ModifiedUnitedHealthcarePolicy CS146TN.K

Electric Tumor Treatment Field (TTF) Therapy for Glioblastoma (Tennessee only)

Policy governing coverage of FDA‑approved electric tumor treatment field (TTF) devices for treatment of supratentorial glioblastoma in Tennessee Medicaid and CoverKids members, including initial and continuation criteria and documentation expectations.

Policy Summary

PayerUnitedHealthcare

PolicyElectric Tumor Treatment Field (TTF) Therapy for Glioblastoma (Tennessee only)

Policy CodePolicy CS146TN.K

Change TypeMaterial and non-material edits (language removed and clarifying additions)

Effective DateJan 1, 2026

Next Review Date

Key ActionSubmit prior authorization with documentation that all coverage criteria are met, including diagnosis of supratentorial GBM, prior surgery and radiation (for ndGBM), KPS ≥ 60 or ECOG ≤ 2, MRI within 2 months for continuation, and device usage ≥ 18 hours/day.

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 for coverage.

Updated supporting sections (Description of Services, Clinical Evidence, FDA, References) to reflect most current information; archived previous policy version CS146TN.J.

18 h/daydaily wear time

3 moinitial approval duration

KPS ≥60

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performance status required

≤2 moMRI recency for continuation

50%minimum compliance threshold

695EF-14 trial participants

Coverage Criteria for TTFields (Glioblastoma)

Initial therapy — newly diagnosed supratentorial GBM (ndGBM)

Covered when ALL of the following are met:

ndGBM initial coverage: 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) KPS ≥ 60 or ECOG ≤ 2; 6) Individual has been counseled that the electric TTF device must be worn at least 18 hours daily;initial approval = 3 months

Initial approval duration specified as 3 months

Initial therapy — recurrent supratentorial GBM (rGBM)

Covered when ALL of the following are met:

rGBM initial coverage: 1) Radiologically confirmed recurrent supratentorial glioblastoma; 2) Device is used as the only treatment; 3) KPS ≥ 60 or ECOG ≤ 2; 4) Individual has been counseled that the electric TTF device must be worn at least 18 hours daily;initial approval = 3 months

Initial approval duration specified as 3 months

Continuation beyond initial 3 months

Covered when ALL of the following are met:

Continuation criteria: 1) MRI 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; for rGBM, device is used as the only treatment; 3) KPS ≥ 60 or ECOG ≤ 2; 4) Documentation that the individual has been using the electric TTF device at least 18 hours daily;not specified

Subsequent approvals contingent on these items

Initial therapy (TTFields + maintenance TMZ)

Covered when ALL of the following are met

NDGBM with standard therapy completed: Patient has newly diagnosed, supratentorial glioblastoma (IDH-wildtype, CNS WHO grade 4) who completed standard radiochemotherapy and is planned for maintenance temozolomide;

Supported by EF-14 trial enrollment criteria and ASCO-SNO/EANO guideline recommendations to consider TTFields after chemoradiation.

Performance status and age considerations: Patient has adequate performance status documented (examples referenced: KPS ≥ 60; many guideline recommendations cite KPS ≥ 70 for more aggressive therapy); candidacy for maintenance TMZ documented;

Guidelines distinguish recommendations by age and performance status (see ASCO-SNO and EANO).

Device use commitment and monitoring: Documentation of plan for device use including counseling to wear device ≥ 18 hours/day and plan for monitoring device-recorded usage;≥50% monthly usage expected to show benefit (higher usage associated with greater benefit)

Recurrent GBM and other tumor types

Mixed coverage stance depending on tumor type and evidence

Recurrent GBM: Evidence suggests TTFields yields overall survival similar to best standard care chemotherapy for rGBM while avoiding some systemic chemotherapy AEs; individualized decision-making or trial enrollment is appropriate;

ECRI assessment: moderate confidence for OS equivalence vs best standard care; additional data needed for combinations with BEV.

Other tumors (NSCLC, mesothelioma, pancreatic, ovarian, brain metastases): Evidence is limited or emerging: LUNAR (metastatic NSCLC) reported OS benefit post‑platinum and STELLAR (mesothelioma) reported encouraging nonrandomized results, but randomized controlled data are lacking for many tumor types; consider investigational status or case‑by‑case review.

RCT evidence generally absent for tumors other than GBM; use considered investigational without stronger data.

Covered with Criteria — Indications per Guidelines and FDA

Coverage consideration aligns with guideline-specified populations and FDA approvals; apply when ALL listed elements are met for a given indication.

Newly diagnosed glioblastoma (ndGBM): Consider TTFields (Optune) in adults with newly diagnosed supratentorial GBM in conjunction with standard focal brain radiotherapy and concurrent/adjuvant temozolomide for patients with good performance status (examples: KPS ≥ 60 or guideline‑specified thresholds);per guideline age/performance criteria

NCCN cites Category 1 recommendation for selected patients; FDA approved Optune+TMZ for ndGBM after radiochemotherapy.

Recurrent glioblastoma (rGBM): Optune is FDA‑approved for adults with GBM that recurs or progresses after chemotherapy and radiation; use may be considered based on device labeling and individual clinical factors though guideline support is mixed;post‑progression after RT and chemotherapy

EF-11 and device labeling support rGBM use; panels differ on strength of recommendation.

Treatment of tumors other than glioblastoma and the concurrent use of electric tumor treating fields (TTFields) with other medical therapies for recurrent GBM (for example, bevacizumab or chemotherapy) are explicitly excluded from coverage because the policy requires that continuation and initial coverage criteria be met for supratentorial GBM and states these concurrent uses are considered unproven and not medically necessary.

Use of TTFields for tumor types other than glioblastoma is not supported by published randomized controlled trial evidence demonstrating long‑term safety and effectiveness; the document specifically notes this evidence gap for non‑small cell lung cancer, brain metastases, pancreatic cancer, ovarian cancer, and mesothelioma, and therefore treats these indications as lacking high‑quality RCT support.

The National Institute for Health and Care Excellence (NICE) guidance states do not offer TTFields as part of management for newly diagnosed grade IV glioma (glioblastoma) and similarly advises do not offer TTFields for recurrent high‑grade glioma; local applicability of this guidance should be considered where binding.

When the policy's specified coverage criteria are not met, use of devices that generate electric TTFields is considered unproven and not medically necessary. This includes requests that lack required documentation (e.g., MRI within ≤ 2 months showing no progression for continuation, performance status thresholds, or documentation of device use ≥ 18 hours/day) and uses outside the defined indications.

Routine use of TTFields for tumor types other than glioblastoma is considered not medically necessary or investigational in the absence of high‑quality randomized evidence. The policy therefore treats non‑GBM indications as investigational or requiring case‑by‑case review rather than routinely covered.

Several guideline panels and evidence assessments report insufficient or mixed evidence of survival benefit for TTFields in certain recurrent settings. For example, EANO notes limited impact of some systemic options on overall survival at recurrence and recommends consideration of clinical trials, while NICE explicitly advises against offering TTFields for recurrent high‑grade glioma, reflecting guideline caution about routine use when benefit is unproven.

Applicable Codes and Key Operational Values

Applicable 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

Applicable Codesmixed

No codes listed

Device daily wear time (minimum daily device wear time required)

Minimum daily wear timeDevice must be worn at least 18 hours per day (counsel patient on target daily use)

Initial approval durationInitial approval for TTF therapy = 3 months

Documentation requiredMedical record must document counseling that device will be worn ≥18 hours/day and recorded daily use

MRI recency for continuation (recency of MRI required for continuation requests)

MRI recency for continuationMRI performed ≤ 2 months prior to request documenting no evidence of disease progression

Continuation condition

Provider Responsibilities, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization: NDGBM with maintenance TMZ

Prior authorization is required for newly diagnosed GBM (ndGBM) receiving maintenance temozolomide (TMZ). Approval for initial therapy (3 months) and any continuation beyond the initial authorization will be granted only when the member meets all coverage criteria: histologically confirmed supratentorial GBM, completed debulking surgery and radiation, receiving TMZ as the only systemic cancer drug (for ndGBM), KPS ≥ 60 or ECOG ≤ 2, counseling that device must be worn ≥ 18 hours/day, and MRI within 2 months prior to continuation requests documenting no disease progression.

Initial approval: up to 3 months when ALL initial criteria met
Continuation approval: MRI ≤ 2 months prior and documentation of device use and ongoing TMZ (ndGBM)
Requests for rGBM require device as only treatment and same performance status and wear-time documentation

Prior Authorization

Prior Authorization and Plan Governance

Coverage determinations and documentation requirements are governed by federal, state, and contractual plan terms. Providers must reference applicable benefit plan language; in the event of conflict, federal/state/contractual requirements govern. UnitedHealthcare may use third‑party criteria (e.g., InterQual) to administer benefits. Missing or insufficient documentation may result in denial.

Regimens and Permitted Combinations

Regimen	Indication / Key Criteria	Coverage stance
TTF (Optune) + maintenance temozolomide (TMZ)	Newly diagnosed supratentorial glioblastoma after debulking surgery and completion of radiation; patient receiving TMZ as the only cancer drug; KPS ≥ 60 or ECOG ≤ 2; patient counselled to wear device ≥ 18 hours/day; initial approval = 3 months	Covered

Regimen	Indication / Key Criteria	Coverage stance
TTF combined with bevacizumab or systemic chemotherapy	Use concurrently with other systemic therapies (e.g., bevacizumab or chemotherapy) for recurrent supratentorial GBM	Not Covered

Regimen	Trial / Device parameters	Coverage stance
TTFields (Optune) concurrent with maintenance temozolomide	As used in EF-14: device delivered ~200 kHz to the scalp; target patient use ≥ 18 hours/day; applied after completion of concomitant radiochemotherapy (median randomization ~3.8 months from diagnosis)	Covered

Regimen	Population / Evidence summary	Coverage stance
TTFields added to standard systemic therapy (LUNAR, STELLAR)	Studied in non‑GBM tumor types: LUNAR (metastatic NSCLC post‑platinum) showed improved OS versus standard therapy in an open‑label RCT; STELLAR (mesothelioma) reported promising single‑arm results for TTFields (150 kHz) with pemetrexed/platinum but lacks randomized comparison; randomized confirmatory data are limited or pending for many non‑GBM indications	Experimental

Regimen	Clinical context / Key criteria	Coverage stance
TTFields (Optune) + temozolomide following maximal safe resection and completion of radiation	Adjunct to standard focal brain radiotherapy with concurrent/adjuvant temozolomide in eligible newly diagnosed supratentorial GBM patients with good performance status (examples: KPS ≥ 60); supported by EF-14 and referenced in NCCN guidance	Covered

Scenario	Policy position / Rationale	Coverage stance
Continuation of same therapy (including TTFields) beyond confirmed progression	ESMO/EANO guidance and policy note that using any treatment beyond confirmed progression on that same treatment (including TTFields and bevacizumab) is not recommended because clinical benefit is unestablished; continuation beyond progression is therefore considered unsupported by evidence	Experimental

Placement of TTFields in Treatment Sequence

first-line — placement of TTFields as first-line (1 top-level node)

First-line (ndGBM): After maximal safe resection and completion of radiation therapy with concurrent temozolomide, TTFields may be used concurrently with maintenance TMZ as adjunct first‑line therapy when initial ndGBM criteria are met;

salvage — placement of TTFields as salvage therapy (1 top-level node)

Salvage (rGBM): Used as sole therapy for radiologically confirmed recurrent supratentorial GBM in patients meeting performance status and counseling criteria; initial approval for 3 months when criteria met;

first-line — additional first-line reference nodes (1 top-level node)

Post-radiochemotherapy maintenance:

Biomarker and Molecular Test References

PTEN mutation (biomarker mention)

Biomarker mentionPTEN mutation described in retrospective data as possibly associated with improved post-progression survival with TTFields in PTEN‑mutant rGBM

Evidence typeFinding based on a retrospective institutional series (limited by small sample size; requires RCT confirmation)

Not required for coveragePTEN mutation testing is not a stated prerequisite for coverage in the policy criteria

MGMT promoter methylation (biomarker reference)

MGMT promoter methylation relevanceMGMT promoter methylation status informs temozolomide activity and treatment selection in older adults; TTFields benefit was reported regardless of MGMT status in pooled analyses

Evidence summary

Definitions and Abbreviations

Karnofsky Performance Status (KPS) definition

Definition (KPS)Karnofsky Performance Status (KPS) is a 0–100 scale measuring ability to perform daily activities; e.g., KPS 60 = requires occasional assistance but can care for most personal needs

Scale descriptorsExamples: 100 = normal; 90 = able to carry on normal activity; 70 = cares for self but unable to do active work; 0 = dead

Clinical useKPS may be used to determine prognosis, track functional change, or assess clinical trial eligibility

ECOG Performance Status definition

Definition (ECOG)Eastern Cooperative Oncology Group (ECOG) Performance Status is a 0–5 scale measuring functional status where 0 = fully active and 5 = dead

Key scoresECOG 1 = restricted in strenuous activity but ambulatory; ECOG 2 = ambulatory and capable of selfcare but unable to work; ECOG ≥3 indicates greater disability

Background on Tumor Treating Fields and Evidence Summary

Tumor treating fields (TTFields) are devices that deliver low‑intensity, intermediate‑frequency alternating electric fields to the scalp overlying intracranial tumors. The therapy is intended to disrupt mitosis in proliferating tumor cells and is applied via transducer arrays connected to a portable device; clinical protocols and trial inclusion typically targeted device use of approximately ≥ 18 hours per day and specified device frequencies in the 100–300 kHz range to achieve antimitotic effects.

Policy Summary

PayerUnitedHealthcare

PolicyElectric Tumor Treatment Field (TTF) Therapy for Glioblastoma (Tennessee only)

Policy CodePolicy CS146TN.K

Change TypeMaterial and non-material edits (language removed and clarifying additions)

Effective DateJan 1, 2026

Next Review Date

SourceLink

On This Page

Compliance-benefit relationship observed in subgroup analyses of EF-14 and observational data.

Required MRI must show no progression to support continuation beyond initial 3 months

Documentation expectationInclude MRI report in medical record for continuation request

Performance status (required performance status for coverage)

Required performance statusKarnofsky Performance Status (KPS) ≥ 60 or ECOG Performance Status ≤ 2

Use in initial and continuation criteriaKPS/ECOG threshold applies to both initial 3-month approvals and subsequent continuation reviews

Documentation requiredRecord KPS or ECOG score in medical record to support coverage determination

Device usage compliance threshold (minimum TTFields compliance threshold associated with improved outcomes)

Monthly compliance threshold associated with improved outcomes≥ 50% monthly TTFields delivery correlates with improved PFS and OS

Higher compliance associated with best outcomesCompliance > 90% associated with the longest median survival (e.g., median survival 24.9 months in subgroup) and higher 5-year survival

Source of measurementCompliance measured by device-recorded percent monthly TTFields delivery from NovoTTF device usage data

Karnofsky Performance Status thresholds referenced

KPS ≥ 60 referencedKarnofsky Performance Status score of 60 is used in coverage criteria (requires occasional assistance but able to care for most personal needs)

KPS ≥ 70 referencedGuideline-recommended example threshold: KPS ≥ 70 when considering standard-of-care aggressive therapy in some recommendations

KPS scale descriptionKPS is a 0–100 scale; higher scores indicate better functional status (100 = normal, 0 = dead)

Benefit coverage is determined by federal, state, or contractual requirements and applicable laws
Use of external tools (for example, InterQual) may inform decisions
In conflicts, plan/federal/state terms take precedence

Documentation Required

Medical Record Requirements

Medical records must fully support medical necessity and be made available upon request. Documentation should be legible and include relevant history, physical exam findings, diagnostic test results, imaging, performance status, and counseling regarding device use. Documentation of device usage (objective device-recorded compliance data: percent monthly delivery and average hours/day) is required for continuation reviews.

Required elements: history, physical exam, pathology confirming supratentorial GBM, operative and radiation reports, TMZ regimen details
MRI performed ≤ 2 months prior to continuation request
Device-recorded compliance: monthly percent delivery and hours/day to document ≥ 18 hours/day target; compliance thresholds informative (evidence supports benefit with higher compliance)

Denial Risk

Documentation/Reporting limitations may affect coverage review

Limitations in reporting and incomplete records can affect coverage review. There is likely reporting bias in second-line therapy data and incomplete treatment reporting may impair assessment of medical necessity. Providers should supply complete, contemporaneous records and objective device usage data to minimize denials due to insufficient information.

Reporting bias for second-line therapies may limit available evidence
Incomplete or missing documentation of prior radiochemotherapy, ongoing TMZ, or device compliance may lead to denial
Provide full treatment timelines and objective device logs when available

Note

Recommended Treatment Sequencing

Recommended sequencing follows guideline-supported standard of care: maximal safe resection (or biopsy), involved‑field radiotherapy with concurrent temozolomide, followed by adjuvant (maintenance) temozolomide. Alternating electric field therapy (TTFields) is an adjunct to maintenance TMZ for eligible patients with supratentorial ndGBM who have completed chemoradiation and meet performance status criteria. For rGBM, TTFields may be considered as monotherapy per FDA labeling, but evidence and guideline recommendations are more variable.

Typical sequence: surgery → radiotherapy with concurrent TMZ → adjuvant (maintenance) TMZ ± TTFields (for ndGBM)
TTFields are adjunctive to maintenance TMZ in ndGBM after completion of standard radiochemotherapy
TTFields for rGBM: considered as device-only therapy; concurrent unapproved combinations (e.g., with bevacizumab) are not supported

TTFields are applied after completion of standard concomitant radiotherapy and temozolomide and used with maintenance TMZ in newly diagnosed GBM as in the EF-14 trial;

EF-14 enrolled patients after radiochemotherapy; guidelines recommend addition at this point.

salvage — additional salvage reference nodes (1 top-level node)

Post-progression / salvage settings: TTFields have been studied in recurrent GBM and in metastatic NSCLC after progression on platinum-based therapy (LUNAR); evidence and approvals vary by indication and should guide salvage use or trial enrollment;

first-line — guideline/FDA-aligned first-line node (1 top-level node)

Guideline/FDA-aligned first-line node: Use of Optune with adjuvant temozolomide following maximal safe resection and completion of radiation therapy for eligible newly diagnosed supratentorial GBM patients with appropriate performance status aligns with NCCN guidance and FDA supplemental approval;

salvage — guideline/FDA-aligned salvage node (1 top-level node)

Guideline/FDA-aligned salvage node: Optune is FDA‑approved for recurrent GBM after prior chemotherapy and radiation; salvage use should consider device labeling and mixed guideline recommendations and prioritize individualized assessment or clinical trial enrollment;

Systematic review/meta-analysis found TTFields combined with Stupp protocol resulted in favorable OS for those with and without MGMT methylation

Clinical useMGMT status guides TMZ decisions but TTFields guidance in policy is not restricted by MGMT methylation

MGMT promoter methylation (duplicate/reference)

MGMT promoter methylation — duplicate referencePolicy cites MGMT promoter methylation as relevant to temozolomide benefit and treatment planning; TTFields benefit observed across methylation subgroups in meta-analysis

Guideline contextNCCN includes TTFields regardless of MGMT status for patients with good performance status (KPS ≥ 60)

No biomarker mandatePolicy does not require MGMT methylation for TTF coverage; MGMT used primarily to guide TMZ choices especially in older adults

Policy thresholdPolicy coverage uses ECOG ≤ 2 as an acceptable performance status

Supratentorial definition

Definition (supratentorial)Supratentorial: the upper portion of the brain comprising the cerebrum, ventricles, choroid plexus, hypothalamus, pineal gland, pituitary gland, and optic nerve

Coverage scopePolicy applies to supratentorial glioblastoma (GBM) as specified in criteria

ExclusionsAlternating electric field therapy is only an option for those with supratentorial disease per NCCN footnote

Temozolomide (TMZ) definition

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

Policy rolePolicy requires ongoing TMZ as the only cancer drug for ndGBM patients receiving TTF

Clinical contextTMZ is given concurrently with radiation then as maintenance per Stupp protocol referenced in guidelines

Compliance (TTFields) — definition and thresholds

Definition (Compliance)Compliance is percent monthly device usage recorded by the NovoTTF device (monthly percent TTFields delivery)

Policy thresholdsPolicy references ≥50% monthly usage associated with improved PFS and OS and notes >90% associated with further extended survival

DocumentationDevice-recorded usage data and hours/day documentation may be required to support continuation requests

TTFields/Optune — device definition

Device definitionTTFields/Optune Treatment Kit (formerly NovoTTF-100A System) — FDA-approved device to generate tumor treating fields for adult GBM per labeled indications

Regulatory notesOptune received initial FDA PMA for rGBM (2011) and supplemental PMA for use with temozolomide in newly diagnosed supratentorial GBM (2015)

Policy usePolicy references use of FDA‑approved devices according to labeled indications, contraindications, warnings, and precautions

Performance Status (KPS) — cross-reference

Cross-reference (KPS usage)KPS is used to stratify patients for treatment decisions; policy references thresholds such as KPS ≥ 60 and guideline examples of KPS ≥ 70 for candidacy

Guideline linkageEANO and NCCN guidance cite KPS thresholds when recommending standard therapy or considering TTFields as adjunct

DocumentationRecord KPS in medical record to support coverage and clinical decision-making