Topical Acyclovir Products
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This policy governs prior authorization and coverage criteria for topical acyclovir products (Zovirax 5% cream and ointment and generics) for Cigna-administered health benefit plans. It affects prescribers and pharmacists seeking coverage for topical acyclovir for members under Cigna plans.
Genital herpes age requirement of 18 years removed.
Limited non-life-threatening mucocutaneous HSV infections language updated and age requirement removed.
Preferred product criteria now include intolerance to oral antiviral agents and inability to swallow tablets (with prior trial of oral suspension).
Coverage Criteria for Topical Acyclovir
inv-01: Acyclovir 5% cream — Herpes labialis (Cold Sores) — medically necessary when ALL of the following are met
Acyclovir 5% cream (Zovirax 5% cream, generic) is considered medically necessary when ALL of the following are met:
[[chunk 7]]
[[chunk 7]]
[[chunk 7]]
[[chunk 7],[9],[10]]
inv-02: Acyclovir 5% ointment — Genital herpes or limited mucocutaneous HSV — medically necessary when ONE of the following is met
Acyclovir 5% ointment (Zovirax 5% ointment, generic) is considered medically necessary when ONE of the following is met:
Approve for 1 year when preferred product criteria met [[chunk 8]]
Approve for 1 year when both conditions met [[chunk 8]]
inv-03: Preferred product criteria / step requirements — Employer and Individual/Family Plans: approve when ONE of the following is met
Preferred product criteria (Employer and Individual/Family Plans): approve when ONE of the following is met
Listed as examples in policy [[chunk 9],[10]]
Policy provides examples of oral antivirals (acyclovir tablets/capsules, famciclovir, valacyclovir) [[chunk 9],[10]]
Policy requires trial of oral suspension if inability to swallow [[chunk 9],[10]]
Specific to ointment per policy text [[chunk 11]]
Topical acyclovir products are not medically necessary for any use other than the covered indications specified in this policy. The policy explicitly lists topical acyclovir products for any other use as not medically necessary and notes that the list may not be exhaustive; criteria will be updated as new published data become available.
Use of topical acyclovir products for shingles (herpes zoster) is considered not medically necessary. The policy explains that shingles is caused by varicella zoster virus and that oral antivirals (acyclovir tablets/capsules/suspension, famciclovir, valacyclovir) are the recommended treatment; topical antivirals are not noted as treatment options for shingles.
Coding Guidance
Provider Actions, Documentation, and Billing
Prior authorization required; approvals typically 1 year
Prior authorization is required for benefit coverage of topical acyclovir products. When policy criteria are met, approvals are typically provided for the duration noted (commonly 1 year).
- Prior Authorization is required for topical acyclovir products.
- Approvals are typically for 1 year when the applicable criteria are met.
Preferred product step requirements and permitted alternatives
For Employer and Individual/Family Plans, topical acyclovir products require meeting one of the preferred product (step) criteria before coverage is approved.
- Trial of TWO oral antivirals (examples listed: acyclovir tablets/capsules, famciclovir tablets, valacyclovir tablets).
- Documented intolerance to an oral antiviral agent such that the patient cannot take any other oral antiviral agent.
- Inability to swallow tablets or capsules AND trial of acyclovir oral suspension.
Required documentation and coding at time of submission
Submit the most appropriate codes as of the date of service and documentation that supports the member meets the medical necessity criteria in this policy.
- Include clinical documentation demonstrating the diagnosis and that the patient meets applicable criteria (e.g., age, immune status, preferred product criteria).
- If relying on intolerance or inability to swallow, provide documentation (e.g., clinical notes) supporting the limitation and prior trials.
Claims without covered codes will be denied
Claims submitted without covered diagnosis or procedure codes under this Coverage Policy will be denied as not covered.
- When billing, use the most appropriate covered diagnosis/procedure codes as of the effective date of submission.
- Reimbursement is not allowed for services billed for conditions or diagnoses that are not covered under this Coverage Policy.
Background
Acyclovir topical formulations in this policy include cream and ointment preparations intended for localized herpes simplex infections. The document distinguishes approved uses (for example, acyclovir 5% cream for recurrent herpes labialis in appropriate patients and acyclovir 5% ointment for certain genital or limited mucocutaneous HSV infections) from other uses. The policy further clarifies that topical acyclovir is not an appropriate therapy for infections caused by varicella zoster virus (shingles), for which oral antiviral agents are the recommended treatment; topical antivirals are not listed as treatment options for shingles in guideline sources cited by the policy.
Definitions
Initial Therapy Requirements
inv-15: Initial therapy requirements — initial authorization requires meeting preferred product/step criteria
Initial authorization requires meeting preferred product/step criteria
Employer and Individual plan language require meeting one of these alternatives before topical product coverage [[chunk 9],[10]]
Continuation / Approval Duration
inv-16: Continuation / approval duration — duration of approvals when criteria met
Duration of approvals when criteria met
[[chunk 7],[8]]
Step Therapy and Alternatives
| Step | Requirement before topical product coverage |
|---|---|
| 1 | Patient has tried TWO of the following oral antivirals: acyclovir capsules or tablets; famciclovir tablets; valacyclovir tablets. |
| 2 | Patient has an intolerance to an oral antiviral agent and cannot take any other oral antiviral agent. |
| 3 | Patient cannot swallow or has difficulty swallowing tablets or capsules AND has tried acyclovir oral suspension. |
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