ModifiedPremera BluecrossPolicy N/A

Topical pharmacologic treatment of actinic keratosis

This policy governs pharmacy-benefit coverage and medical necessity criteria for topical drugs used to treat actinic keratosis (AK) and some indications for external genital and perianal warts (EGW) for Premera Blue Cross members.

Policy Summary

PayerPremera Bluecross

PolicyTopical pharmacologic treatment of actinic keratosis

Policy CodePolicy N/A

Change TypeMaterial updates — added generic imiquimod 3.75% coverageremoved discontinued brand products

Effective DateMar 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization under the pharmacy benefit; document trials of generic imiquimod 5% and a generic topical fluorouracil and submit office visit notes to show medical necessity.

SourceLink

POLICY UPDATE CHANGES

Added coverage criteria for generic imiquimod 3.75% for the treatment of actinic keratosis and external genital and perianal warts (EGW).

Removed Aldara (imiquimod 5%) and brand imiquimod 3.75% from the policy because they have been discontinued and are no longer commercially available.

Clarified that the medications listed in this policy are subject to the product's FDA dosage and administration prescribing information.

Clarified that non-formulary exception review authorizations for all drugs listed in this policy may be approved up to 12 months.

Up to 12 monthsMax auth period

added: 1Generic added

removed: 2Brand removed

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Coverage Criteria

Topical agent coverage criteria (Carac, brand fluorouracil, Klisyri, Tolak, Zyclara, generic imiquimod 3.75%)

Covered when ALL of the following are met for the specified topical drugs:

Age: Individual is aged 18 years and older (age requirement based on FDA labeling).>=18 years

Applies to Carac (fluorouracil 0.5%), brand fluorouracil, Klisyri (tirbanibulin), Tolak (fluorouracil 4%), Zyclara (imiquimod 2.5% and 3.75%), and generic imiquimod 3.75% when used for actinic keratosis.

Prior imiquimod trial: Has tried generic imiquimod 5% first and had an inadequate response or intolerance to generic imiquimod 5%, unless use is contraindicated.trial and inadequate response/intolerance

Step requirement prior to many branded or alternative topical agents.

Prior topical fluorouracil trial: Has tried one generic topical fluorouracil product first and had an inadequate response or intolerance to topical fluorouracil, unless use is contraindicated.trial and inadequate response/intolerance

Step requirement prior to many listed agents.

Generic imiquimod 3.75% coverage for EGW

Covered when ALL of the following are met for generic imiquimod 3.75% for external genital and perianal warts (EGW):

Age (EGW): Individual is aged 12 years and older for external genital and perianal warts.>=12 years

Applies specifically to generic imiquimod 3.75% when used for EGW.

Prior imiquimod 5% trial for EGW: Has tried generic imiquimod 5% first and had an inadequate response or intolerance to generic imiquimod 5%.trial and inadequate response/intolerance

Step requirement for generic imiquimod 3.75% in EGW per policy.

Updates affecting covered products

Policy updates and coverage clarifications:

Product availability and formulation: Coverage is maintained for listed topical agents that are commercially available; discontinued brand products (Aldara (imiquimod 5%) and brand imiquimod 3.75%) were removed from the policy and are no longer covered, and coverage criteria were added for generic imiquimod 3.75% for actinic keratosis and EGW.

Reviewers should reference FDA prescribing information for dosing and administration; non-formulary exception approvals for listed drugs may be authorized for up to 12 months.

All uses of the topical agents listed in this policy that are not specifically described in the coverage criteria are considered investigational. Reviewers should apply the policy’s specified indications and limits; requests for care outside those indications may be denied as investigational.

Brand products that have been discontinued are not covered because they are no longer commercially available. Examples removed from this policy include Aldara (imiquimod 5%) and brand imiquimod 3.75%.

In the 2025 update the policy was revised to remove discontinued brand products and to add coverage criteria for the generic formulation of imiquimod 3.75%. Requests for products that have been discontinued (for example, Aldara (imiquimod 5%) and brand imiquimod 3.75%) will be denied because those products are no longer commercially available; providers should confirm and document the specific product and strength for any request.

This medical policy is a guide for determining medical necessity and coverage; actual benefits are subject to the limits and conditions of each member’s benefit plan. Reviewers and providers must consult the member’s benefit booklet or customer service for plan-specific coverage. This policy does not apply to Medicare Advantage.

Provider Actions and Operational Notes

Prior Authorization

Pharmacy benefit prior authorization

Prior authorization is required under the pharmacy benefit for the medications listed in this policy. Submit a pharmacy benefit prior authorization request when seeking coverage for any listed product.

Non-formulary exception reviews for drugs listed in this policy may be approved for up to 12 months.
All other reviews for initial authorization and re-authorization may be approved for up to 12 months when coverage criteria are met and chart notes document continued positive clinical response.

Prior Authorization

Non-formulary exception duration

Non-formulary exception review authorizations for drugs listed in this policy may be approved for up to 12 months. Re-authorization may also be approved for up to 12 months provided the drug-specific coverage criteria continue to be met and chart notes document ongoing clinical benefit.

Coding

No applicable codesmixed

No codes listed

Background

Actinic keratoses (AK) are common, rough, scaly precancerous epithelial lesions that result from cumulative ultraviolet light exposure and most often occur on chronically sun-exposed skin such as the face, scalp, neck, and hands. Although only a minority of AKs progress to invasive squamous cell carcinoma over time, treatment is commonly pursued; choice of therapy depends on lesion number and distribution, prior response, and tolerability. Topical field therapies and photodynamic therapy are commonly used to treat multiple lesions and reduce risk of progression.

Definitions

Actinic keratosis (AK) — Definition and typical locations.

DefinitionA rough, scaly precancerous lesion resulting from chronic ultraviolet (UV) light exposure.

Typical locationsFace, scalp (including bald scalp), neck, ears, lips, back of hands, and forearms.

Clinical significanceConsidered precancerous with a minority transforming to squamous cell carcinoma over years; often treated to reduce cancer risk.

Presentation noteLesions are often more easily felt than seen and may be itchy or painful.

Treatment contextTreatment options include lesion-directed procedures (e.g., cryotherapy), topical therapies, and photodynamic therapy; choice depends on lesion number and location.

EGW — External genital warts definition.