ModifiedUnitedHealthcarePolicy CSNCT0582.04

Electric Tumor Treatment Field Therapy (for North Carolina Only)

Policy governs coverage of FDA‑approved electric tumor treatment field devices (TTF) for members in North Carolina with histologically confirmed supratentorial glioblastoma, specifying initial and continuation approval criteria and exclusions.

Policy Summary

PayerUnitedHealthcare

PolicyElectric Tumor Treatment Field Therapy (for North Carolina Only)

Policy CodePolicy CSNCT0582.04

Change TypeMaterial: removed CPT 77299other editorial updates

Effective DateJan 1, 2026

Next Review Date

Key ActionObtain prior authorization documenting that all coverage criteria are met (initial approval 3 months; continuation requires recent MRI, performance status, ongoing TMZ for ndGBM or device-only use for rGBM, and adherence ≥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.

Removed CPT code 77299 from the list of applicable codes.

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

3 monthsinitial approved duration

≥18 hrs/dayrequired wear time

KPS ≥60 / ECOG ≤2

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required performance status

≤2 monthsMRI recency (continuation)

A4555, E0766, E0767applicable HCPCS codes

20.9 momedian OS (TTFields+TMZ)

Coverage Criteria for Tumor‑Treating Fields (TTF)

Initial Therapy (newly diagnosed GBM)

Covered when ALL of the following are met

ndGBM initial approval

Diagnosis: Histologically confirmed supratentorial glioblastoma (ndGBM)
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Surgery: Debulking surgery has been completed
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Radiation: Treatment with radiation therapy has been completed
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Chemotherapy: Individual is receiving temozolomide (TMZ) as the only cancer drug
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Performance status: KPS ≥ 60 or ECOG ≤ 2
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Counseling and adherence: Individual has been counselled that the electric TTF device must be worn at least 18 hours daily>= 18 hours/day
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Initial Therapy (recurrent GBM)

Covered when ALL of the following are met

rGBM initial approval

Diagnosis: Radiologically confirmed recurrence of GBM in the supratentorial region
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Treatment use: Device is used as the only treatment
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Performance status: KPS ≥ 60 or ECOG ≤ 2
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Counseling and adherence: Individual has been counselled that the electric TTF device must be worn at least 18 hours daily

Continuation Therapy

Continuation covered when ALL of the following are met

Continuation approval

Recent MRI: Magnetic resonance imaging (MRI) scan performed ≤ 2 months prior to request showing no evidence of disease progression≤ 2 months
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Ongoing therapy: For ndGBM: individual continues to receive TMZ as the only cancer drug; for rGBM: device is used as the only treatment
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Performance status: KPS ≥ 60 or ECOG ≤ 2
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Not Medically Necessary / Unproven

Unproven or NMN indications

Other tumors: Treatment of tumors other than glioblastoma multiforme (GBM)
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Concurrent therapy in rGBM: Use of electric TTF therapy with concurrent medical therapy (e.g., bevacizumab or chemotherapy) for treatment of rGBM
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Failure to meet coverage criteria: Any situation where required coverage criteria are not met
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Initial therapy — TTFields with maintenance TMZ

Covered when ALL of the following are met

ndGBM + treatment context: Patient has newly diagnosed supratentorial glioblastoma (IDH-wildtype per guideline recommendation) and has completed standard concomitant radiochemotherapy prior to initiation of TTFields

Based on EF-14 enrollment and ASCO/SNO guidance

Concurrent systemic therapy: TTFields is used in combination with maintenance temozolomide (TMZ) as adjuvant therapy

EF-14 showed improved PFS and OS with TTFields+TMZ

Performance status/age considerations: Patient clinical status consistent with guideline standard of care (e.g., KPS criteria) and age considerations per guideline recommendations; MGMT status may inform TMZ benefit

Guideline context: KPS thresholds and MGMT considerations

Device compliance expectation:

Recurrent GBM and non-GBM tumors

Conditional/experimental coverage considerations

Recurrent GBM (rGBM): Evidence from systematic reviews and ECRI indicates overall survival similar to best standard care chemotherapy with different toxicity profile (fewer systemic chemo adverse events but more skin reactions); treatment choice may depend on patient preferences and prioritized outcomes

ECRI and systematic review findings

Tumors other than GBM: Randomized and single-arm trials exist for NSCLC (LUNAR), mesothelioma (STELLAR), and other tumors with some promising signals, but RCT evidence is limited and long-term safety/effectiveness data are insufficient to support routine coverage

Limited RCT evidence across non-GBM tumors; further randomized data needed

Clinical guideline and regulatory context

Guideline and regulatory context relevant to coverage decisions for TTF/Optune:

NCCN-recommended uses: NCCN includes alternating electric field therapy (TTFields) as an option with standard radiation therapy and temozolomide for newly diagnosed supratentorial GBM in patients with good performance status (KPS ≥ 60) and references FDA approval for ndGBM and rGBM based on EF-14 and EF-11 trials

NCCN guidance and category statements

EANO context: EANO endorses standard therapy for IDH-wild-type glioblastoma and at recurrence recommends considering surgery, radiotherapy, nitrosoureas, TMZ rechallenge, and clinical trial enrollment; EANO advises against continuing a treatment beyond confirmed progression, including TTFields

EANO recommendations and caution about use beyond progression

NICE stance: NICE recommends not offering TTFields for newly diagnosed grade IV glioma and for recurrent high-grade glioma, citing insufficient evidence of benefit

NICE guidance may affect regional decisions

The policy lists specific exclusions under the Not Medically Necessary / Unproven section. In particular, treatment of tumors other than glioblastoma multiforme (GBM) is considered unproven and not medically necessary. Also, the policy specifies that use of electric TTF therapy with concurrent medical therapy (for example, bevacizumab or chemotherapy) for recurrent GBM (rGBM) is not covered. These exclusions apply whenever the policy’s required coverage criteria are not met.

The document states there is a lack of published randomized controlled trial (RCT) evidence

The policy references clinical guidance noting that the European Society for Medical Oncology (ESMO) advises against continuing any treatment beyond confirmed progression on that same therapy, including tumor‑treating fields. In other words, continuing TTFields after documented disease progression is discouraged because a clinical benefit for that practice has not been established.

The policy cites National Institute for Health and Care Excellence (NICE) guidance that explicitly recommends 'Do not offer tumor treating fields (TTF)' for management of newly diagnosed grade IV glioma (glioblastoma) and also for recurrent high‑grade glioma. NICE therefore does not support offering TTFields in these settings based on their review of the evidence.

The policy states that use of devices to generate electric tumor‑treating fields is unproven and not medically necessary when the policy’s required criteria are not met and for indications outside those specified. This includes any situation where documentation does not meet the stated coverage requirements (for example, missing recent MRI, inadequate performance status, or failure to document recommended device wear time).

The policy summarizes evidence assessments noting a Hayes health technology assessment rating of C, describing a small, low‑quality body of evidence for several TTFields uses. Hayes rated TTFields as C for monotherapy in recurrent GBM and for TTFields with concomitant temozolomide in newly diagnosed GBM; overall the assessment characterized the evidence as low quality and limited in scope.

The policy cites EANO and ESMO guidance that recommend against using any treatment beyond confirmed progression on that same treatment — explicitly including tumor‑treating fields — because the clinical benefit of continuing a therapy after progression has not been shown. This guidance supports the policy position that continuation of TTFields beyond progression is not recommended.

Coding and Key Operational Thresholds

Applicable 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

Covered CPT/HCPCS/ICD codesmixed

No codes listed

Removed/Updated CPT CodesCPT

77299

Previously listed CPT code removed from applicable codes

inv-18: Device wear time — ≥ 18 hours/day

Required wear timeDevice must be worn at least 18 hours per day for coverage (counseling and documentation required)

Initial approval noteCounseling that device be worn ≥18 hours/day is required for initial 3-month approval

Continuation documentationContinuation requests must document ongoing device use ≥18 hours/day

inv-19: MRI recency for continuation — performed ≤ 2 months prior to request

Recency requirementA brain MRI must have been performed ≤ 2 months prior to the continuation request showing no evidence of progression

Purpose

Provider Actions, Prior Authorization, and Documentation

Prior Authorization
Prior Authorization Required
Prior authorization is required. Requests must document that all coverage criteria are met. Initial approval for newly diagnosed GBM (ndGBM) or recurrent GBM (rGBM) is for 3 months; continuation beyond the initial 3 months requires meeting the continuation criteria (including recent MRI, ongoing appropriate systemic therapy or device-only use for rGBM, performance status, and documentation of device use).
Prior authorization required for initial and continuation courses
Initial approval: 3 months
Continuation: recent MRI (≤ 2 months), continued TMZ as only cancer drug for ndGBM or device-only use for rGBM, KPS ≥ 60 or ECOG ≤ 2, and documentation of ≥ 18 hours/day device use

Prior Authorization
Prior Authorization for TTFields in ndGBM
For newly diagnosed supratentorial GBM (ndGBM), prior authorization may be approved when Optune or another FDA-approved TTF device is requested in addition to maintenance temozolomide after completion of radiochemotherapy and when all coverage criteria are met. Initial authorization is for 3 months. Continuation approvals require documentation that there is no radiographic progression on MRI performed ≤ 2 months before the request, ongoing TMZ as the only systemic therapy, adequate performance status, and documented device use compliance.

Covered Regimens and Permitted Combinations

Regimen	Indication / Key conditions	Coverage stance
TTF (Optune) combined with temozolomide (TMZ)
Newly diagnosed supratentorial glioblastoma after completion of concomitant radiochemotherapy; patient receiving TMZ as the only cancer drug; KPS ≥ 60 or ECOG ≤ 2; counseling on device wear time (≥18 hours/day)
Covered when all policy criteria are met (initial approval 3 months; continuation requires recent MRI ≤2 months, performance status, and adherence documentation)

Regimen	Trial context / dosing	Coverage stance
TTFields (Optune) combined with maintenance temozolomide
As studied in the EF-14 trial: initiated after completion of radiochemotherapy following maximal safe resection; standard maintenance TMZ dosing per trial (adjuvant cycles as per Stupp EF-14 protocol)
Covered for newly diagnosed supratentorial glioblastoma meeting policy criteria

Regimen	Trial population / protocol	Coverage stance
TTFields delivered to the thorax plus systemic chemotherapy
Per trial protocols: LUNAR (metastatic NSCLC after progression on platinum-based therapy) and STELLAR (unresectable malignant pleural mesothelioma) used continuous thoracic TTFields plus standard systemic chemotherapy regimens defined by each study
Experimental / not standard covered indication (insufficient RCT body for routine coverage)

Regimen	Indication / timing	Coverage stance
Tumor‑treating fields (Optune) plus maintenance temozolomide
Adjunct to standard maintenance temozolomide following maximal safe resection and completion of radiation therapy with concomitant temozolomide (per FDA supplemental approval and EF-14 trial entry criteria)
Covered for selected newly diagnosed supratentorial GBM patients when policy criteria are met

Regimen	Context / evidence summary	Coverage stance
Continuation or re‑use of TTF beyond confirmed progression
Guideline and evidence statements (EANO/ESMO/NICE) note that continuing a treatment beyond confirmed progression, including TTF, lacks established clinical benefit; trial and guideline sources discourage use beyond progression
Not covered / considered not medically necessary or unproven when used beyond confirmed progression or in settings without demonstrated benefit

Applicable Lines of Therapy

first-line

First-line context: Used after maximal safe resection (if performed) and completion of radiochemotherapy as adjunct to maintenance temozolomide in newly diagnosed supratentorial GBM when criteria are met

Policy specifies post-radiochemotherapy initiation consistent with EF-14 and standard care

salvage

Salvage context: Use as sole therapy for radiologically confirmed recurrent supratentorial GBM; evidence demonstrates similar overall survival to best standard care chemotherapy with different adverse event profiles

Consider patient preferences and toxicity tradeoffs

first-line

Biomarker and Molecular Status

inv-49: PTEN, MGMT promoter methylation, IDH — (biomarker list)

Biomarker panelPTEN, MGMT promoter methylation, and IDH mutation status noted in evidence and analyses relevant to GBM

PTEN contextRetrospective analyses suggested PTEN-mutant rGBM patients may have improved post-progression survival with TTFields (limited, nonrandomized data)

MGMT and IDH roleMGMT promoter methylation and IDH mutation status are referenced in trials/guidelines as prognostic or predictive factors influencing treatment decisions

inv-50: MGMT promoter methylation

MGMT relevanceMGMT promoter methylation status informs temozolomide benefit and treatment selection in older adults and is reported in systematic reviews of TTFields outcomes

Not required for coverage

Definitions and Terminology

inv-35: Karnofsky Performance Status (KPS) — A 0–100 scale; policy requires KPS ≥ 60 for coverage.

DefinitionKarnofsky Performance Status (KPS) is a 0–100 scale assessing ability to perform ordinary tasks; higher scores indicate better function

Policy thresholdPolicy requires KPS ≥ 60 for initial and continuation coverage of TTFields

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

inv-36: ECOG Performance Status — A 0–5 scale; policy requires ECOG ≤ 2 for coverage.

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

Policy thresholdPolicy requires ECOG ≤ 2 for initial and continuation coverage of TTFields

Background and Evidence Summary

Tumor‑treating fields (TTF) are described as low‑intensity, intermediate‑frequency electric fields applied via scalp arrays to disrupt cancer cell division. The Optune system is a portable device that delivers alternating electric fields to the scalp, requires frequent array changes, and depends on sustained daily wear to deliver therapy. Standard management of newly diagnosed GBM includes maximal safe resection when feasible, followed by radiation and temozolomide, with TTFields considered as an adjunct in selected settings.

Policy Revision History

2026-01-01policy_revisionLatest

Removed CPT code 77299 from the list of applicable codes and removed prior language stating that therapeutic radiology treatment‑planning software used with TTF is unproven; updated medical records documentation language and supporting sections (Description of Services, Clinical Evidence, FDA, and References).

Policy Summary

PayerUnitedHealthcare

PolicyElectric Tumor Treatment Field Therapy (for North Carolina Only)

Policy CodePolicy CSNCT0582.04

Change TypeMaterial: removed CPT 77299other editorial updates

Effective DateJan 1, 2026

Next Review Date

SourceLink

On This Page

Adherence documentation: Documentation that the individual has been using the electric TTF device at least 18 hours daily>= 18 hours/day

Documented plan for TTFields device use and monitoring of compliance; counseling that improved outcomes correlate with higher usage (threshold >=50% monthly)

>=50% monthly device usage associated with benefit

Based on EF-14 subgroup analysis

FDA approvals: Optune (NovoTTF-100A) received FDA approval for recurrent GBM in 2011 and a supplemental approval in 2015 for use with temozolomide in newly diagnosed supratentorial GBM after maximal debulking surgery and completion of radiation with concomitant chemotherapy

FDA approval is informational and not alone determinative of coverage

MRI documents lack of disease progression as a condition for continued approval

DocumentationMRI report must be included in the medical record for continuation review

inv-20: Performance status — KPS ≥ 60 or ECOG ≤ 2

Coverage performance thresholdKarnofsky Performance Status (KPS) ≥ 60 or ECOG Performance Status ≤ 2 is required for initial and continuation coverage

KPS scale contextKPS is a 0–100 scale measuring ability to perform ordinary tasks (e.g., KPS 60 = requires occasional assistance but able to care for most personal needs)

ECOG scale contextECOG is a 0–5 scale measuring functional status (e.g., ECOG 2 = ambulatory and capable of self-care; up and about >50% of waking hours)

inv-21: Device usage compliance threshold — >= 50% monthly usage associated with improved PFS and OS; >90% associated with best outcomes

Best-outcome complianceMonthly device usage > 90% correlated with the best reported median survival (e.g., median survival 24.9 months in subgroup) and higher 5-year survival

MeasurementCompliance is calculated from device-recorded percent monthly TTFields delivery captured by the NovoTTF-100A device

Indication: ndGBM after completion of radiotherapy with concurrent temozolomide
Initial approval duration: 3 months
Continuation criteria summarized above

Billing Rule
Applicable Codes and Prior Authorization
Applicable codes for prior authorization and billing should reflect covered device and supply codes. Note that CPT code 77299 has been removed from the applicable codes list; prior authorization processes may reference the current set of applicable CPT/HCPCS codes and supporting documentation requirements.
Do not use CPT 77299 (removed from applicable codes)
Confirm current applicable CPT/HCPCS codes with payer prior to submission

Denial Risk
Triggers for Denial
Requests may be denied if continuation criteria are not met, if required documentation is missing or incomplete, or if the requested use is for indications not covered by the policy (including use with concurrent systemic therapies for rGBM). Specific triggers for denial include outdated imaging, insufficient device compliance, inadequate performance status, or concurrent non-permitted therapies.
Denial triggers: MRI > 2 months old for continuation requests
Denial triggers: documented device use < 18 hours/day or lack of compliance data
Denial triggers: KPS < 60 or ECOG > 2
Denial triggers: use of TTF concurrently with other systemic therapies for rGBM (e.g., bevacizumab)

Note
Population Applicability
Population applicability: the policy applies to individuals with histologically confirmed supratentorial GBM. For ndGBM, enrollment in key trials occurred after completion of radiochemotherapy and excluded those who progressed during radiochemotherapy. The policy is not applicable for tumors other than GBM or for uses not meeting the stated criteria.
Applies to histologically confirmed supratentorial GBM
ndGBM: device added after completion of radiochemotherapy (per clinical trial enrollment and FDA-labeled use)
Not applicable to non-GBM tumors or indications outside the coverage criteria

Documentation Required
Documentation Completeness
Medical record documentation must fully support medical necessity. Lack of complete supporting documentation may lead to denial or inability to determine coverage. Benefit coverage is determined by federal, state, or contractual requirements and applicable laws; documentation may be requested to assess whether criteria are met but does not guarantee coverage.
Medical record must contain relevant history, physical exam, and diagnostic test/procedure results
Documentation must be legible, maintained in the medical record, and available upon request
Incomplete documentation may result in denial or request for additional information

Documentation Required
Required Documentation
Required documentation for prior authorization and review includes histologic confirmation of supratentorial GBM, recent MRI imaging, performance status, and counseling about device use. For continuation requests, provide an MRI within 2 months showing no progression, evidence of ongoing eligible systemic therapy (for ndGBM), and device usage data showing at least 18 hours/day average use.
Histologic confirmation of supratentorial GBM (pathology report)
MRI report dated ≤ 2 months prior to request for continuation
KPS score (≥ 60) or ECOG performance status (≤ 2)
Documentation of counseling that device must be worn ≥ 18 hours daily
For ndGBM: documentation patient is receiving temozolomide as the only cancer drug
For rGBM continuation: documentation that the device is being used as the only treatment

Documentation Required
Required Clinical Documentation
Required clinical documentation includes device usage/compliance records (monthly percent delivery or hours/day) because higher compliance correlates with improved outcomes, performance status measures, recent MRI results, and records of prior surgery and radiotherapy completion. Provide device usage data from manufacturer/device logs when available.
Device compliance data (monthly percent TTFields delivery or average hours/day) — manufacturer/device logs preferred
Records of prior debulking surgery or biopsy and completion of radiotherapy
Pathology, imaging, and treatment history documenting timing of radiochemotherapy completion relative to device initiation

Note
Recommended Treatment Sequencing
Recommended treatment sequencing: standard of care generally follows maximal safe resection (or biopsy) → involved-field radiotherapy with concurrent temozolomide → adjuvant maintenance temozolomide. For ndGBM meeting criteria, TTF is recommended as an adjunct to maintenance temozolomide after completion of radiochemotherapy. At recurrence, treatment sequencing is individualized; TTF may be used as device-only therapy for rGBM when criteria are met.
Standard sequence: resection/biopsy → concurrent radiotherapy + temozolomide → 6 cycles maintenance temozolomide
TTF sequencing for ndGBM: add TTF during adjuvant (maintenance) temozolomide after radiochemotherapy completion
rGBM: TTF may be used as the only treatment option per policy criteria

Note
Clinical Sequencing Context
Clinical sequencing context: clinical guidelines (NCCN, EANO, ESMO) support using alternating electric field therapy as an adjunct to standard therapy in specified settings for supratentorial GBM. Trial enrollment and guideline recommendations informed the policy timing of device initiation (after radiochemotherapy) and the requirements for ongoing systemic therapy or device-only use depending on ndGBM versus rGBM.
NCCN: alternating electric field therapy is an option for supratentorial disease and recommended in combination with adjuvant TMZ for appropriate patients
EF-14 trial: enrollment occurred after radiochemotherapy completion, excluding early progressors — informs timing for device initiation

First-line (EF-14 context):

After completion of radiochemotherapy, TTFields may be initiated concurrently with maintenance temozolomide in newly diagnosed supratentorial GBM to improve PFS and OS as demonstrated in EF-14

EF-14 randomized trial context

salvage

Salvage (evidence considerations): For recurrent disease, TTFields have been compared to best standard care; some evidence indicates comparable OS and distinct toxicity profile, and additional data are needed to define benefit versus chemotherapy or combination approaches

ECRI and trial evidence (LUNAR) referenced

first-line

First-line (trial outcomes): EF-14 randomized participants showed improved PFS and OS with TTFields added to maintenance TMZ compared to TMZ alone; median OS improvements reported in final analyses

Stupp et al. EF-14/EF-14 final analysis

salvage

Salvage (safety and surveillance): Post-marketing surveillance and randomized trial data indicate the most common TTFields-related adverse events are array-associated skin reactions; surveillance of large cohorts shows no new safety concerns

Safety profile documented in post-marketing surveillance and trials

MGMT status is not required to determine TTFields coverage per the policy; it is informational for systemic therapy selection

Evidence summaryMeta-analyses reported TTFields combination therapy improved survival regardless of MGMT status, though optimal regimens may differ by MGMT methylation

inv-51: IDH mutation status

IDH mutation roleIDH mutation status (e.g., IDH‑wildtype) is used in guideline-based classification and was the referenced population in trials supporting TTFields in ndGBM

Diagnostic contextIDH mutation status helps define tumor classification (IDH‑wildtype glioblastoma) relevant to guideline recommendations for TTFields

Not required for coverageIDH testing is informational and not mandated for TTFields coverage per policy

inv-52: MGMT promoter methylation

MGMT evidence summarySystematic reviews and meta-analyses report that TTFields plus standard therapy improved survival regardless of MGMT promoter methylation, though treatment rankings vary by methylation status

Clinical implicationMGMT status may guide choice of standard systemic therapy (e.g., TMZ) but is not a prerequisite for TTFields coverage

Trial dataSubgroup analyses in EF-14 and pooled analyses included MGMT status in evaluating outcomes with TTFields+TMZ

Example meaningECOG 2 = ambulatory and capable of self-care but unable to work; up and about more than 50% of waking hours

inv-37: Supratentorial — Upper portion of the brain; policy limits coverage to supratentorial GBM.

Anatomic definitionSupratentorial refers to the upper portion of the brain (cerebrum and related structures); policy limits coverage to supratentorial GBM

Coverage implicationTTFields coverage applies only to supratentorial glioblastoma per policy and guideline footnotes

Trial populationEF-14 and FDA labeling pertain to supratentorial GBM populations included in randomized trials

inv-38: Temozolomide (TMZ) — Oral alkylating chemotherapy used as first-line treatment; policy requires ongoing TMZ as the only cancer drug for ndGBM...

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

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

Trial contextEF-14 randomized trial evaluated Optune combined with maintenance TMZ after completion of radiochemotherapy

inv-39: Newly diagnosed glioblastoma (ndGBM) — Supratentorial glioblastoma in adults after completion of radiochemotherapy; population enrolled in EF-14...

Population definitionNewly diagnosed glioblastoma (ndGBM) refers to supratentorial GBM in adults after completion of radiochemotherapy; EF-14 enrolled patients after radiochemotherapy

Coverage timingTTFields are initiated after maximal safe resection and completion of radiation therapy with concomitant TMZ

Initial approval durationInitial approval in ndGBM is for 3 months per policy when criteria are met

inv-40: TTFields compliance — Percent monthly device usage captured by the device; higher compliance (≥50%, best outcomes >90%)

DefinitionTTFields compliance is percent monthly device usage (hours/day averaged as a monthly percentage) recorded by the device

Outcome correlationHigher compliance (≥50% monthly usage associated with improved PFS and OS; best outcomes observed >90%) correlates with better survival

Source of dataCompliance-outcome relationship derived from subgroup analysis of EF-14 and device-recorded usage data

inv-41: Optune (NovoTTF-100A) — A medical device delivering tumor-treating fields approved by the FDA for adults with recurrent GBM and with supplemental approval...

Device identificationOptune (formerly NovoTTF-100A) is a medical device that delivers tumor‑treating fields (alternating electric fields) for glioblastoma treatment

Regulatory statusOptune received FDA approval for recurrent GBM in 2011 and supplemental approval with TMZ for newly diagnosed supratentorial GBM in 2015

Trial evidenceEF-14 randomized trial (Stupp et al.) evaluated Optune + TMZ versus TMZ alone demonstrating improved PFS and OS

inv-42: Alternating electric field therapy / TTField — Therapy involving alternating electric fields applied to the scalp for treatment of supratentorial glioblastoma.

Therapy descriptionAlternating electric field therapy (TTFields) applies low‑intensity, intermediate‑frequency alternating electric fields to the scalp to disrupt tumor cell division in supratentorial GBM

Clinical useTTFields are used as an adjunct to maintenance temozolomide in newly diagnosed supratentorial GBM per trial evidence and guideline recommendations

Device requirementsTreatment requires scalp arrays, frequent array changes, and sustained daily wear to achieve effective monthly compliance