TEMODAR (temozolomide)

Self-Administration - oral

Medical Administration - intravenous

Indications for Prior Authorization:
  • Newly Diagnosed Glioblastoma: Temodar® is indicated for the treatment of adult patients with newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment.
  • Refractory Anaplastic Astrocytoma: Temodar® is indicated for the treatment of adult patients with refractory anaplastic astrocytoma who have experienced disease progression on a drug regimen containing nitrosourea and procarbazine.
Coverage Criteria:

For diagnosis of glioblastoma:

  • Dose does not exceed 200 mg/m2 per day, AND
  • Patient is 18 years of age or older, AND
  • Prescribed by or in consultation with an oncologist, AND
  • Chart note documentation provided confirms diagnosis of glioblastoma, AND
  • One of the following (A or B):
    • A. Both of the following:
      • Patient is newly diagnosed, and
      • Used in combination with radiotherapy, OR
    • B. Used as maintenance treatment; AND
  • For Brand Temodar® capsules only: Trial and failure, contraindication, or intolerance to generic Temodar® capsules

For diagnosis of anaplastic astrocytoma:

  • Dose does not exceed 200 mg/m2 per day, AND
  • Patient is 18 years of age or older, AND
  • Prescribed by or in consultation with an oncologist, AND
  • Chart note documentation provided confirms diagnosis of anaplastic astrocytoma, AND
  • Patient’s condition has progressed on a drug regimen containing a nitrosourea agent and procarbazine; AND
  • For Brand Temodar® capsules only: Trial and failure, contraindication, or intolerance to generic Temodar® capsules
Reauthorization Criteria:

For diagnosis of glioblastoma OR anaplastic astrocytoma:

  • Dose does not exceed 200 mg/m2 per day, AND
  • Patient is 18 years of age or older, AND
  • Patient does not show evidence of progressive disease while on therapy
Coverage Duration:
  • Initial: 1 year
  • Reauthorization: 1 year
Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information:
  • Temozolomide is contraindicated in patients with a history of hypersensitivity reactions to:
    • Temozolomide or any other ingredients in temozolomide; and
    • Dacarbazine (since both temozolomide and dacarbazine are metabolized to the same active metabolite 5-(3-methyltriazen-1-yl)-imidazole-4-carboxamide.
  • Warnings and Precautions:
    • Myelosuppression
    • Myelodysplastic syndrome and secondary malignancies
    • Pneumocystis pneumonia
    • Hepatotoxicity
    • Embryo-fetal toxicity
Policy Updates:
  • 11/16/2021 – New policy reviewed by P&T.
References:
  • Temodar Prescribing Information, Merck & Co, Inc. Whitehouse Station, NJ. November 2019.
  • National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology. Central Nervous System Cancers v.1.2019. Available by subscription at: http://www.nccn.org/professionals/physician_gls/pdf/cns.pdf. Accessed on November 2, 2021.

 

 

Last review date: November 16, 2021