CurrentCentenePolicy CP.PMN.210

Acyclovir Buccal Tablet (Sitavig) Coverage

Defines medical necessity and prior authorization criteria for Sitavig (acyclovir buccal tablet) for treatment of recurrent herpes labialis in adults for Centene-affiliated lines of business.

Policy Summary

PayerCentene

PolicyAcyclovir Buccal Tablet (Sitavig) Coverage

Policy CodePolicy CP.PMN.210

Change TypeStep therapy additionIllinois HIM exemption

Effective DateNov 16, 2016

Next Review DateNov 25, 2025

Key ActionProvider must obtain prior authorization and document age ≥18, diagnosis of recurrent herpes labialis, trial of preferred oral acyclovir unless contraindicated or inability to swallow, and dose ≤50 mg (1 tablet).

SourceLink

POLICY UPDATE CHANGES

Added step therapy bypass for Illinois HIM per IL HB 5395.

Revised initial-criteria language to require use of preferred formulary oral acyclovir formulations unless contraindicated or not tolerated.

50 mgtablet strength

≥18minimum age

1 monthinitial approval

No re-authcontinuation

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Coverage Criteria

Initial Therapy

Covered when ALL of the following are met:

Herpes Labialis initial criteria: Diagnosis of recurrent herpes labialis (cold sores)

Herpes Labialis initial criteria: Age ≥ 18 years

Herpes Labialis initial criteria: Member must use preferred formulary oral acyclovir formulation (e.g., generic tablets, capsules, or oral suspension) unless contraindicated, clinically significant adverse effects occur, or documentation supports inability to swallow oral formulations

Herpes Labialis initial criteria: Dose does not exceed 50 mg (1 tablet)≤ 50 mg (1 tablet)

Other Indications / Off-label

Alternative routing for other indications or recently changed labeling:

Other indications handling: If this drug has had a label change within the last 6 months not yet reflected in this policy, follow the applicable formulary/no-coverage or non-formulary policy for the relevant line of business (see CP.CPA.190, HIM.PA.33, CP.PMN.255 or CP.CPA.190, HIM.PA.103, CP.PMN.16 as applicable)

Other indications handling: If the requested use (diagnosis, age, dosing) is not listed under section III AND the recent label change criterion does not apply, refer to the off-label use policy for the relevant line of business (CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, CP.PMN.53 for Medicaid)

Requests for uses that are non‑FDA approved and are not explicitly addressed in this policy are not authorized unless the provider submits sufficient documentation demonstrating efficacy and safety per the applicable off‑label use policy (CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, or CP.PMN.53 for Medicaid) or other evidence of coverage documents.

For the indication of herpes labialis, re‑authorization is not permitted. Members seeking additional courses beyond the initial approval must meet the initial approval criteria again; continuation beyond the initial authorization is not authorized and approval duration for reauthorization is not applicable.

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Approval will be granted when the initial criteria for recurrent herpes labialis are met, including age ≥18, a diagnosis of recurrent herpes labialis (cold sores), use of preferred formulary acyclovir formulation unless contraindicated or not tolerated, and dose not exceeding 50 mg (1 tablet). Approval duration: 1 month (up to 2 doses).

Approval duration: 1 month (up to 2 doses)
Dose limit: ≤ 50 mg (1 tablet)
Age: ≥ 18 years
Member must use preferred formulary acyclovir formulation unless contraindicated or unable to swallow oral formulations

Step Therapy

Step Therapy Requirement

Member must use a preferred formulary acyclovir formulation (e.g., generic tablets, capsules, or oral suspension) prior to Sitavig unless contraindicated, clinically significant adverse effects occur, or documentation shows inability to swallow oral formulations. For Illinois HIM requests, step therapy requirements do not apply as of 1/1/2026 per IL HB 5395.

Preferred agents include generic oral acyclovir tablets, capsules, or oral suspension
Exception: contraindication, intolerable adverse effects, or documented inability to swallow oral formulations
Illinois HIM: step therapy bypass effective 2026-01-01 per IL HB 5395

Documentation Required

Required Documentation

Provider must submit documentation (such as office chart notes, laboratory results, or other clinical information) supporting that the member has met all approval criteria.

Examples: office chart notes detailing diagnosis and prior therapies, lab results if applicable, documentation of contraindications or adverse reactions to preferred acyclovir formulations, documentation of inability to swallow oral formulations

Denial Risk

Non‑Covered Indications / Off‑Label Use Risk

Requests for non-FDA approved indications that are not addressed in this policy may be denied unless sufficient documentation is provided demonstrating efficacy and safety per the applicable off-label use policies.

Non-FDA indications require documentation meeting off-label use policy criteria
Coverage may be denied if insufficient evidence of efficacy/safety is provided

Initial Therapy Criteria

Initial Therapy

Initial approval for treatment of recurrent herpes labialis

Initial therapy for recurrent herpes labialis: Diagnosis of recurrent herpes labialis; Age ≥ 18 years; prior use/trial of preferred formulary oral acyclovir formulation unless contraindicated, intolerant, or unable to swallow oral formulations; dose ≤ 50 mg (1 tablet).

Approval duration: 1 month (up to 2 doses)

Step Therapy Requirements

Requirement	Details
Step therapy requirement	Member must trial a preferred formulary oral acyclovir formulation (e.g., generic tablets, capsules, or oral suspension) prior to Sitavig unless contraindicated, clinically significant adverse effects occur, or documentation supports inability to swallow oral formulations.
Dose limitation	Dose must not exceed 50 mg (1 tablet).
Age requirement	Member must be age ≥ 18 years.
Illinois HIM exception (state-specific)	For Illinois HIM requests, the step therapy requirement does not apply effective 1/1/2026 per IL HB 5395 (step therapy bypass for IL HIM).
Approval duration	Approval duration: 1 month (up to 2 doses).

Policy Summary

PayerCentene

PolicyAcyclovir Buccal Tablet (Sitavig) Coverage

Policy CodePolicy CP.PMN.210

Change TypeStep therapy additionIllinois HIM exemption

Effective DateNov 16, 2016

Next Review DateNov 25, 2025

SourceLink

On This Page

OpenPayer

Acyclovir Buccal Tablet (Sitavig) Coverage

Coverage Criteria

Coding and Dosing

Provider Actions and Requirements

Background

Definitions

Initial Therapy Criteria

Continuation Therapy Criteria

Step Therapy Requirements

Quantity Limits