Minocycline Micronized Foam (Amzeeq) Form

Minocycline micronized foam 4% (Amzeeq™) is a tetracycline.
FDA Approved Indication(s) Amzeeq is indicated to treat inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years of age and older.
Limitation(s) of use: This 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. 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 Amzeeq is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Acne Vulgaris (must meet all):

1. Diagnosis of acne vulgaris;
2. Age ≥ 9 years;

3. Failure of ≥ 2 of the following topical preparations, each from different medication classes, each used for ≥ 2 months, unless all are contraindicated or clinically significant adverse effects are experienced: a. Topical antibiotics: clindamycin, erythromycin; b. Topical anti-infectives: benzoyl peroxide; c. Topical retinoids: tretinoin;

   4. Dose does not exceed 1 container per month.
      Approval duration:
      Medicaid – 12 months Commercial – 12 months or duration of request, whichever is less
      B. Other diagnoses/indications (must meet 1 or 2):
   5. 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): Page 1 of 5

   CLINICAL POLICY
   Minocycline Micronized Foam
   a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial and CP.PMN.255 for Medicaid; 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: CP.CPA.190 for commercial and CP.PMN.16 for Medicaid; 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: CP.CPA.09 for commercial and CP.PMN.53 for Medicaid.
      II. Continued Therapy A. Acne Vulgaris (must meet all):
   3. 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);
4. Member is responding positively to therapy;

5. Dose does not exceed 1 container per month.
   Approval duration:
   Medicaid – 12 months Commercial – 12 months or duration of request, whichever is less
   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: CP.CPA.190 for commercial and CP.PMN.255 for Medicaid; 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: CP.CPA.190 for commercial and CP.PMN.16 for Medicaid; 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: CP.CPA.09 for commercial and CP.PMN.53 for Medicaid.
      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 – CP.CPA.09 for commercial and CP.PMN.53 for Medicaid, or evidence of coverage documents. Page 2 of 5

   CLINICAL POLICY
   Minocycline Micronized Foam
   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 clindamycin (Cleocin T®) Apply a thin film BID erythromycin (Erygel®, Ery®) Apply a thin film BID benzoyl peroxide (Benzac®, BPO®, Brevoxyl®, PanOxyl®) tretinoin (Retin-A®) 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 Apply QD QD Dose Limit/ Maximum Dose BID BID BID Appendix C: Contraindications/Boxed Warnings • Contraindication(s): hypersensitivity to tetracyclines or any ingredients within Amzeeq • Boxed warning(s): none reported V. Dosage and Administration Indication Acne vulgaris Dosing Regimen Apply topically once daily Maximum Dose Once daily application VI. Product Availability Foam (30 g can): 4% VII.