Noxafil (posaconazole) — Blue Cross Blue Shield of Oklahoma

Initial criteria

• ONE of the following:
• A. The patient has a diagnosis of oropharyngeal candidiasis AND ONE of: (1) The patient has stage four advanced, metastatic cancer and the requested agent is used to treat the cancer or related conditions, and its use is consistent with best practices and FDA-approved; OR (2) The patient is currently being treated with and stable on the requested agent; OR (3) The patient has tried and had inadequate response to itraconazole or fluconazole; OR (4) Itraconazole or fluconazole was discontinued due to lack of efficacy, diminished effect, or an adverse event; OR (5) The patient has intolerance or hypersensitivity to itraconazole or fluconazole; OR (6) The patient has an FDA labeled contraindication to BOTH fluconazole AND itraconazole; OR (7) Itraconazole or fluconazole is expected to be ineffective, cause adherence barrier or harm; OR (8) Itraconazole or fluconazole is not in the patient’s best medical interest; OR (9) The patient tried another drug in the same class which was discontinued due to lack of efficacy or adverse event.
• B. The requested agent is prescribed for prophylaxis of invasive aspergillosis or Candida AND the patient is severely immunocompromised (e.g., HSCT, hematologic malignancy, high-risk transplant).
• C. The patient has a diagnosis of invasive aspergillosis AND ONE of: (1) The patient has stage four advanced, metastatic cancer and the agent is used for cancer or related condition consistent with FDA approval; OR (2) The patient is currently treated and stable; OR (3) The patient has tried and had inadequate response to voriconazole, amphotericin B, or isavuconazole; OR (4) Those agents were discontinued due to lack of efficacy or adverse event; OR (5) The patient has intolerance or hypersensitivity to those agents; OR (6) The patient has an FDA labeled contraindication to voriconazole, amphotericin B, AND isavuconazole; OR (7) Those agents expected to be ineffective, adherence barrier, or cause harm; OR (8) Those agents not in patient’s best interest; OR (9) The patient tried another drug in same class discontinued due to lack of efficacy or adverse event.
• D. The patient has another FDA-approved indication for the requested agent and route of administration; OR
• E. The patient has another compendia-supported indication AND age is appropriate per FDA labeling or supported use AND
• The patient does NOT have any FDA labeled contraindications to the requested agent.

Reauthorization criteria

• The patient has been previously approved for the requested agent through the plan’s Prior Authorization review process AND
• ONE of the following:
• A. The requested agent is prescribed for prophylaxis of invasive Aspergillus or Candida AND the patient continues to be severely immunocompromised (e.g., HSCT, hematologic malignancy, high-risk solid organ transplant); OR
• B. The patient has a diagnosis of invasive aspergillosis AND has continued indicators of active disease (e.g., biomarkers, biopsy, culture, radiographic evidence); OR
• C. The patient has a diagnosis other than invasive aspergillosis or prophylaxis AND there is support for continued use for the requested indication AND
• The patient does NOT have any FDA labeled contraindications.

Approval duration

6 months