CurrentUnitedHealthcarePolicy CANCER 039.15

Electric Tumor Treatment Field Therapy

Policy governing medical necessity coverage criteria, continuation criteria, definitions, applicable codes, and evidence summary for use of FDA‑approved electric tumor treatment field (TTF) devices (e.g., Optune) for supratentorial glioblastoma (newly diagnosed and recurrent) and discussion of other tumor sites (not covered/evidence insufficient).

Policy Summary

PayerUnitedHealthcare

PolicyElectric Tumor Treatment Field Therapy

Policy CodePolicy CANCER 039.15

Change TypeRemoved, Revised (documentation), Removed (code), Updated sections

Effective DateOct 1, 2025

Next Review Date

Key ActionPrior authorization should be requested to approve an initial 3 months of electric TTF therapy only when all initial criteria for ndGBM or rGBM are met.

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.

Updated Medical Records Documentation Used for Review; added requirements for physician notes for newly diagnosed and recurrent glioblastoma.

Removed CPT code 77299 from Applicable Codes.

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

2Covered clinical scenarios (ndGBM, rGBM)

3Initial approval duration (months)

Required daily wear hours (≥)

≥60Minimum KPS for eligibility

FDA PMARegulatory approvals noted

Do not offerContrasting guideline position (NICE)

Coverage Summary

Policy CANCER 039.15 (Effective October 1, 2025) covers use of FDA‑approved electric tumor treatment field (TTF) devices (e.g., the Optune Treatment Kit) for newly diagnosed supratentorial glioblastoma (ndGBM) and recurrent supratentorial glioblastoma (rGBM) when specified clinical criteria are met; other indications and uses not meeting the criteria are considered not medically necessary or unproven. Covered scenarios include ndGBM after debulking surgery, completion of radiation therapy, and when the patient is receiving temozolomide (TMZ) as the only cancer drug; and rGBM when the device is used as the sole treatment. Initial approval for either ndGBM or rGBM is for an initial 3 months, with continuation permitted only if continuation criteria are met. Key eligibility thresholds include documented device wear time of at least 18 hours per day, a performance status of KPS ≥ 60 or ECOG < 2, and MRI within 2 months showing no progression for continuation requests. Uses not meeting these criteria (including treatment of tumors other than GBM or concurrent use with other systemic therapies for rGBM) are not covered.

Key thresholds & quick facts

Device wear time≥ 18 hours per day

Karnofsky Performance Status (KPS)≥ 60

ECOG Performance Status< 2

MRI interval for continuationPerformed within < 2 months and documents no evidence of disease progression

Initial approval duration3 months

Covered clinical scenarios2 (newly diagnosed GBM, recurrent GBM)

Regulatory approvalsFDA PMA April 2011; supplemental PMA October 2015

Medical-Necessity Criteria

Medically necessary — Newly diagnosed supratentorial glioblastoma (ndGBM)

Covered when ALL of the following are met:

ALL of the following

Debulking surgery has been completed.
Use of a US Food and Drug Administration (FDA)–approved device to generate electric tumor treatment fields (TTF) when used according to FDA labeled indications, contraindications, warnings, and precautions.
Radiation therapy has been completed.
Individual has a Karnofsky Performance Status (KPS) score \u2265 60 or Eastern Cooperative Oncology Group (ECOG) Performance Status < 2.

Provider Actions & Operational Requirements

Prior Authorization

Initial authorization requirement

Prior authorization/coverage approval is required. An initial 3 months of electric TTF therapy will be approved only when all initial criteria for newly diagnosed supratentorial glioblastoma (ndGBM) or recurrent supratentorial glioblastoma (rGBM) are met. Applicable codes: E0766, A4555, E0767.

Codes: E0766, A4555, E0767
Initial approval: 3 months only when initial ndGBM or rGBM criteria are met

Documentation Required

Clinical documentation for initial and continuation requests

Required documentation for initial and continuation requests includes: completion of debulking surgery (if ndGBM); completion of radiation therapy (if ndGBM); current Karnofsky Performance Status (KPS) or ECOG score; confirmation that temozolomide (TMZ) is the only cancer drug for ndGBM or that the device is the sole therapy for rGBM; counseling that the device must be worn at least 18 hours per day; and for continuation requests, a brain MRI performed within < 2 months documenting no evidence of disease progression.

Coding

Applicable HCPCS / supply codes (reference only)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 / Previously Listed CPT codesCPT

77299

Previously listed CPT code removed from Applicable Codes (no longer included)

Coverage Rationale & Evidence Summary

Electric tumor treatment field (TTF) therapy delivers low‑intensity, intermediate‑frequency electric fields (approximately 100–300 kHz) via transducer arrays placed on the scalp to disrupt cell division in brain tumors. The Optune kit includes the portable field generator, transducer arrays, power supply, and consumable supplies; arrays are placed on the scalp according to tumor location and typically require scalp shaving and array replacement once to twice weekly. The manufacturer and policy describe noninvasive, portable treatment intended to be used continuously for at least 18 hours per day (treatment given for a minimum of 4 weeks per the device instructions). The most common adverse events associated with TTF are array‑associated skin reactions (dermatologic toxicity), generally mild to moderate and manageable; other reported sensations include under‑array warmth, tingling, and headache, while systemic serious toxicities are uncommon.

Policy‑level coverage rationale notes that the Optune Treatment Kit received FDA premarket approval in April 2011 for adults with recurrent GBM and a supplemental PMA in October 2015 for use with temozolomide in newly diagnosed supratentorial GBM following maximal debulking surgery and completion of radiation therapy. Major guideline positions are mixed: ASCO/SNO (2022) supports adding alternating electric field therapy to adjuvant TMZ in selected newly diagnosed supratentorial GBM patients (evidence quality: moderate; recommendation: weak); NCCN includes alternating electric field therapy as an option with standard RT and temozolomide for patients with good performance status (KPS ≥ 60) and recognizes FDA approvals for ndGBM and rGBM; EANO/ESMO cautions against treatments beyond confirmed progression (including TTFields) because benefit is unestablished; and NICE (2018, updated 2021) recommends not offering TTFields for newly diagnosed grade IV glioma or recurrent high‑grade glioma. Safety evaluations and post‑marketing surveillance report a favorable overall safety profile with dermatologic AEs the most specific device‑related toxicity and no new safety signals or treatment‑related deaths in cited studies. These regulatory, guideline, and safety considerations inform the policy’s specified inclusion and exclusion criteria and continuation requirements.

Definitions

Term	Definition
Supratentorial
A term used to describe the upper portion of the brain comprised of the cerebrum, ventricles, choroid plexus, hypothalamus, pineal gland, pituitary gland, and optic nerve.
Karnofsky Performance Status (KPS)
A standard way of measuring the ability of cancer patients to perform ordinary tasks. KPS scores range from 0 to 100; a higher score means a person is better able to carry out daily activities. KPS ≥ 60 is used as an eligibility threshold in this policy.
ECOG Performance Status
Eastern Cooperative Oncology Group (ECOG) Scale of Performance Status describing functional status; ECOG < 2 is used as an eligibility threshold in this policy.
Temozolomide (TMZ)
An oral alkylating chemotherapy drug used as first-line treatment for glioblastoma.
TTFields
Tumor Treating Fields — alternating electric fields therapy delivered by devices such as the Optune Treatment Kit.
Optune Treatment Kit
Novocure device (formerly NovoTTF-100A) approved by the FDA for rGBM with supplemental approval with temozolomide for newly diagnosed supratentorial glioblastoma.
ndGBM
Newly diagnosed glioblastoma.
rGBM
Recurrent glioblastoma.

Revision History

2025-10-01removedLatest

2025-10-01revisedLatest

Updated Medical Records Documentation Used for Reviews; added requirements that for newly diagnosed glioblastoma physician notes include history of all relevant surgeries, and for recurrence physician notes include current treatments.

Policy Summary

PayerUnitedHealthcare

PolicyElectric Tumor Treatment Field Therapy

Policy CodePolicy CANCER 039.15

Change TypeRemoved, Revised (documentation), Removed (code), Updated sections

Effective DateOct 1, 2025

Next Review Date

Key ActionPrior authorization should be requested to approve an initial 3 months of electric TTF therapy only when all initial criteria for ndGBM or rGBM are met.

On This Page

Individual is receiving temozolomide (TMZ) as the only cancer drug.

Individual has been counseled that the electric TTF device must be worn at least 18 hours daily.

When all of the above criteria are met for newly diagnosed supratentorial glioblastoma (ndGBM), an initial 3 months of electric TTF therapy will be approved.

Initial approval for ndGBM

Initial approval: 3 months when the ndGBM criteria above are met.

Medically necessary — Recurrent supratentorial glioblastoma (rGBM)

Covered when ALL of the following are met:

ALL of the following

The device is used as the only treatment.
Use of an FDA-approved device to generate electric TTF after initial chemotherapy when used according to FDA labeled indications, contraindications, warnings, and precautions.
Individual has a Karnofsky Performance Status (KPS) score \u2265 60 or Eastern Cooperative Oncology Group (ECOG) Performance Status < 2.
Individual has been counseled that the electric TTF device must be worn at least 18 hours daily.

When all of the above criteria are met for recurrent supratentorial glioblastoma (rGBM), an initial 3 months of electric TTF therapy will be approved.

Initial approval for rGBM

Initial approval: 3 months when the rGBM criteria above are met.

Continuation (beyond initial 3 months) for ndGBM and rGBM

Coverage for continuation beyond the initial 3 months is based on ALL of the following:

ALL of the following

For ndGBM: individual continues to receive temozolomide (TMZ) as the only cancer drug; OR for rGBM: the device is used as the only treatment.
Continuation requirement differs by ndGBM versus rGBM as specified.
Magnetic resonance imaging (MRI) performed within the prior 2 months documents no evidence of disease progression.
Individual has a Karnofsky Performance Status (KPS) score \u2265 60 or Eastern Cooperative Oncology Group (ECOG) Performance Status < 2.
Documentation that the individual has been using the electric TTF device at least 18 hours daily.

Continuation differs by ndGBM vs rGBM per the first child above.

Not medically necessary / Unproven

Use of devices to generate electric TTF is unproven and not medically necessary when the criteria above are not met and for all other indications including but not limited to:

Treatment of tumors other than glioblastoma (GBM).

Use of electric TTF therapy with concurrent medical therapy (for example, bevacizumab or chemotherapy) for treatment of recurrent GBM.

Any other indication or clinical scenario that does not meet the medically necessary criteria above.

Debulking surgery completion (if ndGBM)
Completion of radiation therapy (if ndGBM)
Current KPS or ECOG performance status
Confirmation of TMZ as only cancer drug for ndGBM or device as sole therapy for rGBM
Counseling that device must be worn ≥18 hours/day
MRI within <2 months showing no progression (for continuation)

Documentation Required

Medical records documentation requirements (added)

New/updated medical records documentation requirement: for newly diagnosed glioblastoma (ndGBM) physician notes must include history of all relevant surgeries; for recurrent glioblastoma (rGBM) physician notes must include current treatments. This requirement was added/updated in the policy's documentation section.

ndGBM: physician notes to include history of all relevant surgeries
rGBM: physician notes to include current treatments

Denial Risk

Denial if criteria not met

Claims or prior authorization requests may be denied if required clinical criteria are not met. Examples include inadequate or missing documentation of performance status (KPS/ECOG), concurrent or disallowed therapies, lack of timely MRI demonstrating no progression, or insufficient documentation of device use/compliance (wear time).

Performance status not meeting KPS ≥60 or ECOG <2
Concurrent therapies that violate coverage criteria (e.g., concurrent chemotherapy for rGBM)
MRI not performed within <2 months or MRI documents progression
No documentation of device use at least 18 hours/day

Billing Rule

Applicable code removal

CPT code 77299 was removed from the policy's list of applicable codes as noted in the revision history. Refer to the revision effective date in the policy history.

Removed code: 77299 (CPT)
Revision effective date: October 1, 2025

Evidence summary — key findings

EF-14 trial outcome (PFS)Median PFS ~7.1 months (TTFields+TMZ) vs 4.0 months (TMZ alone)

EF-14 trial outcome (OS)Per-protocol median OS ~20.5 vs 15.6 months; intent-to-treat median OS 19.6 vs 16.6 months

Meta-analyses findingsSystematic reviews/meta-analyses show improved median OS for ndGBM; compliance ≥75% associated with better outcomes

EF-14 MOS value (reported elsewhere)MOS reports include values ~20.5 months (per-protocol) and other analyses listing MOS up to ~22.6 months in pooled studies

Grade ≥3 adverse eventsSystemic grade ≥3 AEs reported: anemia ~11%, neutropenia ~9%, thrombocytopenia ~5% (in non-GBM STELLAR and pooled reports)

Skin reaction incidenceDermatologic AEs common: reported ~66% grade 1-2 and ~5% grade 3 in thoracic trial; skin irritation reported in EF-14 (e.g., 52%)

Hayes HTA ratingHayes Health Technology Assessment: rating C for rGBM monotherapy and for use with concomitant TMZ in ndGBM (small, low-quality evidence)

Removed CPT code 77299 from Applicable Codes.

2025-10-01revised

Updated Description of Services, Clinical Evidence, FDA, and References sections to reflect current information and archived previous policy version CANCER 039.14.