Prior Authorization Criteria for Approval

Initial Evaluation

Noxafil (posaconazole) will be approved when BOTH of the following are met:

1. ONE of the following:
   1. The patient has a diagnosis of oropharyngeal candidiasis AND ONE of the following:OR
      1. The patient has tried and had an inadequate response to fluconazole or an alternative antifungal medication
         OR
      2. The patient has an intolerance or hypersensitivity to fluconazole or an alternative antifungal medication
         OR
      3. The patient has an FDA labeled contraindication to fluconazole or an alternative antifungal medication
         OR
   2. The requested medication is being prescribed for prophylaxis of invasive Aspergillus or Candida AND patient is severely immunocompromised, such as a hematopoietic stem cell transplant [HSCT] recipient, or hematologic malignancy with prolonged neutropenia from chemotherapy, or is a high-risk solid organ (lung, heart-lung, liver, pancreas, small bowel) transplant patient, or long term use of high dose corticosteroids (greater than 1 mg/kg/day of prednisone or equivalent)
      OR
   3. The patient has a diagnosis of invasive Aspergillus AND ONE of the following:
      1. The patient has tried and had an inadequate response to an alternative antifungal medication
         OR
      2. The patient has an intolerance or hypersensitivity to an alternative antifungal medication
         OR
      3. The patient has an FDA labeled contraindication to an alternative antifungal medication
         OR
   4. The patient has another indication that is supported in CMS approved compendia for the requested medication
      AND
2. The patient does NOT have any FDA labeled contraindications to the requested medication
    

Length of Approval:
One month for oropharyngeal candidiasis
6 months for all other indications

Renewal Evaluation

Noxafil (posaconazole) will be approved when ALL of the following are met:

1. The patient has been previously approved for the requested medication through the plan’s Prior Authorization criteria
   AND
2. ONE of the following:
   1. The requested medication is being prescribed for prophylaxis of invasive Aspergillus or Candida and patient continues to be severely immunocompromised, such as a hematopoietic stem cell transplant [HSCT] recipient, or hematologic malignancy with prolonged neutropenia from chemotherapy, or is a high-risk solid organ (lung, heart-lung, liver, pancreas, small bowel) transplant patient, or long term use of high dose corticosteroids (greater than 1 mg/kg/day of prednisone or equivalent)
      OR
   2. The patient has a diagnosis of invasive Aspergillus AND patient has continued indicators of active disease (e.g., continued radiologic findings, positive cultures, positive serum galactomannan assay for Aspergillus)
      OR
   3. BOTH of the following:
      1. The patient has a diagnosis of oropharyngeal candidiasis
         AND
      2. The patient has had clinical benefit with the requested medication
         OR
   4. BOTH of the following:
      1. The patient has another indication that is supported in CMS approved compendia for the requested medication
         AND
      2. The patient has had clinical benefit with the requested medication
         AND
3. The patient does NOT have any FDA labeled contraindications to the requested medication

Length of approval:
One month for oropharyngeal candidiasis
6 months for all other indications