CurrentUnitedHealthcarePolicy CS146PA.M

Electric Tumor Treatment Field Therapy (for Pennsylvania Only)

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Pennsylvania Medicaid managed-care coverage and prior authorization for FDA-approved electric tumor treatment field devices used for newly diagnosed or recurrent supratentorial glioblastoma.

Policy Summary

PayerUnitedHealthcare

PolicyElectric Tumor Treatment Field Therapy (for Pennsylvania Only)

Policy CodePolicy CS146PA.M

Change TypeAdministrative and reference updateno material clinical or coverage change

Effective DateOctober 1, 2026

Next Review DateN/A

Key ActionSubmit prior authorization requests with documentation of the applicable GBM criteria and required clinical records.

SourceLink

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CurrentUnitedHealthcarePolicy CS146PA.M

Electric Tumor Treatment Field Therapy (for Pennsylvania Only)

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Pennsylvania Medicaid managed-care coverage and prior authorization for FDA-approved electric tumor treatment field devices used for newly diagnosed or recurrent supratentorial glioblastoma.

Policy Summary

PayerUnitedHealthcare

PolicyElectric Tumor Treatment Field Therapy (for Pennsylvania Only)

Policy CodePolicy CS146PA.M

Change TypeAdministrative and reference updateno material clinical or coverage change

Effective DateOctober 1, 2026

Next Review DateN/A

Key ActionSubmit prior authorization requests with documentation of the applicable GBM criteria and required clinical records.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

PA onlyGeographic scope

3 monthsInitial approval

≥18 hoursDaily device wear

KPS ≥60 or ECOG ≤2Functional status

MRI ≤2 monthsContinuation imaging

Other tumors/concurrent therapyExcluded uses

Coverage Criteria

Initial therapy for newly diagnosed GBM

Covered as proven and medically necessary when all criteria are met.

Newly diagnosed supratentorial GBM

Required treatment and clinical criteria: Debulking surgery has been completed; radiation therapy has been completed; the individual is receiving temozolomide as the only cancer drug; KPS is ≥60 or ECOG is ≤2; and the individual has been counseled that the device must be worn at least 18 hours daily.KPS ≥60 or ECOG ≤2; device wear at least 18 hours daily
All listed elements are required.

Initial therapy for recurrent GBM

Covered as proven and medically necessary when all criteria are met.

Recurrent supratentorial GBM

Required treatment and clinical criteria: The device is used as the only treatment; KPS is ≥60 or ECOG is ≤2; and the individual has been counseled that the device must be worn at least 18 hours daily.KPS ≥60 or ECOG ≤2; device wear at least 18 hours daily
All listed elements are required.

Continuation therapy

Continuation beyond the initial 3 months is approved when all criteria are met.

Continuation therapy for histologically confirmed supratentorial GBM: An MRI scan was performed no more than 2 months before the request and documents no evidence of disease progression; for newly diagnosed GBM, temozolomide remains the only cancer drug, or for recurrent GBM, the device remains the only treatment; KPS is ≥60 or ECOG is ≤2; and documentation shows device use for at least 18 hours daily.MRI ≤2 months before request; KPS ≥60 or ECOG ≤2; device use at least 18 hours daily

Applies to continuation beyond the initial 3 months.

Electric tumor treatment field devices are unproven and not medically necessary for tumors other than glioblastoma (GBM).

Electric tumor treatment field therapy is unproven and not medically necessary when used with concurrent medical therapy for recurrent glioblastoma, including bevacizumab or chemotherapy.

Use is unproven and not medically necessary when the stated coverage criteria are not met.

Due to insufficient evidence of efficacy, electric tumor treatment field devices are unproven and not medically necessary for all other indications, including tumors other than GBM and recurrent GBM treated with concurrent medical therapy such as bevacizumab or chemotherapy.

Coding and Operational Parameters

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.

Daily device wear

Required wear timeAt least 18 hours daily

Applies toInitial and continuation electric tumor treatment field therapy for qualifying glioblastoma

Continuation documentationActual device use of at least 18 hours daily must be documented

Karnofsky Performance Status threshold

Minimum KPSKarnofsky Performance Status score of ≥ 60

Initial therapyRequired for newly diagnosed and recurrent supratentorial glioblastoma

Continuation therapy

Prior Authorization and Documentation

Prior Authorization

Pennsylvania Prior Authorization Required

In Pennsylvania, prior authorization is required for electric tumor treatment field (TTF) therapy. Requests that do not meet the Prior Authorization Review Panel (PARP) criteria are evaluated case by case under Pennsylvania Code § 55.1101.31(f); when criteria are met, the initial approval period is 3 months.

Applies only to Pennsylvania requests.
Use an FDA-approved device according to FDA-labeled indications, contraindications, warnings, and precautions.
Initial approval is limited to 3 months for newly diagnosed GBM or recurrent GBM when the applicable criteria are met.

Documentation Required

Submit Medical Necessity Records

Submit legible medical records that fully support medical necessity for the requested TTF therapy. Records must be maintained in the patient's medical record and made available upon request; documentation supports clinical review but does not guarantee coverage.

Therapy Background

Electric tumor treatment field therapy uses low-intensity, intermediate-frequency alternating electric fields, generally 100 to 300 kHz, to disrupt cell division in proliferating brain tumor cells. The fields are delivered through skin-applied transducer arrays. This policy addresses FDA-approved devices for newly diagnosed and radiologically confirmed recurrent supratentorial glioblastoma.

Policy Definitions

Eastern Cooperative Oncology Group (ECOG) Scale of Performance Status

PurposeStandard measure of how disease affects self-care, daily activity, and physical ability

Score range0 through 5

Score interpretation0 means fully active; 5 means dead; a score of 2 means ambulatory and capable of self-care but unable to work

Karnofsky Performance Status (KPS)

PurposeStandard measure of a patient's ability to perform ordinary tasks

Score range0 to 100

Score of 60

Evidence by Line of Therapy

First-line

Evidence setting for first-line therapy.

Newly diagnosed GBM treatment setting: Debulking surgery and radiation therapy have been completed, and the individual is receiving temozolomide as the only cancer drug.

The policy authorizes initial electric tumor treatment field therapy for 3 months when all coverage criteria are met.

Salvage

Evidence setting for salvage therapy.

Recurrent GBM treatment setting: Radiologically confirmed supratentorial GBM recurrence is present after initial chemotherapy, and the electric tumor treatment field device is used as the only treatment.

The policy authorizes initial electric tumor treatment field therapy for 3 months when all coverage criteria are met.

Salvage

Biomarker and Molecular Characteristics

PTEN mutation status

FindingPTEN-mutant tumors showed longer postprogression survival with TTFields than PTEN-wild-type tumors

PTEN-mutant comparisonMedian postprogression survival was 22.2 months with TTFields versus 9.3 months without TTFields

Study limitationThe finding came from a retrospective analysis with a small sample size

MGMT promoter methylation

Methylated subgroupTTField combination therapy was associated with favorable survival

Unmethylated subgroupTTField combination therapy was also associated with favorable survival

Therapy Regimens and Comparative Evidence

Regimen	Clinical setting	Coverage status
Electric tumor treatment field therapy with temozolomide as the only cancer drug	Newly diagnosed, histologically confirmed supratentorial glioblastoma after debulking surgery and radiation therapy	Covered

Regimen	Clinical setting	Coverage status
Electric tumor treatment field therapy as the only treatment	Radiologically confirmed recurrent supratentorial glioblastoma after initial chemotherapy	Covered

Regimen	Clinical setting	Coverage status
Electric tumor treatment field therapy with bevacizumab or chemotherapy	Recurrent glioblastoma with concurrent medical therapy	Not covered

Regimen	Clinical setting	Coverage status
TTFields plus maintenance temozolomide	Newly diagnosed glioblastoma after completion of concomitant radiochemotherapy	Covered

Regimen	Clinical setting	Coverage status
TTFields with or without bevacizumab compared with best standard care or chemotherapy	Recurrent glioblastoma	Neutral

Regimen	Clinical setting	Coverage status
TTFields plus gemcitabine/nab-paclitaxel	Unresectable, locally advanced pancreatic adenocarcinoma	Neutral

Regimen	Clinical setting	Coverage status
TTFields plus paclitaxel	Platinum-resistant epithelial ovarian cancer	Not covered

Regimen	Clinical setting	Coverage status
TTFields plus paclitaxel versus paclitaxel alone	Platinum-resistant epithelial ovarian cancer	Experimental

Regimen	Clinical setting	Coverage status
TTFields plus standard systemic therapy versus standard therapy alone	Metastatic non-small-cell lung cancer after progression on or after platinum-based therapy	Experimental

Regimen	Clinical setting	Coverage status
Thoracic TTFields at 150 kHz plus intravenous pemetrexed and cisplatin or carboplatin every 21 days for up to six cycles, followed by TTFields maintenance when appropriate	Unresectable malignant pleural mesothelioma in the front-line setting	Experimental

Regimen	Clinical setting	Coverage status
Optune/alternating electric field therapy with temozolomide	Newly diagnosed supratentorial glioblastoma after maximal debulking surgery, radiation, and concomitant standard-of-care chemotherapy	Experimental

Regimen	Clinical setting	Coverage status
Alternating electric field therapy as an option considered by NCCN; EF-11 compared it with physician's-choice chemotherapy	Recurrent glioblastoma	Experimental

Policy Summary

PayerUnitedHealthcare

PolicyElectric Tumor Treatment Field Therapy (for Pennsylvania Only)

Policy CodePolicy CS146PA.M

Change TypeAdministrative and reference updateno material clinical or coverage change

Effective DateOctober 1, 2026

Next Review DateN/A

Key ActionSubmit prior authorization requests with documentation of the applicable GBM criteria and required clinical records.

SourceLink

On This Page

KPS documentation is required beyond the initial 3 months

ECOG Performance Status threshold

Maximum ECOG scoreECOG Performance Status of ≤ 2

Initial therapyRequired for newly diagnosed and recurrent supratentorial glioblastoma

Continuation therapyECOG documentation is required beyond the initial 3 months

Continuation MRI timing

Imaging requiredMagnetic resonance imaging scan

TimingPerformed no more than 2 months before the request

Required findingNo evidence of disease progression

Initial approval duration

Initial approval period3 months

Applies toQualifying newly diagnosed or recurrent supratentorial glioblastoma

Further treatmentContinuation beyond 3 months requires the specified MRI, treatment-status, performance-status, and device-use documentation

Include relevant medical history, physical examination findings, and pertinent diagnostic test or procedure results.

Documentation Required

Document Clinical Criteria

Document the clinical facts needed to establish the applicable GBM criteria before submitting the request.

Histologic confirmation and supratentorial location of the newly diagnosed or recurrent GBM.
Treatment history, including initial chemotherapy for recurrent GBM.
Completion of debulking surgery and radiation therapy for newly diagnosed GBM.
Current therapy status: Temozolomide as the only cancer drug for newly diagnosed GBM, or TTF as the only treatment for recurrent GBM.
KPS score of ≥ 60 or ECOG performance status of ≤ 2.
Counseling that the device must be worn at least 18 hours daily; for continuation, document actual use of at least 18 hours daily.
For continuation requests, MRI performed ≤ 2 months before the request with no evidence of disease progression.

Denial Risk

Watch for Nonqualifying Indications or Concurrent Therapy

TTF therapy is unproven and not medically necessary when the stated criteria are not met, including non-GBM indications or concurrent treatment for recurrent GBM.

Tumors other than GBM do not qualify under this policy.
For recurrent GBM, do not use TTF concurrently with medical therapy such as bevacizumab or chemotherapy; the device must be used as the only treatment.

Denial Risk

Initial Newly Diagnosed GBM Criteria Not Met

An initial newly diagnosed GBM request is at risk for denial when any required criterion is absent or undocumented.

GBM is not histologically confirmed or is not supratentorial.
Debulking surgery or radiation therapy has not been completed.
The individual is receiving a cancer drug other than Temozolomide, or Temozolomide is not the only cancer drug.
KPS is < 60 or ECOG performance status is > 2.
The individual has not been counseled to wear the device at least 18 hours daily.

Denial Risk

Initial Recurrent GBM Criteria Not Met

An initial recurrent GBM request is at risk for denial when any required criterion is absent or undocumented.

Recurrence is not radiologically confirmed or is not in the supratentorial region.
TTF is not being used after initial chemotherapy, or the device will not be used as the only treatment.
KPS is < 60 or ECOG performance status is > 2.
The individual has not been counseled to wear the device at least 18 hours daily.

Denial Risk

Continuation Criteria Not Met

Continuation beyond the initial 3 months is at risk for denial when the required follow-up evidence or ongoing treatment criteria are not met.

MRI was not performed within 2 months before the request or shows evidence of disease progression.
For newly diagnosed GBM, Temozolomide is no longer the only cancer drug; for recurrent GBM, TTF is not the only treatment.
KPS is < 60 or ECOG performance status is > 2.
Documentation does not show device use for at least 18 hours daily.

Requires occasional assistance but can care for most personal needs

Supratentorial

Anatomical locationUpper portion of the brain

Primary structureComprises the cerebrum

Associated structuresIncludes the ventricles, choroid plexus, hypothalamus, pineal gland, pituitary gland, and optic nerve

Temozolomide

Drug typeOral alkylating chemotherapy drug

UseUsed to treat some brain cancers

Glioblastoma roleDescribed in the policy as a first-line treatment for glioblastoma

Tumor treating fields (TTFields)

Treatment typeLow-intensity, intermediate-frequency alternating electric fields

Delivery methodDelivered through skin-applied transducer arrays

Therapeutic effectDisrupts the rapid cell division exhibited by cancer cells

Recurrent glioblastoma (rGBM)

Disease stateGlioblastoma that has returned or progressed

TimingOccurs after initial treatment

AbbreviationrGBM

Newly diagnosed glioblastoma (ndGBM)

Disease stateGlioblastoma newly diagnosed before or during initial treatment

Treatment contextIncludes participants who completed concomitant radiochemotherapy before maintenance therapy

AbbreviationndGBM

Evidence setting for salvage therapy.

Disease setting: TTFields evidence was evaluated in recurrent glioblastoma at first recurrence or in glioblastoma at any line of recurrence in postmarketing surveillance.

Evidence setting; not an explicit coverage criterion.

First-line

Evidence setting for first-line therapy.

Post-chemoradiation maintenance setting: Participants had glioblastoma that was resected or biopsied and had completed concomitant radiochemotherapy before randomization to TTFields plus maintenance temozolomide or temozolomide alone.

Evidence setting; not an explicit coverage criterion.

First-line

Evidence setting for first-line therapy.

STELLAR eligibility and treatment setting: Unresectable malignant pleural mesothelioma was treated with front-line TTFields delivered to the thorax plus pemetrexed and platinum chemotherapy.At least one measurable or evaluable lesion; ECOG 0–1

Single-arm phase 2 evidence; participants without progression after chemotherapy received TTFields maintenance.

Second-line

Evidence setting for second-line therapy.

LUNAR eligibility and treatment setting: Metastatic NSCLC that progressed on or after platinum-based therapy was treated with TTFields plus standard systemic therapy.ECOG 0–2

Randomized phase 3 evidence; squamous and nonsquamous histologies were included.

First-line

Evidence setting for first-line therapy.

Newly diagnosed glioblastoma adjuvant setting: Alternating electric field therapy may be added to adjuvant temozolomide after completion of chemoradiation in newly diagnosed supratentorial glioblastoma.IDH-wild-type, CNS WHO grade 4; NCCN performance status generally KPS ≥60

ASCO/SNO describes the recommendation as weak with moderate-quality evidence; NCCN lists radiation therapy plus concurrent and adjuvant temozolomide with alternating electric field therapy as a category 1 option in specified age, performance-status, and MGMT groups.

Salvage

Evidence setting for salvage therapy.

Recurrent or progressive glioblastoma: Alternating electric field therapy may be considered for recurrent or progressive glioblastoma.NCCN category 2B; KPS and disease characteristics guide treatment selection

NCCN notes divided panel opinion because EF-11 did not demonstrate clear survival efficacy; clinical trials, systemic therapy, surgery, reirradiation, or supportive care may also be considered.

The favorable survival association was observed regardless of MGMT promoter methylation status

Known actionable mutations

Study populationAdults with newly diagnosed NSCLC brain metastases suitable for stereotactic radiosurgery

Exclusion criterionParticipants with known actionable mutations were excluded

Treatment studyMETIS evaluated stereotactic radiosurgery followed by TTFields versus stereotactic radiosurgery alone

MGMT promoter methylation

Possible statusMethylated, unmethylated, or indeterminate

Treatment relevanceMGMT promoter methylation status informs glioblastoma treatment selection

Guideline contextAlternating electric field therapy is listed among treatment options across the stated MGMT subgroups

IDH status

Possible classificationIDH-wild-type or IDH1/2-mutant

Newly diagnosed glioblastoma guidanceThe ASCO/SNO recommendation addresses newly diagnosed supratentorial glioblastoma that is IDH-wild-type and CNS WHO grade 4

Recurrent disease guidanceNCCN identifies IDH1/2-mutant glioma categories separately in recurrent or progressive disease recommendations

1p/19q codeletion

StatusCodeleted

Genetic finding1p/19q codeletion

Guideline contextListed in the recurrent or progressive oligodendroglioma category

H3 mutation

StatusH3-mutated

Disease contextRecurrent or progressive high-grade glioma

Guideline contextListed among disease categories for which treatment options may include clinical trials or systemic therapy

Tumor genetic subtype

StudyLUNAR phase 3 study in metastatic non-small-cell lung cancer

FindingThe relationship between TTFields efficacy and tumor genetic subtype was not established

Reason notedThe study began before standard genetic profiling by next-generation sequencing in NSCLC