CurrentCignaPolicy IP0276

Topical Antiviral Products (acyclovir, penciclovir, Xerese)

Defines medical necessity criteria, authorization durations, reauthorization, and non-covered indications for topical antiviral products (acyclovir 5% cream/ointment, penciclovir 1% cream, Xerese). Applies to Cigna-administered health benefit plans; plan-specific terms may supersede this policy.

Policy Summary

PayerCigna

PolicyTopical Antiviral Products (acyclovir, penciclovir, Xerese)

Policy CodePolicy IP0276

Change TypeNo material change

Effective DateNov 1, 2023

Next Review DateNov 1, 2024

Key ActionProviders must document inadequate response, contraindication, or intolerance to TWO specified oral antivirals and relevant age/immune status when requesting coverage.

POLICY UPDATE CHANGES

No material changes to clinical or coverage criteria

6Topical products listed

12Auth duration (months)

2Required failed oral agents

ShinglesExample not covered

Coverage Summary

Scope: Defines medical necessity criteria, authorization durations, reauthorization, and non-covered indications for topical antiviral products (acyclovir 5% cream/ointment, penciclovir 1% cream, Xerese) and applies to Cigna‑administered health benefit plans; plan‑specific terms may supersede this policy. Policy number: IP0276.

Overview: This policy states the coverage stance as covered_with_criteria for topical antiviral products (acyclovir, penciclovir, and acyclovir/hydrocortisone combination) when the specified medical necessity criteria are met.

Coverage thresholds — age limits and prior therapy requirement

Age — Herpes Labialis (acyclovir/Denavir/Zovirax cream)>= 12 years

Age — Xerese (Recurrent Herpes Labialis)>= 6 years

Age — Genital Herpes and Mucocutaneous infections (ointment)>= 18 years

Prior therapy requirementInadequate response, contraindication, or intolerance to >= 2 listed oral antivirals (acyclovir, famciclovir, valacyclovir)

Medical Necessity Criteria (by product / indication)

General statement

The products in the table below are considered medically necessary when the following are met:

General statement: Use is for one of the specified indications covered below (Herpes Labialis, Recurrent Herpes Labialis, Genital Herpes, or Mucocutaneous Herpes Simplex Virus infections) and meets the product-specific criteria

Coverage varies across plans; refer to customer's benefit plan document. Receipt of sample product does not satisfy criteria.

acyclovir 5% cream - Herpes Labialis (Cold Sores)

Individual meets ALL of the following (A, B, and C):

A: Age: Individual is 12 years of age or older>= 12 years
B: Immune status: Individual is immunocompetent
C: Prior oral antiviral therapy: There is documentation the individual has had an inadequate response, contraindication, or is intolerant to TWO of the following oral antiviralsInadequate response/contraindication/intolerance to >= 2 of listed oral antivirals
Listed oral antivirals: acyclovir (capsules/tablets/suspension), famciclovir tablets, valacyclovir tablets

acyclovir 5% ointment - Genital Herpes

Individual meets BOTH of the following (A and B):

A: Age: Individual is 18 years of age or older>= 18 years
B: Prior oral antiviral therapy: There is documentation the individual has had an inadequate response, contraindication, or is intolerant to TWO of the followingInadequate response/contraindication/intolerance to >= 2 of listed oral antivirals
Listed oral antivirals: acyclovir (capsules/tablets/suspension), famciclovir tablets, valacyclovir tablets

acyclovir 5% ointment - Mucocutaneous Herpes Simplex Virus infections

Individual meets ALL of the following (A, B, and C):

A: Age: Individual is 18 years of age or older>= 18 years
B: Immune status: Individual is immunocompromised
C: Prior oral antiviral therapy: There is documentation the individual has had an inadequate response, contraindication, or is intolerant to TWO of the followingInadequate response/contraindication/intolerance to >= 2 of listed oral antivirals
Listed oral antivirals: acyclovir (capsules/tablets/suspension), famciclovir tablets, valacyclovir tablets

Denavir (penciclovir) 1% cream

Designated product; individual must meet the general topical antiviral rules and indication-specific requirements (e.g., prior oral therapy failure as specified by plan).

General rule: Individual meets ALL of the following criteria — specific indication criteria follow product rules
Providers must document prior oral antiviral therapy and age/immune status where required.

Xerese (acyclovir and hydrocortisone) 5%-1% cream

Recurrent Herpes Labialis (Cold Sores) criteria

A: Age: Individual is 6 years of age or older>= 6 years
B: Prior oral antiviral therapy: There is documentation the individual has had an inadequate response, contraindication, or is intolerant to TWO of the followingInadequate response/contraindication/intolerance to >= 2 of listed oral antivirals
Listed oral antivirals: acyclovir (capsules/tablets/suspension), famciclovir tablets

Zovirax 5% cream - Herpes Labialis

Individual meets ALL of the following criteria:

Zovirax (acyclovir) 5% cream - Herpes Labialis

A: Age: Individual is 12 years of age or older>= 12 years
B: Immune status: Individual is immunocompetent
C: Prior oral antiviral therapy: There is documentation the individual has had an inadequate response, contraindication, or is intolerant to TWO of the followingInadequate response/contraindication/intolerance to >= 2 of listed oral antivirals
Listed oral antivirals: acyclovir (capsules/tablets/suspension), famciclovir tablets, valacyclovir tablets

Zovirax 5% ointment - Genital Herpes

Individual meets BOTH of the following:

Zovirax (acyclovir) 5% ointment - Genital Herpes

A: Age: Individual is 18 years of age or older>= 18 years
B: Prior oral antiviral therapy: There is documentation the individual has had an inadequate response, contraindication, or is intolerant to TWO of the followingInadequate response/contraindication/intolerance to >= 2 of listed oral antivirals
Listed oral antivirals: acyclovir (capsules/tablets/suspension), famciclovir tablets, valacyclovir tablets

Reauthorization Criteria

Topical Antiviral Products are considered medically necessary for continued use when:

1: Initial criteria met: Initial criteria are met
2: Beneficial response: There is documentation of beneficial response

Provider Actions & Authorization Requirements

Prior Authorization

Documentation of prior oral antiviral therapy required

Providers must document inadequate response, contraindication, or intolerance to TWO specified oral antivirals (acyclovir, famciclovir, valacyclovir) as applicable to the product and indication when requesting coverage.

Documentation Required

Age and immune status documentation

Document the patient’s age and whether they are immunocompetent or immunocompromised as required by the specific indication (e.g., immunocompetent for herpes labialis creams; immunocompromised for mucocutaneous HSV infections).

Prior Authorization

Reauthorization requires benefit evidence

For continued coverage or reauthorization, document that the initial criteria were met and there is evidence of a beneficial response to therapy.

Billing Rule

Authorization duration

Initial authorization and any reauthorization approvals may be granted for up to 12 months.

Coding

No procedure or CPT/HCPCS codes specifiedmixed

No codes listed

Oral comparator drug formulations referenced (not coverage codes)NDC

acyclovir 200 mg capsule	referenced oral comparator formulation
acyclovir 400 mg tablet	referenced oral comparator formulation
acyclovir 800 mg tablet	referenced oral comparator formulation
acyclovir 200 mg/5 mL suspension	referenced oral comparator formulation
famciclovir tablets 125/250/500 mg	referenced oral comparator formulation
valacyclovir tablets 500/1000 mg	referenced oral comparator formulation

No codes listed

Background & Evidence

Background: This policy provides medical necessity criteria for several topical antiviral products including acyclovir 5% cream and ointment, Denavir (penciclovir) 1% cream, and Xerese (acyclovir/hydrocortisone) 5%-1% cream.

Plan variation: Coverage varies by plan and may require use of preferred products; refer to the customer's benefit plan document for specific coverage details.

Sample policy note: Receipt of sample product does not satisfy any criteria requirements for coverage.

Authorization and reauthorization: Initial and reauthorization approvals are up to 12 months, and continued use requires that initial criteria were met and there is documentation of a beneficial response.

Evidence	Summary
CDC guidance	Topical antivirals offer minimal benefit for genital herpes; oral antivirals recommended

Definitions

Definitions:

Inadequate response: Documented failure of therapeutic benefit from the compared oral antiviral agent(s) per clinical record.

Revision History

2023-11-01policy_effectiveLatest

Policy effective / last reviewed