Topical Antibiotics

Restricted Products:

Brand name topical acne products

• Aczone® (dapsone)
• Acanya® (clindamycin/benzoyl peroxide)
• clindamycin/benzoyl peroxide (Acanya)
• Aktipak® (benzoyl peroxide-erythromycin)
• Azelex® (azelaic acid)
• Benzaclin®(clindamycin/benzoyl peroxide)
• Benzamycin® (erythromycin/benzoyl peroxide)
• Cleocin-T® (clindamycin)
• Clindagel® (clindamycin)
• Clindamycin (Clindagel)
• Duac® (clindamycin/benzoyl peroxide)
• Erygel® (erythromycin)
• Evoclin® (clindamycin)
• Finacea® (azelaic acid)
• Klaron® (sulfacetamide sodium)
• Metrocream® (metronidazole)
• Metrogel® (metronidazole)
• Metrolotion® (metronidazole)
• Noritate® (metronidazole)
• OnextonTM (clindmycin/benzoyl peroxide)

Unrestricted/Suggested Alternative(s):

• azelaic acid 15% gel (generic Finacea)
• erythromycin gel (generic Erygel)
• clindamycin phosphate gel (generic Cleocin-t)
• clindamycin phosphate-benzoyl peroxide gel (Benzaclin)
• clindamycin phosph-benzoyl peroxide (refrig) (Duac)
• benzoyl peroxide-erythromycin gel (Benzamycin)
• sulfacetamide sodium lotion 10% (acne) (Klaron)
• metronidazole cream 0.75% (Metrocream)
• metronidazole gel 0.75%
• metronidazole lotion 0.75% (Metrolotion)

FDA Approved Use:

• for the topical treatment of acne vulgaris

Rationale:

• Other products, such erythromycin gel (generic Erygel®) and clindamycin phosphate gel (generic Cleocin-t®), treat the same condition at a substantially lower cost to members with equal results.

Criteria Summary:

Trial of effect and lower cost product

Criteria for Approval of Restricted Product(s):

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 they have not tried; AND
3. For formularies that exclude (non-formulary) the requested medication, approval may be warranted when the criteria above is met (Non-formulary Exception Criteria outlined below)*

Duration of Approval: 365 days (1 year)

*Non-formulary Exception Criteria

Non-Formulary Exception criteria applies on formularies which exclude requested product(s). Satisfactory completion of criteria points (above) may satisfy some, or all, portions of the Non-Formulary Exception Criteria. This criteria is summarized as:

1. Request must be for an FDA approved indication; AND
2. Patient must have a trial and failure of up to TWO formulary medications or a clinical contraindication/intolerance to those medications not tried.

References:

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

Policy Implementation/Update Information:

Nov 2018: Generic for Finacea added to the unrestricted medications.

Jul 2018: Authorized generics for Acanya and Clindagel added to restricted medications.

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 Essential Formulary. Removal of Non-FDA approved products.

Jan 2016: original utilization management criteria issued.