Glioblastomas (grade IV astrocytomas)

are one of the most common types of primary malignant brain tumors in adults. These tumors develop from glial cells in the brain and are usually highly malignant (cancerous) because the cells reproduce quickly, and they are supported by a large network of blood vessels. The overall prognosis is poor, even with the best standard of care.

Currently, the standard of care for glioblastoma multiforme (GBM) includes debulking surgery, combination treatment with radiotherapy and Temozolomide (TMZ) chemotherapy, and adjuvant chemotherapy with TMZ. With optimal treatment, the median survival time is approximately 10 to 14 months. Only approximately one third of patients survive for one year following diagnosis of GBM, and fewer than 5% live beyond 5 years. Virtually all patients with newly diagnosed GBM relapse despite best available treatment. Patients with recurrent GBM have a median survival time of five to seven months.

Malignant mesothelioma

is a rare neoplasm that arises most commonly from the mesothelial surfaces of the pleural cavity, less commonly from the peritoneal surface, and extremely rarely from the tunica vaginalis or pericardium. It often has an extremely poor prognosis; the median survival is 4 to 13 months for untreated patients and 6 to 18 months for treated patients, regardless of the therapeutic approach.

Tumor treating fields (TTF) therapy utilizes mild electrical field pulses to inhibit tumor cell proliferation and/or destroy tumor cells.TTF aims to disrupt the rapid cell division exhibited by malignant cells. TTF have not been shown to have an effect on cells that are not undergoing division.

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Tumor Treating Fields 1

The Optune-lua system produces tumor treating fields within the human body through transducer arrays placed on surface of the scalp or chest.

Clinical Guideline Coverage Criteria

The Plan considers the use of U.S. Food and Drug Administration (FDA) approved tumor treating fields (TTF) device (e.g., Optune-lua) medically necessary documentation confirms ALL the following:

1. Newly diagnosed supratentorial glioblastoma following both debulking surgery and radiation therapy with concomitant chemotherapy and ALL of the following are met:
   • TTF is in combination with temozolomide (TMZ); and
   • Member is 22 years of age or older; and
   • Member has the ability to use the device for an average of 18 hours each day; and
   • Member has Karnofsky score > 70 or Eastern Cooperative Oncology Group (ECOG) performance status 0-1
2. TTF as monotherapy in member with histologically or radiologically confirmed recurrent glioblastoma (GBM) in the supratentorial region of the brain after receiving chemotherapy and ALL the following are met:
   • Surgical and radiation options have been exhausted; and
   • Member is 22 years of age or older; and
   • Member has the ability to use the device for an average of 18 hours each day.

Adult member with unresectable, locally advanced or metastatic, malignant pleural mesothelioma (MPM) when used concurrently with pemetrexed and platinum-based chemotherapy

Note: Authorization will be in 3-month increments

Limitations

The use of tumor treating field (TTF) devices for all other indications as this is considered experimental and investigational.

Supporting Information

Eastern Cooperative Oncology Group (ECOG) performance status

• Grade 0: Fully active, able to carry on all pre-disease performance without restriction
• Grade 1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light housework, office work
• Grade 2: Ambulatory and capable of all self-care but unable to carry out any work activities; up about more than 50% of waking hours
• Grade 3: Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours
• Grade 4: Completely disabled; cannot carry on any selfcare; totally confined to bed or chair
• Grade 5: Dead

Karnofsky Performance Status Scale

• Able to carry on normal activity and to work; no special care needed:
  • 100% - No complaints; no evidence of disease
  • 90% - Able to carry on normal activity; minor signs or symptoms of disease
  • 80% - Normal activity with effort; some signs or symptoms of disease
• Unable to work; able to live at home and care for most personal needs; varying amount of assistance needed:
  • 70% - Cares for self; unable to carry on normal activity or to do active work
  • 60% - Requires occasional assistance but is able to are for most personal needs

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• Value (%) 50% : Requires considerable assistance and frequent medical care
• Value (%) 40% : Disabled; requires special care and assistance
• Value (%) 30% : Severely disabled; hospital admission indicated although death not imminent
• Value (%) 20% : Very sick; hospital admission necessary; active supportive treatment necessary
• Value (%) 10% : Moribund; fatal processes progressing rapidly
• Value (%) 0% : Dead