CurrentCignaPolicy IP0180

Aklief (trifarotene cream) — topical acne vulgaris

Cigna coverage policy for Aklief (trifarotene cream) for treatment of acne vulgaris in patients aged 9 years and older; describes medical necessity criteria and preferred product step requirements for employer and individual/family plans.

Policy Summary

PayerCigna

PolicyAklief (trifarotene cream) — topical acne vulgaris

Policy CodePolicy IP0180

Change TypeClarified prior therapy requirementsadded IFP

Effective DateApr 1, 2025

Next Review Date

Key ActionObtain prior authorization with prescriber attestation that the patient is ≥ 9 years old and has tried — and per prescriber experienced inadequate efficacy or significant intolerance to — topical adapalene, tazarotene, and tretinoin.

SourceLink

POLICY UPDATE CHANGES

Preferred product requirements were updated to specify that the patient has tried, and according to the prescriber, experienced inadequate efficacy or significant intolerance with ALL the listed topical agents (adapalene, tazarotene, tretinoin).

Individual and Family Plans (IFP) were added to the policy.

≥ 9 yearsminimum patient age for indication

1 yearinitial approval duration

3 agentsrequired prior topical therapies

IP0180

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Coverage Criteria

Initial Therapy — Covered when ALL of the following are met

Covered when ALL of the following are met:

FDA indication and approval duration: Patient is >= 9 years of age AND diagnosis is acne vulgaris; approve for 1 year.

from FDA‑approved indication (Coverage Policy Number: IP0180)

Preferred product prior therapy (Employer Plans): Patient has tried, and according to the prescriber, experienced inadequate efficacy or significant intolerance with ALL the following: (A) a topical adapalene product; AND (B) a topical tazarotene product; AND (C) a topical tretinoin product.

Examples: adapalene (Differin), tazarotene (Tazorac, Arazlo, Fabior), tretinoin (Retin‑A, Altreno, etc.)

Preferred product prior therapy (Individual and Family Plans): Patient has tried, and according to the prescriber, experienced inadequate efficacy or significant intolerance with ALL the following: (A) a topical adapalene product; AND (B) a topical tazarotene product; AND (C) a topical tretinoin product.

Examples listed in policy

Any use of Aklief (trifarotene cream) other than for the treatment of acne vulgaris is considered experimental, investigational, or unproven and may be denied.

Initial Therapy

Initial Therapy — initial coverage criteria for Aklief (top-level criteria group)

Initial coverage criteria for Aklief

Age: Patient is >= 9 years of age.

FDA‑approved indication; approve for 1 year if met

Prior topical therapy: Patient has tried, and according to the prescriber, experienced inadequate efficacy or significant intolerance with a topical adapalene product AND a topical tazarotene product AND a topical tretinoin product.

Examples provided in policy for each class; receipt of sample does not satisfy criteria

Continuation Therapy

Continuation Therapy — continuation of therapy criteria

Continuation of therapy

Continuation/renewal: Renewal may be approved consistent with initial criteria; duration initially approved up to 1 year and may be adjusted based on clinical response and tolerability.

Approve for 1 year per FDA‑approved indication; adjust based on response

Provider Actions & Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Approvals may be granted for up to 1 year for treatment of acne vulgaris in patients aged ≥ 9 years who meet the preferred product criteria.

Approval duration: up to 1 year
Age requirement: ≥ 9 years

Step Therapy

Step Therapy Required

Step therapy (trial of preferred topical agents) is required prior to coverage of Aklief (trifarotene cream). The patient must have tried — and per the prescriber experienced inadequate efficacy or significant intolerance with — ALL three of the following topical agents:

Topical adapalene product (e.g., Differin)
Topical tazarotene product (e.g., Tazorac, Arazlo, Fabior)
Topical tretinoin product (e.g., Retin-A, Retin-A Micro, Altreno, Atralin, Avita)

Step Therapy Details

Required prior topical therapies
Patient has tried, and according to the prescriber, experienced inadequate efficacy or significant intolerance with ALL the following: (A) a topical adapalene product (e.g., Differin, adapalene); AND (B) a topical tazarotene product (e.g., Tazorac, Arazlo, Fabior); AND (C) a topical tretinoin product (e.g., Retin-A, Retin-A Micro, tretinoin, Altreno, Atralin, Avita).

Definitions & Preferred Product Criteria

Preferred product criteria

Required prior topical therapiesPatient must have tried, and according to the prescriber, experienced inadequate efficacy or significant intolerance with ALL the following: a topical adapalene product; a topical tazarotene product; and a topical tretinoin product (examples listed in policy).

Examples of adapalene productsDifferin, adapalene (policy examples).

Examples of tazarotene productsTazorac, tazarotene, Arazlo, Fabior (policy examples).

Examples of tretinoin productsRetin-A, Retin-A Micro, tretinoin, Altreno, Atralin, Avita (policy examples).

Age requirementPatient is ≥ 9 years of age (FDA‑approved indication).

Background

Aklief (trifarotene) is a topical retinoid indicated for the topical treatment of acne vulgaris in patients aged ≥ 9 years. Treatment decisions should consider disease severity, alternative therapies, prior response, and tolerability; when medically necessary and criteria are met, coverage may be approved for up to 1 year.

Aklief is positioned as a topical retinoid option within acne management and is subject to prior authorization and step-therapy requirements per plan: approval requires documentation that the patient meets age and indication criteria and, for many plans, that prior topical retinoid therapies have been tried as specified in the policy.