Noxafil (posaconazole) — Blue Cross Blue Shield of Montana

Initial criteria

• ONE of the following:
• A. The patient has a diagnosis of oropharyngeal candidiasis AND ONE of the following: 1. BOTH of the following: A. ONE of the following: 1. The patient has stage four advanced, metastatic cancer and the requested agent is used to treat the cancer OR 2. The patient has stage four advanced, metastatic cancer and the requested agent is used to treat an associated condition related to the cancer [chart notes required] AND B. The use of the requested agent is consistent with best practices, supported by peer-reviewed literature, and FDA approved OR 2. The patient is currently being treated with the requested agent and is stable [chart notes required] OR 3. The patient has tried and had an inadequate response to itraconazole or fluconazole [chart notes required] OR 4. Itraconazole or fluconazole was discontinued due to lack of efficacy or adverse event [chart notes required] OR 5. The patient has intolerance or hypersensitivity to itraconazole or fluconazole [chart notes required] OR 6. The patient has FDA labeled contraindication to BOTH fluconazole AND itraconazole [chart notes required] OR 7. Itraconazole or fluconazole is expected to be ineffective, cause significant barrier to care, worsen comorbidity, or cause adverse effects [chart notes required] OR 8. Itraconazole or fluconazole is not in the best interest of the patient based on medical necessity [chart notes required] OR 9. The patient has tried another prescription drug in same class and it was discontinued due to lack of efficacy or adverse event [chart notes required] OR
• B. BOTH of the following: 1. The agent is prescribed for prophylaxis of invasive aspergillosis or Candida AND 2. The patient is severely immunocompromised (e.g., HSCT recipient, hematologic malignancy with neutropenia, or high-risk solid organ transplant recipient) OR
• C. The patient has a diagnosis of invasive aspergillosis AND ONE of the following: 1. The agent used for metastatic cancer treatment as above OR 2. The patient is stable on current therapy [chart notes required] OR 3. Tried and had inadequate response to voriconazole, amphotericin B, or isavuconazole [chart notes required] OR 4. One of the above agents discontinued due to lack of efficacy or adverse event [chart notes required] OR 5. Intolerance or hypersensitivity to voriconazole, amphotericin B, or isavuconazole [chart notes required] OR 6. FDA labeled contraindication to voriconazole, amphotericin B, AND isavuconazole [chart notes required] OR 7. Expected ineffectiveness, barriers to care, or adverse reaction with those agents [chart notes required] OR 8. Those agents not in the best interest due to medical necessity [chart notes required] OR 9. Tried another prescription drug in same class and it was discontinued [chart notes required] OR
• D. The patient has another FDA approved indication for the agent and route of administration OR
• E. The patient has another compendia-supported indication AND
• If the patient has an FDA labeled indication, then ONE of the following: A. Patient’s age is within FDA labeling OR B. There is support for use at that age AND
• The patient does NOT have any FDA labeled contraindications to the agent OR
• The member resides in Ohio AND plan is Fully Insured or HIM Shop (SG) AND BOTH: A. No FDA labeled contraindications AND B. ONE of the following: another FDA labeled indication, another compendia-supported indication, or two peer-reviewed journal articles supporting the use

Reauthorization criteria

• The patient has been previously approved via plan PA process (patients not previously approved require initial review) AND
• ONE of the following:
• A. BOTH of the following: 1. The agent prescribed for prophylaxis of invasive Aspergillus or Candida AND 2. The patient continues to be severely immunocompromised (e.g., HSCT recipient, hematologic malignancy with neutropenia, or high-risk solid organ transplant recipient) OR
• B. BOTH of the following: 1. Diagnosis of invasive aspergillosis AND 2. Continued indicators of active disease (e.g., biomarkers, biopsy, microbiologic cultures, radiographic evidence) OR
• C. BOTH of the following: 1. Diagnosis other than above AND 2. Support for continued use for the indication AND
• The patient does NOT have any FDA labeled contraindications to the requested agent

Approval duration

6 months