Subject: Oravig Limit 2946-H P10-2024_R

Drug

ORAVIG  (miconazole)

Policy:

Indications

FDA-approved Indications

Oravig is indicated for the local treatment of oropharyngeal candidiasis (OPC) in adults.

Initial Limit Quantity

The duration of 25 days is used for a 30-day fill period to allow time for refill processing.

These drugs are for short-term acute use; therefore, the intent is for prescriptions of the requested drug to be filled one month at a time; there should be no 3 month supplies filled.

Drug	1 Month Limit	3 Month Limit
Oravig (miconazole buccal tablet)	14 tablets / 25 days	Does Not Apply

Place of Service:

Outpatient

The above policy is based on the following references:

1. Oravig [package insert]. Marietta, GA: Galt Pharmaceuticals, LLC; June 2021.
2. Lexicomp Online, Lexi-Drugs Online. Waltham, MA: UpToDate, Inc.; 2024. https://online.lexi.com. Accessed September 10, 2024.
3. Micromedex (electronic version). Merative, Ann Arbor, Michigan, USA. Available at: https://www.micromedexsolutions.com/ (cited: 09/10/2024).
4. Pappas PG, Kauffman CA, Andes DA, 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)e1-50.
5. Panel on Guidelines for the Prevention and Treatment of Opportunistic Infections in Adults and Adolescents with HIV. Guidelines for the Prevention and Treatment of Opportunistic Infections in Adults and Adolescents with HIV. National Institutes of Health, Centers for Disease Control and Prevention, the HIV Medicine Association, and the Infectious Diseases Society of America. Available at https://clinicalinfo.hiv.gov/en/guidelines/adult-and-adolescent-opportunistic-infection. Accessed September 13, 2024.

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.

February 16, 2025