CurrentHealth NetPolicy CP.CPA.133

Clindamycin Phosphate/Benzoyl Peroxide (Onexton, Acanya) - Clinical Policy

Defines medical necessity criteria, prior authorization and continued therapy conditions for topical clindamycin phosphate/benzoyl peroxide (Onexton, Acanya) for members of the Health Net/Centene lines of business, primarily for treatment of acne vulgaris in patients aged 12 and older.

Policy Summary

PayerHealth Net

PolicyClindamycin Phosphate/Benzoyl Peroxide (Onexton, Acanya) - Clinical Policy

Policy CodePolicy CP.CPA.133

Change TypeMinor review — no material changes

Effective DateNov 16, 2016

Next Review DateNov 25, 2025

Key ActionSubmit prior authorization with documentation showing diagnosis, age ≥12, trial of ≥2 preferred generics (unless contraindicated), and dose ≤1 pump/month.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Age ≥ 12Minimum age for FDA-approved indication

≥ 2Required trials prior to approval

1 pump/monthMaximum dose limit

12 moContinued therapy approval

Coverage Criteria

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Initial therapy / medical necessity criteria

Covered when ALL of the following are met:

Initial Acne Vulgaris criteria

Diagnosis of acne vulgaris
Age ≥ 12 years
Step therapy: Failure of ≥2 preferred generic topical clindamycin phosphate/benzoyl peroxide products unless adverse effects/contraindications
Dose limit: Dose does not exceed 1 pump container per month

Continued therapy criteria

Continued therapy covered when ALL of the following are met:

Continued therapy for Acne Vulgaris

Eligibility: Currently receiving medication via Centene benefit OR previously met initial approval criteria OR continuity of care regulations apply
Response: Member is responding positively to therapy
Dose limit: Dose does not exceed 1 pump container per month

Requests for use of topical clindamycin phosphate/benzoyl peroxide for non‑FDA approved indications that are not specifically addressed in this policy are excluded from coverage unless the provider supplies sufficient documentation of efficacy and safety per off‑label use policy CP.CPA.09 or applicable evidence of coverage documents.

Operationally, when a request is for an indication that is not FDA‑approved and is not listed in this policy, the submission must include documentation that meets the requirements of Health Net’s off‑label use policy CP.CPA.09. Absent that documentation, the request may be considered not medically necessary and denied.

Provider Actions and Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for topical clindamycin phosphate/benzoyl peroxide, Onexton, and Acanya. Requests will be reviewed against the initial and continued therapy criteria in this policy. Approval duration is up to 12 months or the duration of request, whichever is less.

Applies to Onexton, Acanya, and generic topical clindamycin/benzoyl peroxide products.
Approval duration: 12 months or duration of request, whichever is less.

Step Therapy

Step Therapy Requirement

Failure of at least two preferred generic clindamycin phosphate/benzoyl peroxide topical products is required prior to approval of branded products (see Appendix B for preferred alternatives). Exceptions are allowed if the member experiences clinically significant adverse effects or all preferred agents are contraindicated.

Step requirement: ≥2 preferred generic products tried and failed.
See Appendix B for the list of preferred alternatives and formulary exception criteria (CP.CPA.190).

Documentation Required

Provider must submit documentation supporting that the member meets all approval criteria. Acceptable documentation includes office chart notes, lab results, prior medication history, and other clinical information demonstrating diagnosis, prior treatment attempts, response to therapy, and any adverse effects or contraindications to preferred agents.

Include documentation of diagnosis (acne vulgaris) and age (≥12 years).
Document trials of ≥2 preferred generics with dates and outcomes, or documentation of adverse effects/contraindications.
For continuation requests, document prior approval or current receipt under Centene benefit, positive response to therapy, and dose (≤1 pump container per month).

Denial Risk

Denial Triggers / Risks

Requests for non‑FDA approved indications addressed by this policy will be denied unless sufficient documentation of efficacy and safety is provided per the off‑label use policies (CP.CPA.09) or evidence of coverage documents. Dose exceeding the policy limit (more than 1 pump container per month) will not be approved.

Non‑FDA indications require off‑label justification and supporting evidence per CP.CPA.09.
Dose limit: ≤1 pump container per month.
Denial risk if documentation of prior trials, response, or contraindications is incomplete.

Background

Clindamycin phosphate/benzoyl peroxide is a topical combination product used to treat acne vulgaris. The formulation pairs clindamycin phosphate, an antibacterial lincosamide, with benzoyl peroxide, an oxidizing agent that has bactericidal and keratolytic effects; together they reduce Cutibacterium acnes and help clear inflammatory and noninflammatory acne lesions. Brand formulations referenced in this policy include Onexton and Acanya, which are FDA‑approved for acne vulgaris in patients 12 years of age and older.

OpenPayer

Clindamycin Phosphate/Benzoyl Peroxide (Onexton, Acanya) - Clinical Policy

Coverage Criteria

Product Coding and Dose Limits

Provider Actions and Authorization Requirements

Background

Definitions