CurrentCignaPolicy N/A

POLICY: Topical Medications for Inflammatory Rosacea Step Therapy Policy

Defines step therapy requirements for coverage of topical agents indicated for inflammatory rosacea (metronidazole formulations, azelaic acid, ivermectin, Epsolay, Zilxi, and related branded/generic products) for Cigna-administered health benefit plans. Applies when a Step 2 product is requested and details required Step 1 trial(s) and exceptions.

Policy Summary

PayerCigna

PolicyPOLICY: Topical Medications for Inflammatory Rosacea Step Therapy Policy

Policy CodePolicy N/A

Change TypeAnnual revisions - no criteria changes; product list update (brand obsolete)

Effective Date

Next Review Date

Key ActionPrior authorization for any Step 2 product requires documentation of a trial of one Step 1 product; approvals are for 1 year.

SourceLink

POLICY UPDATE CHANGES

Annual revisions noted with 'No criteria changes' (reviews on 03/06/2024, 03/05/2025, 01/14/2026).

Finacea gel brand marked as obsolete 12/31/2023 in product list.

2Step Levels (Step 1 & Step 2)

11Products listed

1 yearApproval duration for authorizations

Coverage Summary

Defines step therapy requirements for topical agents indicated for inflammatory rosacea. Covered agents include topical metronidazole, azelaic acid, ivermectin, benzoyl peroxide (Epsolay), and minocycline foam (Zilxi). Coverage stance: covered_with_criteria. Approvals are provided for 1 year.

Initial / Step Therapy Criteria (Step 2 products)

Step Therapy Criteria (Initial Coverage for Step 2 Products)

Step 2 products are covered as medically necessary when the following Step Therapy criteria are met. All approvals are for 1 year.

ALL of the following

ALL of the following
- Patient has tried one Step 1 Product prior to approval of a Step 2 Product.
- If the Step Therapy rule is not met at point of service, coverage will be determined by the Step Therapy criteria below (i.e., requirement above).
- Soolantra DAW allowance: Soolantra with DAW 9 (indicating substitution is allowed by prescriber but Plan requests brand) will count as a Step 1 Product.

Continuation Therapy

All approvals are for 1 year. Renewal should follow the same criteria as initial approvals and requires documentation of ongoing benefit or adherence to the Step Therapy requirements (i.e., documented trial of one Step 1 product) for continued coverage.

Applicable Products / Code Groups

Step 2 Products (require prior Step 1 trial)mixedCovered

Epsolay	benzoyl peroxide 5% cream (Step 2)
Finacea foam	azelaic acid 15% aerosol foam (Step 2)
Finacea gel	azelaic acid 15% gel (brand/generic) (Step 2)
MetroCream	metronidazole 0.75% cream (Step 2)
MetroGel	metronidazole 1% gel (Step 2)
MetroLotion	metronidazole 0.75% lotion (Step 2)
Noritate cream	metronidazole 1% cream (Step 2)
Rosadan Cream Kit	Rosadan cream + Rehyla Wash kit (Step 2 - listed under Step 2 kits)
Rosadan Gel Kit	Rosadan gel + Rehyla Wash kit (Step 2 - listed under Step 2 kits)
Soolantra	ivermectin 1% cream (Step 2)

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Provider Actions & Prior Authorization

Prior Authorization

Step therapy prior authorization requirement for Step 2 products

Prior authorization/coverage for any Step 2 product requires documentation of a trial of one Step 1 product prior to approval; approvals provided for 1 year. See Step 1 and Step 2 product lists.

See Step 1 and Step 2 product lists

Documentation Required

Documentation of Step 1 trial

Provider must document that the patient tried one Step 1 product (including Soolantra with DAW 9 counting as a Step 1 product) before approving a Step 2 product.

Soolantra with DAW 9 counts as Step 1

Denial Risk

Denial if step not met

If the Step Therapy rule (trial of one Step 1 product) is not met at point of service, coverage will be determined by the Step Therapy criteria and may be denied as not medically necessary.

Clinical Evidence & Guidance

Guideline sources cited: AARS 2019 update and the ROSCO consensus (2017, updated 2019). The policy aligns with guideline recommendations noting first-line therapies for mild-to-moderate inflammatory papules/pustules include topical azelaic acid, topical ivermectin, topical metronidazole, and oral doxycycline; severe disease recommendations include topical ivermectin, oral doxycycline, and oral isotretinoin. The policy supports use of Step 1 generic/topical agents before Step 2 products and provides 1-year approvals.

Background

Topical metronidazole, topical azelaic acid, topical ivermectin, benzoyl peroxide (Epsolay), and minocycline foam (Zilxi) are indicated for treatment of inflammatory rosacea. Guidelines recommend topical azelaic acid, topical ivermectin, and topical metronidazole as first-line options for mild-to-moderate inflammatory papules/pustules, with oral doxycycline recommended depending on severity. Note: the Finacea gel brand is marked obsolete (12/31/2023) in the product listing but the azelaic acid formulations remain listed.

Definitions & Stats

DAW 9 definitionDispense as written: substitution allowed by prescriber but Plan requests brand; counts as Step 1 when used with Soolantra.

Step Levels2 (Step 1 & Step 2)

Products listed11

Approval duration1 year

Revision History

2023-12-31product_obsolete

Finacea gel brand marked as obsolete 12/31/2023 in product list.

2024-03-06annual_revision

Annual revisions noted with No criteria changes

2025-03-05annual_revision

Annual revisions noted with No criteria changes

2026-01-14annual_revisionLatest

Annual revisions noted with No criteria changes

Policy Summary

PayerCigna

PolicyPOLICY: Topical Medications for Inflammatory Rosacea Step Therapy Policy

Policy CodePolicy N/A

Change TypeAnnual revisions - no criteria changes; product list update (brand obsolete)

Effective Date

Next Review Date

Key ActionPrior authorization for any Step 2 product requires documentation of a trial of one Step 1 product; approvals are for 1 year.

SourceLink

On This Page

OpenPayer

POLICY: Topical Medications for Inflammatory Rosacea Step Therapy Policy

Coverage Summary

Initial / Step Therapy Criteria (Step 2 products)

Continuation Therapy

Exclusions / Not Covered (if any)

Applicable Products / Code Groups

Provider Actions & Prior Authorization

Clinical Evidence & Guidance

Background

Revision History