Modifiedpartners_health_managementPolicy NC.CP.MP.145

Electric Tumor Treating Fields (Optune)

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Clinical coverage criteria for use of electric tumor treating fields (Optune) in adults with glioblastoma, including initial and continuation authorization requirements and stated contraindications; affects providers seeking authorization for Optune therapy.

Policy Summary

Payerpartners_health_management

PolicyElectric Tumor Treating Fields (Optune)

Policy CodePolicy NC.CP.MP.145

Change TypeMaterial clinical revisions

Effective Date

Last ReviewDec 1, 2025

Next Review DateDec 1, 2025

Key ActionObtain prior authorization documenting indication, KPS ≥ 60, absence of contraindications, and patient agreement to wear the device ~18 hours/day.

SourceLink

POLICY UPDATE CHANGES

Changed Karnofsky Performance Status requirement in IA1.a.ii and IB1.b.ii from ≥ 70 to ≥ 60.

Added age restriction of > 22 years.

Added requirement that the member agrees to wear the TTF device for 18 hours per day (and compliance requirement for continuation).

>22minimum age for coverage

90dinitial authorization duration

90dcontinuation interval

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Modifiedpartners_health_managementPolicy NC.CP.MP.145

Electric Tumor Treating Fields (Optune)

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Policy Summary

Payerpartners_health_management

PolicyElectric Tumor Treating Fields (Optune)

Policy CodePolicy NC.CP.MP.145

Change TypeMaterial clinical revisions

Effective Date

Last ReviewDec 1, 2025

Next Review DateDec 1, 2025

Key ActionObtain prior authorization documenting indication, KPS ≥ 60, absence of contraindications, and patient agreement to wear the device ~18 hours/day.

SourceLink

POLICY UPDATE CHANGES

Changed Karnofsky Performance Status requirement in IA1.a.ii and IB1.b.ii from ≥ 70 to ≥ 60.

Added age restriction of > 22 years.

Added requirement that the member agrees to wear the TTF device for 18 hours per day (and compliance requirement for continuation).

>22minimum age for coverage

90dinitial authorization duration

90dcontinuation interval

18h/daydevice wear time

Coverage Criteria — Optune (Tumor Treating Fields) for Glioblastoma

Initial 90-day therapy (Adults >22 years)

Covered when ALL of the following are met

Initial therapy criteria: 1) Age > 22 years.

Indication - one of the following: (a) Newly diagnosed glioblastoma, histologically confirmed, AND all of: (i) tumor located in the supratentorial region; (ii) Karnofsky Performance Status (KPS) >= 60; (iii) alternating electric field therapy (TTF/Optune) will be delivered in conjunction with temozolomide after standard surgical and radiation therapies are completed. OR (b) Recurrent glioblastoma, histologically- or radiologically-confirmed, AND all of: (i) tumor located in the supratentorial region; (ii) Karnofsky Performance Status (KPS) >= 60; (iii) alternating electric field therapy (TTF/Optune) will be used as monotherapy after prior standard treatment with chemotherapy, surgery, and/or radiation.

Contraindications absent: None of the following contraindications are present: implanted medical device (deep brain stimulator, spinal cord stimulator, vagus nerve stimulator, pacemaker, defibrillator, or programmable shunt); skull defect such as a missing bone with no replacement or retained bullet fragment; pregnancy; known sensitivity to conductive hydrogels (e.g., ECG/TENS gel).

Device wear agreement: Member agrees to wear the TTF device for 18 hours per day.

Continuation therapy (additional 90 days)

Covered when ALL of the following are met

Continuation criteria: 1) No disease progression in the last 90 days of TTF therapy.

Device wear agreement and compliance: 2) Member agrees to wear the TTF device for 18 hours per day AND was compliant with wearing the device during the prior authorization period.

Other indications

Not supported

Insufficient evidence: TTF therapy is considered to have insufficient evidence to support use for all other (non-specified) indications.

NovoTal mapping software: NovoTal computer mapping software is considered to have insufficient evidence to establish efficacy for planning TTF therapy.

The policy excludes members with certain implanted devices and other specific contraindications. Contraindications include implanted medical devices such as deep brain stimulators, spinal cord stimulators, vagus nerve stimulators, pacemakers, defibrillators, or programmable shunts. Other exclusions are a skull defect (missing bone without replacement) or retained bullet fragment, pregnancy, and known sensitivity to conductive hydrogels (for example, gels used with ECG stickers or TENS electrodes). These conditions must be absent for a request to meet coverage criteria for TTF therapy.

Use of Tumor Treating Fields (TTF) outside the specified glioblastoma indications is considered unsupported by current evidence. Specifically, the policy states there is insufficient evidence to support TTF therapy for all other (non‑specified) indications. Additionally, the NovoTal computer mapping software used for array planning is also considered to have insufficient evidence to establish efficacy for planning TTF therapy.

When applying this clinical policy, be aware of higher‑priority coverage authorities. For Medicaid members, state Medicaid coverage provisions take precedence where they conflict with this policy; consult the applicable state Medicaid manual. For Medicare members, reviewers should review applicable NCDs, LCDs, and Medicare Coverage Articles (for example, CMS LCD L34823) prior to applying these criteria to ensure alignment with Medicare coverage guidance.

Coding and Key Parameters

HCPCS codes referencedHCPCS

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

Referenced LCDmixed

L34823

Local Coverage Determination: Tumor treatment field therapy (TTFT)

inv-09: Device wear time — required 18 hours/day

Required wear timeMember agrees to wear the TTF device for 18 hours per day

Continuation complianceFor continuation authorization, member must have been compliant with wearing the device ~18 hours/day during prior authorization period

DocumentationPrior authorization must document patient agreement to wear device 18 hours/day and compliance evidence for continuation

inv-10: Karnofsky Performance Status — required KPS ≥ 60

KPS threshold for coverageKarnofsky Performance Status (KPS) ≥ 60 is required for covered indications

Application to newly diagnosed GBM

Provider Actions, Authorization, and Documentation

Prior Authorization

Prior authorization required for initial and continuation 90‑day periods

Prior authorization is required for the initial 90-day course and for each additional 90-day continuation period. Authorization requests must document the indication (newly diagnosed or recurrent supratentorial glioblastoma), Karnofsky Performance Status (≥ 60), absence of listed contraindications, and patient agreement to wear the TTF device ~18 hours per day; for continuation requests, documentation of compliance with the wear-time requirement during the prior authorization period is required.

Initial authorization interval: 90 days.
Continuation authorization: additional 90 days (requires no progression in prior 90 days and demonstrated compliance).
Required documentation elements: indication, KPS, contraindications absent, member agreement to wear device ~18 hours/day; compliance evidence for continuation.

Prior Authorization

Align prior authorization with Health Plan procedures and applicable Medicare coverage

Follow the Health Plan's administrative procedures when submitting prior authorization requests; criteria application may need to align with Medicare NCDs/LCDs where applicable.

Intended Line of Therapy

first-line

Newly diagnosed GBM adjunct therapy: Used in conjunction with standard radiation therapy plus concurrent temozolomide and adjuvant temozolomide (Optune is adjunct to, not a substitute for, standard surgery and radiation); histologic confirmation required; tumor must be supratentorial; KPS >= 60.

salvage

Recurrent GBM monotherapy: Used as monotherapy for recurrent glioblastoma after prior standard treatment with chemotherapy, surgery, and/or radiation; histologic or radiologic confirmation required; tumor must be supratentorial; KPS >= 60.

Covered Regimens and Clinical Context

Regimen	Indication	Key coverage requirements	Authorization interval	Coverage
Optune plus temozolomide	Newly diagnosed glioblastoma (GBM), supratentorial	Age > 22 years; histologic confirmation of GBM; supratentorial tumor location; Karnofsky Performance Status ≥ 60; used in conjunction with standard surgery and radiation plus temozolomide (adjunct to, not a substitute for, standard treatments); member agrees to wear device ~18 hours/day; no contraindicated implanted devices or other exclusions	Initial: 90 days	covered

Regimen	Indication	Key coverage requirements	Authorization interval	Coverage
Optune monotherapy	Recurrent glioblastoma (GBM), supratentorial	Age > 22 years; histologic or radiologic confirmation of recurrent GBM; supratentorial tumor location; Karnofsky Performance Status ≥ 60; TTF used as monotherapy after prior standard treatments (chemotherapy, surgery, and/or radiation); member agrees to wear device ~18 hours/day and demonstration of compliance for continuation; no contraindicated implanted devices or other exclusions	Initial: 90 days (continuation: additional 90-day intervals if no disease progression and compliance demonstrated)	covered

inv-26: MGMT promoter methylation — both methylated and unmethylated/indeterminate included per NCCN guidance

Included MGMT statusesBoth MGMT promoter methylated and unmethylated/indeterminate statuses are encompassed per NCCN guidance

Testing not required for coverageMGMT promoter methylation status is not required for coverage determination; both statuses are included

Guideline sourceNCCN recommends TTF for newly diagnosed GBM for patients with either methylated or unmethylated/indeterminate MGMT status

Definitions and Terminology

inv-21: Tumor Treating Fields (TTF) — definition of therapy delivered by Optune

DefinitionTumor Treating Fields (TTF) are low-intensity alternating electric fields applied to the brain via transducer arrays placed on the scalp to disrupt mitosis of dividing tumor cells

Device exampleTTF therapy is delivered by the Optune (NovoTTF) system, including Optune Gio (second-generation, more portable device)

Mechanism specificsFrequency is cell-type specific (e.g., ~200 kHz for glioblastoma) and fields do not meaningfully heat tissue or stimulate nerves/muscles

inv-22: Karnofsky Performance Status (KPS) threshold — policy requires KPS ≥ 60

Policy KPS requirementPolicy requires Karnofsky Performance Status (KPS) ≥ 60 for covered indications

Performance assessment

Background and Evidence Summary

Tumor Treating Fields (TTF) therapy uses low‑intensity alternating electric fields delivered to the scalp via transducer arrays to target dividing tumor cells and disrupt mitosis while having minimal effect on nondividing normal brain tissue. The Optune system (NovoTTF) is the commercial device for this modality; a later generation (Optune Gio) provides a smaller, more portable form factor intended to improve handling and patient compliance. Randomized clinical evidence (notably the EF‑14 trial) supports improved progression‑free and overall survival when TTF is added to temozolomide for newly diagnosed glioblastoma; randomized and registry evidence also describe activity and favorable toxicity/quality‑of‑life profiles in recurrent disease. In clinical use, TTF is delivered at frequencies appropriate for glioblastoma (e.g., ~200 kHz) and is intended to be used as an adjunct to, not a substitute for, standard surgical and radiation treatments for newly diagnosed disease.

Safety and evidence summaries include randomized trials and a large post‑marketing safety dataset. A global post‑marketing surveillance analysis reports safety data on >25,000 patients treated with TTFields between 2011 and 2022. Recent 2024 systematic and overview sources (including a 2024 international review and a 2024 CADTH optimal‑use review) summarize current evidence on mechanism, efficacy, and safety, and are cited to contextualize ongoing evaluation of benefits and harms.

Policy Revision History

2025-12-01annual_reviewLatest

Annual review: Changed Karnofsky Performance Status requirement from ≥ 70 back to ≥ 60 for initial and continuation criteria; references reviewed and updated; external specialist reviewed.

2024-12annual_review

Annual review: Previously changed Karnofsky Performance Status requirement to ≥ 70 and added related performance-status language.

2022-11

Policy Summary

Payerpartners_health_management

PolicyElectric Tumor Treating Fields (Optune)

Policy CodePolicy NC.CP.MP.145

Change TypeMaterial clinical revisions

Effective Date

Last ReviewDec 1, 2025

Next Review DateDec 1, 2025

Key ActionObtain prior authorization documenting indication, KPS ≥ 60, absence of contraindications, and patient agreement to wear the device ~18 hours/day.

SourceLink

On This Page

KPS ≥ 60 required when TTF given in conjunction with temozolomide after standard surgery and radiation

Application to recurrent GBMKPS ≥ 60 required for recurrent glioblastoma when used as monotherapy after standard treatments

inv-11: Initial authorization interval — 90 days

Initial authorization durationInitial authorization interval is 90 days

Subsequent intervalsContinuation requests are for additional 90-day periods when continuation criteria met

Authorization documentationPrior authorization must document indication, KPS, contraindications absent, and patient agreement to wear device for the authorization period

Ensure submissions comply with plan-level prior authorization processes and any applicable Health Plan administrative policies.
For Medicare members, review applicable NCDs, LCDs, and Medicare Coverage Articles before applying these criteria.

Step Therapy

Step therapy / sequencing — no required steps specified

No formal step therapy sequencing is specified in this policy. For newly diagnosed glioblastoma, TTF is covered when delivered in conjunction with temozolomide after standard surgery and radiation; for recurrent glioblastoma, TTF is covered as monotherapy after standard treatments.

Newly diagnosed: TTF must be used with temozolomide following standard surgical and radiation therapies.
Recurrent: TTF may be used as monotherapy after prior chemotherapy, surgery, and/or radiation.

Documentation Required

Required documentation to support medical necessity

Include documentation demonstrating histologic or radiologic confirmation of glioblastoma, supratentorial tumor location, Karnofsky Performance Status (≥ 60), prior standard therapies (surgery and radiation for newly diagnosed; prior chemotherapy/surgery/radiation for recurrent), and member agreement to wear the TTF device ~18 hours/day; for continuation requests, include evidence of compliance with the wear-time requirement and no disease progression in the prior 90 days.

Histologic confirmation (or radiologic confirmation for recurrent disease) of glioblastoma.
Documentation that tumor is supratentorial.
Karnofsky Performance Status score ≥ 60.
Records of prior standard therapies as applicable (surgery, radiation, chemotherapy).
Member agreement to wear device ~18 hours/day and compliance evidence for continuation.

Denial Risk

Denial risk if request does not conform to policy criteria

Requests that do not meet the policy-specified indication, minimum age, performance status, absence of contraindications, device wear agreement/compliance, or continuation criteria may be denied.

Missing or unsupported indication (not newly diagnosed or recurrent supratentorial GBM).
Age ≤ 22 years (policy requires adults > 22 years).
KPS < 60.
Presence of contraindications (e.g., implanted medical devices, skull defect without replacement, pregnancy, sensitivity to conductive hydrogels).
No member agreement to wear device ~18 hours/day or lack of demonstrated compliance for continuation.

Note

Coverage subject to plan terms, exclusions, and regulatory requirements

Coverage decisions and benefit administration are subject to all terms, conditions, exclusions, and limitations of the member's coverage documents and to applicable state and federal requirements and Health Plan administrative policies and procedures.

State Medicaid coverage provisions take precedence if they conflict with this clinical policy.
For Medicare members, applicable NCDs/LCDs and Medicare Coverage Articles should be reviewed and considered.

Note

Administrative/provider note — supplementary submission guidance

Supplemental guidance: ensure authorization requests reference the specific policy criteria (indication, KPS, contraindications, device wear agreement) and include clear clinical notes and supporting reports to expedite review.

Attach operative reports, radiation records, pathology or imaging reports, and KPS documentation.
Clearly state whether TTF will be delivered with temozolomide (newly diagnosed) or as monotherapy (recurrent).

Note

Consult NCDs, LCDs, and Medicare Coverage Articles when applicable

Providers should consult applicable Medicare National Coverage Determinations (NCDs), Local Coverage Determinations (LCDs), and Medicare Coverage Articles prior to applying these criteria for Medicare members.

Refer to CMS resources (http://www.cms.gov) for NCDs, LCDs, and Medicare Coverage Articles relevant to tumor treating field therapy.

KPS must be documented in the prior authorization to demonstrate good performance status

Relation to continuationContinuation authorizations require ongoing demonstration of suitability (no progression) and prior compliance; KPS remains an element of clinical assessment

inv-23: Tumor Treating Fields (TTFields) / Optune — alternate naming and device reference

Alternate namesTumor Treating Fields (TTFields) is also referred to as alternating electric field therapy or NovoTTF/TTF therapy

Device referencesOptune (formerly NovoTTF-100A; NovoTTF-200A system) is the marketed device delivering TTFields; Optune Gio is a second-generation portable system

Clinical contextTTFields/Optune are discussed in clinical literature and post-marketing surveillance including large datasets (>25,000 patients between 2011–2022)

Annual review: Added requirement that member agrees to wear the TTF device for 18 hours per day and for continuation also documents prior-period compliance.

2024-01administrative_update_with_policy_development

CCH-specific policy developed and wording updates made (no impact to criteria); removed ICD-10 codes and updated description wording.

?material_change

Added age restriction of > 22 years.

This policy was revised in the most recent review cycle with material changes. Notable modifications include lowering the Karnofsky Performance Status requirement in certain criteria from ≥ 70 to ≥ 60, and adding an explicit age restriction of over 22 years for eligibility. The policy also now requires documented member agreement to wear the TTF device for 18 hours per day and includes compliance with that wear requirement as part of continuation authorization. These changes were made per the annual review and with input from external clinical specialists.