CurrentCignaPolicy IP0752

Topical Acyclovir Products (acyclovir 5% cream and ointment)

This policy governs prior authorization and coverage criteria for topical acyclovir 5% cream and ointment (Zovirax and generics) for covered Cigna health benefit plans. It specifies indications, required criteria, and non-covered uses.

Policy Summary

PayerCigna

PolicyTopical Acyclovir Products (acyclovir 5% cream and ointment)

Policy CodePolicy IP0752

Change TypeMaterial clinical revisions (criteria updates and additions)

Effective Date

Next Review Date

Key ActionObtain prior authorization for topical acyclovir products and document required criteria to secure a 1-year approval when indications are met.

SourceLink

POLICY UPDATE CHANGES

Removed age requirement of 18 years of age or older for Genital Herpes

Updated 'Mucocutaneous Herpes Simplex Virus infections' to 'Limited Non-Life-Threatening Mucocutaneous Herpes Simplex Virus Infections'

Added preferred product criteria allowing approval when patient has intolerance to oral antivirals and cannot take any other oral antiviral, with examples

Removed preferred product step requirement criteria for Denavir and Xerese for Employer Plans

2 formulationstopical products covered

1 yearstandard approval duration

≥12 yrsminimum age (cream)

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Coverage Criteria

Acyclovir 5% cream (Herpes labialis)

Covered when ALL of the following are met

Herpes labialis criteria: A) Patient is ≥ 12 years of age; AND B) Patient is immunocompetent; AND C) Preferred product criteria is met for the products as listed in the below tablesN/A

Approve for 1 year if all met

Acyclovir 5% ointment (Genital herpes and limited mucocutaneous infections)

Covered when ONE of the following groups is met

Genital Herpes: Preferred product criteria is met for the products as listed in the below tablesN/A

Approve for 1 year

Limited Non-Life-Threatening Mucocutaneous HSV Infections: A) Patient is immunocompromised; AND B) Preferred product criteria is met for the products as listed in the below tablesN/A

Approve for 1 year

Preferred Product Criteria (Employer and Individual Plans)

For preferred product approval, ONE of the following must be met

Oral antiviral trials: Patient has tried TWO of: acyclovir capsules or tablets; famciclovir tablets; valacyclovir tablets2 agents tried

Examples of oral antivirals are listed in policy

Intolerance to oral antivirals: Patient has an intolerance to an oral antiviral agent and cannot take any other oral antiviral agentN/A

Policy lists examples of oral antivirals

Swallowing impairment: Patient cannot swallow or has difficulty swallowing tablets or capsules AND has tried acyclovir oral suspensionPrior trial of oral suspension required

Brand (Zovirax) exception for ointment

Individual/Family Plans additional clause

Brand vs generic ointment: Patient has tried the bioequivalent generic acyclovir 5% ointment [may require prior authorization], AND cannot take the generic due to a formulation difference in inactive ingredient(s) that, per the prescriber, would cause a significant allergy or serious adverse reactionN/A

Specific to Zovirax (brand) ointment for Individual and Family Plans

Topical acyclovir products used for indications other than those specifically listed as covered in this policy are considered not medically necessary. The policy explicitly lists off‑label and non‑covered uses; providers should not expect coverage for topical acyclovir when the clinical indication falls outside the approved criteria (see covered indications for cream and ointment).

Use of topical acyclovir for shingles (Herpes Zoster) is considered not medically necessary. The policy notes that shingles is caused by varicella zoster virus and that oral antivirals (acyclovir capsules/tablets/suspension, famciclovir, valacyclovir) are the recommended treatments; topical antivirals are not listed as treatment options for shingles.

Coding

Covered Topical Products (by product description)mixedCovered

acyclovir 5% cream	Zovirax (acyclovir 5% cream) and generics
acyclovir 5% ointment	Zovirax (acyclovir 5% ointment) and generics

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior Authorization is required for benefit coverage of topical acyclovir products. Requests should include clinical documentation supporting the requested indication and any prior trials or intolerances to oral antivirals when applicable.

Applies to topical acyclovir 5% cream and 5% ointment (Zovirax and generics).
Include diagnosis, relevant medical history, and prior medication trial information in the PA submission.

Documentation Required

Approval Duration

Approvals are issued for the durations listed by indication below. Ensure the submitted request specifies the indication to align with the correct approval period.

Herpes labialis (cold sores): Approve for 1 year when patient is ≥ 12 years, immunocompetent, and preferred product criteria are met.
Genital herpes: Approve for 1 year when preferred product criteria are met.

Definitions

inv-14: Limited Non-Life-Threatening Mucocutaneous Herpes Simplex Virus Infections — definition and scope clarification

TermLimited Non-Life-Threatening Mucocutaneous Herpes Simplex Virus Infections

ScopeIncludes mucocutaneous HSV infections that are limited in extent and not life-threatening, occurring in immunocompromised patients

Applicable productAcyclovir 5% ointment (Zovirax and generics)

Patient populationImmunocompromised patients (per policy language)

Approval conditionApprove for 1 year when patient is immunocompromised AND preferred product criteria are met

Exclusion noteDoes not expand indication to life‑threatening or systemic HSV infections; topical products for other uses are not medically necessary

Background

Topical acyclovir products included in this policy are acyclovir 5% cream and acyclovir 5% ointment (Zovirax and generics). The cream formulation is indicated for recurrent herpes labialis (cold sores) and coverage requires the patient to be ≥ 12 years of age and immunocompetent, with preferred product criteria met. The ointment formulation is indicated for genital herpes (initial treatment) and for limited non‑life‑threatening mucocutaneous herpes simplex virus infections in immunocompromised patients, with preferred product criteria met. Prior authorization is required for these topical acyclovir products, and approvals for approved indications are provided for 1 year when criteria are satisfied.

Revision History

2025-11-01Annual RevisionLatest

Removed age requirement of 18 years for genital herpes; updated phrase to 'Limited Non-Life-Threatening Mucocutaneous Herpes Simplex Virus Infections'; added preferred product criteria allowing approval when patient has intolerance to oral antivirals and cannot take any other oral antiviral; added criterion for inability to swallow with trial of acyclovir oral suspension; removed preferred product step requirement for Denavir and Xerese for Employer Plans.