CurrentUnitedHealthcarePolicy CS146ID.A

Electric Tumor Treatment Field Therapy (for Idaho Only)

This policy governs coverage of FDA‑approved electric tumor treatment field (TTF) devices for treatment of supratentorial glioblastoma in Idaho (including Idaho Medicaid Plus), specifying criteria for newly diagnosed and recurrent disease and requirements for initial and continuation approvals.

Policy Summary

PayerUnitedHealthcare

PolicyElectric Tumor Treatment Field Therapy (for Idaho Only)

Policy CodePolicy CS146ID.A

Change TypeNew Medical Policy

Effective DateJun 1, 2025

Next Review DateN/A

Key ActionPrior authorization required and approved only when documented coverage criteria are met, including counseling that the device be worn ≥18 hours daily and initial approval limited to 3 months.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3 monthsinitial approved duration for TTF therapy

18 hrs/dayminimum daily device wear time

KPS ≥60 / ECOG ≤2performance status requirement

MRI ≤2 monthsrecent imaging for continuation

695

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EF-14 pivotal trial participants

2FDA approvals referenced

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 therapy criteria: 1) FDA‑approved TTF device used per labeled indications; 2) Histologically confirmed supratentorial glioblastoma; 3) Debulking surgery has been completed; 4) Radiation therapy has been completed; 5) Individual is receiving temozolomide (TMZ) as the only cancer drug; 6) Karnofsky Performance Status (KPS) ≥ 60 or ECOG ≤ 2; 7) Individual has been counselled that the electric TTF device must be worn at least 18 hours daily; 8) When all of the above criteria are met, an initial 3 months of electric TTF therapy will be approved.

Initial therapy — recurrent GBM

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

rGBM initial therapy criteria: 1) FDA‑approved TTF device used per labeled indications after initial chemotherapy; 2) The device is used as the only treatment; 3) Karnofsky Performance Status (KPS) ≥ 60 or ECOG ≤ 2; 4) Individual has been counselled that the electric TTF device must be worn at least 18 hours daily; 5) When all of the above criteria are met, an initial 3 months of electric TTF therapy will be approved.

Continuation therapy

Criteria for subsequent/continuation approval beyond initial 3 months:

Continuation criteria: 1) MRI performed ≤ 2 months prior to request documenting no evidence of disease progression; 2) For ndGBM, individual continues to receive TMZ as the only cancer drug OR for rGBM the device is used as the only treatment; 3) Karnofsky Performance Status (KPS) ≥ 60 or ECOG ≤ 2; 4) Documentation that the individual has been using the electric TTF device at least 18 hours daily.

Coverage for newly diagnosed glioblastoma (ndGBM)

Covered when ALL of the following are met

ndGBM with prior chemoradiation: Patient has newly diagnosed supratentorial glioblastoma who completed standard radiochemotherapy prior to initiation of TTFields.

EF-14 enrolled patients after completion of radiochemotherapy; see Stupp et al. (2015,2017)

Concomitant maintenance TMZ: TTFields is given in combination with maintenance temozolomide as per the EF-14 protocol.

Survival benefit demonstrated for TTFields + TMZ vs TMZ alone (EF-14)

Device usage/compliance: Planned patient use should aim for monthly device compliance >=50% to correlate with improved outcomes; higher compliance (>90%) associated with best outcomes.>=50% monthly

Compliance-outcome relationship reported in subgroup analyses and pooled data

Recurrent GBM and non-GBM tumors

Considered/experimental when any of the following apply

Recurrent GBM: For recurrent GBM, evidence is limited and of variable quality; TTFields may be considered but evidence rating is limited (Hayes rating C) and patient preference regarding avoidance of chemotherapy AEs may guide use.

Hayes and ECRI assessments indicate limited/low-quality evidence for rGBM

Tumors other than GBM: Indications such as metastatic non-small cell lung cancer, malignant pleural mesothelioma, and other solid tumors have limited randomized evidence; available trials (e.g., LUNAR for NSCLC, single-arm STELLAR for mesothelioma) are not definitive and these uses are considered experimental.

Randomized and single-arm trials exist but long-term RCT evidence is lacking

Coverage considerations: newly diagnosed and recurrent GBM

Coverage consideration should reflect guideline recommendations and FDA approvals; clinical criteria from cited guidelines include:

Newly diagnosed supratentorial GBM (ndGBM)

Patient-level criteria: Good performance status (typically KPS ≥ 60; many guidance sources emphasize KPS ≥ 70 for strongest evidence); age considerations: primary category 1 NCCN group ≤ 70 years but older patients with good PS may be considered.
Tumor characteristics: Supratentorial location, histologically confirmed glioblastoma (IDH‑wildtype as applicable), and maximal safe resection performed or documented rationale if resection not feasible.
Prior therapy: Completion of standard concomitant radiochemotherapy prior to initiation of adjuvant TTFields with temozolomide (as in EF-14 trial).

Due to insufficient evidence of efficacy for indications other than glioblastoma, the use of devices that generate electric tumor‑treating fields (TTF) is considered unproven and not medically necessary when the coverage criteria in this policy are not met. The policy explicitly lists treatment of tumors other than GBM and the use of TTF concurrently with other medical therapy for recurrent GBM (for example, bevacizumab or chemotherapy) as not medically necessary. Computer software used for therapeutic radiology treatment planning in conjunction with TTF (e.g., NovoTAL) is likewise considered unproven and not medically necessary due to insufficient evidence.

There is a lack of published randomized controlled trial evidence demonstrating long‑term safety and effectiveness of TTFields for tumors other than glioblastoma. Examples specifically noted include non‑small cell lung cancer, brain metastases, pancreatic cancer, ovarian cancer, and mesothelioma; because randomized evidence is insufficient, routine use of TTFields for these non‑GBM indications is not supported.

The National Institute for Health and Care Excellence (NICE) advises against offering TTFields for management of newly diagnosed grade IV glioma (glioblastoma) and, in an updated 2021 recommendation, also advises do not offer TTFields for recurrent high‑grade glioma. These recommendations emphasize consideration of performance status, patient preferences, time from last treatment, tumor molecular markers, and prior therapies when discussing options at recurrence.

TTF devices are covered only for supratentorial glioblastoma under the specific clinical conditions defined in this policy. Use of TTF devices for indications other than supratentorial GBM, concurrent use with systemic therapies for recurrent GBM (for example, bevacizumab or chemotherapy), and use of planning software such as NovoTAL as part of therapeutic radiology planning are considered unproven and not medically necessary due to insufficient evidence of benefit.

The NovoTAL™ simulation system uses MRI measurements (axial and coronal T1 postcontrast) of head size and tumor location to plan transducer array configuration for Optune therapy. Published clinical evidence for NovoTAL is limited (small case series, modeling, and surveys), and there is insufficient data to conclude that use of NovoTAL improves long‑term health outcomes; therefore its routine use for therapeutic planning is not supported.

The European Society for Medical Oncology (ESMO) guidance advises against continuing the same treatment beyond confirmed disease progression, explicitly including bevacizumab and tumor‑treating fields. ESMO states the clinical benefit of continuing a therapy after confirmed progression has not been established and recommends considering alternative options or clinical trial enrollment at recurrence.

Covered and Investigational Regimens

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

Regimen	Indication / Key criteria	Coverage status
TTF (Optune) as single modality
Radiologically confirmed recurrent supratentorial GBM after prior chemotherapy and radiation; device used as the only treatment; KPS ≥ 60 or ECOG ≤ 2; counselled to wear device ≥ 18 hours daily; initial approval 3 months
Covered

Regimen	Indication / Key criteria	Coverage status
TTF + concurrent systemic therapy (e.g., bevacizumab)
Use of electric TTF concurrently with systemic therapies for recurrent GBM (concurrent bevacizumab or chemotherapy)
Not covered

Regimen	Indication / Key criteria	Coverage status
TTFields (Optune) delivered >18 hours/day in combination with maintenance temozolomide
Newly diagnosed supratentorial glioblastoma initiated after completion of standard concomitant radiochemotherapy; patient counselled to use device ≥ 18 hours/day; KPS ≥ 60 or ECOG ≤ 2; MRI and documentation per continuation rules for ongoing approval
Covered

Regimen	Indication / Key criteria	Coverage status
TTFields added to standard systemic therapy (LUNAR trial regimen)
Metastatic non-small cell lung cancer after progression on platinum-based therapy as studied in the randomized open-label LUNAR trial (TTFields + standard systemic therapy vs standard therapy alone)
Experimental

Regimen	Indication / Key criteria	Coverage status
TTFields (150 kHz to thorax) concomitant with pemetrexed + platinum (STELLAR single-arm phase II)
Frontline treatment of unresectable malignant pleural mesothelioma as evaluated in a single-arm phase II study with TTFields delivered to the thorax concomitant with pemetrexed and platinum; no randomized comparator
Experimental

Regimen	Indication / Key criteria	Coverage status
Tumor Treating Fields (Optune) plus maintenance temozolomide (per EF-14 evidence and NCCN guidance)
Adjunct to adjuvant temozolomide in adults with newly diagnosed supratentorial glioblastoma after completion of chemoradiation; patients typically with good performance status (KPS ≥ 60 or ECOG ≤ 2); counselled to use device ≥ 18 hours/day; documented benefit in EF-14 (improved PFS and OS)
Covered

Regimen	Indication / Key criteria	Coverage status
Tumor Treating Fields (Optune) alone or per device labeling
Recurrent GBM after surgery, radiation, and chemotherapy; FDA-approved for rGBM but guideline recommendations and strength of support vary (NICE recommends not offering; NCCN lists as an option with lower category); consider case-by-case assessment and counseling about limited evidence
Mixed

Coding and Usage Metrics

Procedure CPT (reference)CPT

77299

Unlisted procedure, therapeutic radiology clinical treatment planning

Durable medical equipment / HCPCSHCPCS

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

FDA product codes referencedmixed

NZK	FDA product code referenced for Optune supplemental approvals

FDA PMA identifiersmixed

P100034	PMA ID for Optune (initial approval)
P100034S013	Supplemental PMA for Optune with temozolomide (newly diagnosed)

TTF daily usage / compliance

Usage thresholdAverage usage rate ≥ 75% (studies associate ≥75% compliance with prolonged survival)

Context of evidenceMeta-analyses and systematic reviews report association between ≥75% device usage and improved overall survival in ndGBM

MeasurementUsage reported as monthly percentage of TTFields delivery from device logs (NovoTTF-100A data in EF-14 subgroup analyses)

MRI recency for continuation

Recency requirementMRI scan performed ≤ 2 months prior to continuation request documenting no evidence of disease progression

Purpose

Provider Actions, Authorization, and Documentation Requirements

Prior Authorization

Prior Authorization and Approval Duration

Prior authorization is required and will be approved only when the policy's coverage criteria are met. For newly diagnosed supratentorial GBM (ndGBM) and radiologically confirmed recurrent supratentorial GBM (rGBM), an initial 3-month authorization is granted when criteria are satisfied. Subsequent continuation approvals require documentation of stable disease on MRI, ongoing temozolomide as the only cancer drug for ndGBM (or device-only use for rGBM), and continued adequate performance status.

Prior authorization required for Optune/TTFields for adults with newly diagnosed or recurrent supratorial GBM
Initial approval: 3 months for ndGBM and 3 months for rGBM when coverage criteria are met
Continuation approvals require evidence of no radiographic progression on MRI performed ≤ 2 months before request

Documentation Required

Required Documentation for Authorization

To support an authorization request, submit the following clinical documentation: histologic confirmation of supratentorial glioblastoma; record of maximal safe resection or biopsy (and date); documentation of completed radiation therapy and dates (for ndGBM); current systemic therapy details showing temozolomide is the only cancer drug for ndGBM or that the device will be used as the only treatment for rGBM; performance status (KPS or ECOG) demonstrating KPS ≥ 60 or ECOG ≤ 2; counseling that device wear time is at least 18 hours/day; and evidence of device adherence when applicable.

Line of Therapy Indications

first-line

First-line (context: newly diagnosed supratentorial GBM following standard initial therapy):

first-line: Used after debulking surgery and radiation, concurrently with maintenance temozolomide as the only cancer drug; initial approval is for 3 months with continuation per criteria.

salvage

Salvage (context: radiologically confirmed recurrent supratentorial GBM):

salvage: Used as sole therapy for radiologically confirmed recurrence after prior chemotherapy and radiation; initial approval is for 3 months with continuation per criteria.

first-line

First-line (evidence context: EF-14 trial enrollment and timing):

Biomarker and Molecular Test Requirements

PTEN mutation

BiomarkerPTEN mutation (identified by tumor sequencing)

Clinical noteRetrospective series reported longer post-progression survival with TTFields in PTEN‑mutant rGBM versus PTEN‑wildtype (limited evidence)

Evidence statusExploratory/retrospective data only; further RCT evidence needed to confirm predictive value

MGMT promoter methylation

BiomarkerMGMT promoter methylation status

Clinical relevanceUsed for prognostic subgrouping and to guide choice of temozolomide versus radiotherapy in older adults; TTFields benefit observed regardless of MGMT status in pooled analyses

Definitions and Abbreviations

KPS — Karnofsky Performance Status

DefinitionKarnofsky Performance Status (KPS): 0–100 scale measuring ability to perform daily tasks; higher score indicates better function

Key thresholdsKPS ≥ 60 required for coverage (indicates requires occasional assistance but able to care for most personal needs)

Common useUsed to determine prognosis, functional change, and clinical trial eligibility

ECOG — Eastern Cooperative Oncology Group Performance Status

DefinitionEastern Cooperative Oncology Group (ECOG) Performance Status: ordinal scale 0–5 measuring functional status

Key thresholdECOG ≤ 2 acceptable for coverage as alternative to KPS ≥ 60 (ambulatory and capable of self‑care)

Background on Tumor Treating Fields

Tumor‑treating fields (TTF) deliver low‑intensity, intermediate‑frequency (100–300 kHz) alternating electric fields intended to disrupt mitosis in dividing tumor cells. The Optune system provides TTF noninvasively via scalp transducer arrays that are configured to tumor location and are typically worn at least 18 hours per day; arrays require periodic replacement and scalp care, and the device includes a portable generator, power supply, and accessories necessary for daily use.

Coding Highlights and Usage Metrics

18minimum daily wear time (hours/day)

3initial approved duration (months)

KPS>=60performance status requirement (Karnofsky)

MRI<=2mrecent imaging required for continuation

Policy Summary

PayerUnitedHealthcare

PolicyElectric Tumor Treatment Field Therapy (for Idaho Only)

Policy CodePolicy CS146ID.A

Change TypeNew Medical Policy

Effective DateJun 1, 2025

Next Review DateN/A

SourceLink

On This Page

Recurrent GBM (rGBM):

TTFields may be considered for adults with progression after surgery, radiation, and chemotherapy; guideline support is mixed (FDA approval for rGBM exists but NICE recommends against offering); consider on a case-by-case basis and clinical trial enrollment when available.

Confirms absence of progression before approving continuation beyond initial 3 months

DocumentationInclude copy of most recent MRI report/images with request

Performance status

KPS thresholdKarnofsky Performance Status (KPS) ≥ 60 required for coverage (indicates requires occasional assistance but able to care for most personal needs)

ECOG equivalentECOG Performance Status ≤ 2 acceptable alternative to KPS ≥ 60

Source definitionKPS is a 0–100 scale measuring ability to perform daily tasks; ECOG is an ordinal 0–5 scale measuring functional status

TTFields device usage compliance

Monthly compliance threshold>= 50% monthly device usage associated with improved PFS and OS (threshold identified in EF-14 compliance analysis)

Optimal usage>90% monthly usage associated with the best outcomes (highest median and 5‑year survival rates)

RelationshipImproved outcomes correlate with increasing compliance; compliance assessed via device-recorded monthly delivery percentage

Histology/pathology report confirming supratentorial GBM
Operative note or surgical report showing debulking/extent of resection or biopsy
Radiation therapy records confirming completion of radiotherapy (ndGBM)
Current medication list supporting temozolomide as the only cancer drug (ndGBM) or statement that device will be sole therapy (rGBM)
Performance status (KPS or ECOG) documented in clinical notes
Patient counseling documentation regarding ≥18 hours/day device wear and adherence reporting
Recent MRI report (see imaging requirements)

Documentation Required

Imaging Requirements and NovoTAL Planning

Imaging used for treatment planning and authorization must include a brain MRI with axial and coronal T1 post-contrast sequences performed within 2 months prior to request. NovoTAL planning requires measurements from axial and coronal T1 postcontrast MRI to determine head size and tumor location for optimal transducer array configuration.

MRI (axial and coronal T1 postcontrast) obtained ≤ 2 months prior to request
Include MRI images or radiology report with measurements used for NovoTAL mapping when applicable
Document tumor location as supratentorial vs. other

Denial Risk

Denial Triggers for Unmet Criteria

Requests that do not meet the policy's specified coverage criteria should be denied. Common denial triggers include: lack of histologic confirmation of supratentorial GBM; MRI showing radiographic progression; performance status below required threshold (KPS < 60 or ECOG > 2); concurrent systemic therapies other than temozolomide for ndGBM or concurrent bevacizumab/chemotherapy for rGBM; use for tumors outside of GBM; and absence of required surgical or radiation therapy documentation when applicable.

Denial if diagnosis is not histologically confirmed supratentorial GBM
Denial if MRI shows progression or MRI is older than 2 months without justification
Denial for concurrent systemic therapy not permitted by criteria (eg, bevacizumab with TTFields for rGBM)
Denial for indications other than GBM due to limited evidence

Denial Risk

Limited Evidence for Non-GBM Indications

There is insufficient randomized evidence supporting use of TTFields for tumors other than GBM (including non–small cell lung cancer, brain metastases, pancreatic, ovarian, and mesothelioma). Requests for TTFields for non-GBM indications should generally be considered not medically necessary and denied absent compelling prospective evidence or coverage pathway.

Limited or no RCT evidence for non-GBM tumor types; non-coverage expected for these indications

Note

Therapy Sequence and Timing

Sequencing considerations: pivotal trials (EF-14 and Stupp et al.) enrolled patients after completion of concomitant radiochemotherapy. For ndGBM, prior completion of standard radiotherapy with concurrent temozolomide is expected before initiation of TTFields per trial protocol and FDA labeling. For rGBM, use is considered after prior chemotherapy and radiation per labeling.

Initiation of TTFields in ndGBM generally follows completion of radiochemotherapy and before or during maintenance temozolomide as per EF-14 trial timing
rGBM use is considered after prior chemotherapy and radiation

Step Therapy

Step Therapy Note

Step therapy sequencing beyond requiring temozolomide as the only cancer drug for newly diagnosed patients is not specified in this policy. There is no mandatory step‑therapy ladder for TTFields; decisions should follow FDA labeling, clinical guidelines, and individual patient circumstances.

No step‑therapy requirements beyond temozolomide being the only cancer drug for ndGBM
EANO/NCCN guidance should inform prior lines of therapy before considering TTFields

Documentation Required

Continuing Treatment Beyond Confirmed Progression

Guideline sources recommend against continuing the same systemic or device therapy beyond confirmed progression. Specifically, use of treatments beyond confirmed progression on that same treatment (including bevacizumab and tumor-treating fields) is discouraged.

Do not continue TTFields or bevacizumab beyond confirmed radiographic progression without clear evidence of benefit
Follow guideline-recommended options at recurrence and consider clinical trials

first-line: Initiation of TTFields occurred after completion of concomitant radiochemotherapy in pivotal EF-14 trial; coverage in this context aligns with EF-14 population (post‑radiochemotherapy maintenance with TMZ).

salvage

Salvage (evidence context: limited comparative data for rGBM):

salvage: Evidence for benefit of TTFields in recurrent GBM is limited and of low quality with some assessments rating evidence as C; consideration should be individualized and may reflect patient preference to avoid systemic chemotherapy toxicities.

first-line

First-line (guideline/evidence-aligned criteria summary):

first-line: Consider adjuvant TTFields with maintenance temozolomide in adults with newly diagnosed supratentorial GBM who have completed standard radiochemotherapy and have good performance status; guideline strength varies by age and KPS but aligns with EF-14 population and FDA supplemental approval.

salvage

Salvage (guideline/evidence-aligned criteria summary):

salvage: In recurrent GBM, consider TTFields as an option after surgery, radiation, and chemotherapy recognizing mixed guideline recommendations and limited high-quality evidence; consider clinical trial enrollment when available.

EvidenceSystematic reviews and meta-analyses report survival benefit with TTFields across MGMT methylated and unmethylated subgroups

MGMT promoter methylation — additional references

DefinitionMGMT promoter methylation: tumor molecular marker used to predict benefit from temozolomide chemotherapy and to inform treatment choices in older adults

Role in guidelinesGuidelines recommend considering MGMT status when selecting TMZ vs radiotherapy for older patients; TTFields shown to improve survival regardless of MGMT status

Evidence summaryMeta-analyses and pooled analyses include subgroup findings by MGMT status supporting TTFields efficacy across methylation groups

Scale examples0 = fully active; 2 = ambulatory and capable of self‑care but unable to work; 5 = dead

Supratentorial — anatomical definition

DefinitionSupratentorial: upper portion of the brain including the cerebrum and related structures; relevant because Optune transducer arrays are placed on the scalp over supratentorial tumors

Coverage relevancePolicy limits TTF use to supratentorial glioblastoma locations per FDA labeling and guideline recommendations

Anatomic examplesIncludes cerebrum, ventricles, choroid plexus, hypothalamus, pineal and pituitary regions and optic nerve (per NCI definitions)

Temozolomide (TMZ)

DefinitionTemozolomide (TMZ): an oral alkylating chemotherapy agent used as first‑line treatment for glioblastoma and the only cancer drug allowed concomitantly with TTFields in ndGBM coverage criteria

Role in regimenPolicy requires ongoing TMZ as the sole cancer drug when approving TTFields for newly diagnosed GBM after chemoradiation

Guideline contextStandard of care includes radiation with concurrent TMZ followed by adjuvant TMZ (Stupp protocol)

NovoTAL — simulation system

DefinitionNovoTAL: simulation software that uses MRI measurements (axial and coronal T1 postcontrast) for head size and tumor location to plan transducer array configuration

Clinical evidenceLimited published clinical evidence supports NovoTAL; insufficient data to demonstrate improved long‑term outcomes

Use in planningOptional tool leased from manufacturer to determine optimal paired transducer array placement

TTFields / Optune

DefinitionTumor Treating Fields (TTFields) / Optune: a noninvasive device system that delivers low‑intensity, intermediate‑frequency alternating electric fields to the scalp via transducer arrays to disrupt tumor cell division

Device componentsOptune kit includes portable field generator, insulated transducer arrays, power supply, and supplies; arrays are placed on the scalp according to tumor location

Usage requirementDevice intended to be worn at least 18 hours daily; transducer arrays replaced once to twice weekly

MGMT promoter methylation — definition and clinical relevance

DefinitionMGMT promoter methylation: a tumor molecular marker used to predict benefit from temozolomide and to inform treatment choices in older adults

Clinical implicationsGuidelines recommend using MGMT status to guide selection of TMZ versus radiotherapy in older patients; TTFields benefit observed irrespective of MGMT status in pooled analyses

EvidenceSystematic reviews and meta-analyses include subgroup analyses by MGMT status showing TTFields-associated survival benefit across methylation groups