Prior Auth Protocol

Prior Authorization Protocol

NUVESSA^TM (metronidazole vaginal gel 1.3%)

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 bacterial vaginosis in non-pregnant women
Health Net Approved Indications and Usage Guidelines:
- For the treatment of bacterial vaginosis in non-pregnant women
AND
- Failure or clinically significant adverse effects to metronidazole gel 0.75% (generic MetroGel-Vaginal, Vandazole)
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:
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Therapeutic Alternatives:

Drug Dosing Regimen Dose Limit/ Maximum Dose
metronidazole gel 0.75% (MetroGel-Vaginal, Vandazole)
One applicatorful (~37.5 mg) intravaginally QD to BID for 5 days
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* Requires Prior Authorization
Recommended Dosing Regimen and Authorization Limit:

Drug Dosing Regimen Authorization Limit
Nuvessa
One applicator (~65 mg) administered intravaginally as a single dose at bedtime
Length of Benefit
Product Availability:

Pre-filled applicator containing vaginal gel (1.3%): 65 mg metronidazole in 5 grams of gel
References:

1. Nuvessa [prescribing information]. Actavis Pharma Inc. Parsippany, NJ; January 2015.
2. Lexicomp Online^R , Lexi-Drugs^R , Hudson, Ohio: Lexi-Comp, Inc.; accessed November 2015.

Drug	Dosing Regimen	Dose Limit/ Maximum Dose
metronidazole gel 0.75% (MetroGel-Vaginal, Vandazole)	One applicatorful (~37.5 mg) intravaginally QD to BID for 5 days	This field intentionally left blank

Drug	Dosing Regimen	Authorization Limit
Nuvessa	One applicator (~65 mg) administered intravaginally as a single dose at bedtime	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.