ModifiedPremera Blue Cross of WashingtonPolicy 1.01.29

Tumor Treating Fields Therapy

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Coverage and prior authorization for tumor treating fields therapy, limited to adults with newly diagnosed supratentorial glioblastoma multiforme or grade IV astrocytoma who meet specified performance-status, prior-treatment, and maintenance-temozolomide requirements; other uses are investigational and not covered.

Policy Summary

PayerPremera Blue Cross of Washington

PolicyTumor Treating Fields Therapy

Policy CodePolicy 1.01.29

Change TypeModified

Effective DateNovember 1, 2026

Last ReviewOct 12, 2026

Next Review DateN/A

Key ActionObtain plan pre-approval and submit documentation showing that all medical-necessity criteria are met before initiating TTF therapy.

SourceLink

POLICY UPDATE CHANGES

In 2018, the policy changed to consider TTF medically necessary in conjunction with maintenance temozolomide for patients with newly diagnosed glioblastoma multiforme and investigational for all other indications.

Malignant pleural mesothelioma was added in 2019 to the list of conditions for which TTF therapy was considered investigational.

Initial-therapy and reauthorization criteria were defined in 2021 for added clarity.

The 11/01/26 annual review updated the literature review through April 6, 2026 and added references without changing the policy statements.

18+ hours/dayRecommended daily Optune use

90 daysInitial rental authorization

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ModifiedPremera Blue Cross of WashingtonPolicy 1.01.29

Tumor Treating Fields Therapy

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Sign up for premerabluecrossofwashington Policy 1.01.29 alerts

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Policy Summary

PayerPremera Blue Cross of Washington

PolicyTumor Treating Fields Therapy

Policy CodePolicy 1.01.29

Change TypeModified

Effective DateNovember 1, 2026

Last ReviewOct 12, 2026

Next Review DateN/A

Key ActionObtain plan pre-approval and submit documentation showing that all medical-necessity criteria are met before initiating TTF therapy.

SourceLink

POLICY UPDATE CHANGES

Malignant pleural mesothelioma was added in 2019 to the list of conditions for which TTF therapy was considered investigational.

Initial-therapy and reauthorization criteria were defined in 2021 for added clarity.

The 11/01/26 annual review updated the literature review through April 6, 2026 and added references without changing the policy statements.

18+ hours/dayRecommended daily Optune use

90 daysInitial rental authorization

Continuation rental period

KPS ≥70%Required Karnofsky Performance Status

6 monthsMRI monitoring interval

Coverage Criteria

Newly diagnosed glioblastoma, adjuvant/maintenance therapy

Covered as medically necessary when ALL of the following are met:

Newly diagnosed glioblastoma eligibility

Patient and tumor requirements
- Age: The individual is at least 18 years old.≥18 years
- Tumor location: The tumor is in the supratentorial region of the brain (the cerebrum).Supratentorial
- Functional status: The individual has a Karnofsky Performance Status score of at least 70%.KPS ≥70%
Completed initial treatment
- Surgery, including resection, debulking, or biopsy.
- Radiation therapy.
- Chemotherapy, if applicable.If applicable
Maintenance therapy: The individual is receiving standard maintenance therapy with Temodar (temozolomide).

Continuation therapy

Continuation may be approved when ALL of the following are met:

No documented progression or recurrence: The tumor has not demonstrated documented progression or recurrence on MRI.No progression or recurrence
MRI monitoring: An MRI report is submitted every six months.Every 6 months

Investigational and not-covered conditions

TTF therapy is considered investigational in ALL other conditions:

Investigational uses

Recurrent or progressive glioblastoma as adjunct: Use as an adjunct to standard medical therapy, such as Avastin (bevacizumab) or chemotherapy, for progressive or recurrent glioblastoma or grade IV astrocytoma.
Recurrent or progressive glioblastoma as alternative: Use as an alternative to standard medical therapy, such as Avastin (bevacizumab) or chemotherapy, for progressive or recurrent glioblastoma multiforme or grade IV astrocytoma.
Malignant pleural mesothelioma: Use as an adjunct to pemetrexed (Alimta) and platinum-based chemotherapy for malignant pleural mesothelioma.
Brain metastases: Use for brain metastases.

TTF therapy is investigational and not covered for progressive or recurrent glioblastoma, including grade IV astrocytoma, whether used as an adjunct to standard medical therapy—such as Avastin (bevacizumab) or chemotherapy—or as an alternative to standard medical therapy.

TTF therapy is investigational and not covered when used for brain metastases, cancer in areas other than the brain, malignant pleural mesothelioma, or non-small cell lung cancer. This includes use as an adjunct to pemetrexed (Alimta) and platinum-based chemotherapy for malignant pleural mesothelioma or as an adjunct to standard medical therapy for non-small cell lung cancer.

This medical policy does not apply to Medicare Advantage. Coverage for other members remains subject to the applicable benefit plan, including its limits and conditions.

Coding and Product Identification

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

FDA product codesmixed

NZK	FDA product code
SDA	FDA product code
SHC	FDA product code

Age requirement

Minimum ageAt least 18 years

Covered populationAdults with newly diagnosed glioblastoma multiforme or grade IV astrocytoma

Coverage concernCoverage may be denied when the individual is younger than 18 years

Tumor location

Required locationSupratentorial region of the brain

Anatomic descriptionThe cerebrum

Coverage concern

Authorization and Documentation Requirements

Prior Authorization

Prior Authorization and Initial Rental

Obtain plan pre-approval before initiating tumor treating fields (TTF) therapy. When coverage criteria are met, the initial authorization may be approved for a 90-day rental.

Submit the request before the device is provided or therapy begins.
Initial authorization period: 90-day rental.

Prior Authorization

Reauthorization for Continuation

Request reauthorization for each additional 90-day rental period. Continuation may be approved until documented tumor progression or recurrence, provided the required monitoring and supporting documentation are submitted.

Submit a reauthorization request for each additional 90-day rental period.
Continuation is permitted until progression or recurrence is documented.
Include the required MRI monitoring and evidence that continuation criteria remain met.

Therapy Overview

Tumor treating fields (TTF) are low-level electrical currents delivered through insulated electrodes placed on the skin. The fields are intended to cause cancer-cell death and are delivered using a helmet or skin-surface electrode arrays. For the covered application, TTF is used as adjunctive therapy in adults with newly diagnosed supratentorial glioblastoma multiforme or grade IV astrocytoma after surgery, radiation therapy, and chemotherapy when applicable, while the individual receives maintenance temozolomide.

Definitions and Abbreviations

Documented progression

Documented progressionTumor growth greater than 25% compared with the smallest tumor area measured during the trial

Additional findingOne or more new brain tumors appear and are radiologically diagnosed as glioblastoma multiforme

Continuation impactContinuation is allowed until documented progression or recurrence

Karnofsky Performance Status

DefinitionA functional-status scale expressed as a percentage from 0 to 100

Relevant thresholdA score of at least 70% is required for covered therapy

Meaning of 70%

Therapy Line Classification

First-line therapy

Adjuvant/maintenance therapy for newly diagnosed glioblastoma: TTF is covered for newly diagnosed glioblastoma or grade IV astrocytoma after surgery, radiation therapy, and chemotherapy if applicable, while the individual receives maintenance temozolomide.KPS ≥70%; age ≥18; supratentorial tumor

Salvage therapy

Recurrent or progressive glioblastoma: TTF used as an adjunct to or alternative to standard medical therapy for progressive or recurrent glioblastoma or grade IV astrocytoma is investigational and not covered.

Biomarker Requirements

MGMT promoter methylation

BiomarkerMGMT gene promoter methylation

Specific coverage requirementNo specific MGMT promoter methylation requirement is stated for TTF coverage

Treatment stratificationNCCN recommendations address methylated, unmethylated, or indeterminate promoter status

MGMT promoter status

Methylated statusIncluded in NCCN treatment stratification

Unmethylated statusIncluded in NCCN treatment stratification

Indeterminate status

Regimens and Indication Context

Indication	Regimen	Coverage
Newly diagnosed supratentorial glioblastoma multiforme or grade IV astrocytoma after initial treatment	TTF therapy adjunctive to standard maintenance Temodar (temozolomide)	Covered

Indication	Regimen	Coverage
Progressive or recurrent glioblastoma or grade IV astrocytoma	TTF as an adjunct to or alternative to standard medical therapy, including Avastin (bevacizumab) or chemotherapy	Not covered; investigational

Indication	Regimen	Coverage
Malignant pleural mesothelioma	TTF adjunctive to pemetrexed (Alimta) and platinum-based chemotherapy	Not covered; investigational

Indication	Regimen	Coverage
Non-small cell lung cancer	TTF adjunctive to standard medical therapy	Not covered; investigational

Indication	Regimen	Coverage
Newly diagnosed supratentorial glioblastoma in adults	Optune/TTF with standard brain radiotherapy, concurrent temozolomide, and adjuvant temozolomide	Covered

Indication	Regimen	Coverage
Recurrent glioblastoma after chemotherapy when surgical and radiation options have been exhausted	NovoTTF-100A/Optune as a stand-alone treatment	Covered

Indication	Regimen	Coverage
Unresectable, locally advanced or metastatic malignant pleural mesothelioma	Optune Lua concurrently with pemetrexed and platinum-based chemotherapy	Covered

Indication	Regimen	Coverage
Metastatic non-small cell lung cancer after progression on or after platinum-based chemotherapy	Optune Lua with concurrent drug treatments	Covered

Indication	Regimen	Coverage
Newly diagnosed glioblastoma multiforme	Tumor Treating Fields Therapy in conjunction with maintenance temozolomide	Covered

Policy Summary

PayerPremera Blue Cross of Washington

PolicyTumor Treating Fields Therapy

Policy CodePolicy 1.01.29

Change TypeModified

Effective DateNovember 1, 2026

Last ReviewOct 12, 2026

Next Review DateN/A

Key ActionObtain plan pre-approval and submit documentation showing that all medical-necessity criteria are met before initiating TTF therapy.

SourceLink

On This Page

Cancer outside the brain: Use for cancer in areas other than the brain.

Non-small cell lung cancer: Use as an adjunct to standard medical therapy for non-small cell lung cancer.

The tumor must be supratentorial; use for cancer outside the brain is investigational

Karnofsky Performance Status

Minimum KPSAt least 70%

ScaleFunctional-status scale expressed as a percentage from 0 to 100

Meaning of 70%Unable to work but able to live at home and care for most personal needs

Optune daily use

Minimum daily useAt least 18 hours per day

DeviceOptune

FDA-label purposeAt least 18 hours a day is recommended for the best response to treatment

MRI monitoring

MRI intervalEvery 6 months

Continuation requirementSubmit an MRI report every six months

MRI findingThe report must demonstrate no documented progression or recurrence

Tumor progression

Tumor growth criterion>25% growth compared with the smallest tumor area measured during the trial

New-tumor criterionAppearance of one or more new brain tumors radiologically diagnosed as glioblastoma multiforme

Criteria nameMacDonald criteria, as used in the EF-14 study

Documentation Required

Initial Medical-Necessity Documentation

Medical records submitted for initial review must demonstrate that the medical-necessity criteria are met for newly diagnosed glioblastoma multiforme or grade IV astrocytoma.

Individual is 18 years of age or older.
Tumor is located in the supratentorial region of the brain.
Karnofsky Performance Status is 70% or higher.
Initial treatment has been completed, including surgery (resection, debulking, or biopsy), radiation therapy, and chemotherapy if applicable.
Individual is receiving standard maintenance therapy with Temodar (temozolomide).

Documentation Required

Continuation MRI Documentation

For continuation of TTF therapy, submit an MRI report every six months to demonstrate that there is no documented progression or recurrence of the tumor.

MRI report required at least every 6 months.
Progression includes tumor growth greater than 25% compared with the smallest tumor area measured during the trial or one or more new brain tumors diagnosed radiologically as glioblastoma multiforme.

Note

Device-Use Counseling and Compliance

Counsel the individual on device-use requirements and confirm willingness to comply with the FDA label. The individual must understand the need for a shaved head and sustained daily use.

Scalp must be shaved for device use.
Use Optune for at least 18 hours per day for the best response.
Complete at least 4 full weeks of therapy; stopping earlier lowers the chance of response.
Document understanding of and willingness to comply with device-use criteria.

Denial Risk

Investigational or Noncovered Indications

TTF therapy is investigational and not covered for conditions or uses outside the covered newly diagnosed supratentorial glioblastoma indication.

Adjunct to standard therapy for progressive or recurrent glioblastoma or grade IV astrocytoma.
Alternative to standard therapy for progressive or recurrent glioblastoma multiforme or grade IV astrocytoma.
Adjunct to pemetrexed (Alimta) and platinum-based chemotherapy for malignant pleural mesothelioma.
Treatment for brain metastases.
Treatment for cancer in areas other than the brain.
Adjunct to standard medical therapy for non-small cell lung cancer (NSCLC).

Denial Risk

Failure to Meet Glioblastoma Coverage Criteria

Coverage may be denied when the individual does not meet all required criteria for TTF therapy as adjuvant treatment of newly diagnosed glioblastoma multiforme or grade IV astrocytoma.

Age is under 18 years.
Tumor is not in the supratentorial region of the brain.
Karnofsky Performance Status is below 70%.
Required initial treatment has not been completed: surgery, radiation therapy, or chemotherapy if applicable.
Individual is not receiving standard maintenance therapy with Temodar (temozolomide).

Denial Risk

Progression or Missing Continuation Documentation

Reauthorization may be denied when continuation criteria are not supported by the submitted records. Coverage does not continue after documented progression or recurrence, or when required continuation monitoring is missing.

MRI report is not submitted every 6 months.
MRI documents tumor progression or recurrence.
Records do not establish that continuation criteria remain satisfied.
The requested continuation period exceeds the approved 90-day rental period without reauthorization.

Unable to work but able to live at home and care for most personal needs

Tumor treating fields

Delivery methodLow-level electrical fields delivered through a helmet or skin-surface electrode arrays

Intended effectThe therapy is intended to cause cancer-cell death

Use requirementIndividuals should use Optune at least 18 hours daily for the best response

Tumor treating fields terminology

AbbreviationTTF

Alternate terminologyAlternating electric field therapy

MeaningTherapy using alternating electric fields as tumor treating fields therapy

GBM

AbbreviationGBM

Expanded termGlioblastoma multiforme

Policy contextOptune is indicated for adult patients with histologically confirmed GBM in the FDA labeling

KPS

AbbreviationKPS

Expanded termKarnofsky Performance Status

ExpressionA percentage-based functional-status score

MGMT

AbbreviationMGMT

Expanded termO6-methylguanine-DNA-methyltransferase

Policy usageMGMT promoter status may be methylated, unmethylated, or indeterminate

AbbreviationRT

Expanded termRadiotherapy

Treatment contextStandard RT plus concurrent temozolomide is referenced for individuals with good performance status

MPM

AbbreviationMPM

Expanded termMalignant pleural mesothelioma

FDA indication contextOptune Lua is used concurrently with pemetrexed and platinum-based chemotherapy for specified adult patients

NSCLC

AbbreviationNSCLC

Expanded termNon-small cell lung cancer

Policy contextTTF used as an adjunct to standard medical therapy for NSCLC is investigational and not covered

Included in NCCN treatment stratification