Subject: Rosacea Products PA 1486-A P07-2025

Drug

EMROSI  (minocycline hydrochloride extended-release)

FINACEA  (azelaic acid)

MIRVASO  (brimonidine)

NORITATE  (metronidazole)

RHOFADE  (metronidazole)

SOOLNTRA  (ivermectin)

Policy:

Indications

FDA-approved Indications

Emrosi

Emrosi (minocycline hydrochloride extended-release) is indicated to treat inflammatory lesions (papules and pustules) of rosacea in adults.

 

Limitation of Use

• This formulation of minocycline has not been evaluated in the treatment or prevention of infections.
• To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, use Emrosi only as indicated.

Finacea Gel

Finacea Gel, 15% is indicated for topical treatment of the inflammatory papules and pustules of mild to moderate rosacea.

Limitations of Use

Although some reduction of erythema which was present in patients with papules and pustules of rosacea occurred in clinical studies, efficacy for treatment of erythema in rosacea in the absence of papules and pustules has not been evaluated.

Finacea Foam

Finacea Foam, 15% is indicated for topical treatment of the inflammatory papules and pustules of mild to moderate rosacea.

Mirvaso

Mirvaso (brimonidine) topical gel, 0.33% is an alpha adrenergic agonist indicated for the topical treatment of persistent (nontransient) erythema of rosacea in adults 18 years of age or older.

Noritate

Noritate is indicated for the topical treatment of inflammatory lesions and erythema of rosacea.

Rhofade

Rhofade (oxymetazoline hydrochloride) cream, 1% is indicated for the topical treatment of persistent facial erythema associated with rosacea in adults.

Soolantra

Soolantra cream is indicated for the treatment of inflammatory lesions of rosacea.

Coverage Criteria

Rosacea

Authorization may be granted for the requested drug when the patient has a diagnosis of rosacea.

Continuation of Therapy

Rosacea

Authorization may be granted for the requested drug when the patient has a diagnosis of rosacea and the following criteria is met:

• The patient has experienced a reduction in symptoms of rosacea from baseline (e.g., inflammatory papules or pustules, facial erythema).

Duration of Approval (DOA)

• 1486-A:
  • Emrosi: Initial therapy DOA: 4 months; Continuation of therapy DOA: 12 months
  • Finacea, Mirvaso, Noritate, Rhofade, Soolantra: Initial therapy DOA: 4 months; Continuation of therapy DOA: 36 months

Place of Service:

Outpatient

The above policy is based on the following references:

1. Emrosi [package insert]. Scottsdale, AZ: Journey Medical Corporation; November 2024.
2. Finacea Gel [package insert]. Madison, NJ: LEO Pharma Inc.; November 2021.
3. Finacea Foam [package insert]. Madison, NJ: LEO Pharma Inc.; December 2020.
4. Mirvaso [package insert]. Fort Worth, TX: Galderma Laboratories, L.P.; December 2022.
5. Noritate [package insert]. Bridgewater, NJ: Bausch Health US, LLC; June 2020.
6. Rhofade [package insert]. Raleigh, NC: Mayne Pharma, LLC; October 2023.
7. Soolantra [package insert]. Fort Worth, TX: Galderma Laboratories, L.P.; October 2022.
8. Lexicomp Online, AHFS DI (Adult and Pediatric) Online. Waltham, MA: UpToDate, Inc.; 2025. https://online.lexi.com. Accessed June 11, 2025.
9. Micromedex® (electronic version). Merative, Ann Arbor, Michigan, USA. Available at: https://www.micromedexsolutions.com/ (cited: 06/11/2025).
10. Thiboutot D, Anderson R, Cook-Bolden F, et al. Standard management options for rosacea: The 2019 update by the National Rosacea Society Expert Committee. J Am Acad Dermatol. 2020 Jun;82(6):1501-1510. doi: 10.1016/j.jaad.2020.01.077.

Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

October 11, 2025