CurrentCentenePolicy CP PMN.225

Clinical Policy: Trifarotene (Aklief)

Defines medical necessity and prior authorization criteria for coverage of topical trifarotene (Aklief) for treatment of acne vulgaris for Centene lines of business (Commercial, HIM, Medicaid) and describes continued therapy and formulary/off-label handling.

Policy Summary

PayerCentene

PolicyClinical Policy: Trifarotene (Aklief)

Policy CodePolicy CP PMN.225

Change TypeNo material change

Effective DateMar 1, 2020

Next Review DateFeb 25, 2025

Key ActionProvider must submit documentation (office chart notes, lab results or other clinical information) showing the member meets all approval criteria.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

9+minimum patient age

1 pump/3 momax dose limit

12 moapproval duration

0.005%product concentration

Comm, HIM, Medlines of business

Coverage Criteria

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Initial Therapy (Acne Vulgaris)

Covered when ALL of the following are met for Acne Vulgaris:

Acne Vulgaris initial therapy: 1) Diagnosis of acne vulgaris; 2) Age >= 9 years; 3) Failure of generic formulary topical tretinoin, tazarotene, and adapalene unless all are contraindicated or clinically significant adverse effects are experienced (prior authorization may be required for tretinoin); 4) Dose does not exceed 1 pump every 3 months.see node text

Approval duration: 12 months

Continuation Therapy

Continued therapy — Covered when ALL of the following are met:

Continued therapy: 1) Member is currently receiving medication via Centene benefit or member has previously met initial approval criteria or member is in a continuity-of-care scenario per state/product regulations; 2) Member is responding positively to therapy; 3) Dose does not exceed 1 pump every 3 months.see node text

Approval duration: 12 months

Non‑FDA approved indications for trifarotene (Aklief) are not covered under this policy unless the request includes sufficient documentation demonstrating efficacy and safety in the intended off‑label use. Such documentation must meet the requirements of the applicable off‑label use policies: CP.CPA.09 for Commercial, HIM.PA.154 for Health Insurance Marketplace, and CP.PMN.53 for Medicaid, or be supported by an evidence of coverage document.

Use of trifarotene (Aklief) for indications that are not FDA‑approved and that do not have supporting off‑label documentation per the referenced policies is considered not authorized for coverage. Requests for such indications may be denied if the required off‑label evidence or policy‑specific documentation is not provided.

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Requests must document failure of generic formulary topical tretinoin, tazarotene, and adapalene unless each is contraindicated or causes clinically significant adverse effects. Note: prior authorization may also be required for tretinoin.

Failure = inadequate response to an adequate trial of each agent
Exceptions allowed if documented contraindication or adverse reaction

Step Therapy

Step Therapy Requirement

Step therapy requires prior failure of generic formulary topical tretinoin, tazarotene, and adapalene unless contraindicated. Approval is contingent on documentation that these formulary alternatives were tried and failed.

Step therapy applies to treatment of acne vulgaris per criteria
Therapeutic alternatives listed in Appendix B (tretinoin, adapalene, tazarotene)

Documentation Required

Required Documentation

Provider must submit supporting documentation (for example, office chart notes, lab results, or other clinical information) showing the member has met all approval criteria, including trials of formulary topical tretinoin, tazarotene, and adapalene or documented contraindications.

Include dates, doses, duration, and clinical response for prior topical trials
Include documentation of contraindications or adverse effects if applicable

Denial Risk

Denial Triggers

Requests lacking documentation that the member meets all approval criteria, or requests for non-FDA–approved indications without sufficient supporting evidence (see off‑label use policies), may be denied.

Non‑FDA indications require sufficient supporting documentation per CP.CPA.09, HIM.PA.154, or CP.PMN.53 as applicable
Missing prior‑therapy documentation is a denial trigger

Background

Trifarotene (Aklief) is a topical retinoid approved by the FDA for the treatment of acne vulgaris in patients aged 9 years and older. The product is formulated as a cream pump at a concentration of 0.005%. The recommended dosing regimen is to apply a thin layer once daily in the evening to clean, dry affected areas, with a maximum of one application per day (policy limits further specify a dispensing threshold of 1 pump every 3 months for approval considerations).