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Medical Necessity Guidelines: Acne and Rosacea Medications
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Medical necessity and prior authorization criteria for topical and related medications used to treat acne vulgaris, rosacea, and select dermatologic conditions for Harvard Pilgrim Health Care members (excludes Medicare members). Applies to pharmacy and medical benefits where specified.
No material clinical or coverage changes in this revision.
Coverage Criteria
Product-specific medical necessity criteria
Covered when ALL of the following are met (per product-specific criteria below):
Systemic therapy considerations referenced in FDA indication text; Panretin is not indicated when systemic anti-KS therapy is required (e.g., >10 new KS lesions in prior month, symptomatic lymphedema, symptomatic pulmonary or visceral involvement).
Clindamycin/Benzoyl Peroxide
Covered when ALL of the following are met for clindamycin/benzoyl peroxide:
Erythromycin/Benzoyl Peroxide
Covered when ALL of the following are met for erythromycin/benzoyl peroxide:
Dapsone (Aczone)
Covered when ALL of the following are met for dapsone (Aczone 5% and 7.5% gel):
Ivermectin (Soolantra)
Covered when ALL of the following are met for ivermectin 1% cream (Soolantra):
Noritate (metronidazole) 1% cream
Covered when ALL of the following are met for Noritate (metronidazole) 1% cream:
Tazarotene
Covered when ANY of the following are met for tazarotene:
Tretinoin
Covered when ALL of the following are met for tretinoin:
This guideline does not apply to Medicare Members (includes dual eligible Members).
Products packaged as medicated swabs or in pump dispensers are noncovered when bulk packaging is available. In addition, these topical products will not be approved for cosmetic purposes.
Coverage designations vary by product and formulation. Certain agents and formulations are designated as Prior Authorization (PA), some carry a Quantity Limit (QL), and others require Step Therapy (STPA) as noted in the formulary listing. Examples include Finacea foam (PA), Azelex cream (PA; QL), many clindamycin-benzoyl peroxide combination gels (PA), and several tretinoin and tazarotene formulations that are PA or STPA. Requests that do not meet the specified prior-treatment or PA/step requirements will not be authorized.
Requests for brand-name products that have AB-rated generic equivalents will be reviewed under the plan's Brand Name criteria. Brand-name requests may be denied if the Brand Name criteria are not met.
Coding
Provider Actions and Administrative Requirements
Obtain prior authorization for many branded topical acne/rosacea products
Many topical acne and rosacea formulations require prior authorization. Examples listed in the formulary include branded products such as Finacea (azelaic acid 15% foam), Mirvaso (brimonidine gel), Soolantra (ivermectin 1% cream), Winlevi (clascoterone 1% cream), Panretin (alitretinoin 0.1% gel), and several tazarotene and tretinoin formulations — each designated PA where indicated in the product listing.
- Finacea 15% foam — Coverage = PA (azelaic acid products) [[see formulary]]
- Mirvaso (brimonidine 0.33% gel) — Coverage = PA
- Soolantra (ivermectin 1% cream) — Coverage = PA
- Winlevi (clascoterone 1% cream) — Coverage = PA
- Panretin (alitretinoin 0.1% gel) — Coverage = PA
- Multiple tazarotene and tretinoin formulations listed as PA
Require PA when step-therapy criteria or prior-treatment failures are specified
Prior authorization is required when the product’s criteria include step-therapy or prior treatment requirements. Requests must document that the member has failed or been intolerant to the specified prior therapies (and meet any age limits) before PA will be approved.
- Clindamycin/benzoyl peroxide and erythromycin/benzoyl peroxide require documented insufficient response to concurrent therapy with the individual components.
- Dapsone, ivermectin, tazarotene, and non-preferred tretinoin formulations require documented prior trials as specified in product criteria.
- Age-based PA rules apply for tretinoin (Members ≥26 years may have PA for preferred agents).
Follow step-therapy for specified vitamin A derivatives and tazarotene/tretinoin
Step therapy (STPA) is required for select vitamin A derivatives and tazarotene/tretinoin products as noted in the formulary; adapalene and tazarotene entries are marked STPA where indicated.
- Adapalene 0.1% (cream, gel, lotion) — Coverage = STPA*
- Tazarotene 0.05/0.1% (cream, gel) — Coverage = STPA*
- Tretinoin formulations have age- and formulation-specific STPA/PA designations per the listing
Document specific step-therapy failures for listed agents
Step therapy applies across multiple agents and must be documented per the product criteria. For combination products, failure of individual components is required before the combination will be covered.
- Clindamycin/benzoyl peroxide — insufficient response to concurrent therapy with clindamycin and prescription-strength benzoyl peroxide required.
- Erythromycin/benzoyl peroxide — inadequate response to concurrent erythromycin and prescription-strength benzoyl peroxide required.
- Dapsone (Aczone) — failure of at least two alternative topicals (benzoyl peroxide, erythromycin, clindamycin, sulfacetamide, sulfacetamide/sulfur).
- Ivermectin (Soolantra) — insufficient response to metronidazole plus one additional generic topical for rosacea.
- Non-preferred or brand tretinoin — trial of two preferred tretinoin formulations required.
Document diagnosis and prior treatment history per product criteria
Providers must document the member’s diagnosis and prior treatment history exactly as required by the product-specific criteria (including age where specified) to support a PA or step-therapy exception.
- Include documented diagnosis (e.g., rosacea, acne vulgaris, Kaposi's sarcoma) per the product criteria.
- Detail prior therapies tried, durations, and reasons for inadequate response or intolerance.
Support PA with prior-therapy details that match the criteria
When step or PA criteria require prior therapy, documentation must specifically show inadequate response to the named alternatives — for example, two preferred tretinoin formulations for non-preferred or brand tretinoin, or metronidazole plus one additional topical for ivermectin.
- Non-preferred or brand tretinoin — member had insufficient response to at least two preferred tretinoin formulations (generic tretinoin 0.025%, 0.05%, 0.1% cream; generic tretinoin 0.01%, 0.025% gel).
- Dapsone — insufficient response to at least two alternative topical products (listed).
- Ivermectin (Soolantra) — insufficient response to metronidazole and at least one additional generic topical.
Denial risk if all required criteria are not met
Requests may be denied if the member does not meet all stated criteria — all conditions listed in a product’s criteria must be satisfied for authorization to be granted.
- Authorization requires that ALL listed criteria for the product are met; missing required prior trials, age limits, or diagnosis documentation are grounds for denial.
Noncoverage for swabs/pump packaging and Brand Name review for AB-rated generics
Products packaged as medicated swabs or in pump dispensers are noncovered when bulk packaging is available; requests for brand-name products with AB-rated generics will be reviewed under Brand Name criteria and may be denied if Brand Name criteria are not met.
- Medicated swabs or pump-dispensed products are noncovered when equivalent bulk packaging exists.
- Brand-name products with AB-rated generics are subject to Brand Name review and may be denied if criteria are not satisfied.
Background
This guideline lists FDA‑approved topical medications used to treat acne vulgaris, rosacea, topical tazarotene for plaque psoriasis and other dermatologic indications (for example, Panretin for Kaposi's sarcoma). Coverage determinations are tied to the documented diagnosis and specified prior-therapy or age limits for each product.
Definitions and Preferred Formulations
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