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Prior Authorization Protocol
ACZONE (dapsone gel 5%, 7.5%), EPIDUOR FORTE (adapalene 0.3% and benzoyl peroxide 2.5%)


NATL
Coverage of drugs is first determined by the member’s pharmacy or medical benefit. Please consult with or refer to the Evidence of Coverage document.
  1. FDA Approved Indications:
    • Aczone Gel 5%, Epiduo Forte: For the topical treatment of acne vulgaris.
    • Aczone Gel 7.5%: For the topical treatment of acne vulgaris in patients 12 years of age and older
  2. Health Net Approved Indications and Usage Guidelines:
    • For topical application in the treatment of acne vulgaris
    AND
    • Failure or clinically significant adverse effects to two preferred topical anti-acne agents (e.g., topical adapalene, tretinoin, benzoyl peroxide-erythromycin, clindamycin, benzoyl peroxide-clindamycin phosphate, erythromycin, sulfacetamide-sulfur)
  3. Coverage is Not Authorized For:
    • Non-FDA approved indications, which are not listed in the Health Net Approved Indications and Usage Guidelines section, unless there is sufficient documentation of efficacy and safety in the published literature.
  4. General Information:
    This field intentionally left blank.
  5. Therapeutic Alternatives:
    Drug Dosing Regimen Dose Limit/ Maximum Dose
    Topical Retinoids

    adapalene (DifferinR)



    Lotion, Cream: 0.1%; Gel: 0.1%, 0.3%
    Apply topically QD



    N/A

    tretinoin (Retin-AR)

    Cream: 0.025%, 0.05%, 0.1%;
    Gel: 0.01%, 0.025%, 0.05%
    Apply topically QD

    N/A

    tretinoin microsphere (Retin-A MicroR)
    Microsphere Gel: 0.04%, 0.1%
    Apply topically QD

    N/A

    Topical Antibiotics

    benzoyl peroxide-erythromycin (BenzamycinR)


    Gel: 5% benzoyl peroxide/3% erythromycin
    Apply topically QD-BID



    N/A

    clindamycin (Cleocin TR, ClindagelR,ClindamaxR)
    Solution, Gel, Lotion, Foam: 1%:
    Solution, Gel, Lotion: Apply topically BID
    Foam: Apply topically QD

    N/A

    benzoyl peroxide-clindamycin phosphate (DuacR, Neuac, Benzaclin)

    DuacR, Neuac: 1.2%clindamycin/5% benzoyl peroxide: Apply topically QD
    BenzaClin: 1% clindamycin/5% benzoyl peroxide: Apply topically BID

    N/A

    erythromycin (ErygelR)

    Solution: 2%; Gel: 2%
    Apply topically BID

    N/A

    sulfacetamide/sulfur

    Various strengths
    Apply topically QD to TID

    N/A

    * Requires Prior Authorization
  6. Recommended Dosing Regimen and Authorization Limit:
    Drug Dosing Regimen Authorization Limit

    Epiduo Forte

    Apply a pea-sized amount to each affected area of the face and/or trunk topically QD after washing

    Length of Benefit

    Aczone 5%

    Apply a thin layer to the acne affected areas topically BID after washing. Rub gently and completely.

    Length of Benefit

    Aczone 7.5%

    Apply a thin layer to the entire face and other affected areas topically QD after washing. Rub gently and completely.

    Length of Benefit

  7. Product Availability:
    Epiduo Forte Gel: 0.3% adapalene/2.5% benzoyl peroxide in 15 g, 30 g, 45 g, 60 g, and 70 g pumps
    Aczone 5% Gel: 60 g, 90 g tube
    Aczone 7.5% Gel: 30 g, 60 g, 90 g tube
  8. References:
    1. Epiduo Forte [Prescribing Information] Fort Worth, TX: Galderma Laboratories; July 2015.
    2. MicromedexR Healthcare Series [Internet Database]. Greenwood Village, CO: Truven Health Analytics. Updated periodically. Accessed June 10, 2016.
    3. Clinical Pharmacology Web Site. Available at: http://cpip.gsm/com/. Accessed June 10, 2016.
    4. Aczone Gel 7.5% [Prescribing Information]. Irvine, CA: Allergan Inc. February 2016.
    5. Aczone Gel 5% [Prescribing Information]. Irvine, CA: Allergan Inc. July 2015.

The material provided to you are guidelines used by this plan to authorize, modify or determine coverage for persons with similar illnesses or conditions. Specific care and treatment may vary depending on individual need and the benefits covered under your contract.