Pharmacy Prior Authorization Criteria

Bacterial Vaginosis Agents

Indications for Prior Authorization

Nuvessa

• For diagnosis of Bacterial Vaginosis
  Indicated for the treatment of bacterial vaginosis in females 12 years of age and older.

Cleocin suppository

• For diagnosis of Bacterial Vaginosis
  Indicated for 3-day treatment of bacterial vaginosis in non-pregnant women. There are no adequate and well-controlled studies of CLEOCIN Vaginal Ovules in pregnant women.

Brand Cleocin vaginal cream

• For diagnosis of Bacterial Vaginosis
  Indicated in the treatment of bacterial vaginosis (formerly referred to as Haemophilus vaginitis, Gardnerella vaginitis, nonspecific vaginitis, Corynebacterium vaginitis, or anaerobic vaginosis). CLEOCIN Vaginal Cream 2%, can be used to treat non-pregnant women and pregnant women during the second and third trimester.

Solosec (secnidazole)

• For diagnosis of Bacterial Vaginosis
  Indicated for the treatment of bacterial vaginosis in female patients 12 years of age and older.

• For diagnosis of Trichomonasis
  Indicated for the treatment of trichomoniasis in patients 12 years of age and older.

Brand Vandazole (metronidazole gel)

• For diagnosis of Bacterial Vaginosis
  Indicated in the treatment of bacterial vaginosis (formerly referred to as Haemophilus vaginitis, Gardnerella vaginitis, nonspecific vaginitis, Corynebacterium vaginitis, or anaerobic vaginosis) in post-menarchal females.

Criteria

Nuvessa, Cleocin suppository, Brand Cleocin vaginal cream, Brand Vandazole

Step Therapy

Length of Approval: 12 Month(s)

• Requested drug is being used for a Food and Drug Administration (FDA)-approved indication
AND
• One of the following:
• Trial and failure of a minimum 5 day supply within the past 180 days, contraindication, or intolerance to generic metronidazole 0.75% vaginal gel
OR
• Trial and failure of a minimum 3 day supply within the past 180 days, contraindication, or intolerance to clindamycin 2% vaginal cream

Solosec

Step Therapy

Length of Approval: 12 Month(s)

• One of the following:
• Both of the following:
• Diagnosis of bacterial vaginosis
AND
• One of the following:
• Trial and failure of a minimum 5 day supply within the past 180 days, contraindication, or intolerance to:
• generic metronidazole 0.75% vaginal gel
OR
• Trial and failure of a minimum 3 day supply within the past 180 days, contraindication, or intolerance to:
• generic clindamycin 2% vaginal cream
OR
• Both of the following:
• Diagnosis of trichomoniasis
AND
• Trial and failure within the past 180 days, contraindication, or intolerance to ONE of the following generics: [6]
• metronidazole tablet
• tinidazole tablet

P & T Revisions

2024-05-01, 2023-10-23, 2023-03-01, 2022-10-26, 2021-04-26

References

1. Nuvessa [package insert]. Florham Park, NJ.: Exeltis USA, Inc.; April 2022.
2. Cleocin vaginal ovules [package insert]. New York, NY.: Pfizer, Inc.; February 2024.
3. Cleocin vaginal cream [package insert]. New York, NY.: Pfizer, Inc.; November 2022.
4. Solosec Prescribing Information. Lupin Pharmaceuticals, Inc. Baltimore, MD. January 2022.
5. Vandazole Prescribing Information. Upsher-smith Laboratories, LLC. Maple Grove, MN. February 2021.
6. Trichomoniasis - STI Treatment Guidelines. (2021, July 20). Www.cdc.gov. https://www.cdc.gov/std/treatment-guidelines/trichomoniasis.htm

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Revision History

• 2024-05-01: 2024 Annual Review - background/references updated
• 2023-10-23: UM guideline update
• 2023-03-01: 2023 Annual Review - Addition of new product, Xaciato
• 2022-10-26: Updated guideline
• 2021-04-26: New ST program

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