ModifiedPremera Blue Cross of WashingtonPolicy 1.01.29

Tumor Treating Fields Therapy

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This policy governs coverage and prior authorization for tumor treating fields therapy. Coverage is provided with criteria for adults with newly diagnosed supratentorial glioblastoma multiforme or grade IV astrocytoma after initial treatment and during temozolomide maintenance; TTF is investigational and not covered for other conditions described in the policy.

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 DateNot specified

Key ActionObtain plan pre-approval and submit documentation supporting medical necessity before initiating TTF therapy.

SourceLink

POLICY UPDATE CHANGES

The policy was created in October 2013 and initially considered tumor treating fields investigational.

HCPCS codes A9900 and E1399 were added to the policy in December 2013.

The November 1, 2026 annual review updated the literature review through April 6, 2026 and added references, while leaving policy statements unchanged.

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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 DateNot specified

Key ActionObtain plan pre-approval and submit documentation supporting medical necessity before initiating TTF therapy.

SourceLink

POLICY UPDATE CHANGES

The policy was created in October 2013 and initially considered tumor treating fields investigational.

HCPCS codes A9900 and E1399 were added to the policy in December 2013.

The November 1, 2026 annual review updated the literature review through April 6, 2026 and added references, while leaving policy statements unchanged.

90 daysInitial rental authorization

90 daysReauthorization periods

≥18 hours/dayRequired device use

6 monthsMRI monitoring interval

≥70%Minimum Karnofsky status

Coverage Criteria

Glioblastoma adjuvant therapy

Covered when ALL of the following are met:

Newly diagnosed glioblastoma eligibility

Patient and tumor criteria
- Age: The individual is at least 18 years of age.≥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%.≥70%
Completed initial treatment
- Surgery consisting of resection, debulking, or biopsy has been completed.
- Radiation therapy has been completed.
- Chemotherapy has been completed when applicable.If applicable
Maintenance therapy: The individual is receiving standard maintenance therapy with Temodar (temozolomide).

Continuation therapy

Continuation is permitted until documented progression or recurrence.

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

Investigational and not covered uses

Considered investigational in any of the following conditions:

Other conditions and uses

Recurrent or progressive glioblastoma: Adjunctive use with standard therapy or alternative use instead of standard therapy for progressive or recurrent glioblastoma multiforme or grade IV astrocytoma.
Malignant pleural mesothelioma: Adjunctive use with pemetrexed and platinum-based chemotherapy for malignant pleural mesothelioma.
Brain metastases: Use for brain metastases.
Cancer outside the brain: Use for cancer in areas other than the brain.

Recurrent Glioblastoma

This is an FDA-approved regulatory indication and does not by itself establish explicit payer coverage.

Recurrent GBM FDA indication: Adult patient with confirmed glioblastoma following confirmed recurrence in an upper region of the brain (supratentorial) after chemotherapy; the device is intended as stand-alone treatment and as an alternative to standard medical therapy after surgical and radiation options have been exhausted.Age ≥22 years

FDA-approved label for NovoTTF-100A/Optune.

Newly Diagnosed Glioblastoma

This is an FDA-approved regulatory indication and does not by itself establish explicit payer coverage.

Newly diagnosed GBM FDA indication: Adult patient with histologically confirmed glioblastoma; Optune is used with temozolomide after maximal debulking surgery and completion of radiation therapy with concomitant standard-of-care chemotherapy.Age ≥22 years; supratentorial disease

FDA-approved label for Optune with temozolomide.

Malignant Pleural Mesothelioma

This is an FDA-approved regulatory indication and does not by itself establish explicit payer coverage.

Malignant pleural mesothelioma FDA indication: Adult patient with unresectable, locally advanced or metastatic malignant pleural mesothelioma treated concurrently with pemetrexed and platinum-based chemotherapy.Adult

Optune Lua indication approved in 2019.

Metastatic Non-Small Cell Lung Cancer

This is an FDA-approved regulatory indication and does not by itself establish explicit payer coverage.

Metastatic NSCLC FDA indication: Adult patient with metastatic non-small cell lung cancer treated with Optune Lua along with concurrent drug treatments after progression on or after platinum-based chemotherapy.Adult; progression on or after platinum-based chemotherapy

Optune Lua indication approved in October 2024.

Tumor treating fields (TTF) therapy is considered investigational and not covered for progressive or recurrent glioblastoma or grade IV astrocytoma, whether used as an adjunct to or an alternative to standard medical therapy.

Coding and Operational Parameters

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 for a tumor treating fields product
SDA	FDA product code for a tumor treating fields product
SHC	FDA product code for a tumor treating fields product

Historical HCPCS Codes AddedHCPCS

A9900	HCPCS code added to the policy in December 2013
E1399	HCPCS code added to the policy in December 2013

Age requirement

Minimum ageAt least 18 years

Applicable populationAdults with newly diagnosed glioblastoma multiforme or grade IV astrocytoma

Coverage settingAfter initial treatment and while receiving standard maintenance temozolomide

Functional status requirement

Required scoreKarnofsky Performance Status of at least 70%

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

Authorization and Provider Actions

Prior Authorization

Prior Authorization and Rental Periods

Pre-approval is required. TTF therapy may be initially authorized for a 90-day rental. Additional 90-day rental periods may be reauthorized until documented tumor progression or recurrence.

Submit the request for plan review before therapy begins.
Reauthorization is contingent on continued eligibility and documentation of no progression or recurrence on MRI.

Documentation Required

Initial Medical Necessity Documentation

For initial authorization, submit medical records demonstrating that the medical-necessity criteria are met for newly diagnosed glioblastoma multiforme or grade IV astrocytoma.

Age ≥18 years and tumor located in the supratentorial region of the brain.
Karnofsky Performance Status (KPS) score ≥70%.

Background

Tumor treating fields (TTF) are low-level electrical currents delivered through small, insulated electrodes placed on the skin, including a scalp-mounted system for brain tumors. The fields are intended to cause cancer-cell death during a later stage of cell development.

Definitions and Abbreviations

Progression definition

Growth thresholdGreater than 25% growth compared with the smallest tumor area measured during the trial

New brain tumorsOne or more new brain tumors diagnosed radiologically as glioblastoma multiforme

Monitoring sourceProgression or recurrence is documented on MRI

Karnofsky Performance Status

Scale rangeRates functional ability from 100% to 0%

100%Normal activity without special care

Relevant score

Line of Therapy

First-line

Adjuvant or maintenance setting

Newly diagnosed disease: Newly diagnosed glioblastoma multiforme or grade IV astrocytoma.
Maintenance temozolomide: The individual is receiving standard maintenance therapy with Temodar (temozolomide).

Salvage

Recurrent or progressive disease: TTF is investigational when used as an adjunct to or alternative to standard therapy for progressive or recurrent glioblastoma or grade IV astrocytoma.

First-line

Biomarker Requirements

MGMT gene promoter methylation

BiomarkerMGMT gene promoter methylation

Clinical contextUsed to characterize glioblastoma

Treatment relevanceHigher response and overall survival rates with temozolomide are associated with MGMT promoter methylation

MGMT promoter methylation status

MethylatedRecognized MGMT promoter methylation status in NCCN treatment guidance

UnmethylatedRecognized MGMT promoter methylation status in NCCN treatment guidance

Indeterminate

Covered Treatment Regimens

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

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

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

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

Regimen	Indication	Coverage
Standard brain radiotherapy plus concurrent and adjuvant temozolomide plus alternating electric field therapy/TTF	Newly diagnosed glioblastoma with good performance status and supratentorial disease	Covered

Regimen	Indication	Coverage
Optune Lua concurrently with pemetrexed and platinum-based chemotherapy	Unresectable, locally advanced or metastatic malignant pleural mesothelioma	FDA-approved indication; coverage not determined by this policy entry

Regimen	Indication	Coverage
TTF with an immune checkpoint inhibitor or docetaxel	Metastatic NSCLC progressed on or after platinum-based chemotherapy	Experimental; evidence insufficient to determine improvement in net health outcome

Regimen	Indication	Coverage
TTF with other chemotherapy	Progressive glioblastoma	Experimental; evidence insufficient to recommend increased overall survival

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 DateNot specified

Key ActionObtain plan pre-approval and submit documentation supporting medical necessity before initiating TTF therapy.

SourceLink

On This Page

Non-small cell lung cancer: Adjunctive use with standard medical therapy for non-small cell lung cancer.

DocumentationThe medical record must include the Karnofsky Performance Status score

Device-use requirement

Daily useAt least 18 hours per day

PurposeThe FDA label identifies this use level as necessary to obtain the best response to treatment

Device understandingThe individual must understand device use and be willing to comply with FDA label use criteria

MRI monitoring

Monitoring intervalMRI report required every 6 months

Continuation requirementThe MRI must document no tumor progression or recurrence

Authorization periodContinuation may be authorized in additional 90-day rental periods until documented progression or recurrence

Tumor progression

Tumor growth criterionGrowth greater than 25% compared with the smallest tumor area measured during the trial

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

Clinical useThe definition is used to determine whether continuation of therapy may proceed

Completion of surgery (resection, debulking, or biopsy), radiation therapy, and chemotherapy, if applicable.

Current standard maintenance therapy with Temodar (temozolomide).

Documentation Required

Six-Month MRI Documentation for Continuation

Continuation requires an MRI report every 6 months demonstrating no documented tumor progression or recurrence. Submit the MRI documentation with the reauthorization request.

Progression is defined as tumor growth >25% compared with the smallest tumor area measured during the trial or the appearance of one or more new brain tumors diagnosed radiologically as glioblastoma multiforme.
Continuation is allowed only until documented progression or recurrence.

Documentation Required

Device-Use Understanding and Compliance

Document that the individual understands TTF device use and is willing to comply with the FDA-label use requirements, including the shaved-head requirement.

The individual should use Optune for at least 18 hours per day for the best response.
The individual should complete at least 4 full weeks of therapy; stopping earlier lowers the chance of response.

Unsupported block type: denial_risk

Denial Risk

Failure to Meet Medical Necessity Criteria

TTF for newly diagnosed glioblastoma multiforme or grade IV astrocytoma is not medically necessary when the required coverage criteria are not met; the request may be denied.

The individual is younger than 18 years.
The tumor is not in the supratentorial region of the brain.
KPS score is <70%.
Initial treatment has not been completed, including surgery, radiation therapy, and chemotherapy if applicable.
The individual is not receiving standard maintenance therapy with Temodar (temozolomide).

Denial Risk

Progression, Recurrence, or Missing MRI Documentation

Continuation or reauthorization may be denied when there is documented tumor progression or recurrence, or when the required six-month MRI documentation is not submitted.

MRI evidence of tumor growth >25% compared with the smallest tumor area measured during the trial.
One or more new brain tumors diagnosed radiologically as glioblastoma multiforme.
No MRI report at the required six-month interval demonstrating no progression or recurrence.

Denial Risk

Insufficient Evidence for Metastatic NSCLC

For metastatic NSCLC after progression on or after platinum-based therapy, available evidence is insufficient to establish an improvement in net health outcome with TTF; coverage may be denied or restricted under the investigational policy criteria.

The LUNAR trial showed a 3.3-month overall-survival increase when TTF was combined with an immune checkpoint inhibitor or docetaxel, but no significant improvement in progression-free survival or overall response rate.
Evidence limitations include the open-label design without a sham comparator, lack of baseline molecular testing, and changes in standard of care.

Denial Risk

Recurrent Glioblastoma Evidence Limitation

For recurrent glioblastoma, NCCN characterizes alternating electric field therapy/TTF as a category 2B option, reflecting lower-level evidence and nonuniform consensus; requests may be denied or restricted when the policy's covered criteria are not met.

NCCN category 1 support applies to selected initial treatment of newly diagnosed glioblastoma with good performance status, including adjuvant temozolomide plus alternating electric field therapy for supratentorial disease.
The policy does not extend coverage to TTF as an adjunct or alternative for progressive or recurrent glioblastoma.

70% indicates inability to work but ability to live at home and care for most personal needs

Tumor treating fields

TherapyLow-level electrical currents generated by small insulated electrodes placed on the skin surface

Brain applicationThe system may use a helmet with small electrodes attached to the scalp

Intended effectIntended to cause cancer-cell death during a later stage of cell development

KPS

MeaningKarnofsky Performance Status

UseA functional performance scale used in the NCCN treatment table

NCCN table contextThe table lists treatment options by age, KPS score, and MGMT promoter status

MGMT

Full nameO6-methylguanine-DNA-methyltransferase

Biomarker usePromoter methylation status is used to characterize glioblastoma and influence treatment options

Treatment relevanceResponse and overall survival rates with temozolomide are higher in individuals with MGMT gene promoter methylation

AbbreviationRT

MeaningRadiotherapy

Glioblastoma treatment roleStandard brain radiotherapy may be given with concurrent and adjuvant temozolomide

TTF

AbbreviationTTF

MeaningTumor treating fields

Treatment descriptionAlternating electric fields generated by insulated electrodes and used as an adjunct to glioblastoma treatment

NCT

AbbreviationNCT

MeaningNational clinical trial identifier

UseIdentifies a national clinical trial

Initial glioblastoma treatment: For individuals with glioblastoma and good performance status, standard brain radiotherapy plus concurrent and adjuvant temozolomide plus alternating electric field therapy is a NCCN category 1 recommendation; alternating electric field therapy is limited to supratentorial disease.Good performance status; supratentorial disease

NCCN category 1 recommendation.

Salvage

Recurrent or progressive glioblastoma: Alternating electric field therapy may be considered for recurrent glioblastoma, but NCCN rates it category 2B and the Congress of Neurological Surgeons states that evidence is insufficient to recommend TTF to increase overall survival.Recurrent or progressive disease

May be considered with other chemotherapy; evidence remains limited.

Salvage

Post-platinum metastatic NSCLC: TTF is used with concurrent standard care, including an immune checkpoint inhibitor or docetaxel, in metastatic NSCLC that has progressed on or after platinum-based therapy.Progression on or after platinum-based therapy

The LUNAR trial showed an overall survival increase but evidence was insufficient to determine improvement in net health outcome.

Recognized MGMT promoter methylation status in NCCN treatment guidance