ModifiedUnitedHealthcarePolicy CS146OH.F

Electric Tumor Treatment Field Therapy (for Ohio Only)

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This policy governs coverage and medical necessity criteria for electric tumor treatment field (TTF) therapy for members of UnitedHealthcare Community Plan in the state of Ohio.

Policy Summary

PayerUnitedHealthcare

PolicyElectric Tumor Treatment Field Therapy (for Ohio Only)

Policy CodePolicy CS146OH.F

Change TypeRevised coverage rationale to require InterQual when policy criteria are indeterminate

Effective DateAugust 1, 2026

Last ReviewAug 1, 2026

Next Review Date

Key ActionObtain prior authorization and document medical necessity using InterQual CP when policy criteria do not clearly determine coverage.

SourceLink

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ModifiedUnitedHealthcarePolicy CS146OH.F

Electric Tumor Treatment Field Therapy (for Ohio Only)

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This policy governs coverage and medical necessity criteria for electric tumor treatment field (TTF) therapy for members of UnitedHealthcare Community Plan in the state of Ohio.

Policy Summary

PayerUnitedHealthcare

PolicyElectric Tumor Treatment Field Therapy (for Ohio Only)

Policy CodePolicy CS146OH.F

Change TypeRevised coverage rationale to require InterQual when policy criteria are indeterminate

Effective DateAugust 1, 2026

Last ReviewAug 1, 2026

Next Review Date

Key ActionObtain prior authorization and document medical necessity using InterQual CP when policy criteria do not clearly determine coverage.

SourceLink

POLICY UPDATE CHANGES

Coverage rationale language was revised to require use of InterQual criteria when medical necessity cannot be determined and to update the conditions for TTF use in recurrent GBM.

References section updated to reflect the most current information and prior policy version archived.

18 hours/dayminimum wear time

3 monthsinitial approved duration

≥ 75%usage threshold

695EF-14 participants

38.4%derm AE prevalence

OAC referencedOhio-specific note

Coverage Criteria for Tumor Treating Fields (TTF)

Initial therapy for recurrent supratentorial GBM

Covered when ALL of the following are met for initial treatment of radiologically confirmed recurrent glioblastoma (rGBM) in the supratentorial region:

rGBM initial coverage criteria: 1) Use of a U.S. Food and Drug Administration (FDA)–approved device to generate electric tumor treatment fields (TTF) after initial chemotherapy and used according to FDA-labeled indications, contraindications, warnings, and precautions; 2) The device is used as the only treatment for the recurrence; 3) Individual has a Karnofsky Performance Status (KPS) score ≥ 60 OR Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2; 4) Individual has been counselled that the electric TTF device must be worn at least 18 hours daily

When these criteria are met, an initial 3 months of electric TTF therapy will be approved.

InterQual-based determination

General medical necessity determination:

InterQual criteria override: When medical necessity cannot be determined using the specified policy criteria, the InterQual CP: Durable Medical Equipment, Tumor Treatment Field Therapy (TTFT) Devices criteria will be used to determine coverage.

InterQual is the primary medical/surgical criteria referenced; plan-, federal-, or state-specific (Ohio Administrative Code) contractual requirements may also govern.

Coverage-aligned clinical scenarios

Coverage is guided by clinical trial evidence and major society guideline recommendations for use in newly diagnosed and recurrent glioblastoma. Key recommended contexts include:

Newly diagnosed supratentorial glioblastoma (ndGBM): TTFields in combination with maintenance temozolomide after completion of chemoradiation may be used for adults with newly diagnosed supratentorial, IDH-wildtype glioblastoma who have completed radiochemotherapy and have adequate performance status (guideline-supported option).KPS >= 60 often used in guideline recommendations; age cutoffs (eg, <=70 years) referenced by guidelines for strongest evidence

Supported by the EF-14 randomized phase III trial and by ASCO/SNO guidance (moderate-quality evidence, weak recommendation) and NCCN recommendations.

Recurrent glioblastoma (rGBM): TTFields is FDA-approved for rGBM and may be considered an option; evidence of overall survival benefit in recurrent disease is less definitive and recommendations are mixed across guideline bodies.Consider KPS and tumor location (supratentorial when applicable)

Systematic reviews and HTAs report similar OS versus best standard care but different adverse event profiles; some guideline bodies advise against routine use for recurrent disease.

Coverage rationale and guideline context

Coverage rationale updated to require InterQual when medical necessity is not determinable via policy criteria; NCCN guidance supports use in selected ndGBM patients.

General condition: Use of FDA‑approved devices to generate electric tumor treatment fields (TTF) after initial chemotherapy is considered proven and medically necessary for initial treatment of radiologically confirmed recurrence of glioblastoma (rGBM) in the supratentorial region when medical necessity cannot be determined using the InterQual criteria and when all listed policy criteria are met.

Policy history revised to add requirement to reference InterQual when policy criteria alone do not establish medical necessity.

NCCN guidance for ndGBM: Concurrent adjuvant temozolomide and alternating electric fields is FDA‑approved and recommended by NCCN for selected newly diagnosed GBM patients (eg, those 70 years or younger with good performance status) and may be reasonable for select older patients with good PS.

NCCN cites EF-14 evidence supporting improved PFS and OS for this combination.

NICE guidance for ndGBM and recurrent high-grade glioma: NICE advises not to offer TTF for newly diagnosed grade IV glioma and does not recommend TTF for recurrent high-grade glioma as part of management; decisions for recurrent disease should consider performance status, patient preference, time since last treatment, tumor molecular markers, and prior treatments.

Electric tumor treatment field (TTF) therapy is considered experimental or investigational and therefore not covered for individuals younger than 22 years due to lack of FDA‑approved indications for this age group.

The National Institute for Health and Care Excellence (NICE) guidance states do not offer TTF as part of management for newly diagnosed grade IV glioma (glioblastoma), and this position is cited in the policy as a relevant guideline informing coverage considerations.

NICE guidance further recommends against offering TTF in the management of recurrent high‑grade glioma and advises that treatment decisions at recurrence should be individualized based on factors such as Karnofsky performance status, patient preference, time from last treatment, and tumor molecular markers; the policy cites this guidance when describing unsupported scenarios.

Consistent with the policy's exclusion language, use of electric TTF therapy in individuals under age 22 is reiterated as not medically necessary/experimental because FDA approvals apply to adults.

Use of TTF outside contexts supported by major guideline bodies — for example, continuing treatment beyond a regimen after confirmed progression or routine use in settings not endorsed by ESMO or NICE — is considered unsupported by the policy and may lead to noncoverage.

The policy notes NICE's explicit non‑recommendation: NICE advises do not offer TTF for both newly diagnosed glioblastoma (ndGBM) and for recurrent high‑grade glioma, and this guidance is cited as part of the evidence context that informs coverage decisions.

Coding and Device Usage Metrics

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

FDA product codes referencedmixed

NZK	FDA product code referenced for Optune supplemental approvals

Device usage/compliance — ≥ 75% usage

Usage associated with improved survivalAverage device usage rate ≥ 75% reported in multiple analyses (systematic reviews/meta-analyses) as consistently associated with prolonged overall survival

Data source exampleBallo et al. meta-analysis (n=1015 reporting usage) found ≥ 75% usage associated with prolonged survival

Supporting pooled evidenceRegev et al. pooled analyses likewise report compliance ≥ 75% associated with improved OS

Device usage compliance thresholds

Minimum monthly compliance linked to improved outcomesMonthly compliance threshold of 50% associated with improved PFS and OS versus TMZ alone (EF-14 subgroup analysis) — outcomes improve as compliance increases

Provider Actions, Prior Authorization and Documentation

Prior Authorization

Prior authorization required; applicable HCPCS codes

Prior authorization is required for Tumor Treating Field therapy; applicable HCPCS codes include A4555, E0766, and E0767. UnitedHealthcare references the InterQual CP: Durable Medical Equipment, Tumor Treatment Field Therapy (TTFT) Devices for medical necessity determinations.

HCPCS: A4555 — Electrode/transducer for use with electrical stimulation device used for cancer treatment, replacement only
HCPCS: E0766 — Electrical stimulation device used for cancer treatment, includes all accessories, any type
HCPCS: E0767 — Intrabuccal, systemic delivery of amplitude‑modulated, radiofrequency electromagnetic field device, includes all accessories

Prior Authorization

Prior authorization submissions should include indication and clinical history

Prior authorization is expected when billing TTF as a device-directed therapy for glioblastoma; submission should document the indication (newly diagnosed vs recurrent), prior therapies (including completion of chemoradiation for ndGBM), performance status, and tumor location when supratentorial disease is relevant.

Background on Tumor Treating Fields

TTF therapy delivers low‑intensity, intermediate‑frequency alternating electric fields via transducer arrays applied to the scalp; these fields are intended to interfere with cancer cell division by disrupting mitotic processes in brain tumor cells. The Optune system is an example of an FDA‑approved device that generates these electric tumor treatment fields.

Definitions and Clinical Scales

ECOG Performance Status

Scale rangeECOG Performance Status ranges from 0 (fully active) to 5 (dead)

UseMeasures impact of disease on functioning (self-care, daily activity, physical ability)

Common coverage threshold contextPolicy uses ECOG ≤ 2 as an acceptable performance status for coverage considerations

Karnofsky Performance Status (KPS)

Scale and interpretationKarnofsky Performance Status (KPS) is scored 0–100; higher scores indicate better functional ability (e.g., KPS 60 = requires occasional assistance but can meet most personal needs)

Use in policyKPS is used to assess patient suitability for TTFields; policy specifies KPS ≥ 60 as a coverage threshold for rGBM

Line of Therapy: First-line and Salvage Use

salvage

Salvage (device after initial chemotherapy): Device use after initial chemotherapy for radiologically confirmed recurrent supratentorial GBM when used per FDA labeling and coverage criteria (device used as only treatment, performance status thresholds, counselling about wear time).

Initial 3 months approved when criteria met; InterQual may be used to determine medical necessity if policy criteria are insufficient.

first-line

First-line (ndGBM) – integration with standard therapy: TTFields combined with maintenance temozolomide after completion of concurrent radiotherapy and temozolomide may be used for newly diagnosed supratentorial GBM in selected patients with good performance status, per clinical trial evidence and guideline recommendations.KPS >= 60 commonly referenced; regimen selection guided by NCCN/ASCO-SNO guidance

Supported by the EF-14 randomized trial; consider sequencing with surgery and chemoradiation prior to initiating adjuvant TTFields.

Biomarkers and Clinical Factors Associated with Outcomes

PTEN mutation status

MarkerPTEN mutation status (reported from next-generation sequencing panels)

Clinical observationRetrospective institutional review (Dono et al.) found PTEN-mutant rGBM treated with TTFields had longer post-progression survival versus PTEN-WT in that cohort

Evidence caveatFindings are retrospective and based on small sample sizes; further prospective validation needed

Dexamethasone dose and device compliance

Dexamethasone dose associationDexamethasone dose ≤ 4.1 mg associated with longer median overall survival in TTFields analyses

Compliance associationTTFields compliance ≥ 75% associated with improved outcomes; some analyses report compliance ≥ 75% lowers OS risk versus <75%

Regimens and Evidence Context

Regimen	Context/Notes	Coverage stance
TTFields combined with bevacizumab (TTFields + BEV)	Reported in network and standard meta-analyses comparing active therapies for recurrent GBM; ranked with favorable OS SUCRA values in some analyses but evidence is heterogeneous.	neutral
Bevacizumab + lomustine (BEV + CCNU)	Identified in network meta-analyses as a top-ranked regimen for OS and PFS in rGBM comparisons; used as a comparator in ranking analyses.	neutral
Regorafenib	Appears among higher-ranked active therapies for ORR, 6‑month PFS, and OS in network meta-analyses; comparative efficacy reported but conclusions limited by heterogeneity.	neutral
Bevacizumab monotherapy or BEV combined with other agents (e.g., irinotecan)	Recommended in some analyses for symptomatic patients or for improving ORR/6‑month PFS; safety and efficacy vary across studies.	neutral

Regimen	Supporting evidence / trial	Coverage stance
Optune/TTFields used >18 hours/day combined with maintenance temozolomide (TMZ)	EF-14 randomized phase III trial (Stupp et al.) demonstrated improved PFS and OS when TTFields was added to maintenance TMZ in newly diagnosed supratentorial GBM; policy and guidelines reference recommended wear time (≥18 hours/day).	Covered

Regimen	Evidence summary	Coverage stance
Device therapy (Optune Gio or similar) as monotherapy versus best standard care (BSC) chemotherapy in rGBM	Systematic reviews and ECRI assessment report similar overall survival between TTFields and BSC in recurrent GBM, with different AE profiles (fewer systemic chemo AEs but more skin reactions); evidence described as mixed and dependent on patient-centered outcome priorities.	Experimental

Regimen	Regulatory / guideline context	Coverage stance
TTF (Optune) concurrent with and/or following temozolomide after maximal debulking and completion of radiation therapy	FDA granted supplemental approval (2015) for Optune with temozolomide in newly diagnosed supratentorial GBM; NCCN recommends this combination for selected patients (Category 1 for patients ≤70 with good performance status and reasonable option for some older patients).	Covered

Regimen	Policy / authorization requirements	Coverage stance
TTF (Optune) for adults with radiologically confirmed recurrent supratentorial GBM	Optune is FDA‑approved for adults ≥22 years with recurrent GBM after chemo and radiation; UnitedHealthcare coverage requires medical necessity to be established per policy criteria or InterQual CP when policy criteria are insufficient—initial approval typically for an initial 3 months when criteria are met.	Covered

Policy Summary

PayerUnitedHealthcare

PolicyElectric Tumor Treatment Field Therapy (for Ohio Only)

Policy CodePolicy CS146OH.F

Change TypeRevised coverage rationale to require InterQual when policy criteria are indeterminate

Effective DateAugust 1, 2026

Last ReviewAug 1, 2026

Next Review Date

Key ActionObtain prior authorization and document medical necessity using InterQual CP when policy criteria do not clearly determine coverage.

SourceLink

On This Page

Patient selection and delivery considerations: Device candidacy typically requires supratentorial tumor location for some guideline recommendations, the ability to comply with recommended device usage, and a plan to manage array-related skin adverse events.Monthly device usage >=50% associated with improved PFS/OS; higher compliance (eg, >=75% or >90%) associated with better outcomes; device counseling targets >=18 hours/day (≥ 18 hours/day)

Skin reactions are common but generally mild/moderate and manageable; postmarketing surveillance does not reveal new safety signals.

NICE NG99 guidance is referenced as a differing health-technology assessment view.

High compliance effect

>90% compliance associated with best observed outcomes (median survival 24.9 months; 5-year survival 29.3% in subgroup analysis)

Recommended daily wear time contextDevice is typically used ≥ 18 hours/day in trials and product labeling; higher daily wear correlates with greater monthly compliance

Indication: specify newly diagnosed (ndGBM) or recurrent (rGBM)
Prior therapies: completion of concurrent radiotherapy and temozolomide when applicable
Performance status: KPS or ECOG as documented
Tumor location: note supratentorial involvement when applicable

Prior Authorization

InterQual may be required to determine medical necessity

UnitedHealthcare uses InterQual as the primary medical/surgical criteria and may require InterQual CP: Durable Medical Equipment, Tumor Treatment Field Therapy (TTFT) Devices to determine medical necessity for TTF when applicable.

InterQual CP referenced as primary tool for medical necessity determinations
If InterQual criteria apply, authorization decisions will follow InterQual guidance

Step Therapy

Authorization follows InterQual criteria when applicable

When InterQual criteria apply for Durable Medical Equipment TTFT devices, treatment authorization will follow those InterQual criteria for medical necessity determination.

Authorization outcomes will be based on InterQual CP: Durable Medical Equipment, Tumor Treatment Field Therapy (TTFT) Devices when used

Step Therapy

Expect standard therapy (surgery, radiation, temozolomide) to be considered/used before TTF

Providers are expected to consider standard therapies (surgery, radiotherapy, temozolomide, and other guideline‑recommended systemic options) prior to or in conjunction with TTF per guideline recommendations.

Document consideration of or prior receipt of maximal safe resection or biopsy and radiotherapy
Document prior or concurrent temozolomide where guideline‑recommended

Note

Follow guideline context — NCCN supports selected use; NICE recommends against TTF for ndGBM

Clinical guidelines differ: NCCN supports integrating TTF with standard therapy for selected newly diagnosed supratentorial GBM patients, whereas NICE recommends not offering TTF for newly diagnosed grade IV glioma.

NCCN: TTF is an option with adjuvant temozolomide for selected ndGBM patients (category 1 for some groups)
NICE: advises do not offer TTF for newly diagnosed grade IV glioma and does not recommend TTF for recurrent high‑grade glioma

Documentation Required

Ensure complete medical record documentation to support medical necessity

Medical records must fully support medical necessity and include relevant medical history, physical examination findings, and pertinent diagnostic test results; documentation must be legible and available upon request.

Include sufficient, legible documentation to demonstrate that coverage criteria are met
Maintain and provide records upon request for utilization review

Documentation Required

Include diagnosis, prior radiochemotherapy, performance status, and MGMT in documentation

Clinical documentation should explicitly state the diagnosis (identify supratentorial location when applicable), prior completion of concurrent radiochemotherapy for ndGBM, performance status (KPS/ECOG), MGMT status when available, and the treatment plan (including combination with maintenance temozolomide if intended).

Diagnosis with tumor location (supratentorial) when relevant
Confirmation of completion of radiochemotherapy for ndGBM where applicable
Performance status (KPS or ECOG) and biomarker data (MGMT) if available
Planned regimen details (e.g., TTF with maintenance temozolomide)

Documentation Required

Reference InterQual and federal/state/contract requirements on requests

When submitting coverage requests, reference InterQual criteria and applicable federal, state (Ohio Administrative Code), or contractual benefit requirements, since these govern coverage decisions and may take precedence.

Cite InterQual CP: Durable Medical Equipment, Tumor Treatment Field Therapy (TTFT) Devices where used
Verify and reference Ohio Administrative Code or plan contract terms for members in Ohio

Denial Risk

Insufficient documentation may lead to denial

Insufficient or missing medical record documentation to support medical necessity may result in denial; benefit coverage is determined by federal, state, or contractual requirements.

Failure to provide legible, supporting records can trigger denial
Coverage determination may be subject to federal/state (OAC) or contractual rules

Denial Risk

Use outside guideline‑supported indications may be denied

Requests for TTF outside guideline‑supported indications (for example beyond confirmed progression, for non‑supratentorial disease, or other settings not supported by referenced guidance) may be denied or considered not supported by evidence.

Use beyond confirmed progression or for non‑supratentorial disease is not supported by ESMO/NICE and may be noncovered
Deviations from indications in FDA labeling and guideline recommendations risk denial

Denial Risk

Coverage may be contingent on InterQual and state/contract terms

Coverage decisions depend on applying InterQual when policy criteria do not suffice; failure to apply InterQual or to follow federal/state/contractual requirements (including Ohio Administrative Code) may affect coverage outcomes.

UnitedHealthcare replaced prior wording to require InterQual when medical necessity cannot be determined by policy criteria
Federal, state (OAC), or contractual requirements govern in the event of conflict

Clinical utilityKPS informs prognosis, trial eligibility, and treatment selection

Supratentorial

Anatomic definitionSupratentorial refers to the upper portion of the brain including the cerebrum, ventricles, choroid plexus, hypothalamus, pineal gland, pituitary gland, and optic nerve

Relevance to coveragePolicy limits some indications (e.g., certain guideline footnotes and FDA supplemental approval) to supratentorial tumor location

SourceDefined per National Cancer Institute (NCI) terminology in policy definitions

TTFields / Alternating electric field therapy

What it isTumor Treating Fields (TTFields) — alternating electric field therapy delivered via transducer arrays applied to the scalp to disrupt tumor cell division

Delivery methodNoninvasive device (Optune) with portable field generator and transducer arrays placed on the scalp; arrays replaced weekly to twice weekly

Typical usageTreatment is delivered for at least 18 continuous hours per day in clinical protocols

ndGBM (newly diagnosed glioblastoma)

DefinitionndGBM = newly diagnosed glioblastoma

ContextTTFields has supplemental FDA approval and guideline-supported use in selected ndGBM patients when combined with maintenance temozolomide after completion of chemoradiation

DifferentiationPolicy discusses ndGBM separately from recurrent disease with distinct evidence bases and guideline recommendations

rGBM (recurrent glioblastoma)

DefinitionrGBM = recurrent glioblastoma

Regulatory statusOptune is FDA‑approved for rGBM (initial PMA 2011) though evidence for OS benefit in recurrence is mixed and guideline panels are divided

Policy coveragePolicy provides coverage for initial therapy of radiologically confirmed recurrent supratentorial GBM when criteria are met and/or InterQual supports medical necessity

Optune (TTF)

Device identityOptune (formerly NovoTTF-100A) — FDA-approved portable system delivering low-intensity alternating electric fields for adult glioblastoma

Regulatory notesInitial FDA PMA approval April 2011 for recurrent GBM; supplemental PMA October 2015 for use with temozolomide in newly diagnosed supratentorial GBM

Kit componentsIncludes portable field generator, insulated transducer arrays, power supply, and supplies; arrays placed on scalp per tumor location

ndGBM / rGBM abbreviations and guideline context

AbbreviationsndGBM = newly diagnosed glioblastoma; rGBM = recurrent glioblastoma

Evidence and guideline differencesNCCN and ASCO/SNO support TTFields in selected ndGBM patients (NCCN Category 1 for some groups); evidence for rGBM is mixed and NICE recommends against offering TTF for newly diagnosed and recurrent high‑grade glioma

Coverage implicationPolicy treats ndGBM and rGBM differently — ndGBM supported in selected patients post-chemoradiation, rGBM coverage conditional on policy criteria or InterQual determination

salvage

Salvage – evidence context: For recurrent disease, evidence is mixed: systematic reviews and an ECRI assessment report similar overall survival for TTFields versus best standard care, while TTFields avoids some chemotherapy-associated systemic adverse events but increases array-related skin reactions; individualization of therapy is recommended.

Some retrospective analyses (eg, PTEN subgroup observations) suggest potential benefit in select molecular subgroups, but evidence is limited and primarily observational.

salvage

Salvage – device and outcomes context: The Optune/TTFields device is FDA-approved for adults with recurrent GBM and postmarketing surveillance demonstrates a consistent safety profile with common mild-to-moderate array-associated skin reactions; device therapy may be considered when prioritizing avoidance of systemic chemotherapy toxicities.

Postmarketing data include >11,000 individuals and show manageable skin AEs; ECRI concluded moderate confidence in evidence for OS comparing TTF vs best standard care.

first-line

First-line – FDA supplemental approval and NCCN recommendations: Supplemental FDA approval (2015) permits use of Optune with temozolomide in newly diagnosed supratentorial GBM following maximal debulking and completion of radiation therapy with concomitant standard chemotherapy; NCCN recommends alternating electric field therapy with adjuvant temozolomide for selected patients with good performance status.

EF-14 trial reported improved median overall survival (eg, Stupp final analysis) supporting this indication; patient selection per NCCN includes supratentorial location and good PS.

Evidence sourcesLi et al. meta-analysis and other pooled analyses report these associations; limitations include heterogeneity and retrospective data

MGMT promoter methylation

MarkerMGMT promoter methylation status

Clinical relevanceMGMT methylation informs expected benefit from temozolomide chemotherapy; meta-analyses report TTFields benefit regardless of MGMT status

Policy useMGMT status is suggested in documentation where available and informs overall treatment planning though TTFields benefit has been observed in both methylated and unmethylated tumors

PTEN mutation (related entry)

Marker (duplicate entry)PTEN mutation — reported subgroup that may derive greater PPS benefit with TTFields in retrospective data

Supporting findingWithin TTFields-treated group, PTEN-mutant rGBM had longer median PPS compared with PTEN-WT (22.2 vs 11.6 months)

LimitationsRetrospective analysis with small numbers; not a required biomarker for coverage

MGMT methylation (related entry)

Marker (related entry)MGMT promoter methylation — used to guide chemotherapy decisions and considered in subgroup analyses

Observed effectMeta-analyses indicate TTFields combined with Stupp protocol improved OS regardless of MGMT methylation status

DocumentationPolicy recommends documenting MGMT status when available for treatment planning and prior authorization submissions