Key Thresholds

Recency of required labsless than 6 months

What the Provider Must Do

Prior Authorization

Complete and submit PA form with attachments

Provider must fully complete the Selzentry prior authorization form, include the prescriber signature and contact information, and attach required documentation; incomplete forms may be returned to the provider.

Prescriber signature and date must be provided
Include prescriber phone/fax and NPI and contact information as requested
Incomplete forms may be returned for completion

Documentation Required

Attach tropism assay report

If tropism testing has been performed, a copy of the assay report MUST be attached to the PA submission; requests will be denied if tropism testing has not been performed.

Documentation Required

Attach current lab results

Attach current laboratory results dated within the last 6 months: CD4 count and viral load are required for all patients; resistance testing must be attached for treatment-experienced patients.

Resistance testing is required for treatment-experienced patients; resistance testing may be omitted for treatment-naïve patients

Documentation Required

Pediatric weight verification

For pediatric patients, include weight verification with the submission to confirm appropriate weight-based dosing.

Denial Risk

Denial for missing tropism or non-CCR5 result

Requests will be denied if tropism testing has not been performed or if the submitted tropism assay does not demonstrate CCR5-tropic HIV-1 (i.e., dual/mixed or CXCR4-tropic results are not acceptable).

Prior Authorization

Approval duration

This prior authorization may be approved for up to 1 year.

Coding / Billing Notes

No procedural or diagnosis codes listedmixed

No codes listed

Clinical and Pharmacologic Background

Maraviroc (Selzentry) is an oral CCR5 antagonist approved for use only in patients with CCR5-tropic HIV-1; use is not recommended for patients with dual/mixed or CXCR4-tropic virus. Its pharmacokinetics are affected by CYP3A enzymes and P-glycoprotein (P-gp), so dose adjustments are required when co-administered with CYP3A or P-gp modulators — for example, 150 mg twice daily with strong CYP3A inhibitors, 300 mg twice daily with agents that are not strong CYP3A inhibitors/inducers, and 600 mg twice daily with CYP3A inducers such as efavirenz.

Defined Terms

Definitions

Treatment-experiencedPatient with prior antiretroviral therapy exposure; resistance testing is required for PA submission.

Treatment-naïvePatient without prior antiretroviral therapy; resistance testing may not be required for PA submission.

Tropism testingLaboratory assay to determine whether a patient's HIV-1 uses the CCR5 co-receptor (CCR5-tropic) versus CXCR4 or mixed/dual tropism.

Quick Policy Metrics

Policy highlights

HIV-1 tropism requiredCCR5-tropic only

Current lab results needed (treatment-experienced)3 labs required (CD4, viral load, resistance testing)

Maximum PA approval durationUp to 1 year