Dapsone (Aczone Gel) Form

Dapsone (Aczone® Gel) is a sulfone. FDA Approved Indication(s) Aczone Gel is indicated for the topical treatment of acne vulgaris. The 7.5% strength is specifically indicated in patients 9 years of age and older. 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 Aczone Gel 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. Member meets one of the following (a or b): a. For dapsone (Aczone) 5% gel: Age ≥ 12 years; b. For dapsone (Aczone) 7.5% gel: Age ≥ 9 years;

   3. Failure of TWO preferred topical anti-acne agents (e.g., topical adapalene, tretinoin, benzoyl peroxide/erythromycin, clindamycin, benzoyl peroxide/clindamycin phosphate, erythromycin, sulfacetamide/sulfur), unless clinically significant adverse effects are experienced or all are contraindicated; Prior authorization may be required for tretinoin
   4. Dose does not exceed 1 tube or pump per month. Approval duration:
      Commercial – 12 months or duration of request, whichever is less HIM – 3 months 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): 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 HIM.PA.33 for health insurance marketplace; or Page 1 of 6

   CLINICAL POLICY Dapsone 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 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: CP.CPA.09 for commercial and HIM.PA.154 for health insurance marketplace.
      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);
3. Member is responding positively to therapy;

4. If request is for a dose increase, dose does not exceed 1 tube or pump per month. Approval duration:
   Commercial – 12 months or duration of request, whichever is less HIM – 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: CP.CPA.190 for commercial and 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: CP.CPA.190 for commercial and 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: CP.CPA.09 for commercial and 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 policies – CP.CPA.09 for commercial and HIM.PA.154 for health insurance marketplace, or evidence of coverage documents.
      Page 2 of 6

   CLINICAL POLICY Dapsone IV. Appendices/General Information Appendix A: Abbreviation/Acronym 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 for all relevant lines of business and may require prior authorization.
   Drug Name Dosing Regimen Dose Limit/ Maximum Dose Topical Retinoids adapalene (Differin®) tretinoin (Retin-A®, Retin-A Micro®) Lotion, Cream: 0.1%; Gel: 0.1%, 0.3% Apply topically QD Cream: 0.025%, 0.05%, 0.1%; Gel: 0.01%, 0.025%, 0.05% Microsphere Gel: 0.04%, 0.1% Apply topically QD Gel: 5% benzoyl peroxide/3% erythromycin Apply topically QD-BID Solution, Gel, Lotion 1%: Apply topically BID Foam 1%: Apply topically QD Topical Antibiotics benzoyl peroxide- erythromycin (Benzamycin®) clindamycin (Cleocin T®, Clindagel®, Clindamax®) benzoyl peroxide/ clindamycin phosphate (Neuac®) erythromycin (Erygel®) sulfacetamide/sulfur Various strengths Neuac: 1.2% clindamycin/5% benzoyl peroxide: Apply topically QD 1% clindamycin/5% benzoyl peroxide: Apply topically BID Solution: 2%; Gel: 2% Apply topically BID Not applicable Not applicable Not applicable Not applicable Not applicable Not applicable Not applicable 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 topically QD to TID Appendix C: Contraindications/Boxed Warnings None reported
   Appendix D: General Information Per the Aczone gel prescribing information, if there is no improvement after 12 weeks, treatment with Aczone should be reassessed. Page 3 of 6

   CLINICAL POLICY Dapsone V. Dosage and Administration
   Indication Acne vulgaris Dosing Regimen 5%: Apply a pea-sized amount in a thin layer to the acne affected areas topically BID after washing Maximum Dose Not applicable 7.5%: Apply a pea-sized amount in a thin layer to the entire face and other affected areas topically QD after washing VI. Product Availability
   • Gel tube (30 g, 60 g, 90 g): 5%, 7.5% • Gel pump (30 g, 60 g, 90 g): 7.5% VII.