Subject: Ketoconazole Oral PA Policy 1024-A 10-2022

Drug

ketoconazole tablets

Policy:

FDA-approved Indications
Ketoconazole tablets are not indicated for treatment of onychomycosis, cutaneous dermatophyte infections, or Candida infections.
Ketoconazole tablets should be used only when other effective antifungal therapy is not available or tolerated and the potential benefits are considered to outweigh the potential risks.
Ketoconazole tablets are indicated for the treatment of the following systemic fungal infections in patients who have failed or who are intolerant to other therapies: blastomycosis, coccidioidomycosis, histoplasmosis, chromomycosis, and paracoccidioidomycosis. Ketoconazole tablets should not be used for fungal meningitis because it penetrates poorly into the cerebrospinal fluid.

Compendial Uses
Cushing’s syndrome ^{2, 3}

COVERAGE CRITERIA
The requested drug will be covered with prior authorization when the following criteria are met:
      •    The patient has any of the following diagnoses: A)
            Blastomycosis, B) Coccidioidomycosis, C) Histoplasmosis, D)
            Chromomycosis, E) Paracoccidioidomycosis
            AND
      •    Other antifungal therapies are ineffective or not tolerated
      OR
      •    The requested drug is being prescribed for a patient with
            Cushing’s syndrome who cannot tolerate surgery or surgery
            has not been curative
      AND
      •    The patient is using the requested drug orally

Place of Service:

Outpatient

The above policy is based on the following references:

1. Ketoconazole Tablets [package insert]. Hoschton, GA: Aavis Pharmaceuticals; September 2021.
2. Lexicomp Online, AHFS DI (Adult and Pediatric) Online, Hudson, Ohio: UpToDate, Inc.; 2022; Accessed September 6, 2022.
3. Micromedex (electronic version). IBM Watson Health, Greenwood Village, Colorado, USA. Available at: https://www.micromedexsolutions.com. Accessed September 6, 2022.
4. Cushing Syndrome. Available at: https://rarediseases.org/rare-diseases/cushing-syndrome/. Accessed September 7, 2022.
5. Nieman LK, Biller BM, Findling JW, et al. Treatment of Cushing’s Syndrome: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2015;100(8):2807-2831.
6. FDA Drug Safety Communication: FDA warns that prescribing of Nizoral (ketoconazole) oral tablets for unapproved uses including skin and nail infections continues; linked to patient death. Available at: https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-fda-warns-prescribing-nizoral-ketoconazole-oral-tablets-unapproved. Accessed September 7, 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