ModifiedUnitedHealthcarePolicy CS146NE.M

Electric Tumor Treatment Field Therapy (for Nebraska Only)

This Nebraska-specific medical policy governs coverage and medical necessity criteria for FDA‑approved electric tumor treatment field (TTF) devices used to treat supratentorial glioblastoma in UnitedHealthcare members in Nebraska.

Policy Summary

PayerUnitedHealthcare

PolicyElectric Tumor Treatment Field Therapy (for Nebraska Only)

Policy CodePolicy CS146NE.M

Change TypeMaterial edits: removed planning-software NMN languageremoved CPT 77299minor operational addition about benefit determination

Effective DateFeb 1, 2026

Next Review Date

Key ActionObtain prior authorization documenting that the member meets all coverage criteria (including histologic supratentorial GBM, completed radiotherapy for ndGBM, KPS ≥60 or ECOG ≤2, counseling on ≥18 hours/day device wear) for initial 3‑month approval.

SourceLink

POLICY UPDATE CHANGES

Removed language indicating computer software used for therapeutic radiology clinical treatment planning in conjunction with electric tumor treatment fields (TTF) therapy is unproven and not medically necessary due to insufficient evidence of efficacy.

Added language that benefit coverage is determined by federal, state, or contractual requirements and that medical records documentation may be required to assess whether the member meets clinical criteria for coverage but does not guarantee coverage.

Removed CPT code 77299 from the list of applicable codes.

3 monthsauthorized initial therapy duration when criteria met

≥18 h/dayminimum daily device wear time counseling requirement

KPS ≥60 / ECOG ≤2

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performance status requirement for coverage

MRI ≤2 morecency requirement for imaging to support continuation

695participants in pivotal EF-14 randomized trial

02/01/2026Most recent policy history entry

Coverage and Medical Necessity Criteria

Initial therapy — newly diagnosed GBM

Covered when ALL of the following are met for newly diagnosed (histologically confirmed) supratentorial glioblastoma:

ndGBM initial coverage: Debulking surgery has been completed; Treatment with radiation therapy has been completed; Individual is receiving temozolomide (TMZ) as the only cancer drug; Karnofsky Performance Status (KPS) score ≥ 60 OR ECOG Performance Status ≤ 2; Individual has been counseled that the electric TTF device must be worn at least 18 hours dailyinitial 3 months approved

When all criteria met, initial 3 months of TTF therapy approved

Initial therapy — recurrent GBM

Covered when ALL of the following are met for radiologically confirmed recurrent supratentorial GBM:

rGBM initial coverage: Device is used as the only treatment; Karnofsky Performance Status (KPS) score ≥ 60 OR ECOG Performance Status ≤ 2; Individual has been counseled that the electric TTF device must be worn at least 18 hours dailyinitial 3 months approved

When all criteria met, initial 3 months of TTF therapy approved

Continuation therapy

Continuation beyond initial 3 months is approved when ALL of the following are met:

Continuation criteria: MRI performed ≤ 2 months prior to request documenting no evidence of disease progression; For ndGBM, individual continues to receive TMZ as the only cancer drug OR for rGBM the device is used as the only treatment; KPS ≥ 60 OR ECOG ≤ 2; Documentation of device use at least 18 hours dailyongoing approval contingent on criteria

Documentation of compliance and recent imaging required

Coverage criteria for TTFields in newly diagnosed glioblastoma

Covered when ALL of the following are met

ndGBM with completed chemoradiation: Patient has newly diagnosed supratentorial glioblastoma and has completed concomitant radiotherapy with temozolomide prior to initiation of TTFields.

EF-14 enrolled patients after completion of concomitant radiochemotherapy; ASCO-SNO guideline permits adding alternating electric field therapy to adjuvant TMZ in this population (weak recommendation).

TTFields in combination with maintenance TMZ: TTFields are used in combination with maintenance temozolomide consistent with trial protocols (Optune + TMZ).

EF-14 demonstrated improved PFS and OS with TTFields + maintenance TMZ vs TMZ alone.

Device usage and monitoring: Plan includes monitoring and support to encourage device usage; compliance ≥50% monthly is associated with improved survival, with greater benefit at higher adherence (>90%).>=50% monthly usage

Compliance data from EF-14 subgroup analysis associated with improved PFS and OS as compliance increases.

Coverage stance for recurrent GBM and other tumors

Covered with more limited evidence or considered experimental when ANY of the following apply

Recurrent GBM: Use in recurrent glioblastoma; evidence indicates similar overall survival to best standard care but may avoid systemic chemotherapy adverse events; additional studies are needed to clarify benefits and optimal combinations.

ECRI assessment: Optune Gio vs best standard care shows similar OS; evidence confidence moderate; TTField plus bevacizumab may increase OS in some people but needs further study.

Non-GBM solid tumors: Use in non-glioblastoma tumors (e.g., metastatic NSCLC, mesothelioma, pancreatic, ovarian) — evidence limited to single randomized trial (LUNAR in NSCLC) or single-arm phase II (STELLAR in mesothelioma); insufficient RCT long-term data for many tumor types.

LUNAR showed OS benefit in metastatic NSCLC post-platinum; STELLAR single-arm mesothelioma showed encouraging OS but lacks comparator; lack of RCT evidence for many tumor types noted.

Coverage considerations (ndGBM and rGBM)

Guideline- and FDA-informed coverage considerations for TTFields in glioblastoma

FDA approval context: Device FDA-approved for adults with recurrent GBM (2011) and for use with temozolomide in newly diagnosed supratentorial GBM after maximal debulking and completion of radiation (2015 supplemental approval)age >=22 per FDA labeling

Informational; FDA approval alone is not a basis for coverage per policy text

NCCN-based consideration for newly diagnosed GBM: Consider TTFields plus temozolomide for newly diagnosed supratentorial GBM in patients with good performance status (KPS ≥ 60) as an option; Category 1 recommendation for many patients aged ≤ 70 years with good PS.KPS >= 60; age <= 70 for Category 1 preferential guidance

NCCN allows regardless of MGMT methylation status

NCCN for recurrence: TTFields is FDA-approved for recurrent GBM; NCCN considers it for diffuse, multifocal, or local recurrence (category 2B) but the panel is divided due to limited efficacy data.

The policy specifies that treatment of tumors other than glioblastoma (GBM) and the concurrent use of tumor‑treating fields (TTF) with other medical therapies (for example, bevacizumab or cytotoxic chemotherapy) for recurrent GBM are excluded from coverage due to insufficient evidence. These exclusions apply when the specified coverage criteria for TTFields are not met and are listed explicitly as non‑covered indications in the policy.

Use of TTFields for tumor types other than glioblastoma (including non‑small cell lung cancer, brain metastases, pancreatic cancer, ovarian cancer, and mesothelioma) is considered investigational or limited because there is a lack of published randomized controlled trials

The National Institute for Health and Care Excellence (NICE) guidance (2018, updated 2021) recommends: Do not offer tumor treating fields (TTF) for management of newly diagnosed grade IV glioma (glioblastoma) and similarly advises do not offer TTF for recurrent high‑grade glioma. The policy records this guideline position but does not itself adopt NICE as the coverage decision driver.

The policy states that when the listed coverage criteria are not met, the use of devices to generate electric tumor‑treating fields is unproven and not medically necessary. This includes indications beyond those specified and explicitly calls out treatment of tumors other than GBM and use of TTF concurrently with other medical therapy (e.g., bevacizumab or chemotherapy) for recurrent GBM as examples of not medically necessary use.

The policy summarizes that TTFields for non‑GBM tumor types are not supported by adequate randomized controlled trial evidence in many indications and therefore may be considered not medically necessary for routine use outside of clinical trials or compelling new data. Specific tumor types cited as lacking RCT data include non‑small cell lung cancer, brain metastases, pancreatic, ovarian cancer, and mesothelioma.

The policy revision dated 02/01/2026 documents a material change removing prior language that had stated computer software used for therapeutic radiology treatment planning in conjunction with TTF therapy was unproven and not medically necessary. That statement has been deleted from the policy and is no longer part of the not‑medically‑necessary rationale.

Applicable Procedure and Billing Codes

Applicable/referenced HCPCS codesHCPCS

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

Removed CPT CodesCPTNot Covered

77299

Previously listed CPT code removed from applicable codes

inv-15: Daily device wear time — ≥ 18 hours/day counseling requirement

Daily wear time requirementDevice must be worn at least 18 hours per day (counseling required)

Documentation for initial approvalCounseling that device must be worn ≥18 hours/day must be recorded in medical record

Documentation for continuationContinuation requests must document continued use of device at least 18 hours daily

inv-16: MRI recency for continuation — MRI performed ≤ 2 months prior to request showing no progression

MRI timing for continuationMRI performed within ≤ 2 months prior to the continuation request documenting no evidence of disease progression

Role in continuation decision

Prior Authorization, Documentation, and Denial Triggers

Prior Authorization
Prior Authorization Required
Prior authorization is required. Requests must document that the member meets all coverage criteria for initial approval of a 3-month course of electric tumor treatment fields (TTF) therapy for newly diagnosed or recurrent supratentorial glioblastoma (GBM).
Applicable HCPCS/Codes for reference: E0766 (electrical stimulation device used for cancer treatment, includes all accessories), A4555 (electrode/transducer for use with electrical stimulation device, replacement only), E0767 (intrabuccal/systemic delivery device — note: inclusion of a code in the policy does not guarantee coverage).
Prior authorization must document meeting all clinical coverage criteria (see Coverage Rationale and Instructions for Use).

Prior Authorization
Prior Authorization for TTFields with TMZ in Newly Diagnosed GBM
For newly diagnosed GBM (ndGBM), prior authorization must confirm ndGBM status, completion of standard radiochemotherapy, and eligibility for maintenance temozolomide (TMZ) as the only cancer drug prior to initiating TTF in combination with TMZ.
Documentation must show histologically confirmed supratentorial GBM and that debulking surgery has been completed (if applicable).

Permitted Treatment Combinations and Regimens

Regimen	Coverage stance	Notes
TTF combined with concurrent systemic therapy (e.g., bevacizumab or chemotherapy)	Not covered / considered not medically necessary when used concurrently with other medical therapy for recurrent GBM	Policy states use of electric TTF therapy with concurrent medical therapy (e.g., bevacizumab or chemotherapy) for rGBM is unproven and not medically necessary due to insufficient evidence of efficacy.

Regimen	Coverage stance	Notes
TTF in combination with maintenance temozolomide (TMZ) for newly diagnosed supratentorial GBM	Covered with criteria	Coverage aligned with EF-14 trial: TTF added to maintenance TMZ after completion of concomitant radiochemotherapy; initial approval for 3 months when all criteria (debunking surgery, completed radiation, TMZ as only cancer drug, KPS ≥60 or ECOG ≤2, counseling on ≥18 hours/day wear) are met.

Regimen	Coverage stance	Notes
TTFields (Optune) delivered ≥18 hours/day plus maintenance temozolomide	Covered when criteria met	EF-14 randomized trial enrolled patients after completion of concomitant radiochemotherapy; Optune used concurrently with maintenance TMZ and required device wear ≥18 hours/day; policy approves initial 3 months when criteria are satisfied and continuation contingent on MRI ≤2 months showing no progression and continued TMZ use.

Regimen	Coverage stance	Notes
TTFields delivered to the thorax plus standard systemic therapy (per LUNAR trial) for metastatic NSCLC after progression on platinum-based therapy	Experimental / limited evidence	LUNAR (Leal et al. 2023) was a randomized phase III trial showing longer OS with TTFields plus standard therapy versus standard therapy alone, but policy notes indications for tumors other than GBM are limited and should be considered investigational or limited due to lack of long-term RCT evidence.

Regimen	Coverage stance	Notes
TTFields (150 kHz to thorax) plus pemetrexed and platinum (STELLAR trial) for unresectable malignant pleural mesothelioma	Experimental / investigational	STELLAR was a single-arm phase II study of TTFields with pemetrexed and platinum showing encouraging median OS (18.2 months) but lacked a comparator group; policy regards non-GBM indications as having limited evidence and needing randomized trial confirmation.

Regimen	Coverage stance	Notes
Tumor treating fields (Optune) plus temozolomide as adjunct to adjuvant TMZ for newly diagnosed supratentorial GBM	Covered when criteria met	NCCN and FDA context: Optune plus adjuvant TMZ is FDA‑approved and recommended by NCCN for selected patients with good performance status (KPS ≥60); policy coverage requires completion of radiochemotherapy, TMZ as sole cancer drug, performance status criteria, and counseling on device wear ≥18 hours/day.

Line of Therapy Designations

first-line

first-line: Used after debulking surgery and completion of radiation with concurrent/adjuvant temozolomide as specified; initial 3 months approval when criteria met

Applies to newly diagnosed supratentorial GBM per policy and EF-14 trial

salvage

salvage: Used for radiologically confirmed recurrence after initial chemotherapy; device used as sole treatment for initial approval

Initial 3 months approved when criteria met

first-line

first-line:

Tumor Biomarkers and Molecular Considerations

inv-46: PTEN — biomarker note (source chunk)

PTEN biomarker noteRetrospective data suggest TTFields may confer post-progression survival benefit in PTEN‑mutant recurrent GBM compared with PTEN‑wildtype, but findings are limited and require RCT confirmation

Evidence limitationsObservations based on small retrospective cohort; further research with randomized trials needed to confirm PTEN association

Not required for coveragePTEN status is exploratory and not required for policy coverage decisions

inv-47: MGMT promoter methylation — methylated vs unmethylated

MGMT methylation categoriesMGMT promoter methylation status categorized as methylated versus unmethylated and used to inform temozolomide benefit assessments

Effect on treatment choice

Key Term Definitions

inv-32: ECOG Performance Status — ECOG 0–5; policy requires ECOG ≤ 2 for coverage

ECOG scale rangeECOG Performance Status ranges 0–5 describing functional status

Policy eligibility thresholdPolicy requires ECOG ≤ 2 for coverage eligibility

ECOG examplesECOG 0 = fully active; ECOG 2 = ambulatory and capable of self-care but unable to work; ECOG 5 = dead

inv-33: KPS — Karnofsky Performance Status 0–100; policy requires KPS ≥ 60 for coverage

KPS scale rangeKarnofsky Performance Status (KPS) ranges from 0 to 100

Policy thresholdPolicy requires KPS ≥ 60 for coverage eligibility

Clinical and Evidence Background

Tumor‑treating fields (TTF) deliver low‑intensity, intermediate‑frequency alternating electric fields via transducer arrays applied to the scalp to disrupt tumor cell division. TTF (Optune) is FDA‑approved for adults with recurrent GBM and for use with maintenance temozolomide after completion of radiochemotherapy in newly diagnosed supratentorial GBM; clinical guidance (e.g., NCCN and ASCO‑SNO) and randomized trial evidence (EF‑14) inform the policy’s coverage criteria. The policy limits coverage to supratentorial GBM and emphasizes performance status requirements and documented device use when determining medical necessity.

Policy Revision History

2026-02-01policy_revisionLatest

Removed language stating that computer software used for therapeutic radiology clinical treatment planning in conjunction with electric tumor treatment fields (TTF) therapy is unproven and not medically necessary; removed CPT code 77299 from applicable codes; added language clarifying that benefit coverage is determined by federal, state, or contractual requirements and that medical records may be required to assess whether the member meets clinical criteria for coverage but do not guarantee coverage.

Policy Summary

PayerUnitedHealthcare

PolicyElectric Tumor Treatment Field Therapy (for Nebraska Only)

Policy CodePolicy CS146NE.M

Change TypeMaterial edits: removed planning-software NMN languageremoved CPT 77299minor operational addition about benefit determination

Effective DateFeb 1, 2026

Next Review Date

SourceLink

On This Page

Clinical context and extent of disease guide management; trials preferred

Recent MRI demonstrating no progression is required for approval beyond initial 3 months

Documentation expectationImaging report must be included in medical record for review

inv-17: TTFields device usage compliance threshold — ≥ 50% monthly usage associated with improved outcomes; higher benefit observed with >90% usage

Minimum compliance thresholdMonthly device usage ≥ 50% is associated with improved progression-free and overall survival

Higher adherence benefitGreater benefit observed with higher adherence; >90% monthly usage associated with median survival ~24.9 months and higher 5‑year survival

Monitoring sourceCompliance assessed from device usage logs recorded by the NovoTTF/Optune device

inv-18: Karnofsky Performance Status (KPS) — ≥ 60 (NCCN context)

KPS threshold for coverageKarnofsky Performance Status (KPS) ≥ 60 required for coverage (policy and NCCN context)

KPS score interpretationKPS ranges 0–100; KPS 60 indicates requires occasional assistance but able to care for most personal needs

Guideline contextNCCN includes alternating electric field therapy as an option for individuals with good performance status (KPS ≥ 60)

Documentation must show radiotherapy has been completed and that the individual is eligible for and receiving maintenance TMZ as the only systemic cancer therapy.

Initial approval for ndGBM is for a 3-month course; continuation requires meeting the continuation criteria (MRI within 2 months showing no progression, continued TMZ as only cancer drug, performance status ≥ KPS 60 or ECOG ≤ 2, and documentation of device use ≥18 hours/day).

Denial Risk
Insufficient Evidence for Non-GBM Indications
Evidence is insufficient to support use of TTFields for tumors other than glioblastoma; requests for such indications are considered unproven and not medically necessary unless robust RCT evidence is provided.
Lack of randomized controlled trial evidence for long-term safety and effectiveness of TTFields in non-GBM tumors (eg, non-small cell lung cancer, brain metastases, pancreatic, ovarian, mesothelioma) may lead to denial.
When considering TTFields for non-GBM tumors, established systemic therapy options should be tried first where supported by evidence and guideline recommendations.

Billing Rule
Documentation and Coding Risks
Medical records must fully support medical necessity; incomplete or missing documentation can result in denial or delayed authorization. Removal of CPT 77299 from applicable codes reflects coding updates — ensure correct billing codes are used.
Medical records should include relevant history, physical exam, operative reports (debulking/biopsy), pathology confirming supratentorial GBM, radiation therapy records, and chemotherapy records documenting maintenance TMZ (when applicable).
MRI imaging reports (performed ≤ 2 months prior to request for continuation) and documentation of device usage (≥18 hours/day) are required for continuation approvals.
Claims billed with obsolete or removed codes (eg, CPT 77299) may be rejected; verify current HCPCS/CPT codes before submission.

Documentation Required
Required Documentation to Support Medical Necessity
The patient's medical record must document histologically confirmed supratentorial GBM, prior debulking surgery or biopsy, completion of radiotherapy (for ndGBM), performance status, and counseling on device wear-time to support medical necessity.
Required documentation elements: pathology report confirming GBM, operative or biopsy report, radiation therapy details (dates, dose, completion), chemotherapy records (TMZ use and schedule), performance status (KPS or ECOG), and counseling note confirming patient informed that device must be worn ≥18 hours/day.
For continuation requests, include MRI within 2 months documenting no progression and objective documentation of device adherence.

Step Therapy
Step Therapy
No step therapy algorithms specific to TTFields are specified in this policy; however, use should align with FDA-labeled indications and the policy's coverage criteria. For non-GBM indications, consider established systemic therapies first per available guidelines.
There is no mandated step-through of specific agents before TTFields when policy criteria for GBM are met.
For tumors other than GBM, payers may require prior trials of established systemic therapies before considering investigational or off-label modalities.

Note
Consider Established Systemic Therapy First for Non-GBM
For non-GBM tumors where evidence is limited, prior authorization reviewers should confirm that established systemic therapy options have been considered or attempted before approving TTFields, consistent with guideline recommendations.
If the request is for a non-GBM indication, include rationale and supporting evidence (clinical trial data or peer-reviewed literature) and documentation of prior systemic therapy trials and outcomes.
Requests lacking evidence of prior appropriate systemic therapy or strong supporting data for non-GBM use are at high risk for denial.

TTFields added to maintenance temozolomide after completion of radiochemotherapy (per EF-14), associated with improved PFS and OS.

EF-14 randomized evidence supports benefit in ndGBM

salvage

salvage: Use in recurrent GBM has evidence showing similar OS to best standard care and may reduce systemic chemotherapy adverse events; additional research needed.

ECRI assessment and LUNAR/other HTA discussions reflect uncertainties in rGBM and non-GBM indications

salvage

salvage: Post-platinum metastatic non-small cell lung cancer treated with TTFields plus standard systemic therapy showed OS benefit in the LUNAR randomized trial population; evidence for broader application remains limited.

LUNAR enrolled patients with ECOG ≤2 after progression on platinum-based therapy

first-line | salvage

Recurrent GBM: TTFields (Optune) FDA-approved for recurrent GBM based on EF-11 trial; considered an option for recurrent diseaseage >=22 per FDA labeling

FDA approval informational; coverage subject to policy criteria

Newly diagnosed GBM adjunctive: TTFields with adjuvant temozolomide after completion of radiation is FDA-approved and recommended by NCCN for selected patients (good PS); based on EF-14 trialpost-radiation completion and concurrent/adjuvant TMZ

ASCO-SNO guideline supports adding TTFields to adjuvant TMZ in select patients

Meta-analysis and trials show TTFields combined with standard therapy improved overall survival regardless of MGMT status, though TMZ benefit may vary by methylation

Not required for coverageMGMT methylation status is informative but not required for coverage under this policy

inv-48: MGMT promoter methylation — additional reference chunks

MGMT subgroup analysesSystematic reviews and EF-14 subgroup analyses indicate TTFields plus Stupp-protocol therapy improves survival for patients both with and without MGMT promoter methylation

Elderly subgroup evidenceEF-14 elderly subgroup (≥65 years) showed improved PFS and OS with TTFields+TMZ versus TMZ alone

Clinical implicationMGMT status may guide expectations for TMZ activity, but TTFields benefit has been observed across MGMT statuses

Example description

KPS 60: requires occasional assistance but able to care for most personal needs

inv-34: Supratentorial — definition and coverage limitation to supratentorial GBM

DefinitionSupratentorial refers to the upper portion of the brain (cerebrum and associated structures)

Coverage limitationPolicy limits coverage of TTFields to supratentorial glioblastoma only

NCCN footnoteNCCN notes alternating electric field therapy is an option only for those with supratentorial disease

inv-35: Temozolomide (TMZ) — defined as required maintenance systemic therapy context

Definition of TMZTemozolomide (TMZ) is an oral alkylating chemotherapy used as first-line treatment for glioblastoma

Policy roleFor newly diagnosed GBM continuation, patient must continue to receive TMZ as the only cancer drug to qualify

Combination with TTFieldsEF-14 trial and FDA supplemental approval evaluated Optune used in combination with maintenance TMZ

inv-36: Newly diagnosed glioblastoma (ndGBM) — definition and EF-14 enrollment timing

Definition of ndGBMNewly diagnosed glioblastoma is GBM at initial presentation; EF-14 enrolled patients after completion of concomitant radiochemotherapy prior to randomization

Enrollment timingEF-14 participants were randomized a median of ~3.8 months from diagnosis after completing radiochemotherapy

Policy implicationTTFields for ndGBM is used after completion of radiotherapy and with maintenance TMZ consistent with trial protocols

inv-37: Recurrent glioblastoma (rGBM) — definition and evidence context

Definition of rGBMRecurrent glioblastoma refers to disease recurrence after initial standard therapy

Evidence contextEvidence for TTFields in rGBM is more limited; ECRI and comparative assessments show mixed OS results versus best standard care

Policy usagePolicy allows TTFields as sole therapy for radiologically confirmed supratentorial rGBM with KPS ≥ 60 or ECOG ≤ 2

inv-38: Optune / tumor treating fields (TTFields) — device definition and FDA status

Device definitionOptune (formerly NovoTTF-100A) is an FDA-approved tumor treating fields device delivering low-intensity alternating electric fields for adults with GBM

FDA statusFDA approved for recurrent GBM (2011) and supplemental approval with temozolomide for newly diagnosed supratentorial GBM (2015)

Clinical trial basisEF-11 and EF-14 pivotal trials support device approvals and clinical use contexts

inv-39: MGMT promoter methylation — biomarker definition and role

MGMT promoter methylation roleMGMT promoter methylation status is a tumor molecular marker used to inform expected temozolomide benefit and treatment selection

Implication for TMZTMZ activity may be greater in MGMT‑methylated tumors; treatment decisions for older adults may rely on methylation status

TTFields contextNCCN allows TTFields regardless of MGMT status for selected patients; systematic reviews show TTFields benefit across MGMT statuses