Subject: Ketoconazole Oral PA 1024-A P10-2024_R

Drug

ketoconazole (brand unavailable)  (ketoconazole)

Policy:

Indications

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

Blastomycosis, Chromomycosis, Coccidioidomycosis, Histoplasmosis, Paracoccidioidomycosis

Authorization may be granted for the requested drug when ALL of the following criteria are met:

• The patient has ANY of the following diagnoses:
  • Blastomycosis
  • Coccidioidomycosis
  • Histoplasmosis
  • Chromomycosis
  • Paracoccicioicomycosis
• Other antifungal therapies are ineffective or not tolerated.
• The patient is using the requested drug orally.

Cushing's Syndrome

Authorization may be granted when the requested drug is being prescribed for a patient with Cushing’s Syndrome who cannot tolerate surgery or surgery has not been curative when the following criteria is met:

• The patient is using the requested drug orally.

Duration of Approval (DOA)

• 1024-A: DOA: 6 months

Place of Service:

Outpatient

The above policy is based on the following references:

1. Ketoconazole Tablets [package insert]. Hawthorne, NY: Taro Pharmaceuticals U.S.A., Inc.; September 2023.
2. Lexicomp Online, AHFS DI (Adult and Pediatric) 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. Cushing Syndrome. Available at: https://rarediseases.org/rare-diseases/cushing-syndrome/. Accessed September 10, 2024.
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 10, 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