Noxafil (posaconazole) — Blue Cross Blue Shield of New Mexico

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 being used to treat the cancer OR
• 2. The patient has stage four advanced, metastatic cancer and the requested agent is being used to treat an associated condition related to stage four advanced metastatic cancer [chart notes required] AND
• B. The use of the requested agent is consistent with best practices for treatment of stage four advanced, metastatic cancer; supported by peer-reviewed, evidence-based literature; and FDA approved OR
• 2. The patient is currently being treated with the requested agent and is currently stable [chart notes required] OR
• 3. The patient has tried and had inadequate response to itraconazole or fluconazole [chart notes required] OR
• 4. Itraconazole or fluconazole was discontinued due to lack of efficacy, diminished effect, or an adverse event [chart notes required] OR
• 5. The patient has an intolerance or hypersensitivity to itraconazole or fluconazole [chart notes required] OR
• 6. The patient has an FDA labeled contraindication to BOTH fluconazole AND itraconazole [chart notes required] OR
• 7. Itraconazole or fluconazole is expected to be ineffective; OR cause significant barrier to adherence; OR worsen comorbid condition; OR decrease functional ability; OR cause adverse reaction or harm [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 the same pharmacologic class as itraconazole or fluconazole and discontinued due to lack of efficacy or an adverse event [chart notes required] OR
• B. BOTH of the following:
• 1. The requested agent is prescribed for prophylaxis of invasive aspergillosis or Candida AND
• 2. The patient is severely immunocompromised (e.g., HSCT recipient, hematologic malignancy with prolonged neutropenia, or high-risk solid organ transplant recipient) OR
• C. The patient has a diagnosis of invasive aspergillosis AND ONE of the following:
• 1. BOTH of the following:
• A. ONE of the following:
• 1. Stage four advanced, metastatic cancer and use as cancer treatment OR
• 2. Stage four advanced, metastatic cancer and use for associated condition [chart notes required] AND
• B. The use of the requested agent is consistent with best practices, supported by peer-reviewed evidence, and FDA approved OR
• 2. The patient is currently stable on the requested agent [chart notes required] OR
• 3. The patient has tried and had inadequate response to voriconazole, amphotericin B, or isavuconazole [chart notes required] OR
• 4. Voriconazole, amphotericin B, or isavuconazole discontinued due to lack of efficacy, diminished effect, 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. Voriconazole, amphotericin B, or isavuconazole expected to be ineffective; cause adherence barrier; worsen comorbidity; harm physical/mental function [chart notes required] OR
• 8. Voriconazole, amphotericin B, or isavuconazole not in best interest based on medical necessity [chart notes required] OR
• 9. The patient has tried another drug in same pharmacologic class as voriconazole, amphotericin B, or isavuconazole and discontinued due to lack of efficacy or adverse event [chart notes required] OR
• D. The patient has another FDA approved indication for the requested agent and route OR
• E. The patient has another compendia-supported indication for the requested agent and route AND
• 2. If FDA labeled indication: ONE of the following:
• A. The patient’s age is within FDA labeling for the requested indication OR
• B. There is support for off-label age use for the requested indication AND
• 3. The patient does NOT have any FDA labeled contraindications to the requested agent
• Additional Ohio approval path: member resides in Ohio AND plan is Fully Insured or HIM Shop AND BOTH:
• A. No FDA labeled contraindications AND
• B. ONE of the following: another FDA labeled or compendia-supported indication OR two peer-reviewed journal articles supporting use

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. BOTH of the following:
• 1. The requested agent is prescribed for prophylaxis of invasive Aspergillus or Candida AND
• 2. The 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. The patient has a diagnosis of invasive aspergillosis AND
• 2. The patient has continued indicators of active disease (e.g., biomarkers, biopsy, microbiologic cultures, radiographic evidence) OR
• C. BOTH of the following:
• 1. The patient has a diagnosis other than invasive aspergillosis or prophylaxis indication AND
• 2. There is support for continued use of the requested agent for the requested indication AND
• 3. The patient does NOT have any FDA labeled contraindications to the requested agent

Approval duration

3 months for oropharyngeal candidiasis; 6 months for all other indications