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Tolsura (itraconazole) — Blue Cross Blue Shield of Oklahoma

histoplasmosis

Preferred products

  • Vfend
  • Noxafil
  • generic itraconazole

Initial criteria

  • 1. The patient has a diagnosis of aspergillosis AND ONE of the following:
  • • The patient is currently being treated with the requested agent and is stable on therapy [chart notes required] OR
  • • The patient has tried and had an inadequate response to Vfend or Noxafil [chart notes required] OR
  • • Vfend or Noxafil was discontinued due to lack of efficacy, diminished effect, or adverse event [chart notes required] OR
  • • The patient has an intolerance or hypersensitivity to Vfend or Noxafil [chart notes required] OR
  • • The patient has an FDA labeled contraindication to Vfend AND Noxafil [chart notes required] OR
  • • Vfend or Noxafil is expected to be ineffective, cause adherence barrier, worsen comorbid condition, decrease functional ability, or cause harm [chart notes required] OR
  • • Vfend or Noxafil is not in the best interest of the patient based on medical necessity [chart notes required] OR
  • • The patient tried another prescription drug in the same pharmacologic class or mechanism as Vfend or Noxafil and it was discontinued due to lack of efficacy or adverse event [chart notes required]
  • OR B. The patient has a diagnosis of blastomycosis or histoplasmosis AND ONE of the following:
  • • The patient meets advanced metastatic cancer criteria AND use consistent with FDA approval and evidence-based literature OR
  • • The patient is currently being treated with the requested agent and is stable on therapy [chart notes required] OR
  • • The patient has tried and had inadequate response to generic itraconazole [chart notes required] OR
  • • Generic itraconazole was discontinued due to lack of efficacy, diminished effect, or adverse event [chart notes required] OR
  • • The patient has an intolerance or hypersensitivity to generic itraconazole [chart notes required] OR
  • • The patient has an FDA labeled contraindication to generic itraconazole [chart notes required] OR
  • • Generic itraconazole is expected to be ineffective, cause adherence barrier, worsen comorbid condition, decrease functional ability, or cause harm [chart notes required] OR
  • • Generic itraconazole is not in the best interest of the patient based on medical necessity [chart notes required] OR
  • • The patient has tried another prescription drug in same pharmacologic class or mechanism as generic itraconazole and it was discontinued due to lack of efficacy or adverse event [chart notes required]
  • OR 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 for the requested agent and route of administration
  • AND If the patient has an FDA labeled indication, ONE of the following: patient's age within FDA labeling OR supported by evidence for use in that age
  • The patient does not have any FDA labeled contraindications to the requested agent

Reauthorization criteria

  • 1. The patient was previously approved for the requested agent through the plan’s prior authorization review AND
  • 2. The patient does NOT have any FDA labeled contraindications AND
  • 3. ONE of the following:
  • • The patient has a diagnosis of aspergillosis, blastomycosis, or histoplasmosis AND continued indicators of active disease (e.g., biomarkers, microbiologic, or radiographic evidence) OR
  • • The patient has another diagnosis and there is support for continued use of the requested agent for the indication

Approval duration

6 months (BCBSIL/BCBSMT); 3 months (others); 12 months (Ohio Fully Insured or HIM Shop)