CurrentCentenePolicy CP PMN.165

Fluorouracil Cream (Tolak) — Coverage Criteria for Actinic Keratosis

Defines Centene's medical necessity criteria, prior authorization and continuation requirements for Tolak (fluorouracil 4% cream) when used to treat actinic keratosis of the face, ears, or scalp for applicable lines of business.

Policy Summary

PayerCentene

PolicyFluorouracil Cream (Tolak) — Coverage Criteria for Actinic Keratosis

Policy CodePolicy CP PMN.165

Change TypeNo material change

Effective DateDec 1, 2018

Next Review DateNov 24, 2024

Key ActionPrior authorization is required and providers must submit documentation supporting that the member meets all approval criteria.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

4 weeksstandard approval duration

4%product concentration

40 gpack size

Coverage Criteria for Tolak (fluorouracil 4% cream)

Initial Approval

Covered when ALL of the following are met

Policy Summary

PayerCentene

PolicyFluorouracil Cream (Tolak) — Coverage Criteria for Actinic Keratosis

Policy CodePolicy CP PMN.165

Change TypeNo material change

Effective DateDec 1, 2018

Next Review DateNov 24, 2024

Key ActionPrior authorization is required and providers must submit documentation supporting that the member meets all approval criteria.

SourceLink

On This Page

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Continuation Therapy

Continued therapy — Covered when ANY of the following apply (and additional conditions are met)

Continued Therapy Options: a) Member currently receiving medication via Centene benefit or previously met initial approval criteria; b) Member currently receiving medication and enrolled in a state/product with continuity of care regulations.

Member must be responding positively to therapy; Tolak therapy for the current requested use has not exceeded 4 weeks; if request is for a dose increase, new dose must not exceed once daily. Approval duration: Up to 4 weeks total per treatment course.

Not Authorized Indications

Not Authorized: Coverage is not authorized for non‑FDA‑approved indications that are not addressed in this policy unless there is sufficient documentation of efficacy and safety per the applicable off‑label use policies (e.g., CP.CPA.09, HIM.PA.154, CP PMN.53) or evidence of coverage documents.

Refer to off‑label and formulary/no‑coverage policies for adjudication.

Fluorouracil topical cream is contraindicated in individuals with known dihydropyrimidine dehydrogenase (DPD) deficiency and in pregnancy. Requests for members with these conditions should be denied in accordance with the contraindications specified in the policy.

Coverage is not authorized for diagnoses or indications that are not FDA-approved and are not specifically addressed in this policy unless there is sufficient documentation of efficacy and safety provided per the applicable off‑label use policies (see referenced off‑label policies for adjudication).

Use of Tolak (fluorouracil topical cream) for non–FDA‑approved indications is not authorized under this policy unless the provider submits sufficient documentation demonstrating efficacy and safety. Such documentation must align with the applicable off‑label use policies (CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP PMN.53 for Medicaid) or other evidence of coverage requirements.

Providers must include supporting clinical information with prior authorization requests (for example, office chart notes, relevant diagnostic data, and any literature or rationale supporting off‑label use). Requests lacking sufficient off‑label justification or the required documentation may be denied.

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior Authorization Required for Tolak. Initial approval is granted only when all clinical criteria are met.

Prior authorization required prior to initiation of Tolak.
Approval duration: Initial approval — 4 weeks.

Documentation Required

Documentation Submission Requirement

Provider must submit clinical documentation supporting that the member meets all approval criteria (for example: office chart notes, lesion assessments, prior topical fluorouracil treatment history, lab results or other relevant clinical information). Requests lacking required documentation will be denied.

Documentation should demonstrate diagnosis, prior therapies, response to treatment, and dosing.
Failure to provide adequate documentation or to support non‑FDA uses will result in denial per policy.

Note

Therapeutic Alternatives and Formulary Preference

Therapeutic alternatives and formulary preference: other fluorouracil 5% topical preparations (e.g., Efudex [fluorouracil 5% cream]) are preferred alternatives and should be considered prior to Tolak when appropriate. Dosing examples: fluorouracil 5% cream — apply to lesions BID for 2 to 6 weeks (per product labeling).

Examples of therapeutic alternatives: fluorouracil 5% topical cream (Efudex).
Formulary status may vary by line of business and may require prior authorization.

Denial Risk

Denial Risk for Insufficient Documentation or Non‑FDA Uses

Requests for non–FDA‑approved indications are not authorized under this policy unless sufficient clinical documentation supports efficacy and safety consistent with Centene off‑label use policies (CP.CPA.09, HIM.PA.154, CP PMN.53) or applicable evidence of coverage documents. Requests lacking such support will be denied.

Non‑FDA uses require robust supporting documentation per off‑label policies.
Refer to state‑specific addendums for continuity of care regulations when applicable.

Background

Fluorouracil topical cream is a topical nucleoside metabolic inhibitor used to treat actinic keratosis lesions of the face, ears, and scalp. Tolak is available as a 4% topical cream and, per the policy, is applied once daily for a standard treatment course of 4 weeks for the FDA‑labeled sites.

Contraindications noted in the policy include DPD deficiency and pregnancy, and prior authorization is required for Tolak with approval granted only when the specified actinic keratosis criteria (site, dosing not exceeding once daily, and treatment duration limits) are met.

Definitions

DPD — Dihydropyrimidine dehydrogenase deficiency as a contraindication

DefinitionDihydropyrimidine dehydrogenase (DPD) deficiency

Clinical significanceDPD deficiency is listed as a contraindication to fluorouracil topical therapy (Tolak).

AbbreviationDPD = dihydropyrimidine dehydrogenase deficiency

Related safety notePregnancy is also listed as a contraindication in the policy's contraindications section.

Source locationAppendices: definition and contraindications (Appendix A and Appendix C).

OpenPayer

Fluorouracil Cream (Tolak) — Coverage Criteria for Actinic Keratosis

Coverage Criteria for Tolak (fluorouracil 4% cream)

Coding and Billing Notes

Provider Actions and Requirements

Background

Definitions