CurrentUnitedHealthcarePolicy CS146ID.B

Electric Tumor Treatment Field Therapy (for Idaho Only)

State-specific UnitedHealthcare medical policy (Idaho only, including Idaho Medicaid Plus) governing coverage of FDA‑approved electric tumor treatment field (TTF) devices for supratentorial glioblastoma (newly diagnosed and recurrent) including initial and continuation criteria and documentation requirements. This part includes coverage rationale, definitions, applicable HCPCS codes, and clinical evidence summaries.

Policy Summary

PayerUnitedHealthcare

PolicyElectric Tumor Treatment Field Therapy (for Idaho Only)

Policy CodePolicy CS146ID.B

Change TypeNo material change

Effective DateMay 1, 2026

Next Review Date

Key ActionProvider must document that all coverage criteria are met (prior debulking surgery and completed radiation for ndGBM; TMZ as only cancer drug for ndGBM; device-only for rGBM; KPS/ECOG threshold; counselling on ≥ 18 hours/day wear) to obtain initial 3-month approval and continuation authorization based on MRI within 2 months and documented device usage.

POLICY UPDATE CHANGES

No material clinical or coverage changes were made in this update.

2Covered Indications (ndGBM, rGBM)

3 monthsInitial approval duration

18 hrs/dayMinimum daily device wear-time requirement

A4555,E0766,E0767Referenced HCPCS codes

This is a state-specific UnitedHealthcare (Idaho only) medical policy (CS146ID.B) for FDA‑approved electric tumor treatment field (TTF) devices used to treat supratentorial glioblastoma (newly diagnosed and recurrent). The policy reflects a mixed coverage stance: TTF is covered for specified ndGBM and rGBM situations when all clinical criteria are met, but is considered not medically necessary when criteria are unmet or for other indications. Key thresholds required for coverage include a performance status of KPS ≥ 60 or ECOG ≤ 2, documented device wear-time of at least 18 hours daily, and an initial approval duration of 3 months when initial criteria are satisfied. Additional documentation and authorization requirements are specified for continuation beyond the initial approval.

Medical-Necessity Criteria

Coverage — Newly Diagnosed Supratentorial Glioblastoma (ndGBM)

Covered when ALL of the following are met:

ALL of the following

Use of U.S. Food and Drug Administration (FDA) approved device to generate electric tumor treatment fields (TTF) used according to FDA labeled indications, contraindications, warnings, and precautions
Debulking surgery has been completed
Treatment with radiation therapy has been completed
Individual is receiving Temozolomide (TMZ) as the only cancer drug
Karnofsky Performance Status (KPS) score of ≥ 60 or Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2KPS ≥ 60; ECOG ≤ 2
Individual has been counselled that the electric TTF device must be worn at least 18 hours dailyAt least 18 hours/day

Initial Authorization — ndGBM

When ALL ndGBM criteria are met:

Initial approval duration: 3 months of electric TTF therapy3 months

Initial Authorization — rGBM

When ALL rGBM criteria are met:

Initial approval duration: 3 months of electric TTF therapy3 months

Continuation/Extension Criteria (beyond initial 3 months)

Subsequent approval(s) for continuation beyond the initial 3 months are based on ALL of the following:

Magnetic resonance imaging (MRI) scan performed ≤ 2 months prior to request documents no evidence of disease progressionMRI ≤ 2 months prior to request

For ndGBM: individual continues to receive TMZ as the only cancer drug; OR for rGBM: the device is used as the only treatment

Specifies continued TMZ for ndGBM or device-only for rGBM

KPS score of ≥ 60 or ECOG Performance Status ≤ 2KPS ≥ 60; ECOG ≤ 2

Documentation that the individual has been using the electric TTF device at least 18 hours dailyAt least 18 hours/day

Not Medically Necessary / Exclusions

Not covered when any of the following apply:

Treatment of tumors other than glioblastoma multiforme (GBM)

Use of electric TTF therapy with concurrent medical therapy (e.g., bevacizumab or chemotherapy) for treatment of rGBM

Use when any required criteria (e.g., performance status, prior surgery/radiation, TMZ status, MRI within 2 months, device use ≥ 18 hours/day) are not metKPS ≥ 60 or ECOG ≤ 2; MRI ≤ 2 months; device use ≥ 18 hours/day; prior debulking surgery and completed radiation (ndGBM); TMZ as only cancer drug (ndGBM) or device-only (rGBM)

Provider Actions

Prior Authorization

Authorization required for initial and continuation therapy

Provider must document that all coverage criteria are met to obtain initial authorization (3 months) and to support continuation beyond the initial approval. For ndGBM this includes prior debulking surgery, completion of radiation, and ongoing Temozolomide (TMZ) as the only cancer drug. For rGBM the device must be used as the only treatment. Performance status thresholds and counselling about required device use are required. Continuation approvals require a recent MRI (≤ 2 months) showing no progression and documentation of device use at least 18 hours/day.

Affected populations: newly diagnosed supratentorial GBM (ndGBM) and recurrent supratentorial GBM (rGBM)
Initial authorization duration: 3 months
Continuation requirements: MRI ≤ 2 months showing no progression; ongoing TMZ only for ndGBM or device-only for rGBM; KPS ≥ 60 or ECOG ≤ 2; documented ≥ 18 hours/day device use

Documentation Required

Medical records documentation

The patient medical record must fully support medical necessity. Required documentation includes relevant medical history and physical examination, diagnostic test results and MRI reports, performance status (KPS or ECOG), documentation of current TMZ treatment status (if ndGBM), counseling about wearing the device at least 18 hours/day, and records documenting device use and training (array changes, scalp care, device operation). Records must be legible, maintained in the chart, and made available on request.

Relevant medical history and physical exam
Pertinent diagnostic test results and MRI reports (including MRI within ≤ 2 months for continuation)
Performance status documentation (KPS score or ECOG)
TMZ treatment status for ndGBM or statement that device is sole therapy for rGBM
Counseling records about wearing device ≥ 18 hours/day
Documentation of device use, array changes, scalp care, and training

Denial Risk

Claims may be denied if criteria not met

Claims may be denied if required clinical criteria are not met. Denial conditions include treatment for tumors other than GBM, lack of required prior surgery/radiation for ndGBM, use of concurrent systemic therapy for rGBM, performance status below policy thresholds, no recent MRI documenting lack of progression for continuation, or insufficient documented device use.

Non-GBM tumor histology
ndGBM without prior debulking surgery or completed radiation
Concurrent systemic therapy in rGBM (e.g., chemotherapy or bevacizumab)
KPS < 60 or ECOG > 2
No MRI within ≤ 2 months for continuation requests or MRI showing progression
Insufficient documentation of device use (< 18 hours/day)

Background, Evidence & Definitions

Tumor‑treating fields (TTF) therapy delivers low‑intensity, intermediate‑frequency electric fields to disrupt tumor cell division and is intended as adjunctive therapy after completion of radiation with temozolomide (TMZ) for newly diagnosed supratentorial GBM and as monotherapy for recurrent radiologically confirmed supratentorial GBM following prior chemotherapy. The Optune kit includes a portable field generator and insulated transducer arrays placed on the shaved scalp and covered by a lightweight cap.

Device use requires frequent maintenance: transducer arrays are typically replaced once to twice weekly and the scalp must be re‑shaved to maintain contact. The device is portable and intended to be worn continuously for at least 18 hours per day (treatment described as at least 18 continuous hours per day for a minimum of 4 weeks).

Study / Source	Key findings
EF-14 randomized trial (Stupp et al., 2017)
TTFields + TMZ improved median PFS (6.7 vs 4.0 months) and median OS (20.9 vs 16.0 months) versus TMZ alone; improved survival and manageable skin toxicity under arrays.
Compliance effect (Toms et al., 2019)
Higher device compliance associated with better outcomes: compliance ≥ 50% improved PFS and OS versus TMZ alone; ≥ 75% associated with significantly lower OS risk; >90% median survival 24.9 months and higher 5-year survival.
Safety (postmarketing surveillance, Shi et al., 2020)
Global postmarketing data (n>11,000) found most common TTFields-related adverse event was array-associated skin reactions (~29–38%), generally mild/moderate and manageable; other AEs included under-array heat/tingling and headache; no new safety concerns.
Hayes HTA (2019, updated)
Hayes Health Technology Assessment rated TTFields C for ndGBM and rGBM (monotherapy rGBM); concluded small, low-quality body of evidence suggests TTFields plus TMZ increases OS and PFS in ndGBM and that evidence for rGBM is limited.

Term	Definition
Supratentorial
Upper portion of the brain comprised of the cerebrum, ventricles, choroid plexus, hypothalamus, pineal gland, pituitary gland, and optic nerve.
Temozolomide (TMZ)
An oral alkylating chemotherapy drug used in the treatment of some brain cancers; first-line treatment for glioblastoma.
Karnofsky Performance Status (KPS)
Standard scale 0–100 measuring ability to perform daily tasks; policy requires KPS ≥ 60 for coverage (60 indicates requires occasional assistance but able to care for most personal needs).
ECOG Performance Status
Eastern Cooperative Oncology Group scale (0–5) measuring functional status; policy requires ECOG ≤ 2 for coverage (0 fully active; 2 ambulatory and capable of selfcare but unable to work; up and about >50% of waking hours).