ModifiedColorado Rocky Mountain Health PlansPolicy CS146.M

Electric Tumor Treatment Field Therapy

Defines coverage criteria for FDA‑approved electric tumor treatment field devices (TTF) for supratentorial glioblastoma (newly diagnosed and recurrent) and the documentation needed for approval, affecting providers submitting authorization requests to Colorado Rocky Mountain Health Plans.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyElectric Tumor Treatment Field Therapy

Policy CodePolicy CS146.M

Change TypeMaterial updates to coverage language and documentation requirementsremoved select code and prior exclusions

Effective DateJan 1, 2026

Next Review Date

Key ActionObtain prior authorization and submit medical records documenting histologic confirmation, surgery and radiation completion (if ndGBM), KPS/ECOG, MRI within 2 months for continuations, and device usage/compliance.

SourceLink

POLICY UPDATE CHANGES

Removed content/language pertaining to the state of Louisiana.

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 that benefit coverage is determined by federal, state, or contractual requirements and that medical records may be required to assess whether the member meets clinical criteria for coverage.

Removed CPT code 77299 from the Applicable Codes section.

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

18 hrs/dayminimum daily device wear time counseled to member

3 months

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approved initial treatment duration for ndGBM and rGBM

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

≤2 monthstiming requirement for MRI prior to continuation requests

A4555,E0766,E0767procedure/device codes listed

20.9 momedian OS with TTFields + TMZ (EF-14)

Coverage Criteria for TTFields (Glioblastoma)

Guideline- and regulator-derived contexts for TTFields coverage

Guideline and regulatory contexts for tumor-treating fields (TTFields) use in glioblastoma (selected excerpts and regulatory status). These excerpts summarize major guideline positions, trial evidence that informed them, and FDA approval context. They are included to provide the clinical and regulatory background used to derive coverage criteria.

NCCN Clinical Practice Guidelines for Central Nervous System Cancers (2025) include alternating electric field therapy (TTFields) as an option with adjuvant temozolomide for newly diagnosed supratentorial glioblastoma in patients with good performance status (KPS ≥ 60) regardless of MGMT status; TTFields is category 1 for patients ≤ 70 years with good PS and is considered a reasonable option for older patients with good PS. For recurrent GBM, TTFields is considered (category 2B) but panel opinion is divided due to less clear efficacy data.

Major randomized evidence (EF-14): The EF-14 randomized phase III trial (Stupp et al.) showed that adding TTFields to maintenance temozolomide in newly diagnosed supratentorial GBM after completion of radiochemotherapy improved progression-free survival (PFS) and overall survival (OS) versus temozolomide alone (median OS ~20.5 months vs ~15.6 months per per-protocol analysis). The trial also documented increased local (scalp) skin reactions but no significant systemic toxicity increase.

Efficacy and subgroups: Subgroup and secondary analyses (Ram et al.; Toms et al.; Magouliotis et al.) indicate benefit in older adults and a correlation of clinical benefit with device compliance (higher daily use associated with better PFS and OS); common device-related adverse events are predominantly mild–moderate scalp/array skin reactions.

Regulatory status (FDA): FDA Premarket Approval: Optune (formerly NovoTTF-100A) received PMA approval in April 2011 for adults with recurrent/progressive GBM after chemotherapy and radiation. A supplemental PMA (October 2015) approved Optune in combination with temozolomide for newly diagnosed supratentorial GBM following maximal debulking surgery and completion of radiation therapy with concomitant standard-of-care chemotherapy.

Safety surveillance and evidence for recurrent GBM: Post-marketing surveillance (Shi et al.) and systematic reviews (ECRI) report a favorable safety profile across large cohorts with common TTFields-related events being skin reactions; evidence for OS benefit in recurrent GBM is less definitive—TTFields may offer comparable OS to best standard care chemotherapy while avoiding some chemotherapy-associated systemic toxicities, but confidence is moderate and subgroup results vary.

Guideline divergence: NICE: NICE (2018, updated 2021) recommends against offering TTFields for newly diagnosed or recurrent high-grade glioma, citing that available evidence does not support use in these contexts. This represents a divergent international guidance position compared with NCCN and the device's FDA approval for specific GBM indications.

Implications for coverage policy: Taken together, guideline recommendations, randomized trial evidence (notably EF-14), regulatory approvals, safety surveillance, and compliance-outcome data support limited coverage for TTFields in FDA-labeled indications for supratentorial GBM (newly diagnosed in combination with temozolomide after standard radiotherapy and for recurrent GBM as monotherapy where labeled). Evidence is insufficient to support routine coverage for tumors other than GBM or for concurrent use with certain systemic therapies outside labeled regimens; some authoritative bodies (e.g., NICE) recommend against offering TTFields, highlighting ongoing uncertainty and the need for adherence to labeled indications and performance/use thresholds.

Regimens and Clinical Contexts Considered Covered

Regimen	Indication / Key criteria	Coverage status
TTF (Optune) + temozolomide
Maintenance therapy for newly diagnosed supratentorial glioblastoma after completion of radiotherapy and debulking surgery; patient receiving temozolomide as the only cancer drug; KPS ≥ 60 or ECOG ≤ 2; counseled to wear device ≥ 18 hours/day; initial approval = 3 months
Covered

Regimen	Indication / Key criteria	Coverage status
TTF (Optune) as sole therapy
Therapy for radiologically confirmed recurrent supratentorial GBM when device is used as the only treatment; KPS ≥ 60 or ECOG ≤ 2; counseled to wear device ≥ 18 hours/day; initial approval = 3 months
Covered

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

Regimen	Indication / Key criteria	Coverage status
TTFields (200 kHz via Optune) + maintenance temozolomide
Newly diagnosed supratentorial glioblastoma after completion of concomitant radiochemotherapy; treatment given in combination with maintenance TMZ; eligibility similar to EF-14 trial population; KPS ≥ 60 or ECOG ≤2; counseled to wear device ≥ 18 hours/day
Covered

Regimen	Indication / Key criteria	Coverage status
TTFields delivered to thorax (150 kHz) combined with systemic therapy (e.g., pemetrexed + platinum)
Investigational use in non‑GBM tumors such as metastatic NSCLC (LUNAR) and malignant pleural mesothelioma (STELLAR); preliminary/single‑arm or early randomized data with limitations; further confirmatory randomized evidence required
Experimental

Regimen	Indication / Key criteria	Coverage status
RT + concurrent temozolomide followed by adjuvant temozolomide with addition of TTFields (Optune) per EF-14
Newly diagnosed supratentorial GBM in patients with good performance status after maximal safe resection and completion of radiotherapy with concurrent TMZ; TTFields added during maintenance TMZ as per EF-14; KPS ≥ 60 or ECOG ≤ 2
Covered

Regimen	Indication / Key criteria	Coverage status
TTFields (Optune) alone or as per device labeling
Use in recurrent GBM after prior chemotherapy and radiation consistent with FDA labeling for Optune; device used as sole therapy and patient meets performance and counseling criteria (KPS ≥ 60 or ECOG ≤2; counseled to wear device ≥ 18 hours/day)
Covered

Applicable Procedure and Supply Codes

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

Removed/Modified CodesCPT

77299

CPT code removed from Applicable Codes section

Performance status — KPS ≥ 60 or ECOG ≤ 2

Required thresholdKarnofsky Performance Status (KPS) ≥ 60 OR ECOG Performance Status ≤ 2 required for initial and continuation coverage

ApplicationApplies to both newly diagnosed supratentorial GBM (ndGBM) and recurrent supratentorial GBM (rGBM) per coverage criteria

DocumentationMedical record must include documented KPS or ECOG score meeting threshold for prior authorization and continuation

MRI timing — MRI performed ≤ 2 months prior to continuation request

Timing requirementMRI performed ≤ 2 months prior to a continuation request and documents no evidence of disease progression

Purpose

Prior Authorization, Documentation, and Provider Responsibilities

Prior Authorization

Prior Authorization and Initial Approval

Prior authorization is required for FDA‑approved tumor treating field (TTF) devices per plan and may be required depending on federal, state, or contractual coverage rules. Initial approvals are for 3 months when the member meets the clinical criteria for newly diagnosed GBM (ndGBM) or recurrent GBM (rGBM). Continued authorization beyond the initial 3 months depends on ongoing clinical criteria and supporting documentation.

Initial approval: 3 months for ndGBM and rGBM when ALL clinical criteria are met (see Coverage Rationale).
Prior authorization determinations are subject to federal, state, and contractual requirements; submission of medical records may be required to adjudicate the request.

Documentation Required

Device Compliance / Usage Documentation

Documented device usage (compliance) is required for consideration of continuation of TTF therapy. Published evidence associates improved outcomes with higher device usage; a commonly used operational threshold is ≥ 50% monthly usage, with greater benefit seen at higher compliance (e.g., > 90%).

Key Definitions and Performance Status Scales

Karnofsky Performance Status (KPS) — scale and coverage interpretation

DefinitionKarnofsky Performance Status (KPS) is a 0–100 scale measuring ability to perform daily activities; higher scores indicate better function

Example score meaningKPS 60 = requires occasional assistance but able to care for most personal needs

Coverage interpretationPolicy requires KPS ≥ 60 for coverage; KPS thresholds inform prognosis and eligibility assessments

ECOG Performance Status — definition and policy threshold

DefinitionECOG Performance Status ranges 0 (fully active) to 5 (dead)

Meaning of ECOG ≤2ECOG ≤ 2 indicates ambulatory and capable of self-care but unable to work; up and about >50% of waking hours

Biomarker Information Relevant to Coverage

PTEN — association with post-progression survival (not required for coverage)

PTEN associationPTEN‑mutant status was associated with improved post-progression survival in a small retrospective series of rGBM treated with TTFields

Coverage implicationPTEN mutation is not required for coverage; findings are exploratory and limited by small sample size

Evidence noteRetrospective analysis suggests PPS benefit in PTEN-mutant subgroup but requires RCT confirmation

MGMT promoter methylation — inventory entry

RoleMGMT promoter methylation predicts greater temozolomide sensitivity and helps guide treatment selection, especially in older adults

CoverageMGMT methylation status is informational and not mandated for TTFields coverage

Placement in Treatment Sequence

inv-41: first-line — 1 top-level node

first-line: Used after surgery and radiation in combination with maintenance temozolomide; initial approval 3 months

Applies to newly diagnosed supratentorial GBM after completion of concomitant radiochemotherapy.

inv-42: salvage — 1 top-level node

salvage: Used as sole therapy after radiologic recurrence of supratentorial GBM; initial approval 3 months

Concurrent systemic therapy for recurrent GBM is excluded.

inv-43: first-line — 1 top-level node

First-line adjunct:

Background and Evidence Summary

TTF therapy delivers low‑intensity, intermediate‑frequency electric fields via transducer arrays applied to the scalp to disrupt tumor cell division. For coverage purposes the policy requires supporting documentation including MRI within ≤ 2 months prior to continuation requests, performance status of KPS ≥ 60 or ECOG ≤ 2, and evidence the individual has been counseled to use the device at least 18 hours/day. When those criteria are not met the use of devices to generate electric TTF is considered unproven and not medically necessary.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyElectric Tumor Treatment Field Therapy

Policy CodePolicy CS146.M

Change TypeMaterial updates to coverage language and documentation requirementsremoved select code and prior exclusions

Effective DateJan 1, 2026

Next Review Date

SourceLink

On This Page

Used to confirm stability/no progression before authorizing continued TTFields beyond initial approval

DocumentationCurrent MRI report must be included with continuation authorization request

TTFields device compliance threshold — ≥ 50% monthly usage; >90% maximal benefit

Primary compliance thresholdMonthly TTFields device usage ≥ 50% correlated with significantly improved PFS and OS versus TMZ alone

Optimal compliance>90% monthly usage associated with maximal observed survival benefit (example: median survival 24.9 months at >90% compliance)

MonitoringDevice usage is tracked by the device (NovoTTF/Optune) and reported for authorization and continuation decisions

Karnofsky Performance Status (KPS) — ≥ 60 or ≥70 depending on guideline and indication

Policy thresholdKPS ≥ 60 required for coverage per this policy (applies to ndGBM and rGBM)

Guideline variationSome guideline contexts (EANO) reference KPS ≥ 70 when defining standard-of-care selection for certain populations

Practical noteCoverage determinations follow policy KPS≥60; higher KPS thresholds (e.g., ≥70) may be cited in guideline recommendations for SOC selection

Provide device-generated usage data showing percent monthly usage; include dates and percent compliance.
Document counseling provided to the member about wearing the device at least 18 hours daily.

Documentation Required

Required Documentation for Authorization

The authorization request must include medical records that establish the clinical context and that the member meets coverage criteria for TTF therapy.

Histologic confirmation of supratentorial glioblastoma for ndGBM requests.
Operative report documenting debulking surgery or biopsy completion when applicable.
Radiation therapy documentation confirming completion of involved-field radiotherapy for ndGBM prior to initiation of TTF.
Current chemotherapy documentation: for ndGBM, documentation that the member is receiving temozolomide (TMZ) as the only cancer drug; for rGBM, documentation that TTF will be used as the only treatment unless otherwise specified by coverage rules.
Recent performance status assessment (KPS ≥ 60 or ECOG ≤ 2).
Recent MRI (performed ≤ 2 months prior to request) documenting no evidence of disease progression when required for continuation.

Documentation Required

Relevant Clinical Documentation

Include relevant clinical history and treatment course to support medical necessity and appropriate sequencing with standard therapies.

Treatment history listing dates and details of surgery, radiotherapy, and chemotherapy (including completion dates of concomitant radiochemotherapy).
For ndGBM: confirmation that TTF will be used in combination with maintenance TMZ per labeled indication.
For rGBM: documentation that prior chemotherapy was completed and that TTF is requested as the sole treatment when applying criteria for rGBM.
If applicable, record of enrollment in clinical trials or reasons for deviation from standard sequencing.

Documentation Required

Medical Records Requirement

Medical records may be requested and must be provided to verify that the member meets clinical criteria; failure to provide requested records may result in denial of coverage.

Submit supporting medical records at the time of prior authorization request or within the timeframe specified by the plan.
Records requested may include operative notes, radiation oncology records, chemotherapy administration records, pathology reports, MRI reports/images, performance status assessments, and device usage logs.

Note

Therapy Context

TTF is covered as an adjunct therapy in specific contexts: for newly diagnosed supratentorial GBM when used in combination with maintenance temozolomide after completion of surgery and radiotherapy, and for recurrent supratentorial GBM when used as the only treatment per labeled indications and plan criteria.

For ndGBM: TTF is covered only when used with maintenance TMZ and after completion of debulking surgery and radiotherapy.
For rGBM: TTF is covered when used as the only treatment and when the individual meets performance-status and other plan criteria.

Note

Sequencing Relative to Standard Therapy

TTF should be sequenced consistent with standard of care for glioblastoma: surgery (resection or biopsy) as feasible, followed by involved-field radiotherapy with concurrent temozolomide, then adjuvant (maintenance) temozolomide with consideration of alternating electric field therapy per guideline recommendations.

Do not substitute TTF for initial radiotherapy or concurrent chemoradiation; TTF is intended as an adjunct during maintenance TMZ for eligible newly diagnosed patients.
At recurrence, consider standard salvage options (surgery, re-irradiation, chemotherapy, clinical trials); document rationale when requesting TTF relative to other therapies.

Use in policyECOG ≤2 is an accepted alternative to KPS ≥60 for initial and continuation coverage assessments

Supratentorial — anatomic definition and coverage restriction

Anatomic definitionSupratentorial = upper portion of the brain (cerebrum and associated structures)

Policy restrictionCoverage for TTFields is limited to supratentorial glioblastoma per policy criteria

ImplicationTumors outside the supratentorial region are considered non-GBM or investigational for TTFields coverage

Temozolomide (TMZ) — definition and role in coverage

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

Policy roleFor newly diagnosed GBM coverage, the individual must be receiving TMZ as the only cancer drug

ContextTTFields is covered as adjunct to maintenance TMZ after completion of radiochemotherapy in ndGBM

TTFields (Tumor-treating fields) — device definition and regulatory context

DefinitionTumor Treating Fields (TTFields) deliver alternating electric fields via transducer arrays (device examples: Optune, NovoTTF-100A, Optune Gio)

Therapeutic contextApproved device (Optune) is FDA-cleared for recurrent GBM and for use with TMZ in newly diagnosed supratentorial GBM following surgery and RT

Common AEsDevice-associated adverse events commonly include reversible scalp/array skin reactions

Stupp protocol / standard of care (SOC) — definition and relation to TTFields

DefinitionStupp protocol / standard of care: maximal safe resection (or biopsy) followed by radiotherapy with concomitant temozolomide and six cycles of maintenance temozolomide

RoleTTFields are considered an adjunct to this standard regimen for selected newly diagnosed patients after completion of concomitant radiochemotherapy

ReferenceEORTC 26981-NCIC CE.3 (Stupp) informs SOC sequencing and guideline recommendations

Tumor Treating Fields (TTFields/Optune) — device description and approvals

Device functionTTFields/Optune deliver low-intensity alternating electric fields to disrupt cancer cell division via transducer arrays placed on the scalp

Regulatory statusOptune received FDA PMA for recurrent GBM (2011) and supplemental PMA for use with temozolomide in newly diagnosed supratentorial GBM (2015)

Usage implicationDevice use must follow FDA-labeled indications, contraindications, warnings, and precautions for coverage

MGMT promoter methylation — biomarker definition and policy relevance

DefinitionMGMT promoter methylation is a tumor biomarker predictive of temozolomide sensitivity; methylation suggests greater TMZ activity

Coverage impactMGMT status informs TMZ selection and may guide treatment intensity but is not required for TTFields coverage

Guideline noteEANO and other guidelines reference MGMT status when tailoring therapy for older adults or those unfit for chemoradiotherapy

EvidenceSystematic reviews and subgroup analyses indicate TTFields benefits regardless of MGMT status, though treatment choice may vary by methylation

IDH mutation status — inventory entry

DefinitionIDH mutation status distinguishes glioblastoma IDH-wildtype from other gliomas and informs guideline-based SOC selection

Policy useGuideline recommendations frequently specify IDH‑wildtype for SOC sequencing; IDH status itself is not required for TTFields coverage

Evidence noteTrials and guideline statements reference IDH-wildtype populations in defining standard-of-care contexts for TTFields use

MGMT promoter methylation — duplicate/related inventory note

Duplicate entryMGMT promoter methylation appears elsewhere in the inventory as a related biomarker entry

Clinical relevanceMGMT status guides temozolomide use but is not a gatekeeper for TTFields coverage

DocumentationMGMT status may be included in medical records but is not required for prior authorization of TTFields

TTFields is used as an adjunct to maintenance temozolomide after completion of concomitant radiochemotherapy in newly diagnosed supratentorial GBM based on EF-14 trial results

EF-14 showed improved PFS and OS; guideline support from ASCO-SNO and NCCN.

inv-44: salvage — 1 top-level node

Recurrent disease: TTFields may be used in recurrent GBM as an alternative to best standard care chemotherapy, with similar OS and potential avoidance of systemic chemo AEs

ECRI assessment indicates moderate confidence for OS equivalence vs best standard care; device-related skin reactions are common.

inv-45: first-line | second-line — 2 top-level nodes

Recurrent GBM: Optune approved for adults 22+ with GBM that recurs or progresses after chemotherapy and radiation (FDA PMA P100034)post-progression

Informational only; FDA approval is not sole basis for coverage.

Newly diagnosed GBM: Supplemental FDA approval for use with temozolomide in adults with newly diagnosed supratentorial GBM following maximal debulking surgery and completion of radiation therapypost-RT and concomitant chemo completed

Based on EF-14 trial results.