Pharmacy Prior Authorization Criteria

Topical Acne Treatments - PA, ST, NF

Indications for Prior Authorization

Acanya (clindamycin phosphate and benzoyl peroxide 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 topical 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.

Ziana (clindamycin phosphate and tretinoin gel)

• For diagnosis of Acne vulgaris
  Indicated for the topical treatment of acne vulgaris in patients 12 years or older.

Criteria

Brand Acanya, Brand Benzamycin, Twyneo, Brand Ziana

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:
• For Brand Acanya, Brand Benzamycin, or Brand Ziana, 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%)
OR
• For Twyneo, one of the following:
• Both of the following:
• Patient is 9 to 11 years of age
• Trial and failure (minimum 30-day supply), contraindication, or intolerance within the past 180 days to adapalene/benzoyl peroxide gel 0.1-2.5% (generic Epiduo)
OR
• Both of the following:
• Patient is 12 years of age or older
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%)

Brand Clindagel

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

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 Epiduo Forte
• Trial (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%

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
• Both of the following:
• Submission of medical records (e.g., chart notes) confirming the patient has experienced intolerance (e.g., allergy to excipient) with Brand Onexton that has the same active ingredient
• Submission of medical records (e.g., chart notes) confirming Brand Onexton 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 Brand Onexton has not been shown to be effective despite having the same active ingredient
AND
• Submission of medical records (e.g., chart notes) or paid claims documenting the patient has tried and failed at least 4 additional formulary alternatives within the same therapeutic class. If less than 4 formulary alternatives within the therapeutic class are available, the patient must have tried all formulary alternatives within the therapeutic class AND additional formulary alternatives to a total of four. If there are no formulary alternatives within the same therapeutic class, the patient must have failed 4 formulary alternatives or have a contraindication or intolerance to all formulary alternatives

Twyneo

Non Formulary

Length of Approval: 12 Month(s)

• Submission of medical records (e.g., chart notes) confirming requested drug is being used for a Food and Drug Administration (FDA)-approved indication
AND
• One of the following:
• Both of the following:
• Patient is 9 to 11 years of age
• Submission of medical records (e.g., chart notes) or paid claims confirming trial and failure (minimum 30-day supply), contraindication, or intolerance within the past 180 days to adapalene/benzoyl peroxide gel 0.1-2.5% (generic Epiduo)
OR
• Both of the following:
• Patient is 12 years of age or older
AND
• Submission of medical records (e.g., chart notes) or paid claims confirming 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%)

P & T Revisions

1970-01-01, 2026-07-01, 2026-04-07, 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

References

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. Bausch Health US, LLC. Bridgewater, NJ. January 2020.
4. Ziana Prescribing Information. Bausch Health US, LLC. Bridgewater, NJ. March 2026.
5. Onexton Prescribing Information. Bausch Health US, LLC. Bridgewater, NJ. July 2025.
6. Twyneo Prescribing Information. Mayne Pharma Commercial LLC. Raleigh, NC. February 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.

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Revision History

• 2026-07-01: Annual Review 2026 - Revised generic clindamycin phos/BPO criteria for standard NF verbiage through same active ingredient product (ie, Onexton) and added trial of 4 additional formulary alternatives verbiage. Background update
• 2026-04-07: Addition of ST and NF criteria for Twyneo. Remove "failure" from Onexton ST criterion through its generic.
• 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.

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