TEMODAR (temozolomide)

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.