WHA

Topical Acne Treatments - PA, ST, NF

Indications for Prior Authorization

Acanya (clindamycin phosphate and benzoyl peroxide gel), Ziana (clindamycin phosphate and tretinoin gel)
  • For diagnosis of Acne vulgaris
    Indicated for treatment of acne vulgaris in patients 12 years and older.

Benzamycin (erthyromycin and benzoyl peroxide gel)
  • For diagnosis of Acne vulgaris
    Indicated for the treatment of acne vulgaris.

Clindagel (clindamycin)
  • For diagnosis of Acne vulgaris
    Indicated for topical application in the treatment of acne vulgaris.

Onexton (clindamycin phosphate and benzoyl peroxide gel)
  • For diagnosis of Acne vulgaris
    Indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.

Twyneo (benzoyl peroxide and tretinoin cream)
  • For diagnosis of Acne vulgaris
    Indicated for the topical treatment of acne vulgaris in adults and pediatric patients 9 years of age and older.

Criteria

Brand Acanya, Brand Benzamycin, Brand Ziana

^ Brand product may be excluded, please consult client-specific resources to confirm formulary coverage. For state-mandated plans in Illinois or other states where applicable: Step therapy requirements do NOT apply. Beginning January 1, 2026, step therapy requirements or use of the authorization of alternative covered medications in a manner that effectively creates a step therapy requirement will not be imposed.

Step Therapy

Length of Approval: 12 Month(s)

  • Requested drug is being used for a Food and Drug Administration (FDA)-approved indication
    • AND
  • Trial and failure (minimum 30-day supply), contraindication, or intolerance within the past 180 days to any one of the following:
    • Epiduo Forte
    • Onexton^ (clindamycin phosphate/benzoyl peroxide gel 1.2-3.75%)
    • Twyneo
Brand Clindagel

For state-mandated plans in Illinois or other states where applicable: Step therapy requirements do NOT apply. Beginning January 1, 2026, step therapy requirements or use of the authorization of alternative covered medications in a manner that effectively creates a step therapy requirement will not be imposed.

Step Therapy

Length of Approval: 12 Month(s)

  • Requested drug is being used for a Food and Drug Administration (FDA)-approved indication
    • AND
  • Trial and failure (minimum 30-day supply) or intolerance to two generic single-agent topical clindamycin products within the past 180 days
Brand Onexton

For state-mandated plans in Illinois or other states where applicable: Step therapy requirements do NOT apply. Beginning January 1, 2026, step therapy requirements or use of the authorization of alternative covered medications in a manner that effectively creates a step therapy requirement will not be imposed.

Step Therapy

Length of Approval: 12 Month(s)

  • Requested drug is being used for a Food and Drug Administration (FDA)-approved indication
    • AND
  • One of the following:
    • Trial and failure (minimum 30-day supply), contraindication, or intolerance within the past 180 days to any one of the following:
      • Epiduo Forte
      • Twyneo
      OR
    • Trial and failure (minimum 30-day supply) or intolerance within the past 180 days to clindamycin/benzoyl peroxide gel 1.2/3.75%
Generic clindamycin phosphate/benzoyl peroxide gel 1.2-3.75%

For state-mandated plans in Illinois or other states where applicable: Step therapy requirements do NOT apply. Beginning January 1, 2026, step therapy requirements or use of the authorization of alternative covered medications in a manner that effectively creates a step therapy requirement will not be imposed. For Non-Formulary review, please reference the State Mandate Reference Document.

Prior Authorization, Non Formulary

Length of Approval: 12 Month(s)

  • One of the following:
    • Submission of medical records (e.g., chart notes) confirming requested drug is FDA-approved for the condition being treated
      • OR
    • If requested for an off-label indication, the off-label guideline approval criteria have been met
    AND
  • One of the following:
    • Submission of medical records (e.g., chart notes) or paid claims confirming at least 6 months of use of brand Onexton (clindamycin phosphate/benzoyl peroxide gel 1.2-3.75%) within the previous 365 days
    • Submission of medical records (e.g., chart notes) confirming the patient has experienced intolerance (e.g., allergy to excipient) with Onexton (clindamycin phosphate/benzoyl peroxide gel 1.2-3.75%) that has the same active ingredient
    AND
  • Submission of medical records confirming Onexton (clindamycin phosphate/benzoyl peroxide gel 1.2-3.75%) has not been effective AND valid clinical justification provided explaining how generic clindamycin phosphate/benzoyl peroxide gel 1.2-3.75% is expected to provide benefit when Onexton has not been shown to be effective despite having the same active ingredient

  • Guideline ID
    GL-459248

  • Formulary
    Premium

  • Effective date
    Jan 1, 2026

  • P&T approval date
    Jul 12, 2016

P & T Revisions

2025-12-17, 2025-07-16, 2025-03-28, 2024-04-30, 2023-10-23, 2023-07-07, 2022-09-06, 2022-08-04, 2022-07-21, 2022-04-05, 2021-06-15, 2020-06-30, 2020-03-27, 2020-01-03, 2019-10-24

  1. Acanya Prescribing Information. Bausch Health US, LLC. Bridgewater, NJ. September 2020.
  2. Benzamycin Prescribing Information. Bausch Health US LLC. Bridgewater, NJ. November 2020.
  3. Clindagel Prescribing Information. Valeant Pharmaceuticals North America LLC; San Antonio, TX. January 2020.
  4. Ziana Prescribing Information. Valeant Pharmaceuticals North America LLC. Bridgewater, NJ. March 2017.
  5. Onexton Prescribing Information. Bausch Health US, LLC. Bridgewater, NJ. July 2025.
  6. Twyneo Prescribing Information. Mayne Pharma Commercial LLC. Raleigh, NC. August 2025.
  7. 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.E1-30.
  • 2025-12-17: Removal of "contraindication" from Onexton ST requirement through its generic. Removal of obsolete drug Veltin from guideline. Addition of IL statute operational note.
  • 2025-07-16: Annual Review 2025 - Program update to remove obsolete/non-target drugs. Criteria updates for standard UM verbiage for ST (no change to clinical intent) and NF (additional criteria added) programs.
  • 2025-03-28: Clindagel GPI update
  • 2024-04-30: Added criteria for Onexton. Background updates.
  • 2023-10-23: Program update to add generic clindamycin/benzoyl peroxide 1.2-3.75% gel as target.
  • 2023-07-07: Annual Review. No changes to clinical intent. Background updates.
  • 2022-09-06: Added Twyneo as a prerequisite option for ST.
  • 2022-08-04: Removed Twyneo due to formulary strategy update. Updated background and references.
  • 2022-07-21: Annual review - no changes.
  • 2022-04-05: Added Twyneo to existing guideline. Updated background and references.
  • 2021-06-15: Annual review - removed obsolete products Aktipak and Duac. Updated background and references.
  • 2020-06-30: Update ST criteria to specify trial and failure "within the past 180 days" to match Comp UM list coding.
  • 2020-03-27: Removed Amzeeq ST due to formulary strategy update.
  • 2020-01-03: Added ST criteria for new product Amzeeq. Added existing clindagel/clindamycin criteria to this guideline. Removed generic clindamycin-benzoyl peroxide 1.2-2.5% product.
  • 2019-10-24: Removed Epiduo as a Step 1 alternative.