ModifiedHealth NetPolicy N/A

Clinical Policy: Dapsone (Aczone Gel)

Covers medical necessity and prior authorization criteria for topical dapsone (Aczone Gel) for treatment of acne vulgaris across specified Health Net/Centene lines of business.

Policy Summary

PayerHealth Net

PolicyDapsone (Aczone Gel) — Clinical Policy

Policy CodePolicy N/A

Change TypeClarifications and duration revision

Effective Date12.01.18

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of two failed preferred topical anti-acne agents and use of generic dapsone for initial approval.

SourceLink

POLICY UPDATE CHANGES

Added HIM line of business and updated references.

Revised approval duration for Commercial line of business to 12 months or duration of request, whichever is less.

Clarified age criteria for dapsone 5% to align with prescriber information and required use of generic dapsone.

Clarified that adapalene and combination products may require prior authorization.

Clarified criteria applies to generic dapsone and member must use generic dapsone in initial approval criteria.

Clarified failure of two preferred topical anti-acne agents from different listed classes is required.

Added clarification stating authorization may be required for tretinoin prior.

Updated Appendix B per Clinical Pharmacology; references reviewed and updated.

7.5%Aczone concentration (age ≥9)

5%Also available

12 moCommercial approval duration

1 tube

Policy Summary

PayerHealth Net

PolicyDapsone (Aczone Gel) — Clinical Policy

Policy CodePolicy N/A

Change TypeClarifications and duration revision

Effective Date12.01.18

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of two failed preferred topical anti-acne agents and use of generic dapsone for initial approval.

SourceLink

On This Page

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coverage and Medical Necessity Criteria

Initial Therapy

Covered when ALL of the following are met for Acne Vulgaris

Acne Vulgaris initial approval: 1. Diagnosis of acne vulgaris; 2. For dapsone 5%: age > 12 years OR for dapsone 7.5%: age ≥ 9 years; 3. Failure of ≥ 2 preferred topical anti-acne agents (must be from 2 different classes listed below) unless clinically significant adverse effects or all are contraindicated; 4. Member must use generic dapsone gel unless clinically significant adverse effects or all are contraindicated; 5. Dose does not exceed 1 tube or pump per month;

Preferred classes include topical antibiotics (clindamycin, erythromycin), topical anti-infectives (benzoyl peroxide, sodium sulfacetamide/sulfur), and topical retinoids (adapalene, tretinoin). Prior authorization may be required for adapalene, tretinoin, and combination products.

Continuation Therapy

Continued therapy — Covered when ALL of the following are met

Continued therapy: 1. Member is currently receiving the medication via the Centene benefit or has previously met initial approval criteria; 2. Member is responding positively to therapy; 3. If request is for a dose increase, the dose does not exceed 1 tube or pump per month; 4. Member must use generic dapsone unless clinically significant adverse effects or all are contraindicated.

Continuity of care may apply per state/product regulations.

Other Indications / Off-label pathway

Other diagnoses/indications

Other uses / off-label pathway: 1. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid): follow the no coverage criteria policy for the relevant line of business (CP.CPA.190 for commercial; HIM.PA.33 for health insurance marketplace); OR 2. For drugs not on the formulary/PDL: follow the non-formulary policy for the relevant line of business (CP.CPA.190 for commercial; HIM.PA.103 for health insurance marketplace); OR 3. If the requested use (diagnosis, age, dosing) is not listed 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; HIM.PA.154 for health insurance marketplace).

Also consider recent label changes (within last 6 months) that may not be reflected in this policy.

Initial Approval

Covered when ALL of the following are met

Initial approval requirements (clarifications 4Q 2024): 1. Member must use generic dapsone for initial approval unless clinically significant adverse effects or all are contraindicated; 2. Member must have failed two preferred topical anti-acne agents from different listed classes prior to coverage; 3. Prior authorization may be required for tretinoin and for adapalene and combination products.

Clarifications added during 4Q 2024 annual review; P&T approval noted 11.24.

Requests for uses that are not FDA‑approved and are not addressed within this policy are not authorized unless there is sufficient documentation of efficacy and safety consistent with the applicable off‑label use policies: CP.CPA.09 for Commercial lines and HIM.PA.154 for Health Insurance Marketplace. Providers should reference those off‑label policies when seeking coverage for non‑FDA indications.

No additional explicit exclusions are listed in the cited policy text beyond standard formulary and off‑label pathways described elsewhere in this document.

Uses for indications that are not FDA‑approved and are not supported by the off‑label use policies (CP.CPA.09 or HIM.PA.154) are considered not authorized and will not be covered under this policy.

The cited document does not contain any explicit statements phrased as 'Not Medically Necessary' for dapsone (Aczone Gel). Denial rationale is framed through lack of FDA approval or lack of support per off‑label policies rather than a specific 'Not Medically Necessary' label in these sections.

Provider Requirements, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required when requesting coverage for dapsone (Aczone) gel and certain topical retinoids/combination products. Providers must obtain prior authorization before dispensing when the request does not meet over-the-counter or automatic coverage criteria.

Affected products: dapsone (Aczone) gel, adapalene, tretinoin, and listed combination products
Initial approval: member must use generic dapsone gel when required unless clinically significant adverse effects or contraindications are documented
Prior authorization may be required for certain topical retinoids and combination products per plan rules

Step Therapy

Step Therapy Required for Topical Acne Agents

For initial approval of topical dapsone (Aczone) gel, the member must have failed therapy with at least two preferred topical anti-acne agents from two different classes listed in the policy prior to coverage. Document trials of the preferred agents and reasons for failure (e.g., lack of efficacy, intolerance, or contraindication).

Product and Terminology Definitions

Aczone Gel — formulations and age indications

FormulationsAczone (topical dapsone) is available as 5% and 7.5% gel formulations.

Age indication for 7.5%The 7.5% strength is specifically indicated for patients 9 years of age and older.

Typical dosing — 5%Apply a pea-sized amount in a thin layer to acne-affected areas topically twice daily (BID) after washing.

Typical dosing — 7.5%Apply a pea-sized amount in a thin layer to the entire face and other affected areas topically once daily (QD) after washing.

Drug classDapsone (Aczone Gel) is a sulfone.

Requirement to use generic dapsone for initial approval

Clinical Background

Dapsone topical gel (Aczone) is a topical sulfone indicated for the treatment of acne vulgaris. It is available in 5% and 7.5% formulations; the 7.5% formulation is indicated for patients aged 9 years and older. Typical dosing per prescribing information is a pea‑sized amount of the 5% formulation applied twice daily and the 7.5% formulation applied once daily. If no clinical improvement is observed after approximately 12 weeks of therapy, treatment should be reassessed per the product labeling. Additionally, the policy clarifies that initial approval criteria require use of generic dapsone where applicable and documents recent updates to authorization requirements (including prior authorization considerations for certain topical retinoids and combination products).