ModifiedUnitedHealthcarePolicy 2025 P 3143-5

Ketoconazole foam - Step Therapy - UnitedHealthcare Commercial Plansopen_in_new

UnitedHealthcare step therapy program requiring trial of ciclopirox or ketoconazole shampoo before ketoconazole foam is approved for treatment of seborrheic dermatitis in immunocompetent patients aged 12 and older. Program applies to UnitedHealthcare commercial plans and may be subject to state mandates and member benefit specifics.

Policy Summary

PayerUnitedHealthcare

PolicyKetoconazole foam - Step Therapy - UnitedHealthcare Commercial Plansopen_in_new

Policy CodePolicy 2025 P 3143-5

Change TypeModified (6/2025 name standardization)

Effective DateSep 1, 2025

Next Review Date

Key ActionObtain documentation that the member has trialed and had failure, contraindication, or intolerance to ciclopirox (generic ciclopirox gel/Loprox) or ketoconazole shampoo (generic Nizoral) before approving ketoconazole foam.

SourceLink

POLICY UPDATE CHANGES

New step therapy program established for ketoconazole foam.

Annual reviews with no clinical changes documented in 2/2022, 2/2023, 2/2024.

6/2025 update changing Extina to ketoconazole foam and updating references.

1Required prior agents

12Minimum age (years)

1 moAuthorization duration

Program effective date

Policy summary & scope

Program applies to UnitedHealthcare commercial plans, effective 2025-09-01, and may be subject to state mandates and member-specific benefit rules; the program intent is to encourage use of lower-cost alternatives prior to ketoconazole foam coverage.

Approval criteria

Initial Approval Criteria

Ketoconazole foam will be approved based on the following criterion:

ALL of the following

Patient is immunocompetent and at least 12 years of age>= 12 years
Indication limited to seborrheic dermatitis
History of
- Failure to ciclopirox (generic ciclopirox gel, generic Loprox)
- Contraindication to ciclopirox (generic ciclopirox gel, generic Loprox)
- Intolerance to ciclopirox (generic ciclopirox gel, generic Loprox)
- Failure to ketoconazole shampoo (generic Nizoral)
- Contraindication to ketoconazole shampoo (generic Nizoral)
- Intolerance to ketoconazole shampoo (generic Nizoral)

ref": "b1_0

title": "Initial Approval Criteria

ref

Authorization Duration

Authorization will be issued for:

Initial approval duration: 1 month1 month

Additional Clinical Rules

Operational rules that may affect approvals:

UnitedHealthcare may approve initial and reauthorization based solely on previous claim/medication history, diagnosis codes (ICD-10) and/or claim logic

Automated approval/ re-approval processes vary by program

Supply limits may apply

State mandates, federal regulatory requirements, and member-specific benefit plans may impact coverage

Referenced codes and comparator products

Referenced diagnostic codingICD-10

No codes listed

Referenced comparator products (not billing codes)mixed

generic ciclopirox gel	generic ciclopirox (Loprox)
ketoconazole shampoo	generic Nizoral

Package insert: Ketoconazole [package insert], Xiromed, LLC; April 2020.

Review article: Del Rosso JQ. Adult Seborrheic Dermatitis: A Status Report on Practical Topical Management. J Clin Aesthet Dermatol. 2011;4(5):32-38.

Step Therapy: A utilization management program requiring trial of specified lower-cost alternatives before coverage of a requested medication.

Intolerance: An adverse reaction to a medication that prevents its continued use.

What clinicians and billers must do

Step Therapy

Step therapy trial requirement

Obtain documentation that the member has trialed and had failure, contraindication, or intolerance to ciclopirox (generic ciclopirox gel/Loprox) or ketoconazole shampoo (generic Nizoral) before approving ketoconazole foam.

Acceptable trial agents: generic ciclopirox gel (Loprox)
Acceptable trial agents: ketoconazole shampoo (generic Nizoral)
Trial may be documented as failure, contraindication, or intolerance

Prior Authorization

Authorization duration

When approved, authorize ketoconazole foam for a 1-month duration.

Authorize for 1 month.

Background and document changes

Indication: Ketoconazole foam is indicated for the treatment of seborrheic dermatitis in immunocompetent patients 12 years of age and older; the safety and efficacy of ketoconazole foam for treatment of fungal infections has not been established.

Program purpose: This step therapy program encourages use of lower-cost alternatives by requiring trial of ciclopirox or ketoconazole shampoo prior to coverage of ketoconazole foam.

8/2020Program created

New step therapy program established for ketoconazole foam.

2/2022Annual review

Annual review documented with no clinical policy changes.

Policy Summary

PayerUnitedHealthcare

PolicyKetoconazole foam - Step Therapy - UnitedHealthcare Commercial Plansopen_in_new

Policy CodePolicy 2025 P 3143-5

Change TypeModified (6/2025 name standardization)

Effective DateSep 1, 2025

Next Review Date

SourceLink

On This Page

Documentation Required

Supportive documentation for automated approvals

Be aware that approvals or reauthorizations may be granted based on prior claim/medication history, diagnosis codes, and claim logic without additional documentation; automated processes vary by program.

Approvals may be granted based on prior claims/medication history, diagnosis codes (ICD-10), and claim logic without requesting additional documentation

Denial Risk

Coverage constraints

Coverage may be denied if step therapy requirements are not met or if member-specific benefits/state mandates do not permit coverage.

Risk of denial if step therapy (trial of ciclopirox or ketoconazole shampoo) is not met
State mandates, federal requirements, or member-specific benefit plans may restrict coverage

2/2023Annual review

Annual review documented with no clinical policy changes.

2/2024Annual review

Annual review updated references and clarified generic products; removed brand Extina due to discontinuation.

6/2025Material changeLatest

Updated policy to change Extina to ketoconazole foam and updated references due to discontinuation of the brand.