Subject: Ketoconazole_Oral_Policy_1024-A_02-2020

Drug

ketoconazole tablets  (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}

 

1. Precertification 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; October 2020.
2. Lexicomp Online, AHFS DI (Adult and Pediatric) Online. Hudson, OH: Wolters Kluwer Clinical Drug Information, Inc. http://online.lexi.com/. Accessed December 2020.
3. Micromedex (electronic version). Truven Health Analytics, Greenwood Village, Colorado, USA. http://www.micromedexsolutions.com/. Accessed December 2020.
4. Cushing Syndrome. https://rarediseases.org/rare-diseases/cushing-syndrome/. Accessed December 2020.
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 Aug;100(8):2807-31.
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. https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-fda-warns-prescribing-nizoral-ketoconazole-oral-tablets-unapproved. Accessed December 2020.

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.

December 30, 2021