ModifiedUnitedHealthcarePolicy N/A

Electric Tumor Treatment Field Therapy In Cs

Defines UnitedHealthcare's medical policy coverage rationale, clinical criteria, documentation and coding notes for electric tumor treatment field (TTF) therapy (Optune) for newly diagnosed and recurrent glioblastoma, with Indiana-specific billing note for HCPCS E0767 and performance-status and usage requirements for coverage.

Policy Summary

PayerUnitedHealthcare

PolicyElectric Tumor Treatment Field Therapy In Cs

Policy CodePolicy N/A

Change TypeCoverage criteria revisedadded proven & medically necessary rGBM criteria

Effective DateApril 1, 2026

Next Review Date

Key ActionProviders must document radiologic confirmation of rGBM, that device will be used as only treatment, KPS ≥ 60 or ECOG ≤=2, and documented counseling that device must be worn ≥ 18 hours/day to obtain an initial 3-month approval.

SourceLink

POLICY UPDATE CHANGES

Replaced language indicating 'electric tumor treatment field therapy for all other indications medically necessary in certain circumstances' with '... considered proven and medically necessary in certain circumstances'.

Added proven and medically necessary criteria for initial treatment of radiologically confirmed recurrence of glioblastoma (rGBM) in the supratentorial region, with device-only use, KPS ≥ 60 or ECOG ≤=2, and counseling on wearing device ≥ 18 hours/day.

Removed language indicating computer software used for therapeutic radiology clinical treatment planning in conjunction with TTF therapy is unproven and not medically necessary.

Added statement that HCPCS code E0767 is not managed for medical necessity review for the state of Indiana; refer to state prior authorization list.

Added statements clarifying medical records documentation may be required, must support medical necessity, and that federal/state/contractual requirements govern coverage.

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Coverage Summary

UnitedHealthcare's policy for Electric Tumor Treatment Field Therapy (TTF/Optune) for glioblastoma takes a mixed coverage stance: it recognizes FDA approvals and allows coverage in specified clinical situations while noting divergent external guidance. The policy is modified and applies to Indiana only, and it defines clinical criteria, documentation and coding notes (including an Indiana-specific billing note for HCPCS E0767) for use in newly diagnosed and recurrent glioblastoma. The policy status is MODIFIED and the subject is Electric Tumor Treatment Field Therapy (TTF / Optune) for glioblastoma.

Quick Facts / Thresholds — Electric Tumor Treatment Field Therapy (TTF)

Karnofsky Performance Status (KPS)≥ 60

ECOG Performance Status≤ 2

Required daily wear time≥ 18 hours/day

Initial approved duration (months)1 (initial 3 months referenced in policy summary; stats list shows 1)

HCPCS code referenced (Indiana note)E0767 — not managed for medical necessity review for Indiana; refer to state prior authorization list

Proven and Medically Necessary Criteria

Approval Duration for rGBM when criteria met

When the rGBM criteria above are met:

ALL of the following

Initial approval duration: 3 months of electric TTF therapy.

NCCN / Clinical Guidance — newly diagnosed GBM (ndGBM) and recurrent GBM (rGBM)

Guidance / recommendations summarized from external bodies:

ANY of the following

NCCN recommendations
- For newly diagnosed GBM (ndGBM): Consider addition of Tumor Treating Fields (TTFields) to maintenance temozolomide after concurrent chemoradiation in appropriate candidates per NCCN guidelines.

Provider Actions & Prior Authorization

Prior Authorization

Initial approval conditions for rGBM

Providers must document radiologic confirmation of recurrent glioblastoma (rGBM) in the supratentorial region, that the electric tumor treatment field (TTF) device will be used as the only treatment, and the individual meets performance status criteria (KPS ≥ 60 or ECOG ≤ 2). The record must also show the patient was counseled and agreed to wear the device at least 18 hours per day. When these initial criteria are met, an initial 3-month approval for TTF therapy will be granted.

E0767

Documentation Required

Medical record documentation requirement

Medical records must contain documentation that fully supports medical necessity for the requested service. This includes, but is not limited to, relevant medical history, physical examination findings, and results of pertinent diagnostic tests or procedures. Documentation should be legible, maintained in the patient's medical record, and must be made available upon request. Medical records may be required to assess whether the member meets the clinical criteria for coverage, but submission of documentation does not guarantee coverage; benefit coverage is determined by applicable federal, state, or contractual requirements and laws.

Coding

HCPCS codes notedHCPCS

E0767

Electrical tumor treatment device (e.g., Optune) — note: HCPCS code E0767 is not managed for medical necessity review for the state of Indiana at this time; refer to the Prior Authorization and Notification List for UnitedHealthcare Community Plan of Indiana

Background, Evidence, and Definitions

Background: The Optune (NovoTTF) device was FDA-approved in April 2011 for adults with recurrent GBM after chemotherapy and radiation, and received a supplemental FDA approval in October 2015 for use with temozolomide in newly diagnosed supratentorial GBM following maximal debulking and completion of radiation therapy. External guidance is divergent: the NCCN supports alternating electric field therapy as an option with adjuvant temozolomide for selected newly diagnosed supratentorial GBM patients and considers it for recurrent GBM (panel divided due to limited efficacy data), whereas NICE (2018, updated 2021) recommends do not offer TTF for both newly diagnosed grade IV glioma (glioblastoma) and recurrent high-grade glioma.

Study/Source	Key point
EF-14 randomized trial (Stupp et al., 2017)	Addition of TTFields to maintenance temozolomide improved PFS and OS versus temozolomide alone in newly diagnosed GBM; benefit observed without significant increase in systemic toxicity; most common AE was mild–moderate scalp skin irritation.
EF-11 trial	Provided safety data supporting FDA approval of Optune for recurrent GBM.

Term	Definition
Supratentorial	Anatomical region of the brain above the tentorium cerebelli, comprising the cerebrum, ventricles, choroid plexus, hypothalamus, pineal gland, pituitary gland, and optic nerve.
KPS	Karnofsky Performance Status; standard measure of ability to perform ordinary tasks with scores 0–100; coverage threshold set at ≥ 60 (KPS of 60 = requires occasional assistance but able to care for most personal needs).
ECOG	Eastern Cooperative Oncology Group Performance Status; standard scale from 0 (fully active) to 5 (dead); coverage threshold set at ≤ 2 (ECOG 2 = ambulatory and capable of selfcare but unable to work; up and about >50% of waking hours).

Revision History

04/01/2026revisedLatest

Replaced language indicating 'electric tumor treatment field therapy for all other indications medically necessary in certain circumstances' with 'electric tumor treatment field therapy for all other indications is considered proven and medically necessary in certain circumstances'.

04/01/2026addedLatest

Added proven and medically necessary criteria for initial treatment of radiologically confirmed recurrence of glioblastoma (rGBM) in the supratentorial region, requiring device-only use, KPS ≥ 60 or ECOG ≤ 2, and counseling on wearing device ≥ 18 hours/day; when criteria met, an initial 3 months of therapy will be approved.