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Tolsura (itraconazole) — Blue Cross Blue Shield of Texas

histoplasmosis

Preferred products

  • Vfend
  • Noxafil
  • generic itraconazole

Initial criteria

  • ONE of the following:
  • A. The patient has a diagnosis of aspergillosis AND ONE of the following:
  • 1. The patient is currently being treated with the requested agent and is stable on therapy OR
  • 2. The patient has tried and had an inadequate response to Vfend or Noxafil OR
  • 3. Vfend or Noxafil was discontinued due to lack of efficacy or adverse event OR
  • 4. The patient has an intolerance or hypersensitivity to Vfend or Noxafil OR
  • 5. The patient has an FDA labeled contraindication to both Vfend AND Noxafil OR
  • 6. Vfend or Noxafil is expected to be ineffective, cause adherence barrier, worsen comorbidity, decrease functional ability, or cause adverse reaction/physical or mental harm OR
  • 7. Vfend or Noxafil is not in the best interest of the patient based on medical necessity OR
  • 8. The patient has tried another drug in the same pharmacologic class as Vfend or Noxafil that was discontinued for lack of efficacy or adverse event
  • B. The patient has blastomycosis or histoplasmosis AND ONE of the following:
  • 1. BOTH of the following:
  • A. ONE of the following:
  • 1. The patient has stage IV advanced metastatic cancer and the requested agent treats the cancer OR
  • 2. The patient has stage IV advanced metastatic cancer and the requested agent treats an associated condition AND
  • B. The use of the requested agent is consistent with best practices, evidence-based literature, FDA-approved OR
  • 2. The patient is currently being treated with the requested agent and is stable on therapy OR
  • 3. Tried and had inadequate response to generic itraconazole OR
  • 4. Generic itraconazole discontinued due to lack of efficacy or adverse event OR
  • 5. Intolerance or hypersensitivity to generic itraconazole OR
  • 6. FDA labeled contraindication to generic itraconazole OR
  • 7. Generic itraconazole expected to be ineffective, cause adherence barrier, worsen comorbidity, decrease functional ability, or cause physical/mental harm OR
  • 8. Not in best interest of patient based on medical necessity OR
  • 9. Tried another drug in same pharmacologic class as generic itraconazole that was discontinued for lack of efficacy or adverse event
  • C. The patient has another FDA labeled indication for the requested agent and route of administration OR
  • D. The patient has another indication supported in compendia (AHFS or DrugDex 1, 2a, or 2b) AND both: (1) Age within FDA labeling or supported for use; (2) No FDA labeled contraindication to requested agent

Reauthorization criteria

  • ALL of the following:
  • 1. The patient has been previously approved for the requested agent through plan’s PA process
  • 2. The patient does NOT have any FDA labeled contraindications
  • 3. ONE of the following:
  • A. BOTH of the following:
  • 1. Diagnosis of aspergillosis, blastomycosis, or histoplasmosis AND
  • 2. Continued indicators of active disease (e.g., biomarkers, biopsy, culture, radiographic evidence) OR
  • B. BOTH of the following:
  • 1. Diagnosis other than above AND
  • 2. Support for continued use for the requested indication

Approval duration

6 months (BCBSIL/BCBSMT), 3 months (all other plans), 12 months (Ohio fully insured/HIM Shop)