This policy version was replaced August 1, 2022. To find the newest version, go to https://www.bluecrossmn.com/providers/medical-policy-and-utilization-management, read and accept the Blue Cross Medical Policy Statement, then select “Blue Cross and Blue Shield of Minnesota Medical Policies.” This will bring up the Medical Policy search screen. Enter the policy number without the version number (last 3 digits).

Tumor treating fields (TTF or TTFields) therapy exposes cancer cells to alternating electric fields of low intensity and intermediate frequency. The use of TTF is proposed to inhibit rapidly dividing tumor cells by arresting cell proliferation, leading to destruction of cells.

Glioblastoma is also known as glioblastoma multiforme (GBM). The term "multiforme" is no longer part of the World Health Organization (WHO) designation, though glioblastoma is still often abbreviated "GBM." Glioblastoma is the most common form of malignant primary brain tumor in adults, and comprises approximately 15% of all brain and central nervous system tumors. Glioblastoma is a WHO grade IV astrocytoma, the most deadly type of glial cell tumor, which is often resistant to standard chemotherapy.  Malignant pleural mesothelioma is an aggressive tumor with few treatment options that is associated with significant morbidity and mortality. 

Optune™ (formerly known as the NovoTTF-100A™ System) received premarket approval (PMA) from the U.S. Food and Drug Administration (FDA) in 2011 as a treatment for adult patients (22 years of age or older) with confirmed GBM, following confirmed recurrence in an upper region of the brain (supratentorial) after receiving chemotherapy. The device was originally intended to be used as a stand-alone treatment, as an alternative to standard medical therapy for recurrent GBM after surgical and radiation options have been exhausted. In October 2015, the FDA approved Optune™ with temozolomide for the treatment of adult patients with newly diagnosed, supratentorial glioblastoma following maximal debulking surgery and completion of radiation therapy together with concomitant standard of care chemotherapy.  In May 2019, the FDA granted Humanitarian Device Exemption (HDE) status to the NovoTTF™-100L System for the treatment of adult patients with unresectable, locally advanced, or metastatic, malignant pleural mesothelioma (MPM), to be used concurrently with pemetrexed and platinum-based chemotherapy.

Tumor treating fields therapy is delivered by a battery-powered, portable device that generates the electrical fields via disposable electrodes that are noninvasively attached over the site of the tumor. The device is used by the patient at home on a continuous basis (20-24 hours per day) for the duration of treatment. 

NovoTAL™ is software that may be used for treatment planning prior to Optune treatment. NovoTAL is an optional software that may be used to create individualized treatment maps for patients undergoing Optune treatment and is performed in-office.

Definitions

Karnofsky Performance Status (KPS) is a standard way of measuring the ability of cancer patients to perform ordinary tasks. The Karnofsky Performance Status scores range from 0 to 100. A higher score means the patient is better able to carry out daily activities. Karnofsky Performance Status may be used to determine a patient's prognosis, to measure changes in a patient’s ability to function, or to decide if a patient could be included in clinical trials.

Progression is defined as tumor growth greater than 25% compared to smallest measured tumor area or the appearance of one or more new GBM lesions in the brain.

The supratentorial region of the brain contains the cerebrum, lateral ventricle and third ventricle (with cerebrospinal fluid shown in blue), choroid plexus, pineal gland, hypothalamus, pituitary gland, and optic nerve.

Recurrent disease is disease that has come back, usually after a period of time during which the disease could not be detected.  In the case of cancer, the disease may come back to the same place as the primary tumor or to another place in the body

I.    Initial Review for Newly Diagnosed Glioblastoma

Tumor treating fields (TTF) therapy for the treatment of newly diagnosed glioblastoma may be considered MEDICALLY NECESSARY AND APPROPRIATE for patients who meet ALL of the following criteria:

• Histologically confirmed newly diagnosed glioblastoma in the supratentorial region of the brain; AND
• Previous treatment with debulking surgery or biopsy followed by chemoradiation with concomitant temozolomide and radiotherapy; AND
• Used in combination with temozolomide (Temodar); AND
• Karnofsky Performance Status (KPS) score ≥70%; AND 
• Patient is willing to wear the device at least 18 hours daily.

II.   Renewal Review for Newly Diagnosed Glioblastoma

Tumor treating fields (TTF) therapy for the treatment of newly diagnosed glioblastoma may be considered MEDICALLY NECESSARY AND APPROPRIATE for patients who meet ALL of the following criteria:

• Previously approved for the device through the initial review process; AND
• Demonstrated positive clinical response as evidenced by advanced imaging (CT, MRI, MR Spectroscopy) within the past 60 days; AND
• Used in combination with temozolomide (Temodar); AND
• Karnofsky Performance Status (KPS) score ≥70%; AND
• Patient is compliant with using the device at least 18 hours daily.

III.  Initial Review for Recurrent Glioblastoma

Tumor treating fields (TTF) therapy for the treatment of recurrent glioblastoma may be considered MEDICALLY NECESSARY AND APPROPRIATE for patients who meet ALL of the following criteria:

• Diagnosis of recurrent glioblastoma in the supratentorial region of the brain; AND
• Previous treatment with standard therapeutic options, such as maximum safe debulking surgery and/or systemic chemotherapy and/or irradiation; AND
• Will be used as monotherapy; AND
• Karnofsky Performance Status (KPS) score ≥70%; AND
• Patient is willing to wear the device at least 18 hours daily.

Documentation Submission

Documentation supporting the medical necessity criteria described in the policy must be included in the prior authorization, when prior authorization is required. In addition, the following documentation must also be included:

Initial Review for Treatment of Glioblastoma

• Documentation of a histological diagnosis of glioblastoma
• Clinical notes describing:
  • Diagnosis and clinical features
  • Advanced imaging (CT, MRI, MR Spectroscopy) within past 60 days read by a radiologist or neuroradiologist
• For treatment of newly diagnosed GBM, documentation that the patient is receiving standard maintenance therapy with temozolomide.

Renewal Review for Treatment of Glioblastoma

• Documentation of prior approval for the device through the initial review process
• Advanced imaging (CT, MRI, MR Spectroscopy) within past 60 days read by a radiologist or neuroradiologist
• For treatment of newly diagnosed GBM, documentation that the patient is receiving standard maintenance therapy with temozolomide.

Initial and Renewal Review for Treatment of Malignant Pleural Mesothelioma

• Documentation that the device is used concurrently with pemetrexed and platinum-based chemotherapy.