CurrentUnitedHealthcarePolicy 2025 P 2241-5

Winlevi (clascoterone) prior authorization/medical necessity

Defines UnitedHealthcare prior authorization and medical necessity criteria for coverage of Winlevi (clascoterone) topical treatment for acne vulgaris for patients age 12 and older, including initial authorization, reauthorization, supply limits note, and potential automated approvals.

Policy Summary

PayerUnitedHealthcare

PolicyWinlevi (clascoterone) prior authorization/medical necessity

Policy CodePolicy 2025 P 2241-5

Change TypeAnnual review (no material change)

Effective DateNov 16, 2025

Next Review Date

Key ActionProviders must document diagnosis of acne vulgaris, age ≥12, and trials/failure or contraindication/intolerance to a topical retinoid, a topical antibiotic with benzoyl peroxide, and topical dapsone for initial approval; initial approvals are for 6 months.

POLICY UPDATE CHANGES

Annual review with no changes noted in 9/2025.

Policy program created in 6/2021 and subsequent annual reviews in 6/2022, 7/2023, 7/2024.

1Indication covered

12Minimum age (years)

6 monthsInitial authorization duration

6 monthsReauthorization duration

Coverage Summary

Coverage stance: covered_with_criteria; status: CURRENT; subject: Winlevi (clascoterone) prior authorization/medical necessity.

Scope summary: Defines UnitedHealthcare prior authorization and medical necessity criteria for coverage of Winlevi (clascoterone) topical treatment for acne vulgaris for patients age 12 and older, including initial authorization, reauthorization, supply limits note, and potential automated approvals.

Indication: Winlevi (clascoterone) is indicated for topical treatment of acne vulgaris in patients 12 years of age and older.

Initial Authorization

Winlevi will be approved based on all of the following criteria:

Diagnosis of acne vulgaris
Age: Patient is 12 years of age or older
Topical retinoid trial: History of failure, contraindication, or intolerance to an adequate trial of a topical retinoid (e.g. tretinoin)
Topical antibiotic + benzoyl peroxide trial: History of failure, contraindication, or intolerance to an adequate trial of a topical antibiotic in combination with benzoyl peroxide (e.g., benzoyl peroxide/clindamycin, benzoyl peroxide/erythromycin)
Topical dapsone trial: History of failure, contraindication, or intolerance to an adequate trial of a topical dapsone (e.g. dapsone topical)

Metadata

Initial Authorization Duration

Authorization duration if approved:

Initial Authorization Duration: Authorization will be issued for 6 months6 months

Reauthorization

Winlevi will be approved for reauthorization when the following are met:

Clinical response: Documentation of positive clinical response to therapy
HPA axis assessment: Patient has been assessed for signs of hypothalamus-pituitary-adrenal (HPA) axis suppression (e.g. fatigue, weight loss, abdominal pain, depression, muscle weakness)

Metadata

Reauthorization Duration

Reauthorization duration if approved:

Reauthorization Duration: Reauthorization will be issued for 6 months6 months

Additional Clinical Rules

Operational rules that may affect approvals:

Automated approvals: UnitedHealthcare may approve initial and reauthorization based solely on previous claim/medication history, diagnosis codes (ICD10) and/or claim logic
Use of automated approval and re-approval processes varies by program
Supply limits may be in place
Prior authorization or quantity limits may be applied operationally
Typical exclusion: Winlevi is typically excluded from coverage

Metadata

Applicable Codes

Relevant diagnosis codesICD-10

Acne vulgaris

Diagnosis referenced in policy (ICD-10 codes for acne vulgaris to be used as appropriate)

Drug identifiers mentionedNDC|mixed

Winlevi	clascoterone topical (brand)
tretinoin	example topical retinoid (generic Retin-A)
benzoyl peroxide/clindamycin	example topical antibiotic combination (generic Duac)
benzoyl peroxide/erythromycin	example topical antibiotic combination (generic Benzamycin)
dapsone	topical dapsone (e.g. generic Aczone)

Provider Actions / Prior Authorization

Prior Authorization

Prior authorization required with trials documented

Prior authorization is required. For initial approval, document: diagnosis of acne vulgaris; patient age ≥12 years; and history of failure, contraindication, or intolerance to adequate trials of the following topical therapies. Initial authorizations are issued for 6 months.

Topical retinoid (e.g., tretinoin / generic Ret-A)
Topical antibiotic combined with benzoyl peroxide (e.g., benzoyl peroxide/clindamycin or benzoyl peroxide/erythromycin)
Topical dapsone (e.g., generic Aczone)

Prior Authorization

Reauthorization documentation

For reauthorization, providers must document a positive clinical response to therapy. Reauthorizations are issued for 6 months.

Documentation Required

Clinical assessment for HPA axis suppression

Assess and document evaluation for hypothalamus–pituitary–adrenal (HPA) axis suppression at reauthorization. Examples of signs to assess and document include fatigue, weight loss, abdominal pain, depression, and muscle weakness.

Fatigue
Weight loss
Abdominal pain
Depression
Muscle weakness

Billing Rule

Supply limits may apply

Supply limits may be enforced operationally. UnitedHealthcare may apply prior authorization or quantity/supply limits and may use automated approvals or reauthorization based on prior claim/medication history, diagnosis codes, and claim logic.

Clinical Evidence & Guidance

Package insert: Winlevi [package insert], Sun Pharmaceuticals; July 2022.

Guideline: Guidelines of care for the management of acne vulgaris. J Am Acad Dermatol 2024;90:1006.e1-30.

Background note: The American Academy of Dermatology recommends topical therapies for mild acne and gives clascoterone a conditional recommendation.

Background & Definitions

Winlevi (clascoterone) is an androgen receptor inhibitor indicated for the topical treatment of acne vulgaris in patients 12 years of age and older. American Academy of Dermatology guidelines recommend topical therapies for mild acne (including retinoids, benzoyl peroxide, and topical antibiotics in combination with benzoyl peroxide) with clascoterone listed with a conditional recommendation.

HPA axis suppression: Clinical signs include fatigue, weight loss, abdominal pain, depression, muscle weakness and assessment for these signs is required at reauthorization.

Revision History

6/2021policy_created

Policy program created (new program).

6/2022annual_review

Annual review; updated references.

7/2023annual_review

Annual review; updated example to generic and updated references.

7/2024annual_review

Annual review; updated references.

9/2025annual_reviewLatest

Annual review with no changes noted in 9/2025.

Policy Summary

PayerUnitedHealthcare

PolicyWinlevi (clascoterone) prior authorization/medical necessity

Policy CodePolicy 2025 P 2241-5

Change TypeAnnual review (no material change)

Effective DateNov 16, 2025

Next Review Date

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