CurrentCignaPolicy N/A

Topical Acyclovir Products Prior Authorization with Step Therapy Policy

Defines prior authorization and step therapy requirements for topical acyclovir 5% cream and ointment (Zovirax and generics) for Cigna-administered health benefit plans; affects prescribers and pharmacies submitting PA requests.

Policy Summary

PayerCigna

PolicyTopical Acyclovir Products Prior Authorization with Step Therapy Policy

Policy CodePolicy N/A

Change TypeRevised clinical criteria

Effective DateN/A

Next Review DateJul 16, 2025

Key ActionObtain prior authorization and follow step therapy: try generic acyclovir 5% ointment before approving brand Zovirax 5% ointment unless documented inability to use the generic.

SourceLink

POLICY UPDATE CHANGES

Clarified reasons a patient cannot use a generic product from 'dyes, fillers, and preservatives' to more specific inactive ingredient differences: buffers, emollients, emulsifiers, and surfactants.

2products covered (cream and ointment)

1 yearapproval duration

≥12min age for labialis

requiredstep therapy

Coverage Criteria

Herpes Labialis (Topical Acyclovir 5% cream)

Covered when ALL of the following are met:

Herpes labialis criteria

Patient is >= 12 years of age.
Patient is immunocompetent.

Genital Herpes (Topical Acyclovir 5% ointment)

Approve for 1 year if ONE of the following is met:

Genital herpes options

Generic acyclovir 5% ointment is requested.
ALL of the following

Policy Summary

PayerCigna

PolicyTopical Acyclovir Products Prior Authorization with Step Therapy Policy

Policy CodePolicy N/A

Change TypeRevised clinical criteria

Effective DateN/A

Next Review DateJul 16, 2025

Key ActionObtain prior authorization and follow step therapy: try generic acyclovir 5% ointment before approving brand Zovirax 5% ointment unless documented inability to use the generic.

SourceLink

On This Page

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Limited Non-Life-Threatening Mucocutaneous HSV Infections

Approve for 1 year if ALL of the following are met:

Limited mucocutaneous HSV infections

Patient is immunocompromised.
ANY of the following
- Generic acyclovir 5% ointment is requested.
- ALL of the following
  - Patient has tried generic acyclovir 5% ointment.
  - Patient cannot use the generic product due to a formulation difference in the inactive ingredient(s) (e.g., difference in buffers, emollients, emulsifiers, preservatives, surfactants) which, per the prescriber, would result in a significant allergy or serious adverse reaction.

Provider Actions & Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is recommended for prescription benefit coverage of topical acyclovir products. Approvals are provided for the durations specified in the coverage criteria (typically 1 year for approved indications). This policy includes a step therapy requirement for acyclovir ointment: patients should try the Step 1 product (generic acyclovir 5% ointment) before coverage of brand Zovirax (acyclovir 5% ointment) is approved, unless a clinical exception is documented.

Prior authorization recommended for topical acyclovir products; approvals granted for specified durations (usually 1 year).
Step therapy: Step 1 — trial of generic acyclovir 5% ointment required prior to approval of Zovirax (acyclovir 5% ointment) except when prescriber documents inability to use generic due to formulation-related allergy or serious adverse reaction.
For genital herpes and certain mucocutaneous HSV infections: approval pathways allow direct generic request or documented trial/failure or intolerance to generic as specified in criteria.

Step Therapy

Step Therapy for Ointment

Step therapy applies to requests for brand Zovirax (acyclovir 5% ointment). Approve when the member has tried generic acyclovir 5% ointment and either clinical response was inadequate or the prescriber documents that the member cannot use the generic because of a clinically significant allergy or serious adverse reaction attributable to differences in inactive ingredients.

Step 1: Trial of generic acyclovir 5% ointment required.
Step 2: Zovirax (acyclovir 5% ointment) may be approved if Step 1 requirement met or a documented formulation-related intolerance/allergy exists.

Documentation Required

Billing Documentation

When submitting prior authorization requests and claims, include the applicable covered diagnosis and/or procedure codes supporting medical necessity. Use the most appropriate and current codes as of the request/claim date. Requests or claims submitted without the covered diagnosis or procedure codes referenced in the applicable Coverage Policy will be denied as not covered.

Include covered diagnosis/procedure codes that match the Coverage Policy's indications (e.g., herpes labialis, genital herpes, or mucocutaneous HSV infections).
Supply clinical documentation supporting step therapy exceptions (e.g., reason generic not tolerated, trial history).
Ensure coding reflects FDA-approved indication or supported off-label use per the policy to avoid denial.

Background

Topical acyclovir 5% is available as a cream and an ointment, with specific FDA-approved indications addressed by this policy. The 5% cream formulation is indicated for recurrent herpes labialis (cold sores) in immunocompetent patients aged ≥ 12 years. The 5% ointment formulation is indicated for genital herpes (initial treatment) and for certain limited, non–life-threatening mucocutaneous HSV infections (including use in some immunocompromised patients). Prior authorization is recommended for topical acyclovir products, and approvals are provided for the durations specified in the criteria (typically 1 year); step therapy favors generic acyclovir 5% ointment before brand ointment when clinically appropriate.

Definitions

Herpes labialis — definition and age/indication summary

DefinitionHerpes labialis (cold sores): recurrent lesions of the lips/face treated with topical acyclovir 5% cream

Age/indication summaryIndicated for immunocompetent patients ≥ 12 years of age

Approval logicApprove for 1 year if patient is ≥ 12 years and is immunocompetent

Genital herpes — definition and relation to ointment/formulary/step-therapy

DefinitionGenital herpes: indication for topical acyclovir 5% ointment for initial treatment

Step-therapy / formulary relationGeneric acyclovir 5% ointment is preferred; brand (Zovirax) requires prior trial of generic or documented inability to use generic due to inactive ingredient differences

Approval durationApprove for 1 year if one of the specified criteria is met

Limited mucocutaneous HSV infections — definition for topical ointment use in immunocompromised patients

DefinitionLimited non-life-threatening mucocutaneous HSV infections: topical acyclovir 5% ointment use in immunocompromised patients

Clinical requirementsPatient must be immunocompromised

Generic-first requirementGeneric acyclovir 5% ointment is requested or patient has tried generic and cannot use it due to formulation differences in inactive ingredients (e.g., buffers, emollients, emulsifiers, preservatives, surfactants)

Approval durationApprove for 1 year when criteria are met

Zovirax (acyclovir 5% cream)	Zovirax 5% cream (Bausch Health, generic)
Zovirax (acyclovir 5% ointment)	Zovirax 5% ointment (Bausch Health, generic)

OpenPayer

Topical Acyclovir Products Prior Authorization with Step Therapy Policy

Coverage Criteria

Coding

Provider Actions & Requirements

Background

Definitions