CurrentMass General Brigham Health PlanPolicy N/A

Carac (fluorouracil)

Prior authorization policy for specified topical topical dermatologic agents (Carac, Fluoroplex, Picato, Tolak, Zyclara) under the pharmacy benefit for Commercial/Exchange plan members, effective 01/01/2024. Governs authorization criteria for members new to plan and initial approval duration.

Policy Summary

PayerMass General Brigham Health Plan

PolicyCarac (fluorouracil)

Policy CodePolicy N/A

Change TypeAdministrative/format change

Effective DateJan 1, 2024

Next Review Date

Key ActionPrior authorization is required under the pharmacy benefit for Commercial/Exchange members for the listed medications.

SourceLink

POLICY UPDATE CHANGES

Policy format switched from SGM to Custom and review occurred 12/13/2023 with effective date 1/1/2024.

5Drugs listed

12 monthsInitial approval duration

Coverage Summary

This policy is a prior authorization policy under the pharmacy benefit for Commercial/Exchange members, effective 01/01/2024, governing the topical dermatologic agents: Carac, Fluoroplex, Picato, Tolak, and Zyclara. Coverage stance: covered_with_criteria. Policy subject: Topical treatments for actinic keratosis and external genital warts.

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Applicable Codes

Drugs governed by this policyNDCCovered

Carac (fluorouracil)	Topical treatment of multiple actinic or solar keratoses of the face and anterior scalp
Fluoroplex (fluorouracil)	Topical cream indicated for multiple actinic (solar) keratoses
Picato (ingenol mebutate)	Topical gel indicated for actinic keratosis
Tolak (fluorouracil)	Topical treatment of actinic keratosis lesions of the face, ears, and/or scalp
Zyclara (imiquimod)	Cream 2.5% and 3.75% indicated for actinic keratoses of full face or balding scalp; 3.75% also for external genital and perianal warts in patients >= 12 years

Provider Actions & Requirements

Prior Authorization

Prior authorization required

Prior authorization is required under the pharmacy benefit for Commercial/Exchange members for the listed medications.

Prior Authorization

Continuity for members new to plan

Authorization may be granted for members new to the plan who are currently receiving treatment with the requested medication, excluding when product was obtained as samples or via manufacturer's patient assistance programs.

Documentation Required

Diagnosis required

Document diagnosis of actinic keratosis for authorization; for Zyclara also document diagnosis of external genital warts when applicable.

Billing Rule

Initial approval duration

Initial approvals will be granted for 12 months.

Background & Definitions

This policy lists FDA-indicated topical therapies for actinic keratosis and Zyclara's additional indication for external genital warts, and establishes prior authorization criteria and continuity rules under the pharmacy benefit for Commercial/Exchange members.

Continuity for new members: Members new to the plan who are currently receiving treatment with the requested medication may have authorization granted, excluding products obtained as samples or via manufacturer's patient assistance programs.