Skip to content
The Policy VaultThe Policy Vault

Tolsura (itraconazole) — Blue Cross Blue Shield of New Mexico

other FDA labeled indication

Preferred products

  • Vfend
  • Noxafil
  • generic itraconazole

Initial criteria

  • The patient is currently being treated with the requested agent and is currently stable on the requested agent [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 or effectiveness, diminished effect, or an 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 based on known clinical characteristics; OR cause adherence barriers; OR worsen comorbid condition; OR decrease functional ability; OR cause adverse reaction or 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 has tried another drug in the same pharmacologic class or mechanism as Vfend or Noxafil and discontinued due to lack of efficacy, diminished effect, or adverse event [chart notes required] OR
  • For blastomycosis or histoplasmosis: patient has diagnosis AND ONE of the following:
  • – The patient has stage 4 advanced metastatic cancer and the requested agent is being used to treat the cancer or an associated condition AND use is consistent with best practices, FDA approved, and supported by literature OR
  • – The patient is currently being treated with the requested agent and is stable [chart notes required] OR
  • – The patient has tried and had an inadequate response to generic itraconazole [chart notes required] OR
  • – Generic itraconazole 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 expected to be ineffective, cause adherence barrier, worsen comorbidity, decrease function, or cause harm [chart notes required] OR
  • – Generic itraconazole not in best interest of the patient based on medical necessity [chart notes required] OR
  • The patient has another FDA labeled indication OR an indication supported in compendia (AHFS or DrugDex 1, 2a, 2b) AND age is within FDA labeling or supported for age AND no labeled contraindications
  • Alternate approval route: member resides in Ohio AND plan is Fully Insured or HIM Shop (SG) AND patient has no labeled contraindication AND ONE of: another FDA labeled indication, compendia-supported indication, or submission of two peer-reviewed journal articles supporting safe and effective use (accepted studies randomized, double blind, placebo controlled). Non-oncology compendia: DrugDex level 1, 2A, or 2B, AHFS-DI; Oncology compendia: NCCN 1 or 2A, AHFS-DI, DrugDex 1–2B, Clinical Pharmacology, or LexiDrugs A.

Reauthorization criteria

  • The patient has been previously approved for the requested agent through prior authorization review AND
  • The patient does NOT have any FDA labeled contraindication(s) AND
  • ONE of the following:
  • – The patient has a diagnosis of aspergillosis, blastomycosis, or histoplasmosis AND continues to have indicators of active disease (biomarkers, biopsy, culture, or radiographic evidence) OR
  • – The patient has another diagnosis and there is support for continued use of the requested agent for that indication

Approval duration

initial: 3–6 months (per plan); renewal: 6 months; special Ohio route: 12 months