Subject: Oravig Limit Policy 2946-H 10-2023

Drug

ORAVIG  (miconazole buccal tablet)

Policy:

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

INITIAL LIMIT QUANTITY
Drug	1 Month Limit*	3 Month Limit*
Oravig (miconazole buccal tablet)	14 tablets / 25 days	Does Not Apply**
* The duration of 25 days is used for a 30-day fill period to allow time for refill processing. ** This drug is for short-term acute use; therefore, the mail limit will be the same as the retail limit. The intent is for prescriptions of the requested drug to be filled one month at a time, even if filled at mail order; there should be no 3 month supplies filled.

 

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.; 2023. https://online.lexi.com. Accessed August 7, 2023.
3. Micromedex (electronic version). Merative, Ann Arbor, Michigan, USA. Available at: https://www.micromedexsolutions.com/ (cited: 08/07/2023).
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 August 21, 2023.

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 11, 2024