CurrentmhnPolicy CP.PMN.210

Acyclovir Buccal Tablet (Sitavig)

Defines medical necessity and prior authorization criteria for Sitavig (acyclovir buccal tablet) for treatment of recurrent herpes labialis in adults for health plans affiliated with Centene, affecting Commercial, HIM, and Medicaid lines of business.

Policy Summary

Payermhn

PolicyAcyclovir Buccal Tablet (Sitavig)

Policy CodePolicy CP.PMN.210

Change TypeStep therapy bypass added

Effective DateNov 16, 2016

Next Review DateNov 25, 2025

Key ActionPrior authorization is required and approved when all initial criteria for recurrent herpes labialis are met (diagnosis, age ≥18, preferred oral acyclovir trial unless exception, and dose ≤50 mg).

SourceLink

POLICY UPDATE CHANGES

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

Age ≥ 18minimum age for coverage

50 mgtablet strength

1 monthinitial approval duration

No re-authcontinuation policy

Commercial, HIM, Medicaidapplicable LOBs

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.

Coverage Criteria

Initial Therapy

Covered when ALL of the following are met:

Herpes Labialis initial approval: 1. Diagnosis of recurrent herpes labialis (cold sores); 2. Age ≥ 18 years; 3. Member has used a preferred formulary oral acyclovir formulation (e.g., generic tablets, capsules, or oral suspension) unless contraindicated, clinically significant adverse effects have occurred, or documentation supports inability to swallow oral formulations; 4. Dose does not exceed 50 mg (1 tablet).dose <= 50 mg

Approval duration: 1 month (up to 2 doses)

Continuation Therapy

Reauthorization: Re-authorization is not permitted. Members must meet the initial approval criteria for each request.N/A

Approval duration: Not applicable

Requests for use of the drug for non‑FDA approved indications that are not specifically addressed by this policy are not authorized unless the provider supplies sufficient documentation demonstrating efficacy and safety in accordance with the applicable off‑label use policy (see CP.CPA.09 for Commercial, HIM.PA.154 for Health Insurance Marketplace, or CP.PMN.53 for Medicaid).

Use of this product for off‑label indications without provision of sufficient supporting documentation should be handled per the off‑label use policy; such requests may be denied if documentation meeting the off‑label policy standards is not provided.

Initial Therapy Criteria (detailed)

Initial Therapy

Sitavig initial: One 50 mg buccal tablet applied as a single dose to the upper gum region for treatment of recurrent herpes labialis in adults, with prior use of preferred oral acyclovir formulations unless exception applies.50 mg single dose

Approval duration: 1 month (up to 2 doses)

Continuation Criteria

Continuation

No continuation: Re-authorization is not permitted; no continuation approvals provided.N/A

Members must meet initial criteria for each request.

Provider Actions & Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required and will be approved when all initial criteria are met (see Initial Approval Criteria). Approval duration: 1 month (up to 2 doses).

Approval duration: 1 month (up to 2 doses)

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 there is a contraindication, clinically significant adverse effects, or documentation supports inability to swallow oral formulations. For Illinois HIM requests, the step therapy requirement does not apply as of 1/1/2026 per IL HB 5395.

Preferred acyclovir formulations: generic tablets, capsules, or oral suspension
IL HIM step therapy bypass effective 2026-01-01 per IL HB 5395

Step Therapy Requirements

Step	Requirement	Exceptions / Notes
1	Trial of preferred formulary oral acyclovir formulation (e.g., generic tablets, capsules, or oral suspension) is required prior to approval of Sitavig (acyclovir buccal tablet).	Approval requires documentation the trial occurred unless an exception applies. Approval duration for Sitavig: 1 month (up to 2 doses).
—	Exception: Do not apply the step therapy requirement for Illinois HIM requests effective 1/1/2026 per IL HB 5395; Sitavig may be considered without prior trial for eligible Illinois HIM members.	Documentation must support contraindication, clinically significant adverse effects, or inability to swallow oral formulations to bypass step therapy for non‑Illinois HIM members.

Coding & Dose Information

inv-05: Maximum single dose — 50 mg (1 tablet)

Maximum single dose50 mg (1 tablet)

Tablet strength50 mg

AdministrationSingle buccal tablet applied to the upper gum region (canine fossa)

inv-15: acyclovir buccal tablet (Sitavig) — quantity limit entry

Quantity limit (per course)1 tablet

Approval duration noteApproval duration: 1 month (up to 2 doses)

Dose limitDose does not exceed 50 mg (1 tablet)

Definitions

inv-11: Recurrent herpes labialis — definition and trial inclusion criteria (e.g., ≥4 episodes in previous year)

DefinitionRecurrent herpes labialis: recurrent cold sores (herpes labialis)

Pivotal trial inclusionPivotal trial required ≥4 herpes episodes in the previous year

Coverage populationImmunocompetent adults age ≥ 18 years

Background

Acyclovir buccal tablet (Sitavig) is an acyclovir formulation approved for treatment of recurrent herpes labialis in immunocompetent adults. The product is formulated as a single, 50 mg mucoadhesive buccal tablet applied to the upper gum region as a single dose for a recurrent episode. The pivotal trial that supported approval enrolled patients with at least ≥4 herpes labialis episodes in the previous year.