Prior Auth Protocol

Prior Authorization Protocol

SITAVIG^R (acyclovir buccal tablets)

NATL

Coverage of drugs is first determined by the member’s pharmacy or medical benefit. Please consult with or refer to the Evidence of Coverage document.

FDA Approved Indications:
- For the treatment of recurrent herpes labialis (cold sores) in immunocompetent adults.
Health Net Approved Indications and Usage Guidelines:
- Diagnosis of recurrent herpes labialis (cold sores) in immunocompetent adults
AND
- Failure or clinically significant adverse effects to generic acyclovir tablets or capsules
Coverage is Not Authorized For:
- Non-FDA approved indications, which are not listed in the Health Net Approved Indications and Usage Guidelines section, unless there is sufficient documentation of efficacy and safety in the published literature.
General Information:
- The clinical study cited in the manufacturer prescribing information evaluated Sitavig in patients with recurrent herpes labialis. All patients had at least 4 herpes episodes in the previous year.

Therapeutic Alternatives:

Drug	Dosing Regimen	Dose Limit/ Maximum Dose
acyclovir (Zovirax^TM)	Treatment 200 mg PO 5 times daily for 10 days OR 400 mg PO TID for 7-10 days Chronic suppression 400 mg PO BID	4000 mg/day
Zovirax^R Cream 5% (acyclovir)	Apply topically 5 times daily for 4 days with a quantity sufficient to cover affected area, including the outer margin	Varies by size of affected area

* Requires Prior Authorization

Recommended Dosing Regimen and Authorization Limit:

Drug Dosing Regimen Authorization Limit
Sitavig
50 mg applied as a single dose to the upper gum region
Length of Benefit
Product Availability:

Buccal Tablet: 50 mg
References:
1. Sitavig [Prescribing Information] Charleston, SC: Innocutis Holdings, LLC; April 2013.
2. Micromedex^R Healthcare Series [Internet database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. June 25, 2015.
3. Clinical Pharmacology Web site. Available at: http://clinicalpharmacology-ip.com. Accessed June 25, 2015.

Drug	Dosing Regimen	Authorization Limit
Sitavig	50 mg applied as a single dose to the upper gum region	Length of Benefit

The material provided to you are guidelines used by this plan to authorize, modify or determine coverage for persons with similar illnesses or conditions. Specific care and treatment may vary depending on individual need and the benefits covered under your contract.