Noxafil (posaconazole) — Blue Cross Blue Shield of Texas

Initial criteria

• ONE of the following:
• A. Diagnosis of oropharyngeal candidiasis AND ONE of the following: (1) patient with stage four advanced metastatic cancer and requested agent used for cancer or associated condition, and use consistent with best practices; OR (2) patient currently stable on requested agent; OR (3) patient has tried and had inadequate response to itraconazole or fluconazole; OR (4) itraconazole or fluconazole discontinued due to lack of efficacy, diminished effect, or adverse event; OR (5) intolerance or hypersensitivity to itraconazole or fluconazole; OR (6) FDA labeled contraindication to BOTH fluconazole and itraconazole; OR (7) itraconazole or fluconazole expected to be ineffective or cause harm; OR (8) itraconazole or fluconazole not in best interest based on medical necessity; OR (9) patient has tried another prescription drug in the same pharmacologic class or same mechanism of action as itraconazole or fluconazole discontinued due to lack of efficacy or adverse event
• B. BOTH of the following: (1) Requested agent prescribed for prophylaxis of invasive aspergillosis or Candida AND (2) Patient severely immunocompromised (e.g., HSCT recipient, hematologic malignancy with prolonged neutropenia, or high-risk solid organ transplant recipient)
• C. Diagnosis of invasive aspergillosis AND ONE of the following: (1) patient with stage four metastatic cancer for cancer/associated condition with evidence-based supported use; OR (2) patient currently stable on requested agent; OR (3) patient has tried and inadequate response to voriconazole, amphotericin B, or isavuconazole; OR (4) those drugs discontinued due to lack of efficacy or adverse event; OR (5) intolerance or hypersensitivity to voriconazole, amphotericin B, or isavuconazole; OR (6) FDA labeled contraindication to voriconazole, amphotericin B, AND isavuconazole; OR (7) those drugs expected ineffective or cause harm; OR (8) not in best interest based on medical necessity; OR (9) patient tried another drug in same class as these discontinued due to lack of efficacy or adverse event
• D. Patient has another FDA approved indication for the requested agent and route of administration OR
• E. Patient has another indication supported in compendia for the requested agent and route of administration AND
• If patient has FDA labeled indication, then ONE of the following: A. Age is within FDA labeling OR B. There is support for using requested agent for patient’s age for the indication AND
• Patient does NOT have any FDA labeled contraindications

Reauthorization criteria

• Patient previously approved for requested agent through plan’s Prior Authorization review process AND
• ONE of the following:
• A. BOTH of the following: (1) Requested agent prescribed for prophylaxis of invasive Aspergillus or Candida AND (2) Patient continues to be severely immunocompromised (e.g., HSCT recipient, hematologic malignancy with prolonged neutropenia, or high-risk solid organ transplant recipient) OR
• B. BOTH of the following: (1) Patient has diagnosis of invasive aspergillosis AND (2) Patient has continued indicators of active disease (e.g., biomarkers in serum assay, biopsy, microbiologic culture, radiographic evidence) OR
• C. BOTH of the following: (1) Patient has diagnosis other than invasive aspergillosis or prophylaxis of invasive Aspergillus or Candida AND (2) Support for continued use of the requested agent for the requested indication AND
• Patient does NOT have FDA labeled contraindications

Approval duration

6 months (varies by plan: 3–6 months)