Sierra Health and Life TTFields Coverage Update

Coverage Criteria for Tumor Treating Fields

Initial therapy for newly diagnosed GBM

Covered when ALL of the following are met for newly diagnosed supratentorial GBM (ndGBM):

ndGBM initial coverage: 1) FDA‑approved TTF device is used according to labeled indications, contraindications, warnings, and precautions; 2) Debulking surgery has been completed; 3) Radiation therapy has been completed; 4) Individual is receiving temozolomide (TMZ) as the only cancer drug; 5) Karnofsky Performance Status (KPS) ≥ 60 or ECOG Performance Status ≤ 2; 6) Individual has been counseled to wear the electric TTF device at least 18 hours dailyinitial 3 months approved

Initial approval for 3 months when criteria met

Initial therapy for recurrent GBM

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

rGBM initial coverage: 1) FDA‑approved TTF device is used according to labeled indications, contraindications, warnings, and precautions; 2) The device is used as the only treatment (no concurrent systemic cancer therapy); 3) Karnofsky Performance Status (KPS) ≥ 60 or ECOG Performance Status ≤ 2; 4) Individual has been counseled to wear the electric TTF device at least 18 hours dailyinitial 3 months approved

Initial approval for 3 months when criteria met

Continuation therapy

Criteria for continuation beyond initial 3 months:

Continuation of TTF: 1) MRI performed within 2 months prior to request shows no evidence of disease progression; 2) For newly diagnosed GBM the individual continues to receive TMZ as the only cancer drug OR for rGBM the device remains the only treatment; 3) Karnofsky Performance Status (KPS) ≥ 60 or ECOG Performance Status ≤ 2; 4) Documentation that the individual has been using the electric TTF device at least 18 hours dailysubsequent approvals based on these criteria

Subsequent approval(s) contingent on imaging, performance status, therapy status, and documented device use

Initial (newly diagnosed) glioblastoma

Covered when ALL of the following are met

ND-GBM coverage (based on EF-14): 1) Patient has newly diagnosed glioblastoma (supratentorial); 2) Patient has completed standard concomitant radiochemotherapy (radiation plus concurrent TMZ) and is planned for maintenance temozolomide; 3) TTFields will be used concurrently with maintenance TMZ as per EF-14 protocol; 4) Device use will be monitored and patient counseling provided to optimize compliance (evidence supports improved outcomes with ≥50% monthly use and greater benefit with higher compliance).N/A

EF-14 randomized trial demonstrated improved PFS and OS with TTFields+TMZ vs TMZ alone (median OS 20.9 vs 16.0 months).

Recurrent glioblastoma

Considered when ALL of the following are met

Recurrent GBM (rGBM): 1) Patient has radiologically confirmed recurrent glioblastoma; 2) Clinical decision considers TTFields as an alternative to or in lieu of further systemic chemotherapy or best supportive care for recurrence; 3) Patient has adequate performance status (KPS ≥ 60 or ECOG ≤ 2); 4) Clinician documents discussion of limited and mixed evidence for benefit in rGBM and any molecular factors (e.g., PTEN mutation) if considered relevant—retrospective data suggest possible enrichment but require validation.N/A

Evidence for rGBM is mixed: Hayes and ECRI assessments note similar OS to best standard care and limited-quality evidence; retrospective data suggest possible PTEN-associated benefit but are not definitive.

Tumors other than glioblastoma

Not routinely covered/experimental when ANY of the following apply

Non-GBM solid tumors: 1) Indication is a tumor type other than glioblastoma (for example non‑small cell lung cancer, brain metastases, pancreatic cancer, ovarian cancer, malignant pleural mesothelioma); 2) Use is being requested outside of a clinical trial with sufficient randomized evidence to support routine use; 3) Lack of confirmatory randomized long-term safety and effectiveness data for the tumor type in question.N/A

LUNAR and STELLAR provide encouraging but nondefinitive data (LUNAR randomized open‑label; STELLAR single-arm phase II); routine coverage for non‑GBM indications is considered investigational pending confirmatory data.

Indications discussed in document

Guideline and FDA-supported scenarios described in the document:

Newly diagnosed supratentorial GBM (ndGBM): TTFields with adjuvant temozolomide is FDA‑approved (supplemental PMA 2015) and is listed by NCCN as an option for adults with newly diagnosed supratentorial glioblastoma who have completed chemoradiation and have good performance status (KPS ≥ 60); NCCN notes the supratentorial location requirement.

ASCO/SNO and NCCN characterize evidence quality and recommendations; EF-14 trial supports benefit when added to maintenance TMZ.

Recurrent GBM (rGBM): TTFields (Optune) is FDA‑approved for recurrent GBM based on EF-11 safety data; NCCN considers it for recurrence but the panel is divided due to limited efficacy data; some guideline bodies (NICE, ESMO) advise against routine use for recurrent high‑grade glioma due to insufficient evidence.

Guideline positions vary and should inform but not replace plan coverage criteria.

Other tumors: Selected non‑GBM indications (for example, STELLAR in mesothelioma or LUNAR in NSCLC) have been evaluated—STELLAR single‑arm phase II and LUNAR randomized open‑label—but evidence is insufficient for routine coverage outside clinical trials pending confirmatory data.

Use of devices that generate tumor treating fields (TTF) is considered unproven and not medically necessary when the specified coverage criteria are not met. The policy explicitly cites lack of evidence to support TTF for indications outside the covered supratentorial glioblastoma scenarios and when key coverage requirements (e.g., performance status, device-only therapy in recurrence, or concomitant temozolomide as the only cancer drug in newly diagnosed disease) are not satisfied. Providers should expect denials or noncoverage for device requests that do not meet the listed criteria.

The policy also states that TTF used concurrently with other systemic cancer therapies for recurrent GBM (for example, bevacizumab or cytotoxic chemotherapy) is not medically necessary, and such combinations should not be submitted as a covered treatment strategy under the plan when the coverage conditions are absent.

The document notes a lack of randomized controlled trial (RCT) evidence

Although a recent randomized pivotal trial in metastatic non-small-cell lung cancer (LUNAR) reported improved overall survival with TTFields plus standard systemic therapy versus standard therapy alone, the policy emphasizes limitations such as open-label design, enrollment heterogeneity, and other study constraints; accordingly, routine coverage for non-GBM indications remains unsupported pending confirmatory randomized data.

NICE guidance (2018, updated 2021) recommends not offering tumor treating fields (TTF) as part of the management of newly diagnosed grade IV glioma (glioblastoma). The guidance also states that TTF should not be offered as part of management for recurrent high-grade glioma and lists this among other interventions that the committee advises against for these settings.

Providers should be aware that NICE’s position contrasts with some other guideline bodies and the FDA labeling; where local coverage is influenced by NICE recommendations, requests for TTF in newly diagnosed or recurrent high-grade glioma may be declined.

The policy specifies that TTF therapy combined with other systemic medical therapies for recurrent GBM (for example bevacizumab or chemotherapy) is not medically necessary. Concurrent use with systemic agents in the recurrent setting does not meet the plan’s coverage criteria and should not be billed as a covered indication.

Documentation supporting device use for recurrent disease must therefore show the device is being used as the only treatment (no concurrent systemic cancer drugs) in order to meet coverage conditions for initial or continued approval.

Routine coverage for TTFields in tumor types other than glioblastoma is not supported by sufficient randomized evidence and is considered experimental/investigational under this policy. The policy lists non-GBM tumors (for example NSCLC, mesothelioma, pancreatic, ovarian, and brain metastases) as indications where the evidence base lacks confirmatory RCTs.

Where randomized data are limited to single-arm or small trials, the policy indicates such uses should be considered investigational and not routinely covered until larger, confirmatory randomized trials are available.

Position statements from guideline bodies such as ESMO and NICE indicate insufficient evidence to support routine use of TTFields beyond confirmed progression or as part of standard management in newly diagnosed grade IV and recurrent high-grade glioma. ESMO specifically advises against using treatments, including TTFields, beyond confirmed progression on the same treatment because clinical benefit has not been established.

These guideline positions inform the policy’s stance that use beyond progression or outside the evidence-based scenarios is not supported and may result in noncoverage.

Billing and Coding References

Applicable Codes (reference)HCPCS

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

Minimum daily device wear time

Minimum daily device wear timeDevice must be worn at least 18 hours per day (≥ 18 hours/day)

Initial approval durationInitial approval when criteria met: 3 months

Documentation for wear timeContinuation requests require documentation of device use ≥ 18 hours/day

MRI for continuation requests

MRI timing for continuationMRI must be performed within 2 months prior to the continuation request and show no evidence of progression

Follow-up MRI schedule (NCCN)NCCN recommends follow-up brain MRI 2 to 8 weeks after RT, then every 2–4 months for 3 years, then every 3–6 months indefinitely

Prior Authorization and Documentation Requirements

Prior Authorization
Prior Authorization Required
Prior authorization required. Document that the patient meets FDA-labeled or guideline-indicated scenarios for tumor-treating fields (TTFields): adults with newly diagnosed supratentorial glioblastoma (ndGBM) after debulking surgery and completion of radiation therapy who will receive maintenance temozolomide (TMZ) as the only systemic cancer drug; or adults with radiologically confirmed recurrent supratentorial GBM (rGBM) after prior chemotherapy when TTFields will be used as the only treatment. Initial authorization for either ndGBM or rGBM is for 3 months when the applicable clinical criteria are met. Subsequent approvals for continuation beyond the initial 3 months require documentation of ongoing benefit and adherence (see items).
Initial approval duration: 3 months for ndGBM or rGBM when criteria are met.
Continuation approval requirements: recent MRI (≤ 2 months) showing no radiographic progression; for ndGBM, continued receipt of TMZ as the only cancer drug; for rGBM, device used as the only treatment; KPS ≥ 60 or ECOG ≤ 2; documentation of device use ≥ 18 hours/day.
Prior authorization must reference FDA labeling/supplemental approvals and relevant guideline indications (e.g., NCCN recommendations for ndGBM and rGBM).

Line of Therapy Categorization

first-line

first-line: TTFields therapy used after debulking surgery and completion of radiation with concurrent temozolomide as the only cancer drug (newly diagnosed supratentorial GBM).initial 3 months approved

Initial approval duration listed as 3 months when criteria met.

salvage

salvage: Device used as the only treatment for radiologically confirmed recurrent supratentorial GBM (rGBM) in patients with KPS ≥ 60 or ECOG ≤ 2 and counseled to wear device ≥18 hours/day.initial 3 months approved

Initial approval duration listed as 3 months when criteria met.

Regimens and Permitted Combinations

Regimen	Indication / Setting	Coverage Status	Supporting Details
TTF (Optune) plus temozolomide	Adjunct to standard chemoradiotherapy for newly diagnosed supratentorial glioblastoma (ndGBM) after completion of radiotherapy	Covered	Covered when all criteria met: FDA‑approved device per label; debulking surgery and radiation completed; receiving temozolomide as the only cancer drug; KPS ≥60 or ECOG ≤2; counselled to wear device ≥18 hours/day. Initial approval for 3 months. EF-14 and Stupp et al. randomized trials demonstrated improved PFS and OS with TTFields + TMZ versus TMZ alone (median OS ~20.9 vs 16.0 months).

Regimen	Indication / Setting	Coverage Status	Supporting Details
TTF plus bevacizumab or other chemotherapy	Concurrent use of TTF with systemic therapies (e.g., bevacizumab) for recurrent supratentorial GBM (rGBM)	Not Covered	Use of TTF combined with other systemic medical therapies for rGBM (for example bevacizumab or chemotherapy) is not medically necessary due to insufficient evidence. Policy states device should be used as the only treatment in rGBM; concurrent systemic therapy with TTF for recurrence is considered unproven.

Regimen	Indication / Setting	Coverage Status	Supporting Details
TTFields (200 kHz) delivered via Optune in combination with maintenance temozolomide	Newly diagnosed glioblastoma after completion of concomitant radiochemotherapy, planned for maintenance TMZ (EF-14 population)	Covered	Covered when criteria mirror EF-14: enrollment after completion of radiochemotherapy and planned maintenance TMZ; device use monitored and counselled to optimize compliance (evidence supports improved outcomes with ≥50% use). Randomized EF-14 trial showed statistically significant improvement in PFS and OS with TTFields + TMZ versus TMZ alone (median OS ~20.9 vs 16.0 months).

Regimen	Indication / Setting	Coverage Status	Supporting Details
TTFields added to standard systemic therapy (LUNAR trial regimen)	Metastatic non-small-cell lung cancer after progression on platinum-based therapy (randomized LUNAR study)	Experimental	LUNAR randomized, open-label pivotal trial reported longer OS with TTFields + standard systemic therapy vs standard therapy alone, but limitations include open-label design and potential generalizability concerns; routine coverage for non-GBM indications is not supported by sufficient randomized evidence per policy. Considered investigational/experimental pending further validation.

Regimen	Indication / Setting	Coverage Status	Supporting Details
TTFields (150 kHz) delivered to the thorax concomitant with pemetrexed plus platinum chemotherapy (STELLAR)	Front-line treatment of unresectable malignant pleural mesothelioma (continuous thoracic TTFields at 150 kHz + pemetrexed + cisplatin or carboplatin)	Experimental	STELLAR was a prospective single-arm phase II study (n=80) showing encouraging median OS (18.2 months) and acceptable safety with skin reactions related to TTFields; however, evidence is nonrandomized and considered investigational — routine coverage for non-GBM tumor types is not supported.

Regimen	Indication / Setting	Coverage Status	Supporting Details
TTFields (150 kHz) to thorax + pemetrexed 500 mg/m2 + cisplatin 75 mg/m2 or carboplatin AUC 5 q21 days up to six cycles, then TTFields maintenance	Unresectable malignant pleural mesothelioma in combination with pemetrexed and platinum chemotherapy (STELLAR trial regimen)	Experimental	STELLAR trial protocol: continuous thoracic TTFields at 150 kHz with IV pemetrexed 500 mg/m2 plus cisplatin 75 mg/m2 or carboplatin AUC 5 every 21 days for up to six cycles; responders received TTFields maintenance. Single-arm phase II (n=80) reported median OS 18.2 months, skin reactions in majority; evidence considered investigational pending randomized data.

Biomarkers and Genetic Testing

MGMT, PTEN referenced (not required for coverage)

Role of MGMT and PTEN in evidenceMGMT and PTEN are referenced in multiple analyses and retrospective studies but are not required for coverage determination

MGMT contextMGMT promoter methylation used for prognostic stratification in studies; TTFields benefit reported regardless of MGMT status in some analyses

PTEN contextRetrospective analyses suggest PTEN mutation may enrich for benefit in rGBM, but evidence is limited and not definitive

PTEN mutation

PTEN mutation comparisonRetrospective review reported improved post-progression survival in PTEN‑mutant rGBM treated with TTFields vs PTEN‑wild-type (22.2 vs 11.6 months in treated subgroup), but sample sizes were small and findings are exploratory

Evidence limitations

Definitions and Abbreviations

ECOG Performance Status

ECOG score requirementECOG Performance Status ≤ 2 is required for initial and continuation approvals

ECOG definitionECOG 0–5 scale: 0 fully active; 2 ambulatory and capable of self‑care but unable to work; higher scores indicate greater disability

Use in documentationPerformance status (ECOG ≤ 2 or KPS ≥ 60) must be documented for coverage and continuation requests

Karnofsky Performance Status (KPS)

KPS threshold for coverageKarnofsky Performance Status (KPS) ≥ 60 is required for initial and continuation approvals

KPS definition examplesKPS scores range 0–100; KPS 60 = requires occasional assistance but able to care for most personal needs; higher scores indicate better function

Background and Evidence Summary

Tumor treating fields (TTF) are a locoregional therapy that delivers alternating electric fields intended to disrupt mitosis in tumor cells. The policy describes TTF (Optune) as used adjunctively in glioblastoma management in the context of FDA approvals and guideline recommendations, while noting divergent guidance from international bodies.

Clinical practice recommendations cited in the document emphasize that standard initial management for newly diagnosed IDH‑wildtype glioblastoma includes resection when feasible, followed by involved-field radiotherapy with concomitant temozolomide and then maintenance temozolomide; TTF is positioned as an adjunct to maintenance temozolomide in the EF-14 randomized trial but guideline bodies (for example, NICE and ESMO) have raised concerns about routine adoption in some settings.

Policy Revision History

2026-01-01template_update_and_consolidationLatest

Template update and creation of a shared policy version to support application to Oxford plan membership; prior policy versions 2025T0582Q and CANCER 039.15 were archived.

OpenPayer

Electric Tumor Treatment Field Therapy (TTFields) for Glioblastoma — Coverage Criteria