Cigna National Formulary Coverage Policy

Prior Authorization Topical Retinoid – Tretinoin Products

Table of Contents Product Identifier(s)

National Formulary Medical Necessity ...... 1 00006 Conditions Not Covered...... 2 Background ...... 2 References ...... 2 Revision History ...... 3

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.

National Formulary Medical Necessity

Drugs Affected • Altreno™ (tretinoin lotion) • Atralin™ (tretinoin gel) • Avita® (tretinoin cream, gel – generic [Avita gel 0.025% is brand only]) • Retin-A® (tretinoin cream, gel – generic) • Retin-A® Micro® (tretinoin gel microsphere – generic) • Retin-A Micro® Pump (tretinoin gel microsphere – generic [Retin-A Micro gel 0.06% and 0.08% are branded products only]) • Tretin-X® (tretinoin cream) • Veltin™ (clindamycin phosphate 1.2% and tretinoin 0.025% gel) • Ziana® (clindamycin phosphate 1.2% and tretinoin 0.025% gel – generic)

Cigna covers topical tretinoin products as medically necessary when the following criteria are met for FDA Indications or Other Uses with Supportive Evidence:

Page 1 of 3 Cigna National Formulary Coverage Policy: PA Topical Retinoid – Tretinoin Products Prior Authorization is recommended for prescription benefit coverage of topical tretinoin products. All approvals are provided for the duration noted below.

I. Coverage of topical tretinoin products is recommended in those who meet the following criteria:

FDA Indication(s)

1. Acne Vulgaris. Approve for 3 years.

Other Uses with Supportive Evidence

2. Treatment of Other Non-Cosmetic Conditions. Approve for 1 year. Note: Examples of other non-cosmetic conditions include acne rosacea, /treatment of precancerous lesions, ichthyosis, diabetic foot ulcers, mucositis, warts, lichen planus, lichen sclerosis, pseudofolliculitis, oral leukoplakia, molluscum contagiosum, Darier’s disease (keratosis follicularis), dermatitis/eczema, folliculitis, keratosis pilaris, basal cell carcinoma (skin cancer), confluent and reticulated papillomatosis, and .

II. Coverage of clindamycin plus tretinoin combination products (Ziana, generic; Veltin) is recommended in those who meet the following criteria:

FDA Indication(s)

1. Acne Vulgaris. Approve for 1 year.

Conditions Not Covered

Topical tretinoin products and topical clindamycin/tretinoin products is considered experimental, investigational or unproven for ANY other use including the following (this list may not be all inclusive):

1. Cosmetic Conditions. Cosmetic use is not recommended for coverage as this indication is excluded from coverage in a typical pharmacy benefit. Note: Examples of cosmetic conditions include liver spots, stretch marks, scarring, solar elastosis, premature aging, treatment of photo-aged or photo-damaged skin, solar lentigines, skin roughness, mottled , age spots, wrinkles, geographic tongue, hyperpigmentation (caused by folliculitis, acne, or eczema), /cholasma, alopecia androgenetic, alopecia areata, seborrheic keratosis, milia, nevus, (of Civatte), purpura (actinic/solar), keloids, and sebaceous hyperplasia.

Background

Overview All of the single-entity and combination topical tretinoin products in this policy are indicated for the topical treatment of acne vulgaris.1,2

Topical tretinoin products have been used to treat numerous other medical skin conditions in addition to acne vulgaris.1,2 Some indications have minimal published clinical data and thus appear experimental. Topical tretinoin 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.2

References

1. Facts and Comparisons Online. Wolters Kluwer Health, Inc.; 2020. Available at: http://online.factsandcomparisons.com/login.aspx?url=/index.aspx&qs=. Accessed on July 27, 2021. Search term: tretinoin.

Page 2 of 3 Cigna National Formulary Coverage Policy: PA Topical Retinoid – Tretinoin Products 2. DRUGDEX® System. Thomson Reuters (Healthcare) Inc. Available at: http://www.micromedexsolutions.com/micromedex2/librarian/. Accessed on July 27, 2021. Search term: tretinoin.

Revision History

Type of Summary of Changes Approval Date Revision Annual revision No criteria changes. 08/04/2021

“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.

Page 3 of 3 Cigna National Formulary Coverage Policy: PA Topical Retinoid – Tretinoin Products