Subject: Rosacea Products PA 1486-A 08-2022

Drug

ROSACEA PRODUCTS

FINACEA  (azelaic acid)

MIRVASO  (brimonidine)

NORITATE  (metronidazole)

RHOFADE  (oxymetazoline)

SOOLANTRA  (ivermectin)

Policy:

FDA-approved Indications
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 (non-transient) 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
The requested drug will be covered with prior authorization when the following criteria are met:
      •     The patient has a diagnosis of rosacea

 

RATIONALE
The intent of the criteria is to provide coverage consistent with product labeling, FDA guidance, standards of medical practice, evidence-based drug information, and/or published guidelines. Finacea (azelaic acid) is indicated for topical treatment of the inflammatory papules and pustules of mild to moderate rosacea. Mirvaso (brimonidine) is indicated for the topical treatment of persistent (non-transient) facial erythema of rosacea in adults 18 years of age or older. Noritate is indicated for the topical treatment of inflammatory lesions and erythema of rosacea. Rhofade (oxymetazoline hydrochloride) is indicated for the topical treatment of persistent facial erythema associated with rosacea in adults. Soolantra (ivermectin) is indicated for the treatment of inflammatory lesions of rosacea.^1-6

 

Place of Service:

Outpatient

The above policy is based on the following references:

1. Finacea Gel [package insert]. Madison, NJ: LEO Pharma Inc.; November 2021.
2. Finacea Foam [package insert]. Madison, NJ: LEO Pharma Inc.; December 2020.
3. Mirvaso [package insert]. Fort Worth, TX: Galderma Laboratories, L.P.; August 2021.
4. Noritate [package insert]. Bridgewater, NJ: Bausch Health US, LLC; June 2020.
5. Rhofade [package insert]. Charleston, SC: EPI Health, LLC; November 2019.
6. Soolantra [package insert]. Fort Worth, TX: Galderma Laboratories, L.P.; July 2018.
7. Lexicomp Online, AHFS DI (Adult and Pediatric) Online, Hudson, Ohio: UpToDate, Inc.; 2022; Accessed June 27, 2022.
8. Micromedex (electronic version). IBM Watson Health, Greenwood Village, Colorado, USA. Available at: https://www.micromedexsolutions.com. Accessed June 27, 2022.

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.

December 10, 2022