CurrentUnitedHealthcarePolicy 2025 P 3151-6

Step Therapy for Zilxi (minocycline) — Coverage Criteria

Defines UnitedHealthcare's step therapy requirement for coverage of Zilxi (topical minocycline) for treatment of inflammatory lesions of rosacea in adults, requiring trial of specified lower-cost topical alternatives before Zilxi coverage.

Policy Summary

PayerUnitedHealthcare

PolicyStep Therapy for Zilxi (minocycline) — Coverage Criteria

Policy CodePolicy 2025 P 3151-6

Change TypeNo material coverage changes in latest revision; maintenance updates

Effective DateAug 1, 2025

Next Review Date

Key ActionObtain prior authorization and document trial (drug, date, and reason) of one lower-cost topical agent (azelaic acid or Soolantra) showing failure, contraindication, or intolerance before Zilxi will be approved.

SourceLink

POLICY UPDATE CHANGES

New program created for Step Therapy - Zilxi (minocycline) in 02/2021.

Updated criteria to require trial of one topical alternative and removed metronidazole from step one options (03/2022).

Annual reviews with updated references (03/2023) and no changes in 04/2024 and 05/2025.

12 moauthorization duration

1required prior trial

2/2021→5/2025program history

Coverage Criteria

Policy Summary

PayerUnitedHealthcare

PolicyStep Therapy for Zilxi (minocycline) — Coverage Criteria

Policy CodePolicy 2025 P 3151-6

Change TypeNo material coverage changes in latest revision; maintenance updates

Effective DateAug 1, 2025

Next Review Date

SourceLink

On This Page

Initial approval criteria

Covered when ALL of the following are met

Initial coverage criteria

Diagnosis: inflammatory lesions of rosacea in an adult (per indication).
Documented history of failure, contraindication, or intolerance to ONE of the following topical therapies: azelaic acid (Finacea) OR Soolantra.
Provider must document the drug tried, date of trial, and reason for therapeutic failure, contraindication, or intolerance.

Coverage is subject to state mandates and the member-specific benefit plan. Any federal regulatory requirements, the member benefit plan, and other policies or utilization management programs may affect coverage determinations for Zilxi.

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Zilxi. When criteria are met, approval will be issued for 12 months.

Prior authorization required
Approval duration: 12 months when criteria met

Step Therapy

Step Therapy Requirement

A step therapy trial is required. Member must have a documented history of failure, contraindication, or intolerance to one of the following lower-cost topical therapies before Zilxi will be approved.

Required step therapy agents: azelaic acid (Finacea) or Soolantra
Document the drug tried, date of trial, and reason for failure/contraindication/intolerance

Documentation Required

Documentation Requirement for Step Therapy

Clinical documentation must include the specific agent tried, the date(s) of the trial, and the reason(s) the agent was ineffective or could not be used (failure, contraindication, or intolerance). Failure to provide this documentation may affect authorization decisions.

Document: drug name, date of trial, and reason for failure/contraindication/intolerance
Incomplete or missing trial history/date/reason may result in denial or delay

Definitions

Definition: Zilxi

DrugZilxi (minocycline) topical formulation

IndicationTreatment of inflammatory lesions of rosacea in adults

Drug classTetracycline-class (topical)

Step therapy roleSubject to step therapy requiring trial of lower-cost topical rosacea medication prior to coverage

Prior agents (examples)Lower-cost topical rosacea medications (e.g., azelaic acid or Soolantra) — trial required per policy

Approval durationAuthorization granted for 12 months when criteria met

Initial Therapy Criteria

Step therapy prior agents

Required lower-cost alternatives prior to Zilxi

Required prior topical therapy: Trial of one of the following topical therapies: azelaic acid (Finacea) OR Soolantra.1 agent

Document drug name, date of trial, and reason for therapeutic failure, contraindication, or intolerance before Zilxi will be approved.

Step	Required prior therapy	Documentation required	Coverage
1	Trial of one lower-cost topical rosacea medication: azelaic acid (Finacea) OR Soolantra	Document the drug tried, date of trial, and reason for therapeutic failure, contraindication, or intolerance	Coverage permitted when criteria met

Site of Care

Note

Site-of-care: no specific restrictions; automated processes and limits may apply

No specific site-of-care restrictions are stated; UnitedHealthcare may use automated approval/re-approval processes and supply limits or notifications may apply.

Automated approval and re-authorization processes may be used.
Supply limits and/or notification requirements may be in place.

Background

Zilxi is a topical tetracycline-class medication (minocycline) indicated for the treatment of inflammatory lesions of rosacea in adults. The Step Therapy program is intended to encourage use of lower-cost topical alternatives prior to authorizing Zilxi; coverage requires documentation of a trial and documented failure, contraindication, or intolerance to one specified topical agent (azelaic acid or Soolantra) before Zilxi will be approved.