Drug and Biologic Coverage Policy

Effective Date ...... 9/1/2021 Next Review Date… ...... 9/1/2022 Coverage Policy Number ...... IP0180

Topical Trifarotene

Table of Contents Related Coverage Resources

Overview ...... 1 Topical Adapalene Products – (IP0181) Medical Necessity Criteria ...... 1 Clascoterone – (IP0173) Reauthorization Criteria ...... 2 Topical Acne – Non-Retinoid Products (IP0166) Authorization Duration ...... 2 Topical Tretinoin Products - (IP0167) Conditions Not Covered...... 2 Topical Azelaic Acid Products – (IP0172) Background ...... 2 Topical Rosacea Products – (IP0003) References ...... 3 Topical Tazarotene Products – (IP0174)

INSTRUCTIONS FOR USE The following Coverage Policy applies to health benefit plans administered by Cigna Companies. Certain Cigna Companies and/or lines of business only provide utilization review services to clients and do not make coverage determinations. References to standard benefit plan language and coverage determinations do not apply to those clients. Coverage Policies are intended to provide guidance in interpreting certain standard benefit plans administered by Cigna Companies. Please note, the terms of a customer’s particular benefit plan document [Group Service Agreement, Evidence of Coverage, Certificate of Coverage, Summary Plan Description (SPD) or similar plan document] may differ significantly from the standard benefit plans upon which these Coverage Policies are based. For example, a customer’s benefit plan document may contain a specific exclusion related to a topic addressed in a Coverage Policy. In the event of a conflict, a customer’s benefit plan document always supersedes the information in the Coverage Policies. In the absence of a controlling federal or state coverage mandate, benefits are ultimately determined by the terms of the applicable benefit plan document. Coverage determinations in each specific instance require consideration of 1) the terms of the applicable benefit plan document in effect on the date of service; 2) any applicable laws/regulations; 3) any relevant collateral source materials including Coverage Policies and; 4) the specific facts of the particular situation. Coverage Policies relate exclusively to the administration of health benefit plans. Coverage Policies are not recommendations for treatment and should never be used as treatment guidelines. In certain markets, delegated vendor guidelines may be used to support medical necessity and other coverage determinations.

Overview

This policy supports medical necessity review for Aklief® (trifarotene) 0.005% cream.

Medical Necessity Criteria

Trifarotene (Aklief) is considered medically necessary when the following are met:

1. Diagnosis of acne vulgaris.

Coverage for trifarotene cream varies across plans and may require the use of preferred products. Refer to the customer’s benefit plan document for coverage details.

Non-covered drugs are considered medically necessary when there is documentation of ONE of the following:

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A. The individual has had inadequate efficacy to the number of covered alternatives according to the table below

OR

B. The individual has a contraindication according to FDA label, significant intolerance, or is not a candidate* for the covered alternatives according to the table below

*Note: Not a candidate due to being subject to a warning per the prescribing information (labeling), having a disease characteristic, individual clinical factor[s], other attributes/conditions, or is unable to administer and requires this dosage formulation)

Employer Group Non-Covered Products and Preferred Covered Alternatives by Drug List: Non-Covered Standard / Value / Cigna Total Legacy Product Performance Advantage Savings

Aklief (trifarotene) ALL of the following: Non-Preferred 0.005% cream • tazarotene 0.1% cream Brand • adapalene* (0.1% cream, 0.3% gel or 0.1% lotion) • tretinoin* (cream [0.025%, 0.05% or 0.1%], gel [0.01%, 0.025% or 0.05%] or micro gel [0.04% or 0.1%])

*Age 46 years or more may require prior authorization. ±Where applicable, documentation that individual has tried the bioequivalent generic product AND cannot take due to a formulation difference in the inactive ingredient(s) [for example, difference in dyes, fillers, preservatives] between the brand and the bioequivalent generic product which, per the prescribing physician, would result in a significant allergy or serious adverse reaction

When coverage is available and medically necessary, the dosage, frequency, duration of therapy, and site of care should be reasonable, clinically appropriate, and supported by evidence-based literature and adjusted based upon severity, alternative available treatments, and previous response to therapy.

Note: Receipt of sample product does not satisfy any criteria requirements for coverage.

Reauthorization Criteria

Trifarotene cream is considered medically necessary for continued use when initial criteria are met AND there is documentation of beneficial response.

Authorization Duration

Initial approval duration is up to 12 months.

Reauthorization approval duration is up to 12 months.

Conditions Not Covered

Trifarotene cream is considered not medically necessary for ANY other use.

Background

OVERVIEW Aklief, a topical retinoid, is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older.

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Aklief has not been added to the guidelines. Topical retinoids are effective for the treatment of acne, both as initial and maintenance therapy. Treatment algorithms and consensus statements do not differentiate between the topical retinoids, but rather refer to them as a therapeutic category.2-5

Topical retinoid products (e.g., tretinoin) have been used to treat numerous other medical skin conditions in addition to acne vulgaris.6 Some indications have minimal published clinical data and thus appear experimental. Topical retinoid products have also been used to treat a variety of cosmetic skin conditions, such as wrinkles, stretch marks, liver spots, premature aging, and photo-aged or photo-damaged skin.

References

1. Aklief® cream [prescribing information]. Fort Worth, TX: Galderma Laboratories; October, 2019. 2. Thiboutot D, Gollnick H, Bettoli, et al. New insights into the management of acne: an update from the Global Alliance to Improve Outcomes in Acne Group. J Am Acad Dermatol. 2009;60:S1-S50. 3. Strauss JS, Krowchuk DP, Leyden JJ, et al. Guidelines of care for acne vulgaris management. J Am Acad Dermatol. 2007;56:651-653. 4. Zaenglein AL, Pathy AL, Schlosser BJ, et al. Guidelines of care for the management of acne vulgaris. J Am Acad Dermatol. 2016;74:945-973. 5. Titus S, Hodge J. Diagnosis and treatment of acne. Am Fam Physician. 2012;86:734-740.

“Cigna Companies” refers to operating subsidiaries of Cigna Corporation. All products and services are provided exclusively by or through such operating subsidiaries, including Cigna Health and Life Insurance Company, Connecticut General Life Insurance Company, Cigna Behavioral Health, Inc., Cigna Health Management, Inc., QualCare, Inc., and HMO or service company subsidiaries of Cigna Health Corporation. The Cigna name, logo, and other Cigna marks are owned by Cigna Intellectual Property, Inc. © 2021 Cigna.

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