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Clinical Policy Bulletin:
Temozolomide (Temodar)
Number: 0876


Policy

Aetna considers temozolomide (Temodar) injection medically necessary for members who are unable to take the oral formulation of temozolomide due to vomiting or inability to absorb capsules sufficiently through the gastrointestinal tract, for the following indications:

  • Ewing's Sarcoma Family of Tumors – for progressive, relapsed or metastatic disease
  • Adult Low-Grade Infiltrative Supratentorial Astrocytoma/Oligodendroglioma (excluding pilocytic astrocytoma) – adjuvant chemotherapy, or for recurrent or progressive disease
  • Adult Medulloblastoma and Supratentorial Primitive Neuroectodermal Tumors (PNET) – progression or recurrence (salvage therapy)
  • Anaplastic Gliomas – adjuvant treatment, and treatment of recurrent disease or salvage therapy
  • Glioblastoma – treatment following resection, or for recurrent disease or salvage therapy
  • Central Nervous System Cancers - Limited (1-3) Metastatic Lesions – for metastases to the brain in disseminated or recurrent disease
  • Central Nervous System Cancers - Multiple (>3) Metastatic Lesions – for metastases to the brain in recurrent stable systemic disease
  • Primary CNS Lymphoma – primary treatment or for progressive or recurrent disease
  • Lung Neuroendocrine Tumors- treatment of stage IIIb-IV low- or intermediate-grade neuroendocrine carcinoma
  • Melanoma - unresectable, recurrent or metastatic disease
  • Carcinoid Tumors - unresectable or metastatic progressive disease
  • Neuroendocrine Tumors of the Pancreas (Islet Cell Tumors) – unresectable locoregional disease or distant metastatic disease
  • Mycosis Fungoides (MF)/Sezary Syndrome (SS) – second line chemotherapy
  • Small cell lung cancer – primary progressive disease or relapse
  • Angiosarcoma
  • Soft tissue sarcoma of the extremity/trunk - synchronous stage IV or recurrent disease with disseminated metastases
  • Retroperitoneal/intraabdominal soft tissue sarcoma – unresectable or progressive disease
  • Solitary Fibrous Tumor/Hemangiopericytoma
  • Uterine sarcoma

Aetna considers temozolomide experimental and investigational for all other indications.



Background

Temodar (temozolomide) was approved by the U.S. Food and Drug Administration for the treatment of adult patients with newly diagnosed glioblastoma multiforme concomitantly with radiotherapy and then as maintenance treatment. The labeling states that temozolomide is indicated for the treatment of adult patients with refractory anaplastic astrocytoma (ie, patients who have experienced disease progression on a drug regimen containing nitrosourea and procarbazine).

Guidelines from the National Comprehensive Cancer Network (2013) list the following indications for temozolomide:

  • Ewing's Sarcoma Family of Tumors - used with growth factor support in combination with irinotecan with or without vincristine
     
    • with or without radiation therapy for relapse
    • for progressive disease following primary treatment
    • as second-line therapy for metastatic disease
       
  • Adult Low-Grade Infiltrative Supratentorial Astrocytoma/Oligodendroglioma (excluding pilocytic astrocytoma)
     
    • Treatment as a single agent for recurrent or progressive disease 
    • Adjuvant chemotherapy as a single agent following
       
      • maximal safe resection
      • biopsy or subtotal resection
         
  • Adult Medulloblastoma and Supratentorial Primitive Neuroectodermal Tumors (PNET) - recurrence/salvage therapy as a single agent for disease progression in patients who have received prior chemotherapy
  • Anaplastic Gliomas
     
    • Adjuvant treatment as 
       
      • concurrent chemoradiation for anaplastic oligodendroglioma, anaplastic oligoastrocytoma, and anaplastic astrocytoma
      • single-agent chemotherapy
         
    • Treatment of recurrent disease or salvage therapy as a single agent or in combination with bevacizumab
       
  • Glioblastoma
     
    • Treatment following resection with or without carmustine polymer as
       
      • concurrent and adjuvant treatment in combination with radiation therapy (RT) for patients with good performance status (PS; Karnofsky Performance Status [KPS] ≥70 )
      • chemotherapy for patients age >70 years with good PS if methylguanine methyltransferase promotor-methylation positive
      • chemotherapy for patients with poor PS (KPS <70)
         
    • Treatment of recurrent disease or salvage therapy as a single agent or in combination with bevacizumab
       
  • Central Nervous System Cancers - Limited (1-3) Metastatic Lesions - consider as a single-agent treatment for brain metastases if active against the primary tumor
     
    • as primary treatment for disseminated disease with poor systemic treatment options
    • for recurrent disease
       
  • Central Nervous System Cancers - Multiple (>3) Metastatic Lesions - Single-agent treatment if active against primary tumor for brain metastases in persons with recurrent stable systemic disease
  • Primary CNS Lymphoma
     
    • Primary treatment combined with high-dose methotrexate and rituximab with deferred radiation therapy
    • Treatment as a single agent or in combination with rituximab for progressive disease in patients who have received prior methotrexate-based regimen without prior radiation therapy (RT) 
       
      • after prolonged response to prior regimen
      • in combination with RT after short or no response to prior regimen
         
    • Consider systemic treatment as a single agent or in combination with rituximab for progressive or recurrent disease in patients with prior who brain radiation therapy
       
  • Lung Neuroendocrine Tumors
     
    •    Use as treatment for stage IIIb (T4 due to multiple lung nodules)-IV low- or intermediate-grade neuroendocrine carcinoma
       
  • Melanoma
     
    • Single agent or in combination with cisplatin and vinblastine with or without interleukin-2 and interferon alfa for
       
      • unresectable stage III in-transit metastases
      • local/satellite and/or intransit unresectable recurrence
      • incompletely resected or unresectable nodal recurrence
      • recurrent or metastatic disease in patients with good performance status
         
  • Carcinoid Tumors - Management of clinically significant locoregional unresectable or metastatic progressive disease 
  • Neuroendocrine Tumors of the Pancreas (Islet Cell Tumors) - Management of unresectable locoregional disease and/or distant metastatic disease in patients with symptoms, clinically significant tumor burden, or clinically significant progression
  • Mycosis Fungoides (MF)/Sezary Syndrome (SS)
     
    • Second-line chemotherapy for patients with Small Cell Lung Cancer (SCLC)
       
      • stage IA-IIA MF with histologic evidence of folliculotropic or large cell transformation or stage IIB with generalized extent tumor, transformed, and/or folliculotropic disease in combination with skin-directed therapy
      • stage IV non-Sezary or visceral disease
      • refractory or progressive stage III MF or SS
         
  • Small cell lung cancer
     
    • Subsequent chemotherapy for patients with performance status 0-2 as a single agent for
       
      • relapse within 6 months following complete or partial response with initial treatment
      • primary progressive disease
         
  • Angiosarcoma - Used as a single agent for angiosarcoma
  • Soft Tissue Sarcoma of the Extremity/Trunk - Single-agent palliative chemotherapy for synchronous stage IV or recurrent disease with disseminated metastases
  • Retroperitoneal/Intraabdominal Soft Tissue Sarcoma - Single-agent palliative chemotherapy for unresectable or progressive disease
  • Rhabdomyosarcoma - Therapy for
     
    • pleomorphic rhabdomyosarcoma as a single agent
    • nonpleomorphic rhabdomyosarcoma in combination with vincristine and irinotecan
       
  • Solitary Fibrous Tumor/Hemangiopericytoma  - In combination with bevacizumab for the treatment of solitary fibrous tumor and hemangiopericytoma
  • Uterine Sarcoma - Single agent
     
    • for medically inoperable disease limited to the uterus
    • may be considered following total hysterectomy with bilateral salpingo-oophorectomy (TH/BSO) for stage I-III disease
    • following TH/BSO for stage IV disease
    • for local recurrence confined to the vagina
    • for extrapelvic recurrence with no prior radiation therapy
    • for isolated metastases. Consider postoperative chemotherapy for resectable isolated metastases
    • for disseminated metastases

Nausea and vomiting are known side effects of treatment and  should be medically treated, when they occur.  Current dosing recommendations by the manufacturer are not to withhold doses due to the adverse effects of vomiting.  Grade 3 or 4 vomiting occurred < 1% in the clinical trials. 

 
CPT Codes / HCPCS Codes / ICD-9 Codes
Other CPT codes related to the CPB:
96413
96415
HCPCS codes covered if selection criteria are met:
J9328 Injection, temozolomide 1 mg
Other HCPCS codes related to the CPB:
J8700 Temozolomide, oral, 1 mg
ICD-9 codes covered if selection criteria are met:
157.0, 157.2, 157.4, 157.9 Malignant neoplasms of pancreas [neuroendocrine tumors of the pancreas (islet cell tumors)]
158.0 - 158.9 Malignant neoplasm of retroperitoneum and peritoneum
162.0 - 162.9 Malignant neoplasm of trachea, broncus, and lung [small cell lung cancer (SCLC)]
170.0 - 170.9 Malignant neoplasm of bone and articular cartilage [ewing's sarcoma family of tumors]
171.0 - 1719 Malignant neoplasm of connective and other soft tissue
172.0 - 172.9 Malignant melanoma of skin
179 - 180.0 Malignant neoplasm of uterus, part unspecified and cervix uteri [uterine sarcoma]
182.0 - 182.8 Malignant neoplasm of endocervix [uterine sarcoma]
191.0 - 191.9 Malignant neoplasm of brain
192.8 Malignant neoplasm of other specified sites of nervous system [anaplastic gliomas, glioblastoma]
192.9 Malignant neoplasm of nervous system, part unspecified [adult low-grade infiltrative supratentorial astrocytoma/oligodendroglioma (excluding pilocytic astrocytoma)]
196.9 Secondary and unspecified malignant neoplasm of lymph nodes, site unspecified [carcinoid tumors]
197.0 Secondary malignant neoplasm of lung [small cell lung cancer (SCLC)]
198.3 Secondary malignant neoplasm of brain and spinal cord [limited (1-3) metastatic lesions, multiple (>3) metastatic lesions, melanoma, small cell lung cancer (SCLC)]
198.5 Secondary malignant neoplasm of bone and bone marrow [small cell lung cancer (SCLC)]
199.0 - 199.1 Malignant neoplasm without specification of site, disseminated, other [melanoma]
200.50 - 200.51 Primary central nervous system lymphoma, , unspecified site, extranodal and solid organ sites, and head, face, and neck [primary CNS lymphoma]
202.10 - 202.28 Mycosis fungoides and Sezary's disease
209.00 - 209.30 Neuroendocrine tumors
235.5 Neoplasm of uncertain behavior of other and unspecified digestive organs [neuroendocrine tumors of the pancreas (islet cell tumors)]
237.5 Neoplasm of uncertain behavior of brain and spinal cord [adult low-grade infiltrative supratentorial astrocytoma/oligodendroglioma (excluding pilocytic astrocytoma)]
251.1 Other specified hypoglycemia [neuroendocrine tumors of the pancreas (islet cell tumors)]
251.4 Abnormality of secretion of glucagon [neuroendocrine tumors of the pancreas (islet cell tumors)]
251.8 Other specified disorders of pancreatic internal secretion [neuroendocrine tumors of the pancreas (islet cell tumors)]
259.2 Carcinoid syndrome [carcinoid tumors]
Other ICD-9 codes related to the CPB:
V10.09 Personal history of malignant neoplasm of other site in gastrointestinal tract [neuroendocrine tumors of the pancreas (islet cell tumors)]
V10.11 Personal history of malignant neoplasm of bronchus and lung [small cell lung cancer (SCLC)]
V10.81 Personal history of malignant neoplasm of bone [ewing's sarcoma family of tumors]
V10.82 Personal history of malignant melanoma of skin [melanoma]
V10.85 Personal history of malignant neoplasm of brain [adult low-grade infiltrative supratentorial astrocytoma/oligodendroglioma (excluding pilocytic astrocytoma), anaplastic gliomas, glioblastoma]
V10.88 Personal history of malignant neoplasm of other endocrine glands and related structures [neuroendocrine tumors of the pancreas (islet cell tumors)]
V10.89 Personal history of malignant neoplasm of other site [carcinoid tumors]
V16.49 Family history of other malignant neoplasm [uterine sarcoma]


The above policy is based on the following references:
  1. Temodar [package insert]. Whitehouse Station, NJ: Merck; January 2013.
  2. Back MF, et al. Improved median survival for glioblastoma multiforme following introduction of adjuvant temozolomide chemotherapy. Annals Academy of Medicine, Singapore. 2007 May;36(5):338-5.
  3. NCCN Clinical Practice Guidelines: Central Nervous System Cancers. V 1.2013. Accessed 3/25/13 at http://www.nccn.org/professionals/physician_gls/pdf/cns.pdf


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Copyright Aetna Inc. All rights reserved. Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.
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