Tumor Treatment Fields Form

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Tumor Treatment Fields - Medical Policy
Updated Revision Effective: February 1, 2026 Policy Number:

UM659POL

Approval Date: 11/11/2025

Line(s) of Business: Commercial
Medicare Advantage
Medicaid (BeHealthy)

Description

Tumor-treatment fields therapy is a noninvasive technology that uses alternating electrical fields. It is used to treat glioblastoma multiforme and has been proposed for use in other tumor types.

The primary treatment for newly diagnosed GBM is resection of the tumor to confirm a diagnosis while debulking the tumor to relieve symptoms of increased intracranial pressure or compression. If total resection is not feasible, subtotal resection and open biopsy are options. During surgery, some patients may undergo implantation of the tumor cavity with a carmustine (BCNU) - impregnated wafer. Due to the poor efficacy of local treatment, postsurgical treatment with adjuvant radiotherapy, chemotherapy (typically temozolomide), or a combination of these two therapies is recommended. After adjuvant therapy, some patients may undergo maintenance therapy with temozolomide. Maintenance temozolomide is given for 5 days of every 28-day cycle for 6 cycles. The response and overall survival rates with temozolomide are higher in patients who have O6 - methylguanine-DNA methyltransferase (MGMT) gene promoter methylation (see 2.04.113 on MGMT promotor methylation for malignant gliomas).

Prognostic factors for therapy success are age, histology, performance status or physical condition of the patient, and extent of resection. National Comprehensive Cancer Network recommendations include patient age and Karnofsky Performance Status score as important determinants of postsurgical treatment choice.

For patients with good performance status, the most aggressive treatment (standard radiotherapy [RT] plus temozolomide) is recommended. For patients with poor performance status, only single treatment cycles or even palliative or supportive care are recommended. Hypo-fractionated RT is indicated for patients with poor performance status because it is better tolerated, and more patients can complete RT. Treatment of GBM is rarely curative, and tumors will recur in essentially all patients

When disease recurs, additional debulking surgery may be used if the recurrence is localized. Due to radiation tolerances, re-radiation options for patients with recurrent GBM who have previously received initial external- beam radiotherapy are limited. There is no standard adjunctive treatment for recurrent GBM. Treatment options for recurrent disease include various forms of systemic medications such as the antivascular endothelial growth factor drug bevacizumab, alkylating agents such as nitrosoureas (e.g., lomustine, carmustine), or retreatment with

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temozolomide. Medical therapy is associated with side effects that include hematologic toxicity, headache, loss of appetite, nausea, vomiting, and fatigue. Response rates in recurrent disease are less than 10%, and the progression-free survival rate at 6 months is less than 20%. There is a need for new treatments that can improve survival in patients with recurrent GBM or reduce the side effects of treatment while retaining survival benefits. Tumor treating fields (TTFs) through a portable medical device that generates low intensity alternating electric fields is also available for treatment of recurrent glioblastoma. Clinicians must be trained and certified to prescribe the device. The device is applied to a shaved scalp, with four transducer arrays connected to a portable battery or power supply operated device; continuous treatment is recommended. The device is an alternative to other salvage therapies for interested patients. Approval in the United States, Europe, and elsewhere was based on results of a clinical trial that randomly assigned 237 patients with recurrent glioblastoma to TTFs or clinician's choice chemotherapy. The majority of patients were enrolled at the time of second or greater recurrence and approximately 20 percent had received prior bevacizumab. Median progression-free and overall survival were similar in those treated with TTFs versus chemotherapy (2.2 versus 2.1 months and 6.6 versus 6 months, respectively). The objective response rate was non significantly higher in patients treated with TTFs compared with chemotherapy (14 versus 10 percent). Quality-of-life data available in only 27 percent of patients were similar between groups. Mild to moderate scalp dermatitis related to transducer arrays was the most common device-related side effect (16 percent). Hematologic and gastrointestinal adverse events, primarily mild or moderate, occurred in 20 percent of those treated with chemotherapy and less than 3 percent of device-treated patients. A subsequent open-label randomized trial in patients with newly diagnosed glioblastoma showed prolonged progression-free and overall survival in the group assigned to TTFs when used in combination with post radiation temozolomide. Consensus-based guidelines published by the National Comprehensive Cancer Network (NCCN) include alternating electric field therapy as a treatment option for patients with recurrent glioblastoma based on the trial data reviewed above as well as postmarketing analysis of >450 patients treated commercially in the United States.

 Line of Business

Commercial:

• Refer to criteria under the Policy section in this medical policy.

Medicaid – BeHealthy:

• Refer to criteria under the Policy section in this medical policy.

• There are no MassHealth guidelines for Tumor Treatment Fields.

Medicare:

• Health New England follows Local Coverage Determination (LCD) Tumor Treatment Field Therapy (TTFT) (L34823). https://www.cms.gov/medicare-coverage-database/search.aspx

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Policy

I. Criteria for Approval of Tumor Treatment Fields (TTF) therapy for Commercial and MassHealth:

A. TTF therapy with U.S. Food and Drug Administration (FDA) approved devices is considered MEDICALLY NECESSARY and initially approved for 3 months for the treatment of NEWLY diagnosed, supratentorial glioblastoma multiforme, as an adjunct to standard maintenance therapy with temozolomide when ALL of the following conditions are met:

1. The individual is ≥18 years of age; AND
2. The individual has completed initial treatment with surgery, radiation therapy and concomitant chemotherapy; AND
3. Has a Karnofsky Performance Status (KPS) score ≥60% or Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2; AND
4. There is documentation of lack of tumor progression following radiation and chemotherapy; AND

5. The individual is willing and capable of wearing the device for at least 18 hours a day.

   B. For recurrent supratentorial GBM, TTF therapy with U.S. Food and Drug Administration (FDA) approved devices is considered MEDICALLY NECESSARY and approved for 3 months when ALL of the following conditions are met:

6. Histologically or radiologically confirmed recurrence in the supra-tentorial region of the brain after receiving chemotherapy; AND
7. Has a KPS score ≥60% or ECOG Performance Status ≤ 2; AND
8. The device is intended to be used as a monotherapy, and is intended as an alternative to standard medical therapy for GBM after surgical and radiation options have been exhausted; AND

9. Documentation of compliance with use of device for initial treatment for at least 18 hours/day.

   C. Subsequent approval(s) for TTF continuation beyond the initial 3 months for treatment of histologically confirmed Supratentorial glioblastoma (GBM) is based on:

10. Magnetic resonance imaging (MRI) scan has been performed ≤ 2 months prior to request and documents no evidence of disease progression; AND
11. Individual with newly diagnosed glioblastoma continues to receive Temozolomide as the only cancer drug or the device is used as the only treatment for an individual with recurrent GBM; AND
12. KPS score of ≥60% or ECOG Performance Status ≤ 2; AND

13. Documentation that the individual has been using the device at least 18 hours daily.

    D. TTF devices are unproven and considered EXPERIMENTAL and INVESTIGATIONAL when the criteria above are not met and for all other indications including but not limited to the following:

14. Treatment of tumors other than GBM.

15. Use of electric TTF therapy with concurrent medical therapy (e.g., bevacizumab or chemotherapy) for treatment of recurrent GBM.

    E. Computer software used for therapeutic radiology clinical treatment planning in conjunction with TTF therapy is considered EXPERIMENTAL and INVESTIGATIONAL due to insufficient evidence of efficacy.

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Policy Guidelines and Definitions

Policy Guidelines:

I. Required Documentation:

Treatment of Newly Diagnosis Glioblastoma:

• Diagnosis. • Physician notes to include the following:
➢ Documenting prior treatment with Radiation Therapy.
➢ Provide results of the Karnofsky Performance Status (KPS) or Eastern Cooperative Oncology Group (ECOG) Performance Status. ➢ Documentation that the member has been counselled that the device must be worn at least 18 hours daily.

Request to Continue Therapy beyond the initial 3 months:

• Date and results of the most recent MRI imaging prior to the request to continue therapy. • Documentation that member is taking Temozolomide as the only cancer drug. • Provide results of the KPS or ECOG Performance Status. • Documentation that the member has been wearing the device for at least 18 hours per day.

Treatment of a Reoccurrence of Glioblastoma:

• Diagnosis.
• Physician notes to include the following:
➢ Provide results of the KPS or ECOG Performance Status. ➢ Documentation that the member has been counselled that the device must be worn at least 18 hours daily.

Definitions:

Eastern Cooperative Oncology Group (EGOG) Performance Status: A measurement of performance status that describes an individual’s level of functioning. Individuals who have a worse performance status and limited functional capacity tend to have more difficulty tolerating rigorous cancer treatments. This scale may also be referred to as the WHO or Zubrod score.
• A score of zero indicates the individual is fully active and has no restrictions. • A score of one indicates that the individual is restricted in physically strenuous activity but is completely ambulatory and cares for self. • A score of two indicates the individual is ambulatory more than 50% of the time and is capable of all self- care but unable to carry out any work activities. • A score of three indicates that the individual is ambulatory 50 percent or less of the time and is capable of only limited self-care. • A score of four indicates bedbound (cannot perform any self-care and is totally confined to bed or chair). (West and Jin, 2015; ECOG-ACRIN Cancer Research Group)

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Karnofsky Performance Status (KPS): A standard way of measuring the ability of cancer patients to perform ordinary tasks. KPS scores range from 0 to 100; a higher score means a person is better able to carry out daily activities. For example, a KPS of 60 means a person requires occasional assistance but is able to care for most of their personal needs. KPS 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 a clinical trial (National Cancer Institute [NCI], 2019; West and Jin, 2015).

Supratentorial: A term used to describe the upper portion of the brain comprised of the cerebrum, ventricles, choroid plexus, hypothalamus, pineal gland, pituitary gland, and optic nerve (NCI, 2019).

Glioblastoma Multiforme (GBM): GBM (Grade IV astrocytoma) is a rapidly growing central nervous system (CNS) tumor. One of the most common types of primary malignant brain tumors in adults. Prognosis is poor with survivor time approximately 10-14 months. For patients with newly diagnosed glioblastoma the initial standard treatment consists of debulking surgery (when feasible), followed by radiation and chemotherapy (NCCN, 2023).

Temozolomide: An oral alkylating chemotherapy drug used in the treatment of some brain cancers. It is a first- line treatment for glioblastoma (NCI, 2019).

The Optune® Treatment Kit: Formerly the NovoTTF-100A System, (Novocure) was approved by the FDA in April 2011, as a novel device to treat adults aged 22 years or older with GBM that recurs or progresses after receiving chemotherapy and radiation therapy. The Optune Treatment Kit has also been approved by the FDA in combination with Temozolomide in adult patients with newly diagnosed, Supratentorial glioblastoma following maximal debulking surgery and completion of radiation therapy. For newly diagnosed GBM, Optune is not intended to be used as a substitute for standard treatments but rather as an adjunct therapy (Novocure, 2020).

Coding Guidance

Code
Description
Auth Required HCPCS

E0766 Electrical stimulation device used for cancer treatment, includes all accessories, any type Yes A4555 Electrode/transducer for use with electrical stimulation device used for cancer treatment, replacement only (Integral part of device-not separately reimbursable) No CPT

1025T Alternating electric fields dosimetry and delivery-simulation modeling, creation and selection of patient-specific array layouts, and placement verification Experimental/ Investigational CPT® Copyright 2026 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.

Note: CPT/HCPCS codes are included for informational purposes and may not be all-inclusive. Inclusion or exclusion of a CPT/HCPCS code(s) does not signify or imply that the service described by the code is a covered or non-covered health service. Benefit coverage for health services is determined by the member’s specific benefit plan document and applicable laws that may require coverage for a specific service. The inclusion of a code does not imply any right to reimbursement or guarantee of payment. Other policies and coverage determination guidelines may apply.

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References

Management of recurrent high-grade gliomas. Management of recurrent high-grade gliomas - UpToDate (access required)

American Brain Tumor Association (ABTA). Glioblastoma (GBM). 2016.

Ceresoli GL, Aerts JG, Dziadziuszko R, et al. Tumour treating fields in combination with pemetrexed and cisplatin or carboplatin as first-line treatment for unresectable malignant pleural mesothelioma (STELLAR): a multicentre, single-arm phase 2 trial. Lancet Oncol. 2019 Dec;20(12):1702-1709.

Chaudhry A, Benson L, Varshaver M, et al. NovoTTF™‐100A System (Tumor Treating Fields) transducer array layout planning for glioblastoma: a NovoTAL™ System user study. World J Surg Oncol. 2015;13:316.

Chen W, Wang Y, Zhao B, et al. Optimal therapies for recurrent glioblastoma: a Bayesian Network meta-analysis. Front Oncol. 2021 Mar 29;11:641878.

Connelly J, Hormigo A, Mohilie N, et al. Planning TTFields treatment using the NovoTAL system-clinical case series beyond the use of MRI contrast enhancement. BMC Cancer. 2016 Nov 4;16(1):842.

Dono A, Mitra S, Shah M, et al. PTEN mutations predict benefit from tumor treating fields (TTFields) therapy in patients with recurrent glioblastoma. J Neurooncol. 2021;153(1):153-160.

ECOG-ACRIN Cancer Research Group; ECOG Performance Status. 2020. Available at: http://ecog- acrin.org/resources/ecogperformance-status. Accessed June 5, 2023.

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) on Tumor Treatment Fields, Optune™ (formerly NovoTTF-100A™ System). (2015, October 5).

https://www.accessdata.fda.gov/cdrh_docs/pdf10/P100034S013b.pdf

Optune: Official Patient Site.
https://www.optunegio.com/

Optune Frequently Asked Questions. (n.d.). Retrieved May 13, 2022

https://www.optune.com/resources/faqs

Tumor Treating Fields (Optune) for Treatment of Glioblastoma, Hayes (December 27, 2019)

https://evidence.hayesinc.com/report/dir.novocure3306

(Subscription and credentials required)

High compliance with Optune linked to greatest survival benefit for glioblastoma (2017, November 17).

https://www.healio.com/hematology-oncology/neuro-oncology/news/online/{95adc542-d750-4364-877a- c7dbf9563c57}/high-compliance-with-optune-linked-to-greatest-survival-benefit-for-glioblastoma

Batchelor, T, MD, MPH, Shih, H, A., MD, MS, MPH, Carter, S, MD, PhD (2019, April 17). Management of recurrent high-grade gliomas.

https://www.uptodate.com/contents/management-of-recurrent-high-grade- gliomas?search=optune%20device&source=searchresult&selectedTitle=1~150&usagetype=default&displa y_rank=1

(Subscription and credentials required)

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Patient education: Glioblastoma (The Basics).

(Subscription and credentials required).

  https://www.uptodate.com/contents/glioblastoma-the-

basics?search=Patient%20education%20glioblastoma&source=searchresult&selectedTitle=1~77&usagety pe=default&display_rank=1

Mun E. J, Babiker HM, Weinberg U, et al. Tumor treating fields: A fourth modality in cancer treatment. Clin Cancer Res. 2018;24(2):266-275,

http://clincancerres.aacrjournals.org/content/24/2/266

Bokstein, F, Blumenthal, D, Limon, Dror, Concurrent Tumor Treatment Fields (TTFields) and Radiation Therapy for newly diagnosed Glioblastoma: A Prospective Safety and feasibility study, Frontiers in Oncology, April 21,

2020. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7186440/

      Begley, S, Creating electric fields in the brain buys glioblastoma patients extra months of life,

      https://www.statnews.com/2017/12/19/glioblastoma-electric-fields-cap/#comment-1355710

      Brain Cancer, Gliomas, NCCN Guidelines for Patients, Version 1.0201.
      https://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=&ved=2ahUKEwiCv7z1i8XwAhWVieA KHUBCCu4QFjAAegQIBxAD&url=https%3A%2F%2Fwww.nccn.org%2Fpatients%2Fguidelines%2Fcontent%2F PDF%2Fbrain-gliomas-patient.pdf&usg=AOvVaw2EjiZt7liZXTBF6znjCM5R

      Batchelor, T, Shih, H, Carter, Bob Management of Recurrent high-grade gliomas (Updated May 6, 2021).

      https://www.uptodate.com/contents/management-of-recurrent-high-grade- gliomas?search=Management%20of%20recurrent%20high- grade%20gliomas&source=searchresult&selectedTitle=1~114&usagetype=default&display_rank=1

      Local Coverage Determination (LCD): Tumor Treatment Field Therapy (TTFT) L34823),

      https://www.cms.gov/medicare-coverage-database/details/lcd-details.aspx?LCDId=34823

      Glioma (Mayo Clinic), April 4, 2020,
      https://www.mayoclinic.org/diseases-conditions/glioblastoma/cdc- 20350148#:~:text=Glioblastoma%20is%20an%20aggressive%20type%20of%20cancer%20that%20can%20oc cur,%2C%20nausea%2C%20vomiting%20and%20seizures.

      Policy Implementation

      Approved by the Medical and Pharmacy Policy Committee

      Kate McIntosh MD MBA

      Chief Medical Officer

      Saad Usmani MD MBA

      Medical Director

      Date Update 11/2018 • Policy original effective date 11/2023 • Minor criteria changes. • References updated.

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Date Update 1/2024 Added Line of Business section. 12/2024 Annual Review. No criteria changes.

10/2025 Minor criteria changes. 1/1/2026 Removed CPT 77299 and added CPT 1025T.

Medical Criteria Disclaimer

Property of Health New England. All rights reserved. The treating physician or primary care provider must submit to Health New England the clinical evidence that the patient meets the criteria for the treatment, testing or surgical procedure. Without this documentation and information, Health New England will not be able to properly review the request for prior authorization. The clinical review criteria reflect how Health New England determines whether certain services or supplies are medically necessary. Health New England established the clinical review criteria based upon a review of currently available clinical information (including clinical outcome studies in the peer-reviewed published medical literature, regulatory status of the technology, evidence-based guidelines of public health and health research agencies, evidence-based guidelines and positions of leading national health professional organizations, views of physicians practicing in relevant clinical areas, and other relevant factors).
Health New England expressly reserves the right to revise these conclusions as clinical information changes and welcomes further relevant information. Each benefit program defines which services are covered. The conclusion that a particular service or supply is medically necessary does not constitute a representation or warranty that this service or supply is covered and/or paid for by Health New England, as some programs exclude coverage for services or supplies that Health New England considers medically necessary. If there is a discrepancy between this guideline and a member's benefits program, the benefits program will govern. In addition, coverage may be mandated by applicable legal requirements of a state, the Federal Government or the Centers for Medicare & Medicaid Services (CMS) for Medicare and Medicaid members. All coding and web site links are accurate at the time of publication. Health New England has adopted the herein policy in providing management, administrative and other services to its Health Plan.