Pharmacy Prior Authorization Criteria

Topical Acne Treatments - PA, ST, NF

Indications for Prior Authorization

Benzaclin (clindamycin phosphate and benzoyl peroxide gel), Benzamycin (erthyromycin and benzoyl peroxide gel)

• For diagnosis of Acne vulgaris
  Indicated for the treatment of acne vulgaris.

Acanya (clindamycin phosphate and benzoyl peroxide gel), Veltin (clindamycin phosphate and tretinoin gel), Ziana (clindamycin phosphate and tretinoin gel)

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

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.

Criteria

Brand Acanya, Brand Benzaclin, Brand Benzamycin, Brand Veltin, Brand Ziana

^ Brand product may be excluded, please consult client-specific resources to confirm formulary coverage.

Step Therapy

Length of Approval: 12 Month(s)

• Requested drug is being used for a Food and Drug Administration (FDA)-approved indication
AND
• History of failure (of a minimum 30-day trial), 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, Brand Clindamycin Phosphate

Step Therapy

Length of Approval: 12 Month(s)

• Requested drug is being used for a Food and Drug Administration (FDA)-approved indication
AND
• History of failure (of a minimum 30-day trial) 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
• History of failure (of a minimum 30-day trial), contraindication, or intolerance within the past 180 days to any one of the following:
• Epiduo Forte
• Twyneo
• 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:
• 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
• Paid claims or submission of medical records (e.g., chart notes) confirming at least 6 months of use of brand Onexton within the previous 365 days
AND
• Justification provided for why the generic is expected to provide benefit when brand Onexton has not been shown to be effective

P & T Revisions

1970-01-01, 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. Benzaclin Prescribing Information. Valeant Pharmaceuticals North America LLC. Bridgewater, NJ. February 2017.
3. Benzamycin Prescribing Information. Bausch Health US LLC. Bridgewater, NJ. November 2020.
4. Clindagel Prescribing Information. Valeant Pharmaceuticals North America LLC; San Antonio, TX. January 2020.
5. Veltin Prescribing Information. Almirall, LLC. Exton, PA. August 2021.
6. Ziana Prescribing Information. Valeant Pharmaceuticals North America LLC. Bridgewater, NJ. March 2017.

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Revision History

• 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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