ModifiedUnitedHealthcarePolicy CS146NE.M

Electric Tumor Treatment Field Therapy (for Nebraska Only)

Policy governs coverage of FDA‑approved electric tumor treatment field (TTF) devices for treatment of supratentorial glioblastoma in Nebraska members, specifying initial and continuation coverage criteria and documentation requirements.

Policy Summary

PayerUnitedHealthcare

PolicyElectric Tumor Treatment Field Therapy (for Nebraska Only)

Policy CodePolicy CS146NE.M

Change TypeModified — documentation and code list updates

Effective DateFeb 1, 2026

Next Review Date

Key ActionObtain prior authorization and provide medical records showing supratentorial GBM diagnosis, performance status (KPS ≥60 or ECOG ≤2), device usage (≥18 hours/day), and a recent MRI (≤2 months) for continuation requests.

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

Initial 3 monthsduration approved when initial criteria met

≥18 h/dayminimum daily wear time counseled

KPS ≥60 or ECOG ≤2required performance status for coverage

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MRI ≤2 monthsrequired imaging recency for continuation

Nebraskageographic application

695patients in pivotal EF-14 trial

Coverage Criteria for Tumor Treating Fields (TTF)

Initial therapy — newly diagnosed GBM

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

ndGBM initial coverage criteria: 1) Histologically confirmed supratentorial glioblastoma; 2) Debulking surgery has been completed; 3) Radiation therapy has been completed; 4) Individual is receiving temozolomide (TMZ) as the only cancer drug; 5) Karnofsky Performance Status (KPS) ≥ 60 OR Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2; 6) Individual has been counselled that the electric TTF device must be worn at least 18 hours dailyinitial approval: 3 months

If all met, initial 3 months of TTF therapy will be approved.

Initial therapy — recurrent GBM

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

rGBM initial coverage criteria: 1) Radiologically confirmed recurrence of GBM in the supratentorial region; 2) The device is used as the only treatment; 3) Karnofsky Performance Status (KPS) ≥ 60 OR ECOG Performance Status ≤ 2; 4) Individual has been counselled that the electric TTF device must be worn at least 18 hours dailyinitial approval: 3 months

If all met, initial 3 months of TTF therapy will be approved.

Continuation therapy

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

Continuation criteria: 1) MRI scan performed ≤ 2 months prior to request documents no evidence of disease progression; 2) For ndGBM, individual continues to receive TMZ as the only cancer drug OR for rGBM the device continues to be the only treatment; 3) Karnofsky Performance Status (KPS) ≥ 60 OR ECOG Performance Status ≤ 2; 4) Documentation that the individual has been using the electric TTF device at least 18 hours dailyeach continuation approval contingent on documentation

Subsequent approvals based on these criteria.

Initial/Adjuvant Therapy (ndGBM)

Covered when ALL of the following are met

Adjunct TTFields for newly diagnosed GBM: 1) Patient has newly diagnosed supratentorial glioblastoma who completed standard concomitant radiochemotherapy; 2) TTFields are administered concurrently with maintenance temozolomide as in the EF-14 trial; 3) Device usage/compliance is documented (higher monthly usage associated with greater benefit); 4) Patient meets performance status criteria (KPS ≥ 60 or ECOG ≤ 2)usage >= 50% associated with improved outcomes; higher compliance correlated with greater benefit

EF-14 randomized trial demonstrated improved PFS and OS with TTFields+TMZ vs TMZ alone; typical skin toxicity under arrays is common but usually mild-moderate.

Recurrent Disease

Considered (evidence mixed) when ALL of the following are met

Recurrent GBM (rGBM): 1) Radiologically confirmed recurrent supratentorial GBM; 2) Patient and clinician have considered available options including surgery, re-irradiation, nitrosoureas, temozolomide rechallenge, and bevacizumab per guideline/label; 3) Rationale for choosing TTFields over systemic chemotherapy (e.g., to avoid systemic AEs) is documented and informed consent obtained; 4) Performance status meets criteria (KPS ≥ 60 or ECOG ≤ 2)N/A

ECRI assessment indicates similar OS to best standard care chemotherapy but tradeoffs in adverse events exist; document rationale and consent.

Other Tumor Types

Experimental/Not routinely covered — evidence insufficient

Non-GBM tumors: Use of TTFields for tumors other than glioblastoma (e.g., non-small cell lung cancer, malignant pleural mesothelioma, pancreatic, ovarian cancer, brain metastases) is investigational; randomized long-term safety and effectiveness evidence is lacking or limited and results are from single-arm or early trials.N/A

Pivotal trials such as LUNAR and STELLAR provide early or single-arm data but lack definitive randomized evidence for routine coverage.

Coverage criteria by indication

Covered when meeting guideline-supported clinical contexts and applicable plan/federal/state/contractual requirements

FDA-approved indications: Device is FDA-approved for adults with recurrent GBM and as adjunct to temozolomide for newly diagnosed supratentorial GBM following maximal debulking surgery and completion of radiation therapy with concomitant temozolomide.

FDA approval is informational; coverage is governed by plan and legal requirements.

NCCN-supported ndGBM patients: For newly diagnosed GBM in patients ≤ 70 years with good performance status, standard RT plus concurrent and adjuvant temozolomide with or without TTFields is NCCN Category 1; consider similarly for selected older patients with good PS per NCCN guidance.KPS ≥ 60 (good PS)

References NCCN guidance and EF-14 trial.

Recurrent GBM: At recurrence, options include surgery, radiotherapy, nitrosoureas, temozolomide rechallenge, and bevacizumab depending on label/country; TTFields has FDA approval for rGBM but efficacy data vary and guideline recommendations are divided; encourage clinical trial enrollment when available.

Requests for Tumor‑Treating Fields (TTF) for indications that do not meet the policy's specified clinical criteria — including treatment of tumors other than supratentorial glioblastoma or use of TTF concurrently with other systemic medical therapies for recurrent GBM (for example, bevacizumab or cytotoxic chemotherapy) — are considered unproven and not medically necessary. Continuation approvals beyond the initial 3 months require documentation that an MRI performed ≤ 2 months prior shows no progression, that performance status meets policy thresholds (KPS ≥ 60 or ECOG ≤ 2), and that the device is being used as specified (device used as the only treatment for rGBM or TTF used with temozolomide as the only cancer drug for ndGBM) with evidence the device is being worn at least 18 hours/day. If these criteria are not met, the use of devices to generate electric TTF is considered unproven and not medically necessary.

The evidence base for using Tumor‑Treating Fields outside of glioblastoma is limited. There is a lack of published randomized controlled trial data examining long‑term safety and effectiveness of TTF for non‑GBM tumors, including non‑small cell lung cancer, brain metastases, pancreatic cancer, ovarian cancer, and mesothelioma; therefore routine coverage for these tumor types is not supported by randomized long‑term evidence.

The National Institute for Health and Care Excellence (NICE) guidance (2018, updated 2021) recommends that TTF should not be offered for management of newly diagnosed grade IV glioma (glioblastoma) and also states that tumor‑treating fields should not be offered as part of management of recurrent high‑grade glioma.

Use of devices that generate electric Tumor‑Treating Fields when the policy criteria are not met, and any use for indications beyond supratentorial glioblastoma (including concurrent use with systemic therapies for recurrent GBM), is considered unproven and not medically necessary and is not supported by this policy.

Use of TTFields as monotherapy or applying the technology to tumor types outside the established indications lacks support from randomized trial evidence. Because randomized controlled trial data on long‑term safety and effectiveness are not available for these settings, such uses are considered investigational or not medically necessary.

Some guideline and evidence summaries conclude that continued use of the same treatment beyond confirmed progression — including tumor‑treating fields — has not been established to provide clinical benefit. ESMO specifically advises against using any treatment beyond confirmed progression on that same treatment, and NICE guidance does not support offering TTF at recurrence; therefore continued use beyond progression is not supported by established evidence in these summaries.

Procedure and Billing Codes

Applicable procedure/HCPCS codes (reference list)HCPCS

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/Modified CPT CodesCPT

77299

Unlisted procedure, radiation therapy (removed from applicable codes)

Device daily usage — counseling and evidence

Daily wear time counselingMember must be counselled to wear the device at least 18 hours per day

Literature compliance associationMeta-analysis found TTFields compliance ≥75% associated with significantly lower mortality risk

Device operational noteOptune is a portable device designed to deliver TTF with recommended continuous daily use and frequent array replacement

MRI recency for continuation

Imaging recency requirementMRI must have been performed within 2 months prior to request and document no evidence of disease progression

Purpose of MRI

Provider Requirements, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required to establish that the member meets clinical criteria for use of FDA‑approved tumor treating fields (TTF) devices for supratentorial glioblastoma (GBM). Requests that do not meet the specified clinical criteria (for example: diagnosis other than supratentorial GBM, inadequate performance status, lack of required prior surgery or radiotherapy for newly diagnosed GBM, failure to document TMZ as the only cancer drug for ndGBM, or absence of counseling/commitment to wear the device ≥18 hours/day) may be denied.

Prior authorization required prior to initiation
Coverage contingent on meeting all listed clinical criteria

Documentation Required

Medical Records Documentation Required

Medical records must be available to support the request and demonstrate medical necessity. Documentation should include relevant medical history, physical examination, diagnostic test results (including MRI results when required), operative reports (if applicable), pathology confirming histologic GBM, and evidence of prior treatments (e.g., dates/records of debulking surgery and completed radiotherapy). Benefit coverage is determined by federal, state, and contractual requirements and applicable law; submission of records to assess criteria does not guarantee coverage.

Regimens and Clinical Contexts Supported by Policy

Regimen	Indication	Coverage stance
TTF (Optune) plus maintenance temozolomide
Newly diagnosed supratentorial glioblastoma following debulking surgery and completion of radiotherapy, given concurrently with maintenance temozolomide
Covered when policy criteria met (KPS ≥ 60 or ECOG ≤ 2; device counselled ≥18 hours/day; initial approval 3 months)

Regimen	Indication	Coverage stance
TTF combined with bevacizumab or other systemic chemotherapy
Recurrent supratentorial glioblastoma when used concurrently with other systemic anticancer therapies (e.g., bevacizumab)
Not covered — concurrent use with systemic therapies for rGBM is considered unproven and not medically necessary

Regimen	Indication	Coverage stance
TTFields (200 kHz via Optune) used >18 hours/day with maintenance temozolomide
Adjunct to maintenance temozolomide in adults with newly diagnosed supratentorial GBM after completion of radiochemotherapy (per EF-14 trial)
Covered when policy criteria met (documented device use ≥18 hours/day, KPS ≥60 or ECOG ≤2; MRI and other continuation requirements apply)

Regimen	Indication	Coverage stance
TTFields delivered to the thorax (150 kHz) in combination with systemic chemotherapy (pemetrexed + platinum) or TTFields + standard therapy as in LUNAR
Metastatic non-small cell lung cancer after progression on platinum therapy; unresectable malignant pleural mesothelioma in combination with pemetrexed+platinum (investigational trials)
Experimental — evidence insufficient; use for non‑GBM tumors is investigational and not routinely covered

Regimen	Indication	Coverage stance
Standard brain radiotherapy plus concurrent temozolomide followed by adjuvant temozolomide with adjunct TTFields
Newly diagnosed supratentorial glioblastoma in patients with good performance status (approach supported by EF-14 trial and reflected in NCCN guidance)
Covered when meeting guideline-supported clinical contexts and policy criteria (e.g., KPS ≥60 or ECOG ≤2; device counselled ≥18 hours/day)

Regimen	Indication	Coverage stance
TTFields (general) not recommended by NICE
Routine use of TTFields for newly diagnosed grade IV glioma (glioblastoma) or recurrent high-grade glioma per NICE guidance
Experimental/Not routinely recommended per NICE guidance

Key Definitions and Clinical Scales

ECOG Performance Status

ECOG scale overviewECOG Performance Status is a 0–5 scale measuring functional status (0 = fully active; 5 = dead)

Policy requirement for coveragePolicy requires ECOG Performance Status ≤ 2 for coverage eligibility

Use in decision-makingECOG is used alongside KPS and other clinical factors to determine suitability for TTFields therapy

Karnofsky Performance Status (KPS)

KPS scale overviewKarnofsky Performance Status ranges 0–100; higher scores indicate better function (e.g., 60 = requires occasional assistance)

Policy requirement for coveragePolicy requires KPS ≥ 60 for coverage eligibility

Intended Line of Therapy

first-line — first-line use node (ndGBM contexts)

First-line (ndGBM): Post-debulking surgery and post-radiation with concurrent temozolomide as the only systemic therapy; device used as adjunct to standard chemoradiotherapy; initial approval 3 months

Salvage (rGBM): Radiologically confirmed recurrent GBM where the device is used as the only treatment; initial approval 3 months

salvage — salvage use node (rGBM contexts)

Salvage (rGBM): Recurrent supratentorial GBM with device used as sole therapy; evidence indicates similar OS to best standard care chemotherapy with different AE profile; use may be appropriate for patients prioritizing avoidance of systemic chemo AEs

Biomarkers and Testing Considerations

PTEN — observational data and policy stance

PTEN observational findingRetrospective series reported PTEN‑mutant rGBM patients treated with TTFields had longer post‑progression survival versus PTEN‑WT in that cohort

Evidence strengthFinding comes from a small retrospective study and is hypothesis‑generating rather than definitive

Policy stance on testingPolicy does not mandate biomarker (PTEN) testing for coverage

MGMT promoter methylation — role and references

Role of MGMT statusMGMT promoter methylation status is prognostic and used to guide temozolomide use; TTFields combination improved survival regardless of MGMT status in pooled analyses

Guideline reference

Background and Evidence Summary

Tumor‑Treating Fields (TTF) deliver low‑intensity, alternating electric fields at intermediate frequencies (typically in the range of approximately 100–300 kHz) via transducer arrays applied to the scalp (Optune system). The fields are intended to disrupt the mitotic processes of dividing tumor cells, impairing tumor cell replication. The Optune system is a portable generator with scalp arrays that are worn for prolonged periods (patients are counseled to wear the device at least 18 hours/day); arrays require frequent replacement and scalp preparation. TTF is intended as a local, non‑invasive adjunctive therapy to standard treatment in selected patients with supratentorial glioblastoma.

Policy Summary

PayerUnitedHealthcare

PolicyElectric Tumor Treatment Field Therapy (for Nebraska Only)

Policy CodePolicy CS146NE.M

Change TypeModified — documentation and code list updates

Effective DateFeb 1, 2026

Next Review Date

SourceLink

On This Page

Guideline panels differ; consider patient preferences and trial enrollment.

Demonstrates stability to support continuation beyond initial 3 months of therapy

Documentation implicationMRI report must be available in the medical record for prior authorization and continuation review

Dexamethasone dose associated with outcomes

Dexamethasone dose linked to outcomesMeta-analysis reported median overall survival longer when dexamethasone dose was ≤ 4.1 mg

Analysis limitationsAuthors noted heterogeneity and small number of included studies affecting certainty

Clinical relevanceLower dexamethasone exposure may be associated with better prognosis in patients receiving TTFields

TTFields monthly compliance — thresholds and outcomes

Monthly compliance thresholds50% monthly compliance threshold associated with improved PFS and OS compared with TMZ alone

High compliance benefit>90% monthly compliance associated with extended median survival (24.9 months) and higher 5-year survival (29.3%)

Compliance measurementCompliance assessed from NovoTTF device as percent monthly usage and correlates with outcomes

Medical record must fully support medical necessity and be legible
Make records available upon request for review

Documentation Required

Document TTFields Usage / Compliance

Continuation approvals beyond the initial 3 months require documentation of device usage/compliance. Submit objective usage data (monthly percent compliance) showing the individual has been using the TTF device at least 18 hours per day (clinical guidance and literature identify higher compliance associated with improved outcomes; compliance thresholds have been reported and monitored via device usage logs). Lack of documented compliance may result in denial of continued coverage.

Provide device-generated monthly percent compliance data (e.g., device logs)
Document counseling and patient acknowledgement of 18+ hours/day wear requirement

Step Therapy

No step therapy sequence is specified in this policy. Coverage is determined by meeting the policy's clinical criteria and prior authorization requirements rather than by a step‑therapy algorithm.

Note

Therapeutic Sequencing and Provider Guidance

Therapeutic sequencing should follow standard of care: for newly diagnosed, resection (or biopsy) followed by involved‑field radiotherapy and concomitant chemoradiation with temozolomide (TMZ), then adjuvant maintenance TMZ. TTF may be used concomitantly with adjuvant/maintenance TMZ for selected ndGBM patients with good performance status, and as monotherapy in some rGBM cases per FDA labeling and guideline recommendations. Ensure documentation shows appropriate prior surgery and radiotherapy (for ndGBM) or prior chemotherapy (for rGBM) when requesting TTF.

TTF with temozolomide for selected ndGBM patients (good performance status)
For ndGBM: document completed debulking surgery and completed radiotherapy prior to TTF initiation
For rGBM: document prior chemotherapy and that TTF is being used as the only treatment when required

Denial Risk

Denial Risk for Incomplete or Non‑conforming Documentation

Requests may be declined if the medical record is insufficient to support medical necessity or if required elements are missing (for example: MRI not performed within required timeframe for continuation requests, KPS/ECOG not documented, lack of proof of prior radiotherapy/surgery, or absent device compliance data). Be aware of potential reporting gaps (such as incomplete second‑line therapy reporting) that can affect review; supply complete records to avoid denials.

Continuation requests: MRI within ≤ 2 months prior to request required when applicable
Document KPS ≥60 or ECOG ≤2
Supply complete treatment history to avoid reporting bias-related issues

Interpretation noteKPS is used to assess prognosis and trial/therapy eligibility alongside ECOG

Supratentorial — coverage limitation

Anatomic definitionSupratentorial denotes the upper portion of the brain (cerebrum and related structures) including ventricles and selected glands

Policy limitationCoverage is limited to supratentorial glioblastoma (GBM)

NCCN noteNCCN specifies alternating electric field therapy is an option only for supratentorial disease

Temozolomide (TMZ) — role with TTFields

Drug class and useTemozolomide (TMZ) is an oral alkylating chemotherapy and first‑line treatment for glioblastoma

Policy requirement for ndGBMFor newly diagnosed GBM, coverage requires concurrent use of TMZ as the only cancer drug during TTFields therapy

Role in EF-14 trialTTFields was studied adjunctively with maintenance TMZ in the pivotal EF-14 randomized trial showing improved PFS and OS

TTFields / Optune — device and adjunctive use

Device descriptionOptune is a portable TTF generator with scalp transducer arrays worn on the scalp to deliver low‑intensity alternating electric fields

Adjunctive useOptune is used adjunctively with maintenance temozolomide for newly diagnosed supratentorial GBM after radiochemotherapy (per EF-14)

Usage practicalitiesTreatment requires wearing arrays ≥18 hours/day, frequent array replacement, and scalp shaving to maintain contact

Compliance (TTFields) — measurement and thresholds

Definition of compliance metricCompliance is measured as percent monthly usage of the NovoTTF device derived from device logs

Clinically relevant thresholdsA monthly compliance threshold of 50% correlates with improved PFS and OS; greater benefit observed with higher compliance (e.g., >90%)

Documentation expectationDevice usage/compliance data should be documented in the medical record for continuation reviews and prior authorization

Optune / TTFields — regulatory and label reference

Regulatory identityOptune (formerly NovoTTF-100A) is FDA‑approved for adults with recurrent GBM and as adjunct to TMZ for newly diagnosed supratentorial GBM

Device componentsOptune Treatment Kit includes the portable generator, insulated transducer arrays, power supply, and supplies

Label contextFDA approvals (2011; supplemental 2015) support use information but coverage depends on plan criteria

Clinical factors guiding selection — MGMT and performance status

Prognostic biomarkerMGMT promoter methylation status is used to guide temozolomide selection and may influence therapy decisions

Performance status as selection factorKPS/ECOG (good PS) is a key clinical factor for selecting patients for TTFields with temozolomide

Guideline contextNCCN and EANO consider MGMT and performance status when recommending TTFields plus TMZ for selected patients

first-line — additional first-line support nodes from evidence/guidelines

Adjuvant/maintenance (ndGBM): TTFields used after completion of concurrent radiotherapy and temozolomide, administered with maintenance TMZ as in EF-14; trial randomized after radiochemotherapy and showed improved PFS and OS

salvage — additional salvage-use nodes (evidence mixed)

Recurrent disease evidence context: Evidence for rGBM is mixed: systematic reviews and assessments report similar OS compared with best standard care but with more skin reactions and falls; patient preference to avoid systemic toxicities may drive choice; additional studies needed for firm conclusions

first-line — first-line node referencing NCCN/EF-14 support

NCCN/EF-14 support for ndGBM: NCCN recommends adjuvant TTFields with maintenance temozolomide for selected patients (≤70 years with good PS) based on EF-14 randomized trial that showed increased PFS and OS when TTFields added to maintenance TMZ.

salvage — salvage node referencing guideline/evidence context

Salvage guideline/evidence context: Guidelines and evidence assessments note that at recurrence standard options vary and that continuing the same treatment beyond progression (including TTFields) lacks established benefit; consider trials and individualized decision-making.

NCCN includes TTFields with TMZ as an option for patients regardless of MGMT status (category 1 for selected patients)

Evidence sourcesSystematic reviews and subgroup analyses (e.g., Jin 2020, EF-14) incorporate MGMT status in assessing benefit

IDH mutation status — classification and trial context

IDH status relevanceIDH mutation status is used for tumor classification and subgroup descriptions; many trials focus on IDH‑wildtype glioblastoma

Trial reporting noteEF-14 and other trials report limited IDH‑mutant cases; most evidence pertains to IDH‑wildtype GBM

Clinical implicationIDH mutation influences prognosis and is considered in guideline‑based treatment planning

MGMT promoter methylation — additional references

Repeated MGMT referencesMGMT promoter methylation is repeatedly referenced across systematic reviews, guidelines, and trial subgroup analyses as relevant to therapy selection

Effect on TMZ activityTMZ activity is greater in MGMT‑methylated tumors, influencing selection between radiotherapy and TMZ-based approaches in older adults

Policy useMGMT status may guide treatment choices but is not mandated for coverage of TTFields