Subject: Oravig Limit Policy 2946-H 10-2022

Drug

ORAVIG  (miconazole buccal tablet)

Policy:

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

RATIONALE
Oravig is indicated for the local treatment of oropharyngeal candidiasis (OPC) in adults. The recommended dosing schedule for Oravig is the application of one 50 mg buccal tablet to the upper gum region (canine fossa) once daily for 14 consecutive days.^1-3 Oravig tablets are packaged in bottles of 14 tablets.¹

According to the Clinical Practice Guideline for the Management of Candidiasis: 2016 Update by the Infectious Diseases Society of America (IDSA), clotrimazole troches 10 mg five times daily or miconazole mucoadhesive buccal 50 mg tablet (Oravig) applied to the mucosal surface over the canine fossa once daily for 7 to 14 days are recommended for mild oropharyngeal candidiasis. For moderate to severe disease, oral fluconazole 100 mg to 200 mg daily for 7 to 14 days is recommended. ⁴ The Guidelines for the Prevention and Treatment of Opportunistic Infections in Adults and Adolescents with HIV consider oral fluconazole, at 100 mg once a day, as the drug of choice to treat oropharyngeal candidiasis except during pregnancy. One to two weeks of therapy is recommended for oropharyngeal candidiasis. Once daily miconazole in 50-mg mucoadhesive buccal tablets (Oravig) or five-times-per-day clotrimazole troches are provided as alternatives to oral fluconazole.⁵ In a multicenter randomized study among HIV-infected individuals, 50-mg mucoadhesive buccal tablets of miconazole applied once daily to the mucosal surface over the canine fossa were as effective as 10-mg clotrimazole troches used 5 times daily. If therapy is required for patients who have recurrent oropharyngeal candidiasis, the IDSA 2016 Update, recommends fluconazole 100 mg 3 times weekly. Chronic suppressive therapy is not needed.⁴ Therefore, based on the recommended dosing schedule along with product availability and applicable guidelines, the limit for Oravig will be 14 tablets per 30 days.

If the patient is requesting more than the initial quantity limit, then the claim will reject with a message indicating that quantity limits are exceeded.

LIMIT CRITERIA
Drug	1 Month Limit*	3 Month Limit*
Oravig	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, Hudson, Ohio: UpToDate, Inc.; 2022; Accessed August 22, 2022.
3. Micromedex (electronic version). IBM Watson Health, Greenwood Village, Colorado, USA. Available at: https://www.micromedexsolutions.com. Accessed August 22, 2022.
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 22, 2022.

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 10, 2023