Electric Tumor Treatment Field Therapy (for Tennessee Only)
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This policy governs coverage of FDA-approved electric tumor treatment field (TTF) devices for Medicaid and CoverKids members in Tennessee. Coverage is limited to specified treatment of newly diagnosed or recurrent supratentorial glioblastoma and requires clinical, treatment, performance-status, and device-use criteria.
Supporting clinical evidence and references were updated to reflect current information.
Medical Necessity and Coverage Criteria
Newly Diagnosed GBM — Initial Therapy
Covered when ALL of the following criteria are met:
ALL of the following
- Histologically confirmed supratentorial glioblastoma (GBM).
- U.S. Food and Drug Administration (FDA)-approved device is used to generate electric tumor treatment fields (TTFs) according to FDA-labeled indications, contraindications, warnings, and precautions.
- Debulking surgery has been completed.
- Treatment with radiation therapy has been completed.
- Individual is receiving Temozolomide as the only cancer drug.
- Individual has a Karnofsky Performance Status (KPS) score of ≥ 60 or an Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2.
- Individual has been counseled that the electric TTF device must be worn for at least 18 hours daily.
Recurrent GBM — Initial Therapy
Covered when ALL of the following criteria are met:
ALL of the following
- Radiologically confirmed recurrent supratentorial glioblastoma (rGBM).
- Initial chemotherapy has been completed.
- U.S. Food and Drug Administration (FDA)-approved device is used to generate electric tumor treatment fields (TTFs) according to FDA-labeled indications, contraindications, warnings, and precautions.
- The device is used as the only treatment.
- Individual has a KPS score of ≥ 60 or an ECOG Performance Status of ≤ 2.
- Individual has been counseled that the electric TTF device must be worn for at least 18 hours daily.
Continuation Beyond Initial 3 Months
Continuation beyond the initial 3 months is covered when ALL of the following criteria are met:
ALL of the following
- Histologically confirmed supratentorial GBM.
- Magnetic resonance imaging (MRI) scan has been performed ≤ 2 months prior to the request and documents no evidence of disease progression.
ONE of the following
- Individual with newly diagnosed GBM continues to receive Temozolomide as the only cancer drug.
- The device is used as the only treatment for an individual with recurrent GBM.
- KPS score is ≥ 60 or ECOG Performance Status is ≤ 2.
- Documentation shows that the individual has been using the electric TTF device for at least 18 hours daily.
Unproven or Not Medically Necessary
Electric TTF therapy is unproven and not medically necessary when coverage criteria are not met or for all other indications, including the following:
Any of the following
- The criteria for initial or continuation therapy are not met.
- Treatment of tumors other than glioblastoma.
- Use of electric TTF therapy with concurrent medical therapy, including bevacizumab, chemotherapy, or other medical therapy, for the treatment of recurrent glioblastoma.
- Any other indication not specifically described as covered under this policy.
Newly Diagnosed Glioblastoma — Clinical Guideline Context
Clinical guideline context; these recommendations are distinct from the payer coverage criteria above.
ALL of the following
- ASCO/SNO guidelines recommend that alternating electric field therapy may be added to adjuvant Temozolomide in people with newly diagnosed supratentorial glioblastoma, IDH-wildtype, CNS WHO grade 4, who have completed chemoradiation therapy. The recommendation is evidence-based; benefits outweigh harms; evidence quality is moderate; and strength of recommendation is weak.
- NCCN recommends alternating electric field therapy as an option for supratentorial disease. For patients ≤ 70 years of age with good performance status (KPS ≥ 60), regardless of MGMT promoter methylation status, category 1 options include standard brain radiation therapy plus concurrent and adjuvant Temozolomide with or without alternating electric field therapy. For MGMT-unmethylated disease, radiation therapy alone may also be considered, particularly when clinical-trial participation is possible.
- For patients > 70 years of age with good performance status, NCCN recommendations vary by MGMT promoter methylation status and include hypofractionated radiation therapy with concurrent and adjuvant Temozolomide or standard radiation therapy plus concurrent and adjuvant Temozolomide and alternating electric field therapy; clinical trials are preferred for eligible patients.
- NCCN describes alternating electric field therapy with concurrent and adjuvant Temozolomide as a category 1 option in specified newly diagnosed glioblastoma populations, while emphasizing that treatment selection depends on age, performance status, and MGMT promoter methylation status.
Recurrent or Progressive Glioblastoma — Clinical Guideline Context
Clinical guideline context; these recommendations are distinct from the payer coverage criteria above.
ALL of the following
- For recurrent or progressive glioblastoma, NCCN recommends consideration of a clinical trial, systemic therapy, surgery when appropriate, alternating electric field therapy for glioblastoma (category 2B), or palliative/best supportive care when performance status is poor. Management depends on disease distribution, resectability, symptoms, and performance status.
- For local, resectable disease, options may include resection, systemic therapy, clinical trials, reirradiation (category 2B), alternating electric field therapy for glioblastoma (category 2B), or palliative/best supportive care.
- For local, unresectable disease, resection is not recommended; options may include clinical trials, systemic therapy, reirradiation (category 2B), alternating electric field therapy for glioblastoma (category 2B), or palliative/best supportive care.
- NCCN states that alternating electric field therapy is FDA approved for recurrent glioblastoma based on safety results from the EF-11 trial. EF-11 did not demonstrate an improvement in survival compared with physician-choice chemotherapy, and the NCCN panel is divided about recommending alternating electric field therapy because of the lack of clear efficacy data.
Metastatic Non-Small-Cell Lung Cancer — Clinical Evidence Context
Clinical evidence and guideline context for metastatic non-small-cell lung cancer (NSCLC); this information does not establish payer coverage.
ALL of the following
- In the phase 3 LUNAR study, 276 participants with metastatic NSCLC that had progressed on or after platinum-based therapy were randomized to TTField therapy plus standard systemic therapy or standard therapy alone. Overall survival was significantly longer with TTField therapy plus standard therapy.
- Serious adverse events occurred in 53% of participants receiving TTField therapy plus standard therapy versus 38% receiving standard therapy alone; TTField-related adverse events occurred in 71%, mostly grade 1 to 2 skin and subcutaneous tissue disorders.
- Study limitations included the open-label design, small enrollment of participants with brain metastases, slower-than-planned accrual, and limited information regarding tumor genetic subtypes.
- ASCO states that, given the lifestyle implications of wearing a device for 18 hours per day, lack of evidence in the immunotherapy-pretreated population, and absence of first-line data in immunotherapy-naive patients, there are insufficient data to definitively recommend adding TTFields to systemic therapy for most patients with advanced NSCLC. Additional clinical studies are needed.
Use of electric tumor treatment field devices for tumors other than glioblastoma is unproven and not medically necessary due to insufficient evidence of efficacy.
Concurrent electric TTF therapy with bevacizumab, chemotherapy, or other medical therapy for recurrent glioblastoma is unproven and not medically necessary.
Electric TTF therapy is unproven and not medically necessary when the stated coverage criteria are not met or for all other indications.
Coding and Authorization Parameters
| A4555 | Electrode/transducer for use with electrical stimulation device used for cancer treatment, replacement only. |
| E0766 | Electrical stimulation device used for cancer treatment, includes all accessories, any type. |
| E0767 | Intrabuccal, systemic delivery of amplitude-modulated, radiofrequency electromagnetic field device, for cancer treatment, includes all accessories. |
Provider Documentation and Authorization Actions
Authorization for Initial and Continued Therapy
Prior authorization is required for initial and continued electric tumor treatment field (TTF) therapy. When applicable clinical criteria are met, initial authorization is for 3 months; continuation beyond the initial 3 months requires submission of updated clinical documentation with the continuation request.
- Submit the diagnosis, treatment history, performance status, prescribed device, and required medical-record documentation for review.
- For continuation, include a recent MRI and documentation of current treatment, response or disease status, performance status, and device use.
Medical Necessity Records Required
The patient's medical record must fully support the medical necessity of the requested TTF services. Documentation must be legible, maintained in the medical record, and made available upon request; submission does not guarantee coverage.
- Include relevant medical history, physical examination findings, and results of pertinent diagnostic tests or procedures.
- Records must support the applicable clinical criteria and the requested initial or continuation therapy.
Document Initial Therapy Criteria
For initial therapy, document the applicable diagnosis and treatment requirements before requesting authorization for FDA-approved TTF therapy.
- Newly diagnosed, histologically confirmed supratentorial glioblastoma (GBM): document completed debulking surgery and radiation therapy; Temozolomide as the only cancer drug; KPS ≥ 60 or ECOG ≤ 2; and counseling that the device must be worn at least 18 hours daily.
- Radiologically confirmed recurrent supratentorial GBM (rGBM): document that TTF follows initial chemotherapy, is the only treatment, KPS ≥ 60 or ECOG ≤ 2, and counseling regarding use at least 18 hours daily.
- Document use of an FDA-approved device according to FDA-labeled indications, contraindications, warnings, and precautions.
Document Continuation Therapy
For continuation beyond the initial 3 months, submit current evidence that the member remains eligible and is benefiting from therapy without documented disease progression.
- Provide an MRI performed ≤ 2 months before the request documenting no evidence of disease progression.
- For newly diagnosed GBM, document continued Temozolomide as the only cancer drug; for recurrent GBM, document that TTF is the only treatment.
- Document KPS ≥ 60 or ECOG ≤ 2 and use of the device for at least 18 hours daily.
Failure to Meet Clinical Criteria May Result in Denial
Authorization may be denied when the requirements for newly diagnosed or recurrent supratentorial GBM are not documented or are not met.
- Newly diagnosed GBM requests require histologic confirmation and documentation of completed debulking surgery, completed radiation therapy, Temozolomide as the only cancer drug, qualifying performance status, and counseling on daily device use.
- Recurrent GBM requests require radiologic confirmation, use after initial chemotherapy, TTF as the only treatment, qualifying performance status, and counseling on daily device use.
- TTF must be provided with an FDA-approved device and according to applicable FDA-labeled requirements.
Noncovered Indications or Combinations
TTF is unproven and not medically necessary for indications or treatment combinations outside the policy criteria.
- Do not request coverage for tumors other than GBM.
- Do not use TTF concurrently with medical therapy, including bevacizumab or chemotherapy, for recurrent GBM.
Disease Progression or Outdated Imaging
Continuation authorization may be denied when current imaging is unavailable, older than the permitted interval, or documents disease progression.
- Submit an MRI performed ≤ 2 months before the continuation request.
- The MRI must document no evidence of disease progression; an outdated or progression-positive scan does not support continued authorization.
Therapy Background
Electric tumor treatment field therapy, also called tumor-treating fields, TTFields, or ETTFs, is a noninvasive therapy that delivers alternating electric fields through transducer arrays placed on the scalp around the tumor. The therapy uses low-intensity, intermediate-frequency electric fields, generally 100 to 300 kHz, to disrupt cell division in brain tumors.
Clinical Definitions
Treatment-Line Context
First-Line
Line-of-therapy context for covered newly diagnosed GBM treatment.
Initial approval is 3 months.
Salvage
Line-of-therapy context for recurrent GBM treatment.
Initial approval is 3 months; continuation requires stable imaging and documented device use.
First-Line
Line-of-therapy context for unresectable malignant pleural mesothelioma.
Evidence came from a prospective single-arm phase 2 trial.
Second-Line
Line-of-therapy context for post-progression solid tumor treatment.
The ovarian trial did not significantly improve overall survival; the NSCLC trial reported improved overall survival.
Salvage
Line-of-therapy context for recurrent or progressive glioblastoma.
NCCN notes divided expert opinion because EF-11 did not show clear efficacy; EANO and NICE do not support use beyond progression or in recurrent high-grade glioma.
Biomarker and Molecular Context
Therapy Regimens and Evidence Context
| Regimen | Indication | Coverage |
|---|---|---|
| FDA-approved TTF device with temozolomide as the only cancer drug | Newly diagnosed, histologically confirmed supratentorial glioblastoma after debulking surgery and completion of radiation therapy | Covered |
| Regimen | Indication | Coverage |
|---|---|---|
| FDA-approved TTF device as the only treatment | Radiologically confirmed recurrent supratentorial glioblastoma after initial chemotherapy | Covered |
| Regimen | Indication | Coverage |
|---|---|---|
| TTF used concurrently with bevacizumab or chemotherapy | Recurrent glioblastoma | Not covered; unproven and not medically necessary |
| Regimen | Indication | Coverage |
|---|---|---|
| TTFields at 150 kHz to the thorax plus pemetrexed 500 mg/m² and cisplatin 75 mg/m² or carboplatin AUC 5 every 21 days for up to six cycles, followed by TTFields maintenance if no progression | Front-line unresectable malignant pleural mesothelioma | Clinical evidence context; not a stated payer coverage criterion |
| Regimen | Indication | Coverage |
|---|---|---|
| TTFields plus standard systemic therapy | Metastatic NSCLC progressing on or after platinum-based therapy | Clinical evidence context; not a stated payer coverage criterion |
| Regimen | Indication | Coverage |
|---|---|---|
| TTFields plus paclitaxel | Platinum-resistant epithelial ovarian cancer | Clinical evidence context; not a stated payer coverage criterion |
| Regimen | Indication | Coverage |
|---|---|---|
| Adjuvant temozolomide plus alternating electric field therapy | Newly diagnosed supratentorial glioblastoma after surgery and radiation or chemoradiation | Clinical guideline context; not a stated payer coverage criterion |
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