CurrentUnitedHealthcarePolicy 2025T0582P

Electric Tumor Treatment Field Therapy

Medical policy governing use of FDA‑approved electric tumor treatment field devices (e.g., Optune) for treatment of newly diagnosed and recurrent supratentorial glioblastoma; applies to UnitedHealthcare commercial/community plan members covered by this policy.

Policy Summary

PayerUnitedHealthcare

PolicyElectric Tumor Treatment Field Therapy

Policy CodePolicy 2025T0582P

Change TypeTemplate update / clarified applicability

Effective DateMay 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization and document histologic confirmation, performance status, and ≥18 hours/day device usage for continuation requests.

SourceLink

POLICY UPDATE CHANGES

Created shared policy version to support application to Rocky Mountain Health Plans membership and removed language indicating the policy did not apply to Colorado.

18 h/dayminimum recommended daily device wear-time

3 monthsinitial approved duration

KPS ≥60 / ECOG ≤2performance status requirement

≥75%usage linked to better survival

695

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EF-14 trial participants

Coverage Criteria for Tumor Treating Fields (TTFields)

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 completed; radiation therapy completed; receiving temozolomide as the only cancer drug; Karnofsky Performance Status (KPS) ≥ 60 or ECOG Performance Status ≤ 2; patient counselled to wear device at least 18 hours daily

Initial approval: 3 months of TTF therapy

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 in the supratentorial region; device used as the only treatment; Karnofsky Performance Status (KPS) ≥ 60 or ECOG Performance Status ≤ 2; patient counselled to wear device at least 18 hours daily

Initial approval: 3 months of TTF therapy

Continuation therapy

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

Continuation criteria: MRI performed within 2 months prior to request showing no evidence of disease progression; for ndGBM individual continues to receive temozolomide as the only cancer drug OR for rGBM the device is used as the only treatment; Karnofsky Performance Status (KPS) ≥ 60 or ECOG Performance Status ≤ 2; documentation of device usage at least 18 hours daily

Subsequent approvals based on these criteria

Evidence summaries relevant to coverage

Clinical evidence highlights

EF-14 pivotal trial findings: In adults with newly diagnosed glioblastoma who completed standard radiochemotherapy, addition of TTFields to maintenance temozolomide improved median PFS (6.7 vs 4.0 months) and OS (20.9 vs 16.0 months)

Stupp et al. 2017 final outcomes (EF-14)

Compliance effect: Higher TTFields device compliance correlates with improved PFS and OS; analyses report a threshold of benefit at ≥ 50% compliance with progressively greater benefit at higher usage (meta-analyses and pooled data)>=50% compliance beneficial

Meta-analyses and observational analyses

Biomarker/subgroup signals: Retrospective data suggest a possible post-progression survival benefit in PTEN‑mutant recurrent GBM treated with TTFields, but evidence is limited and observational

Dono et al. 2021 retrospective analysis

Guideline and Regulatory Positions

Guideline recommendations and regulatory status relevant to TTFields use include the following positions from major organizations:

ASCO-SNO (2022): Alternating electric field therapy may be added to adjuvant temozolomide for newly diagnosed supratentorial glioblastoma, IDH‑wildtype, CNS WHO grade 4 after completion of chemoradiation (evidence-based, moderate quality; weak recommendation).

ASCO-SNO guideline

NCCN (2022-2023): NCCN includes standard RT + concurrent and adjuvant temozolomide with or without alternating electric field therapy for individuals with good performance status (KPS ≥ 60); offers option in recurrence (category 2B).KPS >= 60

NCCN guidance

EANO/ESMO (2021): EANO describes standard care for IDH‑wildtype glioblastoma and lists multiple options at recurrence; ESMO advocates against continuing the same treatment beyond confirmed progression, including TTFields.

EANO/ESMO guidance

NovoTAL

NovoTAL simulation system evidence summary:

NovoTAL evidence: NovoTAL uses MRI axial and coronal T1 postcontrast measurements to plan optimal transducer array configuration; published clinical evidence is limited (small case series, modeling, user surveys) and insufficient to demonstrate improved long‑term health outcomes.

Connelly 2016; Wenger 2016; Chaudhry 2015; Trusheim 2017

Treatment of tumors other than glioblastoma multiforme (GBM) is excluded from coverage. The policy explicitly states that, due to insufficient evidence of efficacy, use of devices to generate electric tumor treating fields (TTFields) for indications other than histologically confirmed supratentorial GBM is considered unproven and not medically necessary.

Use of electric TTF therapy concurrently with other systemic medical treatments for recurrent GBM (for example, bevacizumab or cytotoxic chemotherapy) is considered unproven and not medically necessary. The policy requires that, for initial coverage of radiologically confirmed recurrent supratentorial GBM, the device be used as the only treatment.

Computer software used to plan therapeutic radiology in conjunction with TTFields (for example, the NovoTAL™ simulation system) is considered unproven and not medically necessary for coverage purposes. NovoTAL uses MRI measurements (axial and coronal T1 postcontrast) to suggest optimal transducer array configurations, but published clinical evidence is limited and does not demonstrate improved long-term health outcomes.

There is a lack of randomized long-term safety and effectiveness data supporting TTFields for tumors other than glioblastoma. While single-arm and early-phase studies (for example, thoracic TTFields in mesothelioma or other tumor-specific trials) exist, randomized controlled evidence demonstrating durable benefit and long-term safety for non-GBM indications is insufficient.

The National Institute for Health and Care Excellence (NICE) advises against offering TTFields for newly diagnosed grade IV glioma (glioblastoma) and also recommends not offering TTFields for recurrent high-grade glioma (updated 2021). This negative recommendation is explicitly cited in the policy.

When the policy's specified coverage criteria are not met, use of devices to generate electric TTFields is considered unproven and not medically necessary. Examples of noncovered situations include indications other than supratentorial GBM and requests that do not meet required clinical documentation, performance status, or device-use requirements.

Evidence is insufficient to conclude that use of the NovoTAL simulation system improves long-term health outcomes. The policy notes only limited published data (small case series, a head model, and a user survey) and therefore considers NovoTAL use for treatment planning to lack robust clinical outcome data.

Given limited published clinical evidence for the NovoTAL™ simulation system, its use for TTFields treatment planning may be considered experimental or of insufficient evidence to support coverage. The policy indicates NovoTAL provides array-layout suggestions based on MRI but does not have compelling outcome data to justify routine coverage.

Referenced Codes and Usage Metrics

Referenced CPT CodesCPT

77299

Unlisted procedure, therapeutic radiology clinical treatment planning

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

TTFields daily usage associated with benefit

Usage threshold associated with improved survival≥ 75% average device usage (commonly cited as correlated with prolonged OS in meta-analyses)

Common reporting denominatorUsage reported as percentage of time worn (e.g., ≥75% of days or hours)

Typical recommended daily wear-timePolicy and device guidance: at least 18 hours per day (minimum recommended)

Provider Actions, Authorization, and Documentation

Prior Authorization

Prior Authorization Required and Applicable Codes

Prior authorization is required for electric tumor treatment field (TTF) therapy under UnitedHealthcare. Submit requests per payer procedures and include supporting clinical documentation. Applicable billing codes for consideration include CPT 77299 (unlisted therapeutic radiology clinical treatment planning) and HCPCS A4555 (electrode/transducer replacement), E0766 (electrical stimulation device used for cancer treatment) and E0767 (intrabuccal RF device) — include the most specific code applicable to the device and supplies provided. Listing of a code in this policy does not guarantee coverage; benefit determination is governed by the member-specific benefit plan.

Prior authorization required — verify member benefits and obtain PA before initiating therapy
Include relevant HCPCS/CPT codes (e.g., 77299, A4555, E0766, E0767) on the authorization request
Attach clinical documentation: pathology confirming GBM, surgical and radiation therapy completion, KPS/ECOG performance status, and MRI imaging

Prior Authorization

Prior Authorization Considerations

Prior authorization decisions should reflect clinical considerations described in the policy: FDA-approved device labeling, indication (newly diagnosed supratentorial GBM after maximal debulking and completion of radiation when used with maintenance temozolomide, or recurrent supratentorial GBM per label), performance status thresholds, and device usage expectations. NovoTAL planning software has limited evidence and is not independently established to improve long-term outcomes — include MRI measurements if NovoTAL is used for array placement planning.

Regimens and Combinations

Regimen	Coverage status	Notes / Rationale
TTFields used concurrently with systemic therapies (e.g., bevacizumab or chemotherapy) for recurrent GBM
Not covered
Policy states concurrent use of electric TTF therapy with other medical therapy for treatment of recurrent GBM is unproven and not medically necessary; listed specifically: bevacizumab or chemotherapy

Regimen	Coverage status	Notes / Rationale
TTFields in combination with temozolomide after completion of debulking surgery and radiation
Covered
Covered when all criteria for newly diagnosed supratentorial GBM are met (histologic confirmation, debulking surgery and completed radiation, receiving temozolomide as the only cancer drug, KPS ≥ 60 or ECOG ≤ 2, counselled to wear device ≥ 18 hours daily). Initial approval: 3 months. EF-14 randomized trial showed improved PFS and OS with TTFields + TMZ vs TMZ alone

Regimen	Coverage status	Notes / Rationale
TTFields delivered via Optune in combination with maintenance temozolomide for newly diagnosed supratentorial GBM after completion of radiochemotherapy
Covered
Policy covers Optune + maintenance temozolomide for ndGBM after completion of standard radiochemotherapy when coverage criteria are met. EF-14 (n=695) demonstrated median PFS 6.7 vs 4.0 months and median OS 20.9 vs 16.0 months (TTFields+TMZ vs TMZ alone)

Regimen	Coverage status	Notes / Rationale
TTFields delivered to the thorax combined with standard systemic chemotherapy (e.g., for metastatic NSCLC after platinum progression; unresectable malignant pleural mesothelioma with pemetrexed + platinum)
Experimental / investigational
Trials (LUNAR for NSCLC; STELLAR for mesothelioma) are single-arm or have limitations; evidence is insufficient for routine coverage and considered investigational per policy excerpts

Regimen	Coverage status	Notes / Rationale
Optune (tumor treating fields) plus adjuvant temozolomide for newly diagnosed supratentorial glioblastoma; Optune monotherapy for recurrent GBM per prior trials
Mixed / covered for specified ndGBM indication; option in recurrence
Policy covers Optune + adjuvant TMZ for ndGBM when coverage criteria are met (see ndGBM criteria). Optune monotherapy is an FDA-approved option for recurrent GBM (EF-11) and may be considered at recurrence; guideline panels vary in recommendation strength

Line of Therapy Designations

first-line (coverage logic node)

first-line: After completion of debulking surgery and radiation, used concomitantly with maintenance temozolomide as the only cancer drug in histologically confirmed supratentorial GBM; KPS ≥ 60 or ECOG ≤ 2; patient counselled to wear device ≥ 18 hours daily

Initial approval: 3 months

salvage (coverage logic node)

salvage: Radiologically confirmed recurrent supratentorial GBM after prior chemotherapy and radiation; device used as sole treatment; KPS ≥ 60 or ECOG ≤ 2; patient counselled to wear device ≥ 18 hours daily

Initial approval: 3 months

first-line (alternate evidence grouping)

first-line:

Biomarker and Medication Constraints

PTEN mutation

BiomarkerPTEN mutation

Evidence typeRetrospective institutional review (Dono et al. 2021) showing PPS improvement in PTEN-mutant rGBM treated with TTFields

Observed effectWithin TTFields-treated rGBM, PTEN-mutant patients had longer median post-progression survival (22.2 vs 11.6 months)

Dexamethasone dose — ≤ 4.1 mg

Dexamethasone dose threshold≤ 4.1 mg (associated with longer median OS in meta-analysis)

Source findingLi et al. (2022) meta-analysis identified lower dexamethasone dose (≤4.1 mg) as linked to improved OS with TTFields

Definitions and Abbreviations

Tumor Treating Fields (TTFields) are a noninvasive therapy that deliver low-intensity, intermediate-frequency electric fields (typically 100–300 kHz) to disrupt cell division and target proliferating tumor cells. The Optune system includes a portable field generator and scalp transducer arrays; arrays are placed according to tumor location and the device is intended to be worn for prolonged daily periods (policy counseling specifies at least 18 hours/day for coverage considerations).

KPS definition

DefinitionKarnofsky Performance Status (KPS): 0–100 scale measuring ability to perform ordinary tasks; higher score = greater function

Coverage thresholdKPS ≥ 60 required for coverage (indicates requires occasional assistance but can care for most personal needs)

Example KPS values60 = requires occasional assistance; 70 = cares for self but unable to do normal activity; 100 = normal, no complaints

ECOG Performance Status definition

Background and Evidence Context

inv-04: Evidence summaries relevant to coverage (also listed under coverage criteria)

Clinical evidence highlights

Stupp et al. 2017 final outcomes

Compliance effect: Higher TTFields device compliance correlates with improved PFS and OS; threshold of 50% compliance associated with improved outcomes versus TMZ alone; >90% compliance associated with substantially extended median and 5-year survival>=50% compliance beneficial

Toms et al. 2019 and meta-analyses

Biomarker/subgroup signals: Retrospective data suggest possible greater PPS benefit in PTEN-mutant recurrent GBM treated with TTFields; evidence is retrospective and limited

Policy Revision History

05/01/2025Template update and scope clarificationLatest

Template updated; policy converted to a shared version to support application to Rocky Mountain Health Plans membership, with removal of language stating the policy did not apply to Colorado; noted application to Individual Exchange.

Policy Summary

PayerUnitedHealthcare

PolicyElectric Tumor Treatment Field Therapy

Policy CodePolicy 2025T0582P

Change TypeTemplate update / clarified applicability

Effective DateMay 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization and document histologic confirmation, performance status, and ≥18 hours/day device usage for continuation requests.

SourceLink

On This Page

NICE (2018, 2021): NICE recommends not offering TTFields for newly diagnosed grade IV glioma and not offering TTFields for recurrent high‑grade glioma (updated 2021).

NICE negative recommendation

FDA approvals: Optune (NovoTTF‑100A) FDA-approved in 2011 for recurrent GBM and received supplemental PMA approval in 2015 for use with temozolomide in newly diagnosed supratentorial GBM after maximal debulking and completion of radiation; FDA status informational only for coverage determinations.

FDA approvals

For newly diagnosed GBM (ndGBM): confirm debulking surgery and completion of radiation, and that temozolomide (TMZ) is the only concurrent cancer drug
For recurrent GBM (rGBM): device may be used as the only treatment per FDA labeling; concurrent systemic therapies (e.g., bevacizumab) for rGBM are not supported by this policy
Continuation approvals require MRI within 2 months showing no progression, documentation of daily device usage ≥ 18 hours, and continued KPS ≥ 60 or ECOG ≤ 2

Note

Verify Prior Authorization Per Member Plan

Verify prior authorization requirements and coverage with the member-specific benefit plan. Member benefit documents and any applicable federal or state mandates take precedence. In the event of a conflict, the member-specific benefit plan governs coverage decisions.

Check the member's plan for medical necessity criteria, prior authorization forms/processes, and any carve-outs or mandate-driven coverage
If Medicare Advantage, review applicable NCD/LCD; absent Medicare guidance, MAO determinations may apply

Denial Risk

No Explicit Authorization or Coding Denial Exceptions Identified (Denial Risks)

This policy does not identify explicit automatic coding denials; however, requests that do not meet the coverage criteria should be expected to be denied. Examples include use for non-GBM tumors, concurrent systemic therapy for rGBM, lack of required performance status documentation, or absence of recent MRI confirming no progression when seeking continuation.

Denial triggers: non-GBM diagnosis, concurrent systemic therapy for rGBM, absence of histologic confirmation, insufficient performance status (KPS < 60 or ECOG > 2), no documentation of daily use ≥ 18 hours, or lack of MRI within 2 months for continuation requests

Documentation Required

Document FDA Approvals and Plan Applicability

Document FDA approvals and applicability to the requested use. FDA approvals inform but do not by themselves determine coverage. Cite the Optune (NovoTTF) PMA for recurrent GBM (April 2011) and the supplemental PMA for use with temozolomide in newly diagnosed supratentorial GBM (October 2015) when relevant.

Include device name and indication (e.g., Optune/NovoTTF per PMA P100034 and supplement P100034S013) in the request
Note HDE approval for mesothelioma (NovoTTF-100L) is not relevant to GBM coverage decisions

Note

Recurrent Disease Management Considerations

At recurrence, management options are less well-defined; prior authorization should reflect individualized clinical decision-making and guideline recommendations. Consider documented prior therapies, surgical or radiotherapy options, and available clinical trials. Be aware that some guideline bodies advise against continuing treatments beyond confirmed progression, including TTFs, absent established clinical benefit.

For rGBM, document prior lines of therapy and rationale for TTF as single-modality treatment per policy
Consider enrollment in clinical trials when available; document that alternative standards (surgery, re-irradiation, chemotherapy options) were considered

Adjuvant/maintenance setting for newly diagnosed GBM: TTFields added to maintenance temozolomide after completion of radiochemotherapy (per EF-14 findings showing improved PFS and OS)

post-concomitant chemoradiation

EF-14 trial evidence

salvage (alternate evidence grouping)

salvage: For recurrent GBM, evidence is mixed; TTFields may yield OS similar to best standard care and can avoid systemic chemotherapy AEs, but evidence quality is limited and guidelines vary; patient selection and preferences should guide use.

Hayes/ECRI assessments and systematic reviews

first-line | second-line (two-node grouping)

Recurrent GBM indication: Optune is FDA approved for recurrent glioblastoma after chemotherapy and radiation (PMA 2011; EF-11 trial).

FDA approval for recurrent GBM

Newly diagnosed GBM indication: Optune received supplemental PMA approval in 2015 for use with temozolomide following maximal debulking and completion of radiation for newly diagnosed supratentorial GBM; included as an option in NCCN and ASCO-SNO guidance for selected patients.

FDA supplemental approval and guideline inclusion

Implication for careLower corticosteroid doses may be favorable when using TTFields, per observational/meta-analytic data

PTEN — mutation present

PTEN status requirementMutation present (PTEN-mutant may derive greater PPS benefit based on retrospective data)

Evidence limitationsFindings are retrospective with small sample sizes; not required for coverage

Clinical notePTEN testing may inform exploratory subgroup expectations but is not mandated by policy criteria

MGMT promoter methylation

BiomarkerMGMT promoter methylation

Role in evidenceMeta-analyses and guideline discussions report TTFields benefit regardless of MGMT status; MGMT guides temozolomide decisions

Clinical implicationMGMT status informs chemotherapy planning but TTFields benefit has been observed in both methylated and unmethylated tumors

MGMT promoter methylation (additional chunks)

MGMT subgroup analysesTTFields combined with standard therapy associated with favorable OS in analyses regardless of MGMT promoter methylation status

Guideline contextNCCN discusses MGMT status when choosing temozolomide strategies; TTFields may be used with or without regard to MGMT in many recommendations

Evidence sourcesJin et al. 2020 systematic review/meta-analysis and NCCN guideline summaries

DefinitionECOG Performance Status: 0–5 scale measuring functional status; 0 = fully active; 5 = dead

Coverage thresholdECOG ≤ 2 required for coverage (ambulatory and capable of self-care; up and about >50% of waking hours)

Common ECOG descriptors1 = restricted in strenuous activity but ambulatory; 3 = limited self-care, confined >50% of waking hours

Supratentorial definition (coverage limitation)

DefinitionSupratentorial: upper portion of the brain including cerebrum, ventricles, choroid plexus, hypothalamus, pineal and pituitary glands, optic nerve

Coverage limitationPolicy limits coverage to supratentorial glioblastoma (Optune use only for supratentorial disease)

NCCN noteAlternating electric field therapy is only an option for those with supratentorial disease (NCCN)

NovoTAL definition

TermNovoTAL (transducer array layout system)

FunctionSimulation/planning software that uses MRI measurements (axial and coronal T1 postcontrast) for head size and tumor location to determine optimal transducer array configuration

Evidence noteLimited published clinical evidence and insufficient data to support improved long-term outcomes with NovoTAL

Software that uses MRI measurements to determine optimal transducer array configuration for TTFields treatment.

DescriptionSoftware that uses axial and coronal T1 postcontrast MRI measurements to determine optimal paired transducer array configuration for maximal field intensity at the tumor site

Use caseOptional planning tool leased from manufacturer to guide array placement based on recent MRI, head size, and tumor location

Evidence limitationSmall case series, head models, and user surveys comprise the limited evidence base; clinical benefit for outcomes not established

Optune (NovoTTF-100A) device definition and FDA-approved indications

DeviceOptune (formerly NovoTTF-100A) tumor treating fields system

FDA indicationsApproved April 2011 for recurrent GBM; supplemental PMA Oct 2015 for use with temozolomide in newly diagnosed supratentorial GBM following maximal debulking and completion of radiation

Components and usePortable electric field generator, insulated transducer arrays, power supply; arrays applied to scalp and worn typically ≥18 hours/day; device presets prevent user adjustment

Randomized long-term safety and effectiveness data for TTFields outside glioblastoma are lacking. The policy references the absence of randomized controlled trials for many non-GBM settings and notes available studies in other tumor types are preliminary, single-arm, or otherwise limited, leaving uncertainty about long-term benefit and safety.