CurrentCentenePolicy CP.PMN.225

Clinical Policy: Trifarotene (Aklief)

Defines medical necessity and prior authorization criteria for Aklief (trifarotene) topical cream for members aged 9 years and older across Centene lines of business, including initial and continued therapy requirements and limits.

Policy Summary

PayerCentene

PolicyTrifarotene (Aklief) topical therapy for acne vulgaris

Policy CodePolicy CP.PMN.225

Change TypeStep therapy bypass addedclarification

Effective DateMar 1, 2020

Next Review DateFeb 26, 2026

Key ActionSubmit documentation (office notes, labs, or clinical information) demonstrating member meets age, diagnosis, prior trial, and dosing criteria for prior authorization.

SourceLink

POLICY UPDATE CHANGES

Added step therapy bypass per IL HB 5395 for Illinois HIM requests such that the step therapy requirements do not apply as of 1/1/2026.

Clarified that prior authorization may be required for tretinoin within the step therapy alternatives.

≥9Minimum age for FDA indication/coverage

1 pump / 3 moDose limit

12 moApproval duration

0.005%Product strength

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Coverage Criteria

inv-01: Initial Therapy

Covered when ALL of the following are met:

Initial Therapy for Acne Vulgaris: 1. Diagnosis of acne vulgaris; 2. Age ≥ 9 years; 3. Failure of all of the following, unless all are contraindicated or clinically significant adverse effects are experienced: (a) generic formulary topical tretinoin; (b) generic formulary tazarotene; (c) generic formulary adapalene; 4. Dose does not exceed 1 pump every 3 months.

Prior authorization may be required for tretinoin; For Illinois HIM requests, the step therapy requirements do not apply as of 1/1/2026 per IL HB 5395. Approval duration: 12 months.

inv-02: Continuation Therapy

Covered when ALL of the following are met:

Continued Therapy for Acne Vulgaris: 1. Member meets one of the following: (a) currently receiving medication via Centene benefit or previously met initial approval criteria; or (b) member is currently receiving medication and is enrolled in a state and product with continuity of care regulations; 2. Member is responding positively to therapy; 3. Dose does not exceed 1 pump every 3 months.

Approval duration: 12 months.

Non-FDA approved indications that are not specifically addressed in this policy are not authorized unless the provider supplies sufficient documentation of efficacy and safety in accordance with applicable off‑label use policies (see related policies). Requests for such indications must include supporting clinical evidence to justify use outside the FDA‑approved acne vulgaris indication.

Use of Aklief (trifarotene) for indications that are not FDA‑approved and are not covered by this policy is considered not authorized / not medically necessary unless the request is supported by documentation meeting the referenced off‑label policies: CP.CPA.09 (Commercial), HIM.PA.154 (Health Insurance Marketplace), or CP.PMN.53 (Medicaid). Providers should follow those off‑label authorization procedures and submit clinical justification and evidence when requesting coverage for off‑label indications.

Coding and Product Availability

Product availability / NDCNDC

0.005% (30 g, 45 g, 75 g)

Product availability and pack sizes (NDCs not specified in document)

Dose limit

Dose limitMaximum 1 pump every 3 months.

Approval duration12 months for initial and continued therapy.

Continuation requirementDose must not exceed 1 pump every 3 months for renewals.

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization required for Aklief (trifarotene). Approval is granted when acne vulgaris criteria are met (including age, required prior topical retinoid trials or documented contraindications, and dosing limits).

Approval duration: 12 months
Dose limit: ≤ 1 pump every 3 months
Age: ≥ 9 years

Step Therapy

Topical Retinoid Step Therapy and Illinois HIM Bypass

Step therapy: Trial and failure of generic formulary topical tretinoin, tazarotene, and adapalene is required unless all are contraindicated or cause clinically significant adverse effects. Note: Prior authorization may be required for tretinoin. For Illinois HIM requests, the step therapy requirements do not apply per IL HB 5395 (effective 1/1/2026) — providers should reference state-specific bypass when submitting HIM requests.

Required trials: generic topical tretinoin, generic tazarotene, generic adapalene

Background

Trifarotene (Aklief) is a topical retinoid FDA‑approved for the treatment of acne vulgaris in patients aged 9 years and older. It is formulated as a 0.005% cream supplied in pump containers (30 g, 45 g, 75 g) and is typically applied once daily in the evening as a thin layer to affected areas.

Definitions

Aklief (trifarotene)

Agent & indicationAklief (trifarotene) — topical retinoid indicated for treatment of acne vulgaris in patients ≥ 9 years.

Strength & presentationCream (pump) 0.005% available in 30 g, 45 g, and 75 g pump sizes.

AdministrationApply a thin layer to affected areas once daily in the evening to clean, dry skin; one application per day.

Typical dosing limitationMaximum one application per day; overall policy dose limit: 1 pump every 3 months.