Subject: Vivjoa PA with Limit 5448-C P01-2026

Drug

VIVJOA  (oteseconazole)

Policy:

Indications

FDA-approved Indications

Vivjoa is 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

Recurrent Vulvovaginal Candidiasis (RVVC)

Authorization may be granted when the requested drug is being prescribed to reduce the incidence of recurrent vulvovaginal candidiasis (RVVC) in a patient with a history of RVVC when ALL of the following criteria are met:

·        The patient is NOT of reproductive potential.

·        The patient meets ONE of the following:

§  The patient has experienced an inadequate treatment response to a course of therapy with fluconazole.

§  The patient has experienced an intolerance to fluconazole.

§  The patient has a contraindication that would prohibit a trial of fluconazole.

·        The requested drug is NOT being used in a footbath.

Quantity Limits Apply

18 capsules per 48 weeks

Duration of Approval (DOA)

·        5448-C: DOA: 48 weeks

Place of Service:

Outpatient

The above policy is based on the following references:

1.      Vivjoa [package insert]. Durham, NC: Mycovia Pharmaceuticals, Inc.; April 2024.

2.     Diflucan [package insert]. New York, NY: Roerig Division of Pfizer Inc.; March 2025.

3.     Lexicomp Online, AHFS DI (Adult and Pediatric) Online. Waltham, MA: UpToDate, Inc.; 2025. https://online.lexi.com. Accessed November 19, 2025.

4.     Micromedex® (electronic version). Merative, Ann Arbor, Michigan, USA. Available at: https://www.micromedexsolutions.com/ (cited: 11/19/2025).

5.     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(4):e1-e50.

6.     Paladine HL, Desai UA. Vaginitis: diagnosis and treatment. Am Fam Physician. 2018;97(5):321-329.

7.     Workowski KA, Bachmann LH, Chan PA, et al. Sexually Transmitted Infections Treatment Guidelines, 2021. MMWR Recomm Rep. 2021;70(4):1-187.

Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

May 26, 2026