ModifiedUnitedHealthcarePolicy CS146LA.I

Electric Tumor Treatment Field Therapy (for Louisiana Only)

Defines UnitedHealthcare Louisiana coverage for FDA‑approved electric tumor treatment field (TTF) devices for supratentorial glioblastoma, including initial and continuation criteria and documentation expectations, applying only in Louisiana.

Policy Summary

PayerUnitedHealthcare

PolicyElectric Tumor Treatment Field Therapy (for Louisiana Only)

Policy CodePolicy CS146LA.I

Change TypeMaterial updates: removed software planning exclusionremoved CPT 77299documentation clarifications

Effective DateJan 1, 2026

Next Review DateN/A

Key ActionObtain prior authorization for TTF therapy; initial approval is for 3 months when coverage criteria are met.

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 clarifying that benefit coverage is determined by federal, state, or contractual requirements and that medical records documentation may be required to assess clinical criteria but does not guarantee coverage.

Removed CPT code 77299 from Applicable Codes.

Updated Description of Services, Clinical Evidence, FDA, and References sections to reflect current information and archived previous policy version.

18 h/dayminimum daily device wear time required for coverage

3 monthsinitial approved duration for TTF therapy

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Coverage Criteria

inv-01: Initial therapy — newly diagnosed GBM

Covered when ALL of the following are met for newly diagnosed supratentorial GBM (ndGBM):

ndGBM initial coverage: Histologically confirmed supratentorial glioblastoma; Debulking surgery has been completed; Radiation therapy has been completed; Individual is receiving temozolomide (TMZ) as the only cancer drug; Karnofsky Performance Status (KPS) ≥ 60 OR ECOG Performance Status ≤ 2; Individual has been counseled that the electric TTF device must be worn at least 18 hours daily; Device is FDA‑approved and used according to labeled indicationsinitial approval = 3 months

Initial approval duration specified in policy

inv-02: Initial therapy — recurrent GBM

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

rGBM initial coverage: Radiologically confirmed recurrence of supratentorial GBM; Device is used as the only treatment; Karnofsky Performance Status (KPS) ≥ 60 OR ECOG Performance Status ≤ 2; Individual has been counseled that the electric TTF device must be worn at least 18 hours daily; Device is FDA‑approved and used according to labeled indicationsinitial approval = 3 months

Initial approval duration specified in policy

inv-03: Continuation therapy

Continuation approval (beyond initial 3 months) is contingent on ALL of the following:

Continuation criteria: MRI performed within 2 months prior to request documents no evidence of disease progression; For ndGBM: individual continues to receive TMZ as the only cancer drug; For rGBM: device is being used as the only treatment; KPS ≥ 60 OR ECOG ≤ 2; Documentation that the individual has been using the electric TTF device at least 18 hours dailynone

Subsequent approvals depend on ongoing stability and compliance

inv-04: Initial therapy for newly diagnosed GBM

Covered when ALL of the following are met

ndGBM initial coverage (evidence/guideline grouping): Member has newly diagnosed supratentorial glioblastoma who have completed standard radiochemotherapy and are candidates for maintenance temozolomide; TTFields offered as adjunctive therapy to maintenance TMZ consistent with the EF-14 trial and guideline recommendations.

Supported by EF-14 randomized trial showing improved PFS and OS (median OS ~20.9 months vs 16.0 months) and guideline recommendations (NCCN, ASCO/SNO).

inv-05: Adherence/usage

Coverage considerations tied to use and adherence

Device usage and monitoring: Documented device usage/compliance is required; subgroup analyses indicate a monthly compliance threshold of ≥ 50% correlates with improved PFS and OS and greater benefit with higher compliance (e.g., >90% associated with extended median survival).>= 50% monthly compliance recommended

Based on EF-14 compliance analyses (Toms et al.) and trial outcomes

inv-06: Guideline-aligned coverage considerations

Coverage considerations referenced to guideline-supported scenarios (document excerpt — full policy criteria may be in other sections):

NCCN-supported ndGBM use: Alternating electric field therapy is listed by NCCN as an option for individuals with newly diagnosed supratentorial glioblastoma with good performance status (KPS ≥ 60) receiving standard RT plus concurrent and adjuvant temozolomide; FDA approval for Optune with temozolomide is acknowledged.KPS ≥ 60

NCCN category 1 for select patients

Recurrent GBM guidance variance: NCCN recognizes alternating electric field therapy as FDA‑approved for recurrent GBM but the panel is divided about recommending it for recurrence; ESMO and NICE advise against routine use at progression for some patients.clinical discretion

Guideline variance across organizations

General standard-of-care notes:

Treatment of tumors other than glioblastoma and concurrent use of tumor-treating fields (TTF) with other medical therapies for recurrent GBM are considered unproven. The policy specifies that when the stated coverage criteria are not met, or when TTF is used concurrently with systemic agents (for example, bevacizumab or chemotherapy) to treat recurrent GBM, such uses are considered not medically necessary due to insufficient evidence of efficacy.

Randomized controlled trial evidence for TTF in non‑GBM tumor types is limited. The document highlights a lack of published RCTs for indications such as metastatic non‑small cell lung cancer, pancreatic, ovarian cancer, and mesothelioma, and summarizes pivotal or single‑arm trial results (e.g., LUNAR, smaller thoracic/mesothelioma studies) as preliminary. Because these data are not yet confirmatory, coverage for non‑GBM indications is not supported outside of established clinical trial contexts.

The National Institute for Health and Care Excellence (NICE) guidance advises against offering tumor‑treating fields as part of routine management for both newly diagnosed grade IV glioma (glioblastoma) and recurrent high‑grade glioma. NICE explicitly lists TTF among interventions that should not be offered for newly diagnosed grade IV glioma and for recurrent high‑grade glioma in its published recommendations.

When the policy's coverage criteria are not met, use of devices that generate electric tumor‑treating fields for any other indications beyond newly diagnosed supratentorial GBM (ndGBM) and radiologically confirmed recurrent supratentorial GBM (rGBM) is considered not medically necessary. Requests that do not document required elements (for example, recent MRI, adequate performance status, or required device use) may be denied.

The evidence does not establish TTF as a standard monotherapy for recurrent GBM or for non‑GBM tumors. Assessments cited in the policy note that TTFields used alone for recurrent disease or when applied to non‑GBM malignancies lack sufficient high‑quality evidence to be considered standard therapy; published reviews and technology assessments characterize these uses as investigational or of limited evidence.

European Society for Medical Oncology (ESMO) guidance cautions against continuing or re‑using therapies beyond confirmed progression on that same treatment, and explicitly includes tumor‑treating fields in this recommendation. ESMO states that using treatments beyond confirmed progression—such as bevacizumab or TTFields—has not been demonstrated to provide clinical benefit and therefore should be avoided.

Covered Regimens

Regimen	Coverage stance	Notes / Evidence
TTF used concurrently with systemic agents (e.g., bevacizumab or chemotherapy) for recurrent GBM
Not covered / considered unproven when used concurrently with other systemic therapies for rGBM
Policy states use of electric TTF with concurrent medical therapy for rGBM is unproven and not medically necessary due to insufficient evidence; network and systematic reviews show mixed or limited benefit and additional studies are needed (Dongpo et al. 2022; Chen et al. 2021; ECRI 2019/2024).

Regimen	Coverage stance	Notes / Evidence
Tumor Treating Fields (TTF) in combination with maintenance temozolomide (post‑radiochemotherapy) for newly diagnosed supratentorial GBM
Covered when policy initial criteria for ndGBM are met (device used per FDA labeling, completed surgery and radiation, TMZ as only cancer drug, KPS ≥ 60 or ECOG ≤ 2, counselled to wear device ≥ 18 hours/day); initial approval = 3 months
EF-14 randomized trial demonstrated improved PFS and OS with TTFields + TMZ versus TMZ alone (median OS ~20.9 vs 16.0 months in final analysis); subgroup analyses support benefit including in older adults. Policy and guidelines (NCCN, ASCO/SNO) support adjunctive use in selected ndGBM patients. Documentation of prior radiochemotherapy and compliance is required for prior authorization.

Regimen	Coverage stance	Notes / Evidence / Regulatory status
TTFields (Optune / NovoTTF device) plus maintenance temozolomide for newly diagnosed supratentorial GBM after radiochemotherapy
Covered with criteria: completion of debulking surgery and radiation, receiving TMZ as sole cancer drug, adequate performance status (KPS ≥ 60 / ECOG ≤ 2), counselled to wear device ≥ 18 hours/day; initial approval 3 months
EF-14 (phase III randomized) showed statistically significant improvements in PFS and OS with TTFields + TMZ vs TMZ alone (final median OS 20.9 vs 16.0 months). Optune has FDA supplemental PMA approval for use with TMZ in newly diagnosed supratentorial GBM. Prior authorization and documentation of radiochemotherapy completion and device compliance are required.

Regimen	Coverage stance	Notes / Evidence
TTFields as monotherapy for recurrent GBM or TTFields combined with other systemic regimens for recurrent GBM and non‑GBM tumors
Investigational / not routinely covered; supportive data limited or mixed
Systematic reviews and RCT evidence for rGBM and non‑GBM indications are limited or show similar OS to best standard care; ECRI assessment found similar OS but different AE profiles for Optune Gio vs BSC. RCTs in non‑GBM tumors (e.g., LUNAR in NSCLC) and other tumor types lack sufficient confirmatory evidence; policy considers these uses investigational or unproven. Guidelines (ESMO) caution against use beyond confirmed benefit at progression.

Regimen	Coverage stance	Notes / Evidence / Eligibility
Alternating electric field therapy (Optune) plus adjuvant temozolomide following completion of radiation therapy for newly diagnosed supratentorial glioblastoma
Covered for selected newly diagnosed GBM patients meeting policy criteria (post‑radiochemotherapy, TMZ as sole cancer drug, adequate performance status); initial approval for 3 months
Supported by EF-14 randomized data and NCCN guideline recommendations listing alternating electric field therapy with adjuvant TMZ as an option for selected ndGBM patients; FDA supplemental approval exists for Optune with TMZ in ndGBM. Compliance and documentation requirements apply for continuation.

Regimen	Coverage stance	Notes / Guideline context
Optune as standalone therapy or used with other agents for recurrent GBM
Coverage approach variable; some organizations advise against routine use for recurrence
Guideline support is variable: NCCN recognizes FDA approval for rGBM but is divided about recommending it for recurrence; NICE advises do not offer TTFields for newly diagnosed grade IV glioma and for recurrent high‑grade glioma; ESMO recommends against continuing treatments beyond confirmed progression. ECRI found Optune Gio and best standard care have similar OS in rGBM but differing AE profiles. Policy treats recurrent and non‑GBM uses cautiously and may consider case‑by‑case with supporting evidence.

Applicable Codes

Applicable device/procedure 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 policy

inv-15: TTF compliance — ≥ 75% device usage (~≥18 hours/day)

MetricDevice usage ≥ 75% (≈ ≥18 hours/day) is associated with improved overall survival in observational and meta-analytic analyses.

OperationalizationPolicy requires documentation of device use ≥ 18 hours/day for initial and continuation coverage.

Evidence sourcesSystematic reviews/meta-analyses and pooled analyses report consistent association of ≥75% usage with prolonged survival (Ballo et al., Li et al.).

inv-16: MRI recency — MRI performed ≤ 2 months prior to continuation request

RequirementMRI performed ≤ 2 months prior to continuation request demonstrating no evidence of progression.

Documentation

Provider Actions & Prior Authorization

Prior Authorization

Prior Authorization Required for TTFields

Prior authorization is required for tumor treating fields (TTF) therapy (electric TTF devices) for newly diagnosed and recurrent supratentorial glioblastoma (GBM). For newly diagnosed GBM (ndGBM), when all initial coverage criteria are met (including prior debulking surgery, completion of radiation therapy, receiving temozolomide [TMZ] as the only cancer drug, adequate performance status, and counseling that device must be worn ≥18 hours/day), an initial approval of 3 months will be authorized. For recurrent GBM (rGBM), when criteria for recurrence are met (device used as the only treatment after initial chemotherapy, adequate performance status, and counseling re: wear time), an initial 3 months will be authorized.

Initial approval: 3 months when all initial criteria for ndGBM or rGBM are met
Device must be FDA-approved and used per labeled indications, contraindications, warnings, and precautions
Wear time counseling: device must be worn at least 18 hours daily

Note

Prior Authorization and Benefit Determination

Prior authorization review is a benefit determination process. UnitedHealthcare will review submitted medical records to confirm that the member meets the policy clinical criteria. Documentation submitted for review does not guarantee approval. UnitedHealthcare may also use third-party tools (e.g., InterQual) as part of the assessment.

Definitions

inv-32: Karnofsky Performance Status (KPS) — scale 0–100; coverage requires KPS ≥ 60

ScaleKarnofsky Performance Status (KPS) scale ranges from 0 to 100 measuring ability to perform ordinary tasks.

Coverage requirementCoverage requires documented KPS ≥ 60.

ExampleKPS 60 = requires occasional assistance but able to care for most personal needs (NCI definition).

inv-33: ECOG Performance Status — scale 0–5; coverage requires ECOG ≤ 2

ScaleECOG Performance Status ranges 0–5 describing functional status from fully active (0) to dead (5).

Coverage requirementCoverage requires ECOG ≤ 2 (ambulatory and capable of self-care; up and about >50% of waking hours).

Line of Therapy

inv-39: first-line

Top-level node indicating first-line use context

first-line (ndGBM): Post‑surgery and post‑radiation; concurrent maintenance TMZ as only systemic therapy; device added as adjunctive therapy; initial approval for 3 months when criteria met.

inv-40: salvage

Top-level node indicating salvage (recurrent) use context

salvage (rGBM): Used after initial chemotherapy for radiologically confirmed recurrence; device must be sole cancer-directed treatment; initial approval for 3 months when criteria met.

inv-41: first-line

Additional first-line node from guideline/evidence sections

Biomarker Requirements

inv-44: PTEN mutation — biomarker reference (high importance)

MarkerPTEN mutation noted as a potential biomarker associated with greater post-progression survival in a retrospective rGBM cohort receiving TTFields.

EvidenceDono et al. (2021) retrospective review found longer post-progression survival in PTEN‑mutant rGBM patients treated with TTFields versus PTEN‑WT in that cohort.

Clinical implicationPTEN status is not required for coverage but may be of high interest for predicting responsiveness; further RCT data needed.

inv-45: MGMT promoter methylation — biomarker reference (high importance)

MarkerMGMT promoter methylation status influences temozolomide benefit but TTFields-associated survival benefit has been observed regardless of MGMT status.

Evidence

Background and Evidence Summary

Tumor‑treating fields (TTF) are delivered noninvasively via transducer arrays placed on the scalp to generate low‑intensity, intermediate‑frequency electric fields (typically in the 100–300 kHz range). These alternating electric fields are intended to disrupt mitotic processes in dividing tumor cells. Delivery requires frequent array changes and scalp care, and typical prescribed use in trials and clinical practice is to wear the device for at least 18 hours/day to achieve the intended therapeutic exposure.

Policy Summary

PayerUnitedHealthcare

PolicyElectric Tumor Treatment Field Therapy (for Louisiana Only)

Policy CodePolicy CS146LA.I

Change TypeMaterial updates: removed software planning exclusionremoved CPT 77299documentation clarifications

Effective DateJan 1, 2026

Next Review DateN/A

Key ActionObtain prior authorization for TTF therapy; initial approval is for 3 months when coverage criteria are met.

SourceLink

On This Page

inv-17: TTFields monthly compliance — >= 50% associated with improved PFS/OS; >90% associated with further extended survival

Thresholds>= 50% monthly compliance correlates with improved progression-free and overall survival; >90% compliance associated with further extended median and 5-year survival.

Supporting analysisToms et al. subgroup analysis of EF-14 showed progressive benefit with increasing monthly percent compliance; >90% median survival ~24.9 months.

ImplicationDocumentation of monthly device-delivery compliance is relevant for assessing benefit and continuation decisions.

Documentation Required

Documentation Requirements and Denial Risk

Requests may be denied if required documentation is missing, incomplete, or does not demonstrate that the member meets coverage criteria. Failure to provide medical records that fully support medical necessity may result in denial or inability to determine coverage.

Medical record must include relevant history, physical exam, and results of pertinent diagnostic tests or procedures
Documentation must be legible, maintained in the patient's medical record, and available upon request

Denial Risk

Triggers for Denial

Specific triggers commonly leading to denial include absence of a recent MRI (performed within 2 months prior to request) documenting no progression for continuation requests, inadequate performance status (KPS < 60 or ECOG > 2), lack of documentation that ndGBM patients completed radiochemotherapy prior to randomization to TTFields, and insufficient evidence of device use (at least 18 hours/day).

No MRI within ≤ 2 months prior to request showing no evidence of progression
KPS < 60 or ECOG Performance Status > 2
For ndGBM: no documentation that radiochemotherapy was completed prior to initiating TTFields
Insufficient documentation of device use (wear time < 18 hours/day or no attestation)

Note

Evidence Limitations and Generalizability

Evidence supporting TTFields in ndGBM comes primarily from open-label randomized trials (EF-14 and its final analyses) showing improved progression-free and overall survival when TTFields are added to maintenance TMZ after completion of radiochemotherapy. However, these open-label designs and trial entry criteria (e.g., enrollment after completion of radiochemotherapy, exclusion of early progressors) limit generalizability to all patients and are a consideration when assessing coverage for non-GBM or other off-label indications.

EF-14 (open-label randomized) supports TTFields + TMZ in ndGBM after radiochemotherapy but excludes early progressors and may not generalize to all populations
Insufficient randomized evidence for tumors other than GBM; open-label or single trials (e.g., LUNAR) limit adoption for non-GBM indications

Note

Position Relative to Standard Therapy

Position relative to standard therapy: Guidelines (NCCN, ESMO and others) list maximal safe resection and radiotherapy with concurrent and adjuvant temozolomide as standard of care. TTFields are recommended by NCCN as an option to add to adjuvant TMZ for selected patients with supratentorial ndGBM and adequate performance status; ESMO and guideline statements note limited options at recurrence and recommend clinical trial enrollment when possible.

NCCN: alternating electric field therapy is an option with adjuvant TMZ for supratentorial ndGBM in patients with KPS ≥ 60 (category 1) and follow-up MRI schedule guidance
ESMO: standard SOC includes resection/radiotherapy and TMZ; at recurrence, therapies are less well defined and trial enrollment encouraged

Step Therapy

Step Therapy Not Specified

Step therapy is not specified in this policy section. Device initiation in ndGBM is permitted after completion of debulking surgery and radiochemotherapy when criteria are met; for rGBM the device may be approved after initial chemotherapy when specified criteria are met. There is no policy-imposed prerequisite sequence beyond the clinical criteria described.

No separate step-therapy algorithm specified — approval depends on meeting clinical criteria for ndGBM or rGBM
For ndGBM: device may be approved after surgery and completion of radiation therapy and while on TMZ per criteria
For rGBM: device may be approved after initial chemotherapy when used as the only treatment and criteria are met

inv-36: TTFields / Optune — alternating electric field therapy delivered via transducer arrays (e.g., Optune/NovoTTF-100A)

Therapy descriptionTTFields are alternating electric fields delivered via transducer arrays applied to the scalp at tumor-specific frequencies to disrupt dividing tumor cells.

Device examplesDelivered using systems such as Optune (NovoTTF-100A) which include generator, transducer arrays, power supply, and accessories.

AdministrationTreatment is noninvasive, portable, typically prescribed for at least 18 hours per day with frequent array changes and scalp care.

inv-37: Optune (NovoTTF) — Optune Treatment Kit: FDA-approved device delivering low electric field tumor treatment for adults with glioblastoma (initial and supplemental PMA references)

Regulatory statusOptune Treatment Kit (formerly NovoTTF-100A) is FDA-approved for adults with glioblastoma (initial and supplemental PMA approvals).

Kit componentsIncludes portable electric field generator, insulated transducer arrays, power supply, and additional supplies for scalp application.

IndicationsApproved for recurrent GBM (2011) and for newly diagnosed supratentorial GBM in combination with temozolomide (supplemental PMA 2015).

inv-38: TTFields — Alternating electric field therapy / Tumor Treating Fields: device-delivered therapy used concurrently with temozolomide in some ndGBM patients

DefinitionTumor Treating Fields (TTFields) are low-intensity, intermediate-frequency alternating electric fields applied to disrupt cancer cell division.

Clinical useUsed concurrently with temozolomide maintenance in some newly diagnosed supratentorial GBM patients per EF-14 trial and guidelines.

Adverse eventsPrimary device-related adverse events are localized reversible scalp skin reactions; systemic toxicity is not substantially increased versus TMZ alone.

inv-43: first-line | salvage

Combined node covering both first-line and salvage contexts

Newly diagnosed (first-line): TTFields concurrent with adjuvant temozolomide is FDA‑approved and recommended for selected newly diagnosed supratentorial GBM patients with good performance status.

Recurrent (salvage): Optune is FDA‑approved for recurrent GBM; guideline panels note limited efficacy data and are divided on routine recommendation for recurrence.

inv-46: MGMT promoter methylation — additional references across document (high importance)

Repeated findingMultiple sections reference MGMT promoter methylation; methylation influences chemotherapy decisions but TTFields benefit seen across methylation subgroups.

Evidence sourcesJin et al. (2020) meta-analysis and guideline summaries note TTFields survival benefit regardless of MGMT status.

Policy implicationMGMT methylation is informative for TMZ use but is not a prerequisite for TTFields coverage under NCCN-consistent criteria.

inv-48: MGMT promoter methylation — notes that methylation status influences TMZ use; TTFields recommendations per NCCN not limited by MGMT status

Primary pointMGMT promoter methylation influences temozolomide benefit, but TTFields recommendations per NCCN and meta-analyses are not limited by MGMT status.

Guideline noteNCCN includes TTFields as an option for patients regardless of MGMT status (category 1 for supratentorial disease with good PS).

Clinical implicationMGMT testing informs chemotherapy planning; TTFields may be offered independent of MGMT methylation status when other criteria met.