Pharmacy Prior Authorization Criteria

Vivjoa (oteseconazole)

Indications for Prior Authorization

Vivjoa (oteseconazole)

• For diagnosis of Recurrent Vulvovaginal Candidiasis
  Indicated to reduce the incidence of recurrent vulvovaginal candidiasis (RVVC) in females with a history of RVVC who are NOT of reproductive potential.

Criteria

Vivjoa

Prior Authorization

Length of Approval: 4 Month(s) [C]

• Diagnosis of recurrent vulvovaginal candidiasis (RVVC)
AND
• Patient is NOT of reproductive potential
AND
• Diagnosis of RVVC confirmed by one of the following [3]:
• Positive potassium hydroxide (KOH) preparation
• Vaginal fungal culture
AND
• Patient has experienced 3 or more symptomatic episodes of vulvovaginal candidiasis (VVC) within the past 12 months [A]
AND
• Trial and failure, contraindication, or intolerance to both of the following: [B]
• One intravaginal product (e.g., clotrimazole, miconazole, tioconazole, terconazole, boric acid)
• Oral fluconazole

P & T Revisions

2024-08-27, 2022-09-21

References

1. Vivjoa Prescribing Information. Mycovia Pharmaceuticals. Durham, NC. April 2024.
2. Pappas PG, Kauffman CA, Andes DR, et al. Clinical practice guideline for the management of candidiasis: 2016 update by the Infectious Diseases Society of America. Clin Infect Dis. 2016;62:e1-50.
3. Vulvovaginal Candidiasis - STI Treatment Guidelines. Cdc.gov. https://www.cdc.gov/std/treatment-guidelines/candidiasis.htm. Published 2021. Accessed August 3, 2022.
4. American College of Obstetricians and Gynecologists (ACOG). Vaginitis in nonpregnant patients: ACOG practice bulletin, number 215. Obstet Gynecol. 2020;135(1):e1-e17

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End Notes

1. Clinical trial inclusion criteria for Vivjoa included patients who had 3 or more episodes of acute vulvovaginitis in the past 12 months. Guidelines define RVVC as ≥ 3 or 4 symptomatic episodes of infection within 1 year. [1-4]
2. For the treatment of recurring vulvovaginal candidiasis, 7 to 14 days of induction therapy with a topical agent or oral fluconazole, followed by oral fluconazole 150 mg weekly for 6 months is recommended. [2-4]
3. Both dosage regimens require 12 weeks of Vivjoa, an additional 4 weeks is added to allow for any delays in obtaining oral fluconazole if needed. [1]

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Revision History

• 2024-08-27: 2024 UM Annual Review. No changes. Background updates.
• 2022-09-21: New program for Vivjoa.

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