Topical Antibiotics – Net Results

Restricted Products:

Brand name topical acne products

• Acanya® (clindamycin/benzoyl peroxide)
• Aczone® (dapsone)
• Azelex® (azelaic acid)
• Benzaclin® (clindamycin/benzoyl peroxide)
• Benzamycin® (erythromycin/benzoyl peroxide)
• Cleocin-T® (clindamycin)
• Clindagel® (clindamycin)
• Erygel® (erythromycin)
• Ery 2% pad (erythromycin)
• Evoclin® (clindamycin)
• Finacea foam/gel (azelaic acid)
• Klaron® (sulfacetamide sodium)
• ZilxiTM (minocycline hcl)

FDA Approved Use:

• For the topical treatment of acne vulgaris.

Criteria for Approval of Restricted Product(s):

1. If the request is for Zilxi:
   1. The patient has had a trial and failure of one generic topical antibiotic; OR
   2. The patient has a clinical contraindication/intolerance to those generic topical antibiotics that they have not tried; OR
2. The requested product is a Brand medication with an unrestricted generic equivalent:
   1. The patient had a sub-therapeutic or intolerant response (therapeutic failure) to an inactive ingredient of the generic product, but not present in the brand; OR
      1. The patient has a documented intolerance to an inactive ingredient of the generic product that are not found in the brand product; AND
   2. The patient has tried and failed ONE other generic topical antibiotic; OR
3. All other requests:
   1. The patient has had a trial and failure of two generic topical antibiotics; OR
   2. The patient has a clinical contraindication/intolerance to those generic topical antibiotics that have not been tried; AND
4. For products that require Medical Necessity PA, refer to the Medical Necessity PA UM Criteria.

Duration of Approval: 365 days (1 year)

References:

All information referenced is from FDA package insert unless otherwise noted below.

Policy Implementation/Update Information:

Criteria and treatment protocols are reviewed annually by the Blue Cross NC P&T Committee, regardless of change. This policy is reviewed in Q1 annually.

May 2022: Criteria update: Removed Aktipak and Duac (obsolete products)

March 2022: Criteria update: Removed generic Dapsone 7.5% from the policy due to MSC code flip from M to Y.

July 2021: Criteria update: Added Dapsone 7.5% back to the policy due to MSC code flip from Y to M

February 2021: Criteria update: Removed Dapsone 7.5% from the policy due to MSC flip. Revised trial and failure language.

January 2021: Criteria change: Changed requirement for Zilxi to t/f ONE generic topical antibiotic.

July 2020: Criteria update: Added Dapsone 7.5% back to the policy due to MSC code flip from Y to M.

July 2020: Criteria update: Removed Amzeeq from policy.

June 2020: Criteria update: Added new to market Zilxi foam to the policy.

Feb 2020: Criteria update: Removed generic Dapsone 5 & 7.5% gel from the policy due to MSC code flip from M to Y.

Jan 2020: Criteria update: Added Dapsone 5% generic and 7.5% authorized generic to Aczone to the policy.

Dec 2019: Criteria update: Added new to market Amzeeq 4% aerosol to policy.

Nov 2019: Criteria update: Removed Clindamycin 1% swab (generic Cleocin-T swab) due to MSC flip M to Y, removed unrestricted/suggested alternatives.

Nov 2019: Criteria update: Added Ery 2% pads to the restricted section due to MSC flip Y to N.

Oct 2019: Criteria update: Added brand Acanya gel to restricted products.

Jul 2019: Added brand Finacea foam and gel to restricted products.Jul 2018: Added authorized generic for Clindagel to restricted products.

Jul 2017: Reformatted criteria; new to market Aktipak added to criteria; brand Akne-Mycin removed as it is no longer on market

Jan 2017: Reviewed for Net Results. Removal of Non-FDA approved products.

Jan 2016: Original utilization management criteria issued.