DUAC, Clindamycin Phosphate-Benzoyl Peroxide (Refrigerate) RETIN-A MICRO, Tretinoin Microsphere BENZAMYCIN, Benzoyl Peroxide-Erythromycin DIFFERIN (cream, gel), Adapalene Form

The following are topical acne treatment agents requiring prior authorization: adapalene cream (0.1%) and gel (0.1%) (Differin®), clindamycin foam (Evoclin®), clindamycin phosphate/benzoyl peroxide gel (BenzaClin®), clindamycin and benzoyl peroxide 1.2-5% (Duac® Gel), erythromycin and benzoyl peroxide (Benzamycin®), minocycline micronized foam 4% (Amzeeq™), tretinoin microsphere gel (Retin-A Micro® 0.1%). Limitations of use:
• Duac gel has not been demonstrated to have any additional benefit when compared with benzoyl peroxide alone in the same vehicle when used for the treatment of non-inflammatory acne. • The Amzeeq formulation of minocycline has not been evaluated in the treatment of infections. To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, Amzeeq should be used only as indicated. FDA Approved Indication(s) Topical acne agents are indicated for the treatment of acne vulgaris.
Policy/Criteria Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.
It is the policy of health plans affiliated with Centene Corporation® that topical acne treatments are medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Acne Vulgaris (must meet all):

1. Diagnosis of acne vulgaris;

2. One of the following (a or b): a. Age ≥ 12 years; b. For Amzeeq requests, age ≥ 9 years;

   3. For BenzaClin: member must use the individual components (i.e., topical clindamycin phosphate, topical benzoyl peroxide) concurrently unless clinically significant adverse effects are experienced or all are contraindicated (e.g., contraindications to the excipients of all brand and generic products);
   4. For Evoclin: member must use clindamycin topical lotion, gel, solution, and swabs unless clinically significant adverse effects are experienced or all are contraindicated; Page 1 of 7

   CLINICAL POLICY
   Topical Acne Treatment

   5. For all other topical acne agents: failure of ≥ 2 of the following topical preparations, each from different medication classes, each used for ≥ 2 months, unless clinically significant adverse effects are experienced or all are contraindicated: a. Topical antibiotics: clindamycin, erythromycin; b. Topical anti-infectives: benzoyl peroxide; c. Topical retinoids: tretinoin;Prior authorization may be required for tretinoin
   6. Dose does not exceed 1 container (tube, can, pump) per month.
      Approval duration:
      Evoclin – 3 months All other topical acne agents – 12 months B. Other diagnoses/indications (must meet 1 or 2):
   7. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: HIM.PA.33 for health insurance marketplace; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: HIM.PA.103 for health insurance marketplace; or
   8. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: HIM.PA.154 for health insurance marketplace.
      II. Continued Therapy A. Acne Vulgaris (must meet all):
   9. Member meets one of the following (a or b): a. Currently receiving medication via Centene benefit or member has previously met initial approval criteria; b. Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B);
3. Member is responding positively to therapy;

4. Dose does not exceed 1 container (tube, can, pump) per month.
   Approval duration: 12 months B. Other diagnoses/indications (must meet 1 or 2):

   1. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: HIM.PA.33 for health insurance marketplace; or Page 2 of 7

   CLINICAL POLICY
   Topical Acne Treatment b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: HIM.PA.103 for health insurance marketplace; or

   2. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: HIM.PA.154 for health insurance marketplace.
      III. Diagnoses/Indications for which coverage is NOT authorized:
      A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policy – HIM.PA.154 for health insurance marketplace or evidence of coverage documents. IV. Appendices/General Information Appendix A: Abbreviation Key FDA: Food and Drug Administration Appendix B: Therapeutic Alternatives
      This table provides a listing of preferred alternative therapy recommended in the approval criteria. The drugs listed here may not be a formulary agent and may require prior authorization.
      Drug Name Dosing Regimen Apply a thin film BID clindamycin (Cleocin T®) lotion, gel, solution, swabs erythromycin (Erygel®, Ery®) Apply a thin film BID benzoyl peroxide (Benzac®, BPO®, PanOxyl®) foam, gel, liquid, lotion tretinoin (Retin-A®) Apply QD at bedtime Therapeutic alternatives are listed as Brand name® (generic) when the drug is available by brand name only and generic (Brand name®) when the drug is available by both brand and generic. Apply or wash QD or BID BID BID QD Dose Limit/ Maximum Dose BID Appendix C: Contraindications/Boxed Warnings • Contraindication(s):
      o Amzeeq: hypersensitivity to tetracyclines or any ingredients within Amzeeq o BenzaClin: hypersensitivity (e.g., anaphylaxis) to clindamycin, benzoyl peroxide, any components of the formulation, or lincomycin; history of regional enteritis, ulcerative colitis, or antibiotic-associated colitis o Benzamycin: hypersensitivity to any of its components o Differin: hypersensitive to adapalene or any of the components in the gel vehicle o Duac: hypersensitivity to clindamycin, benzoyl peroxide, any components of the formulation, or lincomycin; history of regional enteritis, ulcerative colitis, or antibiotic-associated colitis (including pseudomembranous colitis) o Evoclin: in individuals with a history of regional enteritis or ulcerative colitis, or a history of antibiotic-associated colitis (including pseudomembranous colitis) Page 3 of 7

   CLINICAL POLICY
   Topical Acne Treatment • Boxed warning(s): none reported V. Dosage and Administration Drug Name adapalene (Differin) clindamycin (Evoclin) clindamycin phosphate/benzoyl peroxide gel (BenzaClin) clindamycin phosphate and benzoyl peroxide (Duac Gel) erythromycin and benzoyl peroxide (Benzamycin)
   minocycline micronized (Amzeeq) tretinoin microsphere (Retin-A Micro)
   Dosing Regimen Apply topically once daily in the evening Apply topically once daily to the affected areas Apply topically to affected areas BID Apply topically once daily in the evening Apply topically twice daily Maximum Dose Once daily application Once daily application Twice daily application Once daily application Twice daily application Apply topically once daily Once daily application Apply topically once daily before bedtime Once daily application VI. Product Availability Drug Name adapalene (Differin) clindamycin (Evoclin) clindamycin phosphate/benzoyl peroxide gel (BenzaClin) clindamycin phosphate and benzoyl peroxide (Duac Gel) erythromycin and benzoyl peroxide (Benzamycin)
   minocycline micronized (Amzeeq) tretinoin microsphere gel (Retin-A Micro)
   Availability Cream, gel (45 g tube): 0.1% Gel (45 g tube): 0.3% Foam (50 g, 100 g aerosol can): 1% Gel (25 g jar; 35 g and 50 g pump): 1-5% Gel (45 g tube): 1.2-5% Gel (46.6 g container): 5-3% Foam (30 g can): 4% Gel (20 g, 45 g tube): 0.1%, 0.04% Gel (50 g pump): 0.04%, 0.06%, 0.08%, 0.1% VII.