CurrentUnitedHealthcarePolicy CS14GNE.L

Electric Tumor Treatment Field Therapy (for Nebraska Only)

Defines UnitedHealthcare medical policy for use of FDA‑approved electric tumor treatment field (TTF) devices (e.g., Optune) for treatment of supratentorial glioblastoma (newly diagnosed and recurrent) in the state of Nebraska, including initial and continuation coverage criteria, exclusions, definitions, applicable codes, and supporting evidence.

Policy Summary

PayerUnitedHealthcare

PolicyElectric Tumor Treatment Field Therapy (for Nebraska Only)

Policy CodePolicy CS14GNE.L

Change TypeCoverage criteria and coding updates

Effective DateJan 1, 2025

Next Review Date

Key ActionSubmit initial and continuation prior authorization with documentation of diagnosis, completed debulking surgery/radiation as applicable, KPS ≥60 or ECOG <2, TMZ as sole therapy for ndGBM or device-only for rGBM, counseling and documentation of device use ≥18 hours/day, and recent MRI (<2 months) for continuation.

POLICY UPDATE CHANGES

Created state-specific policy version for the state of Nebraska (no change to coverage guidelines).

Revised coverage criteria to require 'debulking surgery has been completed' for newly diagnosed supratentorial GBM.

Replaced counseling language to specify 'the electric TTF device must be worn at least 18 hours daily'.

Updated definitions (ECOG, KPS) and updated applicable HCPCS codes to reflect quarterly edits; added E0767.

Updated Services, Clinical Evidence, FDA, and References sections to reflect the most current information and archived prior policy CS146.K.

2Indications Addressed (ndGBM, rGBM)

3Initial approval duration

>=18 hrs/dayRequired daily device wear time

<2MRI recency for continuation (months)

1Supporting HCPCS Code Added (E0767)

multipleGuideline Sources Cited

Coverage Summary

This section summarizes coverage for FDA‑approved electric TTF devices (for example, Optune) when used according to labeled indications for supratentorial GBM in Nebraska. Refer to detailed criteria groups below for specific requirements for initial and continuation approvals.

Key Thresholds / Quick Facts

Device wear time>= 18 hours daily

Initial approval duration3 months

MRI recency for continuation< 2 months

Karnofsky Performance Status (KPS)>= 60

ECOG Performance Status< 2

Indications addressedndGBM, rGBM

Coverage - Newly Diagnosed Supratentorial Glioblastoma (ndGBM)

Covered when ALL of the following are met:

ALL of the following

Histologically confirmed newly diagnosed supratentorial glioblastoma (ndGBM)
Debulking surgery has been completed (when feasible)
Radiation therapy has been completed
Use of an FDA-approved device to generate electric TTF when used according to FDA labeled indications, contraindications, warnings, and precautions
Performance and treatment
- Karnofsky Performance Status (KPS) interpreted as >= 60

Initial Approval Duration - ndGBM

Initial approval for ndGBM

ALL of the following

When the ndGBM coverage criteria are met, approve an initial 3 months of electric TTF therapy
Approval duration: 3 months3 months

Coverage - Recurrent Supratentorial Glioblastoma (rGBM)

Covered when ALL of the following are met for recurrent radiologically confirmed supratentorial GBM (rGBM):

ALL of the following

Radiologically confirmed recurrence of supratentorial GBM (rGBM)
Device is used as the only treatment for rGBM (no concurrent systemic therapy)
Use of an FDA-approved device to generate electric TTF when used according to FDA labeled indications, contraindications, warnings, and precautions
Performance and counseling
- Karnofsky Performance Status (KPS) interpreted as >= 60>= 60

Initial Approval Duration - rGBM

Initial approval for rGBM

ALL of the following

When the rGBM coverage criteria are met, approve an initial 3 months of electric TTF therapy
Approval duration: 3 months3 months

Continuation Approval (beyond initial 3 months)

Criteria for continuation approval beyond the initial 3 months (must ALL be met):

ALL of the following

Ongoing therapy: For ndGBM: individual continues to receive Temozolomide (TMZ) as the only cancer drug; OR for rGBM: device continues to be used as the only treatment
Magnetic resonance imaging (MRI) scan performed within < 2 months of the continuation request documenting no evidence of disease progression< 2 months
Include date of MRI and report documenting no progression
Karnofsky Performance Status (KPS) >= 60 or ECOG Performance Status < 2>= 60 / < 2
Document most recent performance status

Not Medically Necessary / Not Covered & Insufficient Evidence

Not Medically Necessary / Not Covered

Unproven and not medically necessary when ANY of the following applies:

Coverage criteria unmet: Criteria for coverage above are not met

Non-GBM tumors: Treatment of tumors other than glioblastoma multiforme (GBM)

Use for non-GBM tumor types is not covered

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

Concurrent systemic therapy with TTF for rGBM considered not medically necessary

Provider Actions & Prior Authorization

Prior Authorization

Initial authorization required

Initial authorization required. Initial approval is contingent on documentation that all coverage criteria for newly diagnosed (ndGBM) or recurrent glioblastoma (rGBM) are met. Initial approval duration: 3 months.

Affected codes: 77299, A4555, E0766, E0767
Initial approval contingent on documentation meeting ALL coverage criteria (see Coverage Rationale)
Initial approval duration: 3 months

Prior Authorization

Continuation authorization requirements

Continuation authorization requirements summarize clinical and imaging criteria that must be documented to approve therapy beyond the initial 3 months.

Coding

Referenced CPTCPT

77299

Unlisted procedure, therapeutic radiology clinical treatment planning

Referenced HCPCS / Supply / Device 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

Applicable HCPCS / Device Codes (updated quarterly; includes supporting code)HCPCS

E0767

Transducer array for use with tumor treating fields device (supporting information added)

Background & Evidence

Electric TTF (tumor treating fields) therapy employs low‑intensity, intermediate‑frequency electric fields (approximately 100–300 kHz) to disrupt tumor cell division and inhibit proliferation. The Optune treatment kit (Novocure) is an FDA‑approved portable electric field generator with transducer arrays placed on the scalp to deliver noninvasive therapy.

Clinical evidence cited in the policy includes randomized controlled trials (notably the EF-14 trial) and multiple systematic reviews and meta-analyses showing improved progression‑free and overall survival when TTF is added to maintenance temozolomide for newly diagnosed GBM. The policy and referenced post‑marketing and pooled analyses also identify dermatologic/array‑associated skin reactions as the most common device‑related adverse events, generally mild to moderate and manageable.

Study / Source	Key finding
EF-14 randomized trial (Stupp et al., JAMA 2017)	Addition of TTFields to maintenance temozolomide improved median PFS (6.7 vs 4.0 months) and median OS (20.9 vs 16.0 months); most common device-related AE was mild-to-moderate scalp skin toxicity (≈52%).
Ballo et al. systematic review & meta-analysis (2023)	Pooled median OS 22.6 months with TTFields vs 17.4 months without; device usage ≥75% consistently associated with prolonged survival; authors note risk of bias in included studies.
Regev et al. systematic review & meta-analysis (2021)	Pooled median OS for newly diagnosed GBM 21.7 months; compliance ≥75% associated with improved OS; pooled dermatologic adverse event prevalence ~38.4% (predominant AE).
STELLAR trial (Ceresoli et al., Lancet Oncol. 2019)	Single-arm phase 2 in unresectable malignant pleural mesothelioma: median OS 18.2 months (95% CI 12.1–25.8); TTFields-associated skin reactions common (66% grade 1–2, 5% grade 3).
ASCO–SNO Guideline (Mohile et al., 2022)	Guideline: alternating electric field therapy may be added to adjuvant temozolomide in newly diagnosed supratentorial GBM after chemoradiation (evidence quality: moderate; strength: weak).
NICE guidance (NG99, 2018; updated 2021)	Recommendation: do not offer TTFields for newly diagnosed grade IV glioma and do not offer for recurrent high-grade glioma (2021 update).

Definitions (key terms)

Key definitions (summary):

Supratentorial: upper portion of the brain (cerebrum) including related structures; term used to describe tumor location for coverage

Defined in policy definitions

KPS: Karnofsky Performance Status (KPS): score 0–100 measuring ability to perform ordinary tasks; policy requires KPS ≥ 60 for coverage/continuation

Revision History

2025-01-01clinical_eligibility_change

Revised coverage criteria for newly diagnosed supratentorial GBM to require that debulking surgery has been completed; effective January 1, 2025.

2025-01-01clinical_counseling_language_revision

Replaced counseling language to specify 'the electric TTF device must be worn at least 18 hours daily' (applied to ndGBM, rGBM, and continuation approvals).

2025-01-01administrative_coding_update

Updated definitions (ECOG, KPS) and updated applicable HCPCS codes to reflect quarterly edits; added E0767 as supporting information — operational/billing impact.

Policy Summary

PayerUnitedHealthcare

PolicyElectric Tumor Treatment Field Therapy (for Nebraska Only)

Policy CodePolicy CS14GNE.L

Change TypeCoverage criteria and coding updates

Effective DateJan 1, 2025

Next Review Date

On This Page

KPS may be recorded as numeric score; 60 corresponds to requiring occasional assistance but able to care for most personal needs

ECOG Performance Status < 2< 2

Individual is receiving Temozolomide (TMZ) as the only cancer drug

Individual has been counselled that the electric TTF device must be worn at least 18 hours daily>= 18 hours daily

Counseling should document wear‑time expectations and adherence requirements

ALL of the following

Note: Initial approval when all ndGBM criteria are met = 3 months
Operational note: KPS interpretation as numeric score is acceptable; document counseling regarding device wear time and expectations

KPS may be recorded as numeric score

ECOG Performance Status < 2< 2

Individual has been counselled that the electric TTF device must be worn at least 18 hours daily>= 18 hours daily

Counseling should document wear‑time expectations and adherence requirements

ALL of the following

Operational note: For rGBM the device must be the only treatment; concurrent use with other systemic therapies (eg, bevacizumab) is not covered

Documentation that the individual has been using the electric TTF device at least 18 hours daily>= 18 hours daily

Compliance documentation (eg, device usage logs) must be provided

ALL of the following

Operational note: Continuation requests must include MRI recency and report, performance status, and objective compliance data (device logs) showing >= 18 hours/day average wear time

Computer software used for therapeutic radiology clinical treatment planning in conjunction with electric TTF therapy (e.g., NovoTAL) is unproven and not medically necessary due to insufficient evidence of efficacy

Limited evidence for NovoTAL as improving long-term outcomes

Not Adequately Supported / Insufficient Evidence

Use is considered experimental/insufficient when ANY of the following applies:

NovoTAL standalone insufficient: Use of NovoTAL simulation system as a standalone that has not demonstrated improved long-term health outcomes

Limited published clinical evidence and insufficient data to support improved long-term outcomes

Non-GBM tumor types insufficient: Use of TTFields for tumor types other than FDA‑approved indications (e.g., non‑GBM solid tumors) without supportive randomized data

Lack of RCT evidence for many non-GBM tumor types

Magnetic resonance imaging (MRI) performed within < 2 months showing no evidence of disease progression
Documented device use >= 18 hours per day
For newly diagnosed GBM (ndGBM): ongoing Temozolomide (TMZ) as the only systemic cancer drug
For recurrent GBM (rGBM): device used as the only treatment (no concurrent chemotherapy)
Documented performance status (KPS > 60 or ECOG < 2)

Documentation Required

Compliance documentation

Compliance documentation required for continuation requests. Providers must document counseling and objective evidence of device use.

Document that the patient was counselled on the need to wear the device at least 18 hours per day
Provide objective documentation of device usage (hours/day or device usage reports) for continuation requests

Denial Risk

Denial if criteria unmet

Denial if required criteria unmet. Claims or prior authorization requests may be denied if the required clinical criteria, imaging, performance status, or documentation of device use are not provided.

Missing documentation of debulking surgery (for ndGBM), radiation with concurrent temozolomide (for ndGBM), or documentation that device is sole therapy (for rGBM) may result in denial
Insufficient or absent objective device usage data (>=18 hrs/day) may result in denial

Prior Authorization

Document surgical and radiation/chemotherapy history

Document surgical and radiation/chemotherapy history. For newly diagnosed GBM, documentation must show completion of debulking surgery and completion of radiation therapy with concurrent temozolomide per the Coverage Rationale.

For ndGBM: documentation of completed debulking surgery (when feasible)
For ndGBM: documentation that radiation therapy was completed and temozolomide (TMZ) is being given as the only cancer drug

Documentation Required

Counseling on device wear time

Counseling on device wear time. Providers must counsel patients and document that they understand the requirement to wear the electric TTF device at least 18 hours daily; include counseling notes in the medical record for continuation requests.

Record counseling that device must be worn >= 18 hours per day
Include patient/caregiver acknowledgment and any barriers to adherence in the chart

Documentation Required

Documentation for continuation beyond 3 months

Documentation for continuation beyond 3 months. Re-authorization requests must reiterate clinical justification and provide objective usage documentation.

Document ongoing device use >= 18 hours per day with objective device usage data or logs
Provide MRI within < 2 months showing no progression, current KPS/ECOG, and confirmation of ongoing TMZ (ndGBM) or device-only therapy (rGBM)

Billing Rule

Use updated HCPCS list

Use updated HCPCS list. Coding edits occur quarterly and E0767 was added to the policy coding list; ensure claims and prior authorization requests use the current HCPCS codes.

Affected code: E0767 (added)
Also referenced: A4555, E0766, and unlisted procedure 77299

Examples: KPS 60 = requires occasional assistance but able to care for most personal needs

ECOG Performance Status: scale 0–5 measuring performance; policy requires ECOG < 2 for coverage/continuation< 2

ECOG examples provided in definitions (0 = fully active; 2 = ambulatory >50% of waking hours; etc.)

TMZ: Temozolomide (TMZ): oral alkylating chemotherapy used as first-line treatment for glioblastoma; policy requires TMZ as the only cancer drug for ndGBM initial and continuation criteria

Electric TTF device: FDA‑approved device that generates alternating electric tumor‑treating fields (e.g., Optune); device must be used per labeled indications

Optune kit includes portable generator and transducer arrays; device therapy is noninvasive and requires array changes and scalp care

2025-10-01policy_publication_state_specificLatest

Created state-specific policy version for the state of Nebraska (no change to coverage guidelines); effective October 1, 2025.

2025-10-01content_update_and_archivalLatest

Updated Services, Clinical Evidence, FDA, and References sections to reflect current information and archived prior policy version CS146.K.