VIVJOA (oteseconazole)

VIVJOA (oteseconazole)

Self-Administration – oral

Diagnosis considered for coverage:

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

Coverage Criteria:

For diagnosis of Recurrent Vulvovaginal Candidiasis (RVVC):

• Dose does not exceed FDA approved dosage regimen (Vivjoa only regimen – 18 capsules per 12 weeks; Vivjoa and fluconazole regimen – 18 capsules per 14 weeks); AND

• Documented diagnosis of recurrent vulvovaginal candidiasis (RVVC) confirmed by one of the following:

  • Positive potassium hydroxide (KOH) preparation

  • Vaginal fungal culture; AND

• Patient is NOT of reproductive potential (see definition in Additional Information section); AND

• Patient has experienced 3 or more symptomatic episodes of vulvovaginal candidiasis (VVC) within the past 12 months; AND

• Trial and failure, contraindication, or intolerance to both of the following:

  • One intravaginal product (e.g., clotrimazole, miconazole, tioconazole, terconazole, boric acid)

  • Oral fluconazole

Coverage Duration:

•  Limited to 4 months

Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information: 

• Dosage and administration:

  • Two recommended Vivjoa dosage regimens:

    • Vivjoa-only regimen: on day 1 administer Vivjoa 600 mg (as a single dose), then on day 2 administer Vivjoa 450 mg (as a single dose), then beginning on day 14 administer Vivjoa 150 mg once a week (every 7 days) for 11 weeks (Weeks 2 through 12)

    • Fluconazole/Vivjoa regimen: on day 1, day 4, and day 7 administer fluconazole 150 mg orally, then on days 14 through 20 administer Vivjoa 150 mg once daily for 7 days, then beginning on day 28 administer Vivjoa 150 mg once a week (every 7 days) for 11 weeks (weeks 4 through 14)

  • Administer Vivjoa orally with food.  Swallow capsules whole.  Do not chew, crush, dissolve, or open the capsules

• Females who are NOT of reproductive potential are defined as: persons who are biological females who are postmenopausal or have another reason for permanent infertility (e.g., tubal ligation, hysterectomy, salpingo-oophorectomy)

• Drug interactions:

  • Breast Cancer Resistance Protein (BCRP) substrates: concomitant use of Vivjoa with BCRP substrates may increase the exposure of drugs that are BCRP substrates

Policy Updates:

•    11/15/2022 – New policy approved by P&T.

References:

1. Vivjoa Prescribing Information. Mycovia Pharmaceuticals. Durham, NC. April 2022.
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