CurrentUnitedHealthcarePolicy N/A

Zilxi (minocycline) topical gel prior authorization

Prior authorization and coverage rules for Zilxi (topical minocycline) for treatment of inflammatory lesions of rosacea in adults under UnitedHealthcare Pharmacy Clinical Pharmacy Programs.

Policy Summary

PayerUnitedHealthcare

PolicyZilxi (minocycline) topical gel prior authorization

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateApr 1, 2024

Next Review DateN/A

Key ActionObtain prior authorization for Zilxi for adults with rosacea and inflammatory lesions; initial approvals are granted for 12 months.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 moinitial authorization duration

12 moreauthorization duration

AdultsFDA-approved indication

Prior authProgram type

Coverage Criteria for Zilxi (topical minocycline)

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Reauthorization / Continuation Criteria

Reauthorization

Reauthorization: Documentation of a positive clinical response to therapy is required for continuation approval.

Authorization issued for 12 months.

Provider Actions and Authorization Processes

Prior Authorization

Prior Authorization Required

Prior authorization required for Zilxi; initial approval granted when there is a diagnosis of rosacea with inflammatory lesions. Authorization will be issued for 12 months.

Diagnosis: rosacea with inflammatory lesions
Initial authorization duration: 12 months

Step Therapy

Step Therapy / Supply Limits

Step Therapy and supply limits may be in place; specific step requirements are not detailed in this document. Providers should verify program-specific step therapy requirements and quantity/supply limits prior to prescribing.

Documentation Required

Program Automated Rules and Limits

UnitedHealthcare may approve initial and re-authorization based on claim/medication history, diagnosis codes (ICD-10) and/or claim logic. Use of automated approval and re-approval processes varies by program and/or therapeutic class.

Approvals may be granted using prior claim or medication history
Authorizations may be based on submitted diagnosis codes (ICD-10) and claim logic
Automated approval/re-approval processes vary by program and therapeutic class

Step	Requirement / notes
1
Step therapy may be required; specific step requirements are not specified in this document. Step Therapy and supply limits may be in place and program automated approval/re-approval rules may apply.

Definitions

Topical minocycline formulation approved for inflammatory lesions of rosacea in adults

Drug nameZilxi (topical minocycline)

FDA‑approved indicationTreatment of inflammatory lesions of rosacea in adults

Not evaluated forTreatment of infections (not indicated for infectious indications)

Formulation classTopical tetracycline‑class antibiotic (minocycline)

Background

Zilxi is an FDA-approved topical formulation of minocycline for the treatment of inflammatory lesions of rosacea in adults. The formulary decision and authorization rules in this policy apply specifically to this topical preparation; as noted in the FDA background, this formulation has not been evaluated for the treatment of infections.