CurrentUnitedHealthcarePolicy 1 = 2025 P 3143-5

Step therapy for ketoconazole foam

Defines UnitedHealthcare's step therapy requirement that members try alternative topical antifungals (ciclopirox or ketoconazole shampoo) prior to coverage of ketoconazole foam for seborrheic dermatitis in eligible patients.

Policy Summary

PayerUnitedHealthcare

PolicyStep therapy for ketoconazole foam

Policy CodePolicy 1 = 2025 P 3143-5

Change TypeUpdated wording for discontinued brandmaterial change

Effective Date9/1/2025

Next Review Date

Key ActionObtain prior authorization and document failure, contraindication, or intolerance to ciclopirox or ketoconazole shampoo before requesting ketoconazole foam.

SourceLink

POLICY UPDATE CHANGES

Updated references and clarified generic products; removed brand Extina due to discontinuation.

Changed Extina to ketoconazole foam since the brand has been discontinued.

1auth duration (months)

12min age

2required prior products

2025-06last P&T

Coverage Criteria

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Initial therapy — Ketoconazole foam

Ketoconazole foam will be approved when ALL of the following are met:

Primary requirement

ONE of
- Option A: Ciclopirox (generic ciclopirox gel, generic Loprox)
- Option B: Ketoconazole shampoo (generic Nizoral)

Authorization length: Approval limited to 1 month authorization per policy.

The safety and efficacy of ketoconazole foam for treatment of fungal infections has not been established and it is not indicated for fungal infections.

Provider Actions & Requirements

Prior Authorization

Prior Authorization Required

Ketoconazole foam requires prior authorization and will be approved only if the member has a documented history of failure, contraindication, or intolerance to required step-therapy alternatives. Provider must submit a prior authorization (PA) request with the required documentation described below.

Authorization duration: 1 month
State mandates and member-specific benefit plan coverage may affect approval

Step Therapy

Required Step Therapies

Member must try one of the following before ketoconazole foam will be approved unless there is documented contraindication or intolerance:

Ciclopirox (generic ciclopirox gel / Loprox)
Ketoconazole shampoo (generic Nizoral)

Documentation Required

Required Documentation

Providers must include documentation with the PA demonstrating why the required step therapies are not appropriate or were unsuccessful. UnitedHealthcare may also approve based on prior claims/medication history, diagnosis codes (ICD-10), and/or claim logic when available.

Clinical documentation of prior failure, contraindication, or intolerance to ciclopirox or ketoconazole shampoo (e.g., progress notes, treatment history)
Relevant medication history or pharmacy claims confirming trial and discontinuation
Supporting diagnosis codes (ICD-10) as applicable
Note: Automated approval/re-approval processes may be used when prior claim/medication history and diagnosis support the request
Supply limits may apply

Initial Therapy Criteria

Initial therapy — Approval criteria and authorization length

Approval criteria and authorization length

Initial approval: History of failure, contraindication, or intolerance to ciclopirox or ketoconazole shampoo is required for coverage of ketoconazole foam.

Authorization will be issued for 1 month.

Step	Required prior therapy	Coverage action
1	Try ciclopirox (generic ciclopirox gel, Loprox) or ketoconazole shampoo (generic Nizoral)	Covered with criteria: ketoconazole foam will be approved only if patient has history of failure, contraindication, or intolerance to ciclopirox or ketoconazole shampoo

Quantity Limits

Quantity limits and related rules for ketoconazole foam

Quantity limit noteSupply limits may apply for ketoconazole foam.

Authorization durationAuthorization will be issued for 1 month.

Other constraintsState mandates, federal requirements, and member-specific benefit plan coverage may affect coverage.

Approval sourcesUnitedHealthcare may approve based on previous claim/medication history, diagnosis codes (ICD-10), and/or claim logic.

Definitions

Ketoconazole foam indication

IndicationTreatment of seborrheic dermatitis in immunocompetent patients aged 12 years and older.

Not indicated forSafety and efficacy for treatment of fungal infections has not been established; not indicated for fungal infections.

Step therapy contextProgram requires trial of ciclopirox or ketoconazole shampoo prior to coverage of ketoconazole foam.

Background

Ketoconazole foam is indicated for the treatment of seborrheic dermatitis in immunocompetent patients aged 12 years and older. The safety and efficacy of ketoconazole foam for treatment of fungal infections has not been established. This policy’s step therapy program encourages use of lower-cost alternatives by requiring a trial of ciclopirox or ketoconazole shampoo prior to coverage of ketoconazole foam.