Subject: Acne Products Topical ST, Post PA 1493-D P08-2024_R

Drug

Acne Products Topical (Brand Only)

ACANYA  (clindamycin phosphate-benzoyl peroxide)

ACZONE  (dapsone)

AMZEEQ  (minocycline)

CLEOCIN-T  (clindamycin phosphate)

CLINDACIN ETZ  (clindamycin phosphate)

CLINDACIN-P  (clindamycin phosphate)

CLINDAGEL  (clindamycin phosphate)

EVOCLIN  (clindamycin phosphate)

KLARON  (sulfacetamide sodium)

NEUAC  (clindamycin phosphate-benzoyl peroxide)

ONEXTON  (clindamycin phosphate-benzoyl peroxide)

Policy:

Indications

FDA-approved Indications

Acanya
Acanya Gel is indicated for the topical treatment of acne vulgaris in patients 12 years or older.

Aczone
Aczone Gel, 5%, is indicated for the topical treatment of acne vulgaris.

Aczone (dapsone) Gel, 7.5%, is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older.

Amzeeq
Amzeeq is indicated for the topical treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in adults and pediatric patients 9 years of age and older.
Limitations of Use
This formulation of minocycline has not been evaluated in the treatment of infections. To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, Amzeeq should be used only as indicated.

Cleocin-T, Clindacin-P, Clindagel
Clindamycin phosphate products are indicated in the treatment of acne vulgaris. In view of the potential for diarrhea, bloody diarrhea and pseudomembranous colitis, the physician should consider whether other agents are more appropriate.

Evoclin
Evoclin Foam is indicated for topical application in the treatment of acne vulgaris in patients 12 years and older.

Klaron
Klaron is indicated in the topical treatment of acne vulgaris.

Neuac
Neuac (clindamycin phosphate and benzoyl peroxide) Gel, 1.2%/5% is indicated for the topical treatment of inflammatory acne vulgaris in patients 12 years and older.
Limitations of Use
Neuac (clindamycin phosphate and benzoyl peroxide) Gel, 1.2%/5% has not been demonstrated to have any additional benefit when compared with benzoyl peroxide alone in the same vehicle when used for the treatment of non-inflammatory acne.

Onexton
Onexton (clindamycin phosphate and benzoyl peroxide) Gel, 1.2% / 3.75% is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.

Initial Step Therapy

Include Rx and OTC products unless otherwise stated.

If the patient has filled a prescription for at least a 30 day supply of a generic acne product (benzoyl peroxide, clindamycin topical, clindamycin/benzoyl peroxide, dapsone topical, erythromycin topical, erythromycin/benzoyl peroxide, sodium sulfacetamide, or sodium sulfacetamide/sulfur) within the past 180 days under a prescription benefit administered by CVS Caremark, then the requested drug will be paid under that prescription benefit. If the patient does not meet the initial step therapy criteria, then the claim will reject with a message indicating that a prior authorization (PA) is required. The prior authorization criteria would then be applied to requests submitted for evaluation to the PA unit.

Coverage Criteria

Acne Vulgaris
Authorization may be granted when the requested drug is being prescribed for the topical treatment of acne vulgairs when ONE of the following criteria is met:

• The patient has experienced an inadequate treatment response to a generic topical acne agent

• The patient has experienced an intolerance to a generic topical acne agent

• The patient has a contraindication that would prohibit a trial of a generic topical acne agent

Continuation of Therapy 

Acne Vulgaris

Authorization may be granted when the requested drug is being prescribed for the topical treatment of acne vulgairs when the following criteria is met:

• The patient has achieved or maintained a positive clinical response as evidenced by improvement (e.g., reduction in number of lesions, patient satisfaction, etc.)

Duration of Approval (DOA)

• 1493-D: Initial therapy DOA: 4 months; Continuation of therapy DOA: 12 months

Place of Service:

Outpatient

The above policy is based on the following references:

1. Acanya [package insert]. Bridgewater, NJ: Bausch Health US, LLC; September 2020.
2. Aczone 5% [package insert]. Exton, PA: Almirall, LLC; December 2020.
3. Aczone 7.5% [package insert]. Exton, PA: Almirall, LLC.; December 2021.
4. Amzeeq [package insert]. Scottsdale, AZ: Journey Medical Corporation; January 2023.
5. Cleocin-T [package insert]. New York, NY: Pharmacia & Upjohn Co; July 2023.
6. Clindacin ETZ Pledgets [package insert]. Ferndale, MI: Ferndale Laboratories; September 2022.
7. Clindacin P and PAC Pledgets [package insert]. Fairfield, NJ: Medimetriks Pharmaceuticals, Inc.; November 2022.
8. Clindagel [package insert]. Bridgewater, NJ: Bausch Health US, LLC; January 2020.
9. Evoclin [package insert]. Morgantown, WV: Mylan Pharmaceuticals Inc.; April 2018.
10. Klaron [package insert]. Bridgewater, NJ: Bausch Health US, LLC; August 2020.
11. Neuac [package insert]. Fairfield, NJ: Medimetriks Pharmaceuticals, Inc.; January 2023.
12. Onexton [package insert]. Bridgewater, NJ: Bausch Health US, LLC; April 2020.
13. Lexicomp Online, AHFS DI (Adult and Pediatric) Online. Waltham, MA: UpToDate, Inc.; 2023. https://online.lexi.com. Accessed June 13, 2023.
14. Micromedex® (electronic version). Merative, Ann Arbor, Michigan, USA. Available at: https://www.micromedexsolutions.com/ (cited: 06/13/2023).
15. Reynolds RV, Yeung H, Cheng CE, et al. Guidelines of care for the management of acne vulgaris. J Am Acad Dermatol. 2024;90(5):1006.e1-1006.e30.

 

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 19, 2024