Subject: Noxafil PA 3094-A P03-2025 v2

Drug

NOXAFIL  (posaconazole)

Policy:

Indications

FDA-Approved Indications

Treatment of Invasive Aspergillosis

Noxafil is indicated for the treatment of invasive aspergillosis as follows:

• Noxafil injection: adults and pediatric patients 2 years of age and older who weigh 10 kg or greater
• Noxafil delayed-release tablets: adults and pediatric patients 2 years of age and older who weigh greater than 40 kg
• Noxafil PowderMix for delayed-release oral suspension: pediatric patients 2 years of age and older who weigh 10 to 40 kg

Prophylaxis of Invasive Aspergillus and Candida Infections

Noxafil is indicated for the prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with graft-versus-host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chemotherapy as follows:

• Noxafil Injection: adults and pediatric patients 2 years of age and older who weigh 10 kg or greater
• Noxafil delayed-release tablets: adults and pediatric patients 2 years of age and older who weigh greater than 40 kg
• Noxafil oral suspension: adults and pediatric patients 13 years of age and older
• Noxafil PowderMix for delayed-release oral suspension: pediatric patients 2 years of age and older who weigh 10 kg to 40 kg

Treatment of Oropharyngeal Candidiasis Including Oropharyngeal Candidiasis Refractory to Itraconazole and/or Fluconazole

Noxafil oral suspension is indicated for the treatment of oropharyngeal candidiasis, including oropharyngeal candidiasis refractory to itraconazole and/or fluconazole in adults and pediatric patients 13 years of age and older.

Coverage Criteria

Oropharyngeal Candidiasis

Authorization may be granted when the requested drug is being prescribed for the treatment of moderate to severe oropharyngeal candidiasis when ALL of the following criteria are met:

• The request is for Noxafil oral suspension (immediate-release).
• The patient has experienced an inadequate treatment response, intolerance or has a contraindication to fluconazole AND itraconazole oral solution.

Prophylaxis of Invasive Aspergillus and Candida Infections

Authorization may be granted when the requested drug is being prescribed for the prevention of invasive aspergillus and candida infections in a patient who is at high risk of developing these infections due to being severely immunocompromised.

Treatment of Invasive Aspergillosis

Authorization may be granted when the requested drug is being prescribed for the treatment of invasive aspergillosis when the following criteria is met:

• The request is for Noxafil injection, Noxafil delayed-release tablets, or Noxafil PowderMix for delayed-release oral suspension.

Duration of Approval (DOA)

• 3094-A: DOA:
  • Prevention of invasive Aspergillus and Candida infections: 6 months
  • Treatment of invasive aspergillosis: 3 months
  • Treatment of moderate to severe oropharyngeal candidiasis: 1 month

Place of Service:

Outpatient

The above policy is based on the following references:

1. Noxafil [package insert]. Rahway, NJ: Merck Sharp & Dohme LLC; January 2026.
2. Lexicomp Online, AHFS DI (Adult and Pediatric) Online. Waltham, MA: UpToDate, Inc.; 2025. https://online.lexi.com. Accessed February 11, 2025.
3. Micromedex (electronic version). Merative, Ann Arbor, Michigan, USA. Available at: https://www.micromedexsolutions.com/ (cited: 02/11/2025).
4. Pappas P, Kauffman C, Andes D, et al. Clinical Practice Guidelines for the Management of Candidiasis: 2016 Update by the Infectious Diseases Society of America. Clinical Infectious Diseases. 2016;62:1-50.

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.

March 18, 2026