Subject: Noxafil PA Policy 3094-A 03-2023

Drug

NOXAFIL (all dosage forms)  (posaconazole)

Policy:

FDA-APPROVED INDICATIONS
Treatment of Invasive Aspergillosis
Noxafil injection and Noxafil delayed-release tablets are indicated for the treatment of invasive aspergillosis in adults and pediatric patients 13 years of age and older.

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
     •   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 40 kg or
          less

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
The requested drug will be covered with prior authorization when the following criteria are met:
     •   The requested drug is being prescribed for the prevention of
          invasive Aspergillus and Candida infections in a patient who is
          at a high risk of developing these infections due to being
          severely immunocompromised
     OR
     •   Noxafil injection or Noxafil delayed-release tablets are being
          prescribed for the treatment of invasive aspergillosis
     OR
     •   Noxafil oral suspension (immediate-release) is being prescribed
          for the treatment of moderate to severe oropharyngeal
          candidiasis
          AND
          •   The patient has experienced an inadequate treatment
               response, intolerance or has a contraindication to fluconazole
               AND itraconazole oral solution

Place of Service:

Outpatient

The above policy is based on the following references:

1. Noxafil [package insert]. Rahway, NJ: Merck Sharp & Dohme LLC; September 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.

August 13, 2023