Acne and Rosacea Medications

Coverage Summary

These Pharmacy Medical Necessity Guidelines provide coverage criteria for topical and related medications used to treat acne, rosacea, Kaposi's sarcoma and certain related dermatologic conditions, and are intended to guide prior authorization (PA) and utilization management decisions for non‑Medicare members. The policy status is mixed and current as of 2025-08-12 (effective and last reviewed on 2025-08-12).

At-a-glance

Products with PA designationMultiple

Quantity limits (Azelex)1 (Azelex 20% cream: 30 grams per fill)

Products with step therapy (STPA) noted1

CPT/HCPCS/ICD-10 codes listed0

Product-specific Clinical Criteria

General coverage rule

The plan may authorize coverage of products used for acne and rosacea for Members, when ALL of the following criteria are met:

ALL of the following

Member is not a Medicare Member (guideline does not apply to Medicare Members, including dual eligible Members)

Adapalene (nonpreferred indication)

Coverage when ALL of the following are met:

ALL of the following

The Member had an insufficient response to therapy with tretinoin

Alitretinoin (Panretin)

Coverage when ALL of the following are met:

ALL of the following

Documented diagnosis of AIDS-related Kaposi's sarcoma
Documentation the Member does not require systemic anti-Kaposi's sarcoma therapy

Azelaic Acid Foam (Finacea)

Coverage when ALL of the following are met:

ALL of the following

Documented diagnosis of rosacea
An inadequate response or intolerance to generic metronidazole gel and at least one additional generic topical agent used for the treatment of rosacea

Azelaic Acid Cream (Azelex)

Coverage when ALL of the following are met:

ALL of the following

Documented diagnosis of acne
An inadequate response to therapy with tretinoin

Benzoyl peroxide (nonpreferred products)

Coverage when ALL of the following are met:

ALL of the following

The Member had an insufficient response to therapy with two of the preferred benzoyl peroxide products

Brimonidine Gel (Mirvaso)

Coverage when ALL of the following are met:

ALL of the following

The Member is at least 18 years of age with the diagnosis of persistent (nontransient) erythema of rosacea
The Member had an insufficient response to at least two alternative generic topical products (e.g., metronidazole, sulfacetamide, retinoid, clindamycin)

Clascoterone Cream (Winlevi)

Coverage when ALL of the following are met:

ALL of the following

The Member has a diagnosis of acne vulgaris
AND
- The Member has had an inadequate response or intolerance to two of the listed agents
- OR the Member has a contraindication to all of the listed agents
Listed agents: a. Spironolactone; b. Topical antibiotic (e.g., clindamycin, erythromycin); c. Oral tetracycline (e.g., minocycline, doxycycline); d. Retinoic acid derivative (e.g., tretinoin, adapalene, isotretinoin); e. Benzoyl peroxide

Clindamycin Foam

Coverage when ALL of the following are met:

ALL of the following

The Member has had an inadequate response to therapy with two preferred topical clindamycin formulations

Clindamycin/Benzoyl Peroxide combination

Coverage when ALL of the following are met:

ALL of the following

The Member had an insufficient response to concurrent therapy with the individual topical ingredients, clindamycin and prescription-strength benzoyl peroxide
The request is for a generic (AB-rated) formulation

Erythromycin/Benzoyl Peroxide combination

Coverage when ALL of the following are met:

ALL of the following

The Member has had an inadequate response to concurrent therapy with the individual topical ingredients, erythromycin and prescription-strength benzoyl peroxide
The request is for a generic (AB-rated) formulation

Dapsone (Aczone)

Coverage when ALL of the following are met:

ALL of the following

The Member had an insufficient response to therapy with at least two alternative topical products: benzoyl peroxide, erythromycin, clindamycin, sulfacetamide or sulfacetamide/sulfur

Ivermectin 1% cream (Soolantra)

Coverage when ALL of the following are met:

ALL of the following

The Member had an insufficient response to therapy with metronidazole and at least one additional generic topical agent used for the treatment of rosacea

Noritate (metronidazole) 1% cream

Coverage when ALL of the following are met:

ALL of the following

The Member had an insufficient response to therapy with metronidazole 0.75% cream, gel or lotion
The Member had an insufficient response to therapy with generic metronidazole 1% gel

Tazarotene

Coverage when ANY of the following are met:

ANY of the following

The Member had an insufficient response to therapy with tretinoin
The request is for an alternative dermatological inflammatory condition, such as plaque psoriasis

Tretinoin (applies to nonpreferred agents for all Members and preferred agents for Members 26+)

Coverage when ALL of the following are met:

ALL of the following

The request is for the treatment of acne, rosacea, cutaneous carcinoma, keratosis follicularis or verruca plana (flat warts)
ANY of the following
- If the request is for a non-preferred formulation or a brand-name product: Member had an insufficient response to therapy with at least two preferred tretinoin formulations (preferred include generic tretinoin 0.025%, 0.05% and 0.1% cream, and generic tretinoin 0.01% and 0.025% gel)
- The Member is 12 years of age or older

Provider Actions & Administrative Requirements

Prior Authorization

Prior authorization required for specific listed products

Prior authorization (PA) is required for many branded and certain non-preferred topical acne/rosacea products as indicated in product coverage lines (PA, QL, STPA designations); providers must submit documentation of prior therapies/intolerance/contraindications as specified per-product.

Documentation Required

Therapy failure/intolerance documentation

For product-specific approvals, providers must document inadequate response or intolerance to specified prior therapies (e.g., trials of specified generic/topical agents, two preferred formulations, or systemic therapy exclusions for Panretin).

Coding

Codesmixed

No codes listed

Background and Scope

These guidelines are intended to establish clinical coverage criteria for topical and related dermatologic medications based on FDA‑approved indications, formulary status, and prior therapy requirements (step therapy) to inform PA and utilization management determinations. Covered conditions specifically include acne vulgaris, rosacea (including persistent erythema and inflammatory lesions), and cutaneous lesions of AIDS‑related Kaposi's sarcoma; product‑specific criteria reference FDA indications and require documentation of prior treatment failures, intolerances, or contraindications for many agents.

The guideline does not apply to Medicare Members (including dual eligible Members) and is used to guide plan coverage decisions on a case‑by‑case basis. The document history notes prior substantive changes (for example, August 8, 2023: Winlevi/clascoterone criteria revised to require step through with two agents or documented contraindications) and administrative updates (August 13, 2024: fax number change); the policy was reviewed August 12, 2025 with no changes.

Definitions: PA = Prior Authorization; QL = Quantity Limit; STPA = Step Therapy Required.

Revision History

2023-08-08material_change

August 8, 2023: Clinical coverage requirement added for clascoterone (Winlevi). Winlevi criteria updated to require step through with two agents or a contraindication to all step-through agents; effective November 1, 2023.

2024-08-13administrative_update

August 13, 2024: Administrative change to fax number (non-clinical administrative update).

2025-08-12policy_reviewLatest

August 12, 2025: Policy reviewed; no changes.