BlueCross BlueShield of Tennessee Medical Policy Manual
Temozolomide (Temodar®) temozolomide
IMPORTANT REMINDER
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan or government program (e.g., TennCare), the express terms of the health plan or government program will govern.
POLICY
INDICATIONS
The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy.
FDA-Approved Indications
Newly Diagnosed Glioblastoma
Temodar is indicated for the treatment of adults with newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment.
Anaplastic Astrocytoma
Temodar is indicated for the:
Compendial Uses
All other indications are considered experimental/investigational and not medically necessary.
COVERAGE CRITERIA
Central nervous system (CNS) cancer
Authorization of 12 months may be granted for treatment of CNS cancers.
CNS metastases from solid tumors
Authorization of 12 months may be granted for treatment of brain metastases due to solid tumors.
Ewing sarcoma
Authorization of 12 months may be granted for treatment of Ewing sarcoma as second-line therapy in combination with irinotecan with or without vincristine for relapsed, progressive or metastatic disease.
Neuroendocrine tumors
Authorization of 12 months may be granted for treatment of neuroendocrine tumors.
Pheochromocytoma/paraganglioma
Authorization of 12 months may be granted for treatment of pheochromocytoma or paraganglioma as single agent first-line therapy for unresectable or metastatic disease.
Cutaneous Melanoma
Authorization of 12 months may be granted for treatment of cutaneous melanoma as single agent subsequent therapy for metastatic or unresectable disease.
Uveal Melanoma
Authorization of 12 months may be granted for treatment of uveal melanoma for unresectable or metastatic disease as a single agent.
Mycosis fungoides (MF)/Sézary syndrome (SS)
Authorization of 12 months may be granted for treatment of MF or SS as single agent subsequent therapy for CNS involvement.
Small cell lung cancer (SCLC)
Authorization of 12 months may be granted for treatment of SCLC as single agent subsequent therapy for relapsed or primary progressive disease.
Soft tissue sarcoma (STS)
Authorization of 12 months may be granted for treatment of STS.
Uterine sarcoma
Authorization of 12 months may be granted for treatment of uterine sarcoma as single agent subsequent therapy for advanced, recurrent/metastatic or inoperable disease.
Neuroblastoma
Authorization of 12 months may be granted for treatment of high-risk neuroblastoma when used in combination with irinotecan, dinutuximab, and sargramostim.
CONTINUATION OF THERAPY
Authorization of 12 months may be granted for continued treatment in members requesting reauthorization for an indication listed in the Coverage Criteria section when there is no evidence of unacceptable toxicity or disease progression while on the current regimen.
BlueCross BlueShield of Tennessee’s Medical Policy complies with Tennessee Code Annotated Section 56-7-2352 regarding coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is recognized in one of the statutorily recognized standard reference compendia or in the published peer-reviewed medical literature.
ADDITIONAL INFORMATION
For appropriate chemotherapy regimens, dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) published by the National Comprehensive Cancer Network®, Drugdex Evaluations of Micromedex Solutions at Truven Health, or The American Hospital Formulary Service Drug Information).
ORIGINAL EFFECTIVE DATE: 3/10/2005
MOST RECENT REVIEW DATE: 9/30/2025
ID_CHS
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
This document has been classified as public information.