Acyclovir Buccal Tablet (Sitavig), Ophthalmic Ointment (Avaclyr) Form

Acyclovir buccal tablet (Sitavig®) is a herpes simplex virus deoxynucleoside analog of DNA polymerase inhibitor. FDA Approved Indication(s) Sitavig is indicated for the treatment of recurrent herpes labialis (cold sores) in immunocompetent adults. Policy/Criteria Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria. It is the policy of health plans affiliated with Centene Corporation® that Sitavig is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Herpes Labialis (must meet all):

1. Diagnosis of recurrent herpes labialis (cold sores);
   2. Age ≥ 18 years;
   3. Member must use preferred formulary acyclovir formulation (e.g., generic tablets, capsules or oral suspension) unless contraindicated, clinically significant adverse effects are experienced, or documentation supports inability to swallow oral formulations;
2. Dose does not exceed 50 mg (1 tablet). Approval duration: 1 month (up to 2 doses) B. Other diagnoses/indications (must meet 1 or 2):

3. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or Page 1 of 5

   CLINICAL POLICY
   Acyclovir Buccal Tablet

4. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above 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, and CP.PMN.53 for Medicaid.
   II. Continued Therapy A. Herpes Labialis (must meet all):
5. Re-authorization is not permitted. Members must meet the initial approval criteria.
   Approval duration: Not applicable B. Other diagnoses/indications (must meet 1 or 2):
6. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or

7. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above 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, and CP.PMN.53 for Medicaid.
   III. Diagnoses/Indications for which coverage is NOT authorized:
   A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policy – CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid, or evidence of coverage documents. IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key FDA: Food and Drug Administration Appendix B: Therapeutic Alternatives This table provides a listing of preferred alternative therapy recommended in the approval criteria. The drugs listed here may not be a formulary agent for all relevant lines of business and may require prior authorization. Page 2 of 5

   CLINICAL POLICY
   Acyclovir Buccal Tablet
   Drug Name Dosing Regimen acyclovir (Zovirax®) off-label Herpes Labialis Initial episode: 200 mg PO 5 times daily for 7-10 days OR 400 mg PO TID for 7-10 days Recurrence:
   400 mg PO TID for 5 days OR 800 mg PO BID for 5 days OR 800 mg TID for 2 days Chronic suppression: 400 mg PO BID Dose Limit/ Maximum Dose 4,000 mg/day Therapeutic alternatives are listed as Brand name® (generic) when the drug is available by brand name only and generic (Brand name®) when the drug is available by both brand and generic Appendix C: Contraindications/Boxed Warnings • Contraindication(s): hypersensitivity to acyclovir, milk protein concentrate, or any other component of the product • Boxed warning(s): none reported Appendix D: General Information • Sitavig pivotal trial inclusion criteria for recurrent herpes labialis required at least 4 herpes episodes in the previous year.
   V. Dosage and Administration Indication Treatment of recurrent herpes labialis (cold sores) Dosing Regimen One 50 mg buccal tablet applied as a single dose to the upper gum region (canine fossa) Maximum Dose 50 mg VI. Product Availability Buccal tablet: 50 mg VII.