UnitedHealthcare TTF Coverage Update, Prior Auth

Coverage Criteria for Tumor Treating Fields (TTFields)

inv-01: Initial therapy — newly diagnosed GBM

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

ndGBM initial coverage: 1) Histologically confirmed supratentorial glioblastoma; 2) Use of FDA‑approved TTF device per labeled indications, contraindications, warnings, and precautions; 3) Debulking surgery has been completed; 4) Radiation therapy has been completed; 5) Individual is receiving temozolomide (TMZ) as the only cancer drug; 6) Karnofsky Performance Status (KPS) ≥ 60 or ECOG Performance Status ≤ 2; 7) Individual has been counseled that the electric TTF device must be worn at least 18 hours dailyinitial approval: 3 months

Initial 3 months approved if all criteria met.

inv-02: Initial therapy — recurrent GBM

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

rGBM initial coverage: 1) Radiologically confirmed recurrence of supratentorial GBM; 2) Use of FDA‑approved TTF device per labeled indications, contraindications, warnings, and precautions; 3) Device is used as the only treatment; 4) Karnofsky Performance Status (KPS) ≥ 60 or ECOG Performance Status ≤ 2; 5) Individual has been counseled that the electric TTF device must be worn at least 18 hours dailyinitial approval: 3 months

Initial 3 months approved if all criteria met.

inv-03: Continuation therapy

Covered for continuation beyond initial 3 months when ALL of the following are met:

Continuation criteria: 1) MRI performed ≤ 2 months prior documents no evidence of disease progression; 2) For ndGBM, 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 dailyrenewal periods per documentation

Subsequent approvals based on these criteria.

inv-04: Initial therapy (ndGBM)

Covered when ALL of the following are met

ndGBM_Evidence: 1) Patient has newly diagnosed, supratentorial glioblastoma (post resection or biopsy) who completed standard concomitant radiotherapy with temozolomide and is receiving maintenance temozolomide; 2) Use of Optune/TTFields per FDA supplemental approval and labeled indications; 3) Patient meets performance status criteria (KPS ≥ 60 or ECOG ≤ 2) and has been counseled on device wear requirements

Based on EF-14 trial design and ASCO/SNO guidance; HRQoL not negatively impacted except for increased itchy skin

inv-05: Recurrent GBM and other tumor types

Mixed or investigational coverage — consider case-by-case

rGBM_and_other_tumors: Evidence for recurrent GBM shows similar overall survival to best standard care but may avoid chemotherapy toxicities; evidence for non-GBM tumors (e.g., metastatic NSCLC post-platinum, malignant pleural mesothelioma) is emerging from trials but randomized evidence is limited

Coverage decisions may require review of trial data and individual patient factors

compliance_impact: Patient is expected/able to maintain device adherence; analyses show clinical benefit correlates with monthly device compliance ≥ 50% and greater benefit with > 90%>=50% monthly usage recommended

Derived from compliance analysis of EF-14 and related studies

inv-06: Guideline and regulatory context

Guideline and regulatory positions relevant to TTFields use in glioblastoma

FDA approvals: Optune is FDA-approved for adults with recurrent GBM and received supplemental approval for use with temozolomide in newly diagnosed supratentorial GBM following maximal debulking surgery and completion of radiotherapy and standard chemotherapy

FDA information provided for context; approval is informational only.

NCCN guidance (supportive): NCCN includes alternating electric field therapy plus adjuvant temozolomide as an option for patients with good performance status (KPS ≥ 60) and supratentorial disease; panel is divided on rGBM

References NCCN GLIO guidance (2024/2025).

ASCO/SNO guidance: ASCO/SNO (2022) states alternating electric field therapy may be added to adjuvant temozolomide in newly diagnosed supratentorial GBM (IDH‑wildtype) after chemoradiation (evidence moderate; recommendation weak)

Supports selective adjunctive use.

Due to insufficient evidence of efficacy, the policy considers use of devices that generate electric tumor treating fields (TTF) to be unproven and not medically necessary for indications other than newly diagnosed or recurrent supratentorial glioblastoma when the specific coverage criteria are not met. Examples of excluded scenarios include treatment of tumors other than GBM and use of TTF concurrently with other systemic medical therapies (for example, bevacizumab or cytotoxic chemotherapy) for recurrent GBM.

Randomized controlled trial evidence supporting routine coverage of TTF is limited to glioblastoma. There is a lack of published RCT evidence for other tumor types — including non‑small cell lung cancer, brain metastases, pancreatic cancer, ovarian cancer, and mesothelioma — and therefore these indications are considered investigational or require case‑by‑case review rather than routine coverage.

The National Institute for Health and Care Excellence (NICE) guidance (2018; updated 2021) explicitly advises: “Do not offer TTField as part of managing a newly diagnosed grade IV glioma (glioblastoma),” and similarly recommends “Do not offer tumor treating fields (TTF) as part of management of recurrent high‑grade glioma.” This restrictive position is noted in the policy’s guideline context section.

When the policy’s specified coverage criteria are not satisfied, TTF therapy is considered unproven and not medically necessary. Continuation beyond the initial approval period is contingent on meeting continuation requirements (for example, recent MRI showing no progression, appropriate performance status, continued temozolomide for ndGBM or device as sole therapy for rGBM, and documented device use ≥ 18 hours/day), and absence of those conditions supports a non‑covered determination.

Use of TTF as monotherapy or as a routine treatment approach for tumor types other than glioblastoma is not supported by adequate randomized controlled trial evidence. The policy therefore does not endorse routine coverage for TTF monotherapy or for non‑GBM tumors outside of trial or individualized review circumstances.

Policy revision effective 01/01/2026 removed prior language that explicitly designated certain therapeutic radiology clinical treatment planning computer software used with TTF as unproven and not medically necessary. That removal reflects reassessment of the evidence regarding those software tools and is documented in the policy history.

Applicable Codes and Coding Notes

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

Previously listed/removed CPT CodesCPT

77299

Unlisted procedure, therapeutic radiology (REMOVED from Applicable Codes section)

Minimum daily wearable time

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

Documentation requirementMedical record must document counseling that device must be worn ≥ 18 hours daily

Continuation monitoringContinuation approvals require documentation that the individual has been using the device ≥ 18 hours daily

TTFields device usage compliance threshold

Compliance threshold linked to benefit>= 50% monthly device compliance associated with improved PFS and OS compared with TMZ alone

Greater benefit with higher adherenceClinical analyses show progressively better outcomes with increasing compliance; >90% monthly compliance associated with longest median survival (24.9 months) and higher 5‑year survival

Prior Authorization, Documentation, and Provider Guidance

Prior Authorization

Prior Authorization Required

Prior authorization is required for electric tumor treatment field (TTF) devices. Requests must demonstrate the member meets the coverage criteria for initial and continuation use described in the policy (e.g., histologically confirmed supratentorial GBM, completion of debulking surgery and radiotherapy for ndGBM, ongoing temozolomide as the only cancer drug for ndGBM, KPS ≥ 60 or ECOG ≤ 2, and counseling that the device is to be worn ≥ 18 hours daily). Initial approval is for 3 months when criteria are met; continuation approvals require updated documentation (see documentation callouts).

Initial authorization: Demonstrate all initial-therapy criteria for ndGBM or rGBM are met; initial approval is 3 months.
Continuation authorization: MRI within ≤ 2 months prior to request showing no progression (for continuation), documentation of device use ≥ 18 hours/day, continued TMZ as sole systemic therapy for ndGBM (or device-only for rGBM), and continued KPS/ECOG eligibility.

Prior Authorization

Authorization Considerations for ndGBM (EF-14 Context)

For newly diagnosed GBM (ndGBM), prior authorization decisions reflect the EF-14 randomized trial evidence showing addition of TTFields to maintenance temozolomide improved progression-free and overall survival. Authorization for ndGBM follows the clinical trial context: enrollment in EF-14 began after completion of concomitant radiochemotherapy, so requests should document standard radiotherapy + concurrent TMZ was completed prior to initiation and that maintenance TMZ is ongoing.

Regimens and Combinations

Regimen	Coverage stance	Notes / supporting criteria
Tumor treating fields (TTF) used concurrently with other systemic therapies (e.g., bevacizumab or chemotherapy) for recurrent supratentorial GBM
Not covered
Policy states use of electric TTF therapy with concurrent medical therapy (e.g., bevacizumab or chemotherapy) for rGBM is unproven and not medically necessary when criteria are not met; concurrent use for rGBM is explicitly listed among not medically necessary indications

Regimen	Coverage stance	Notes / supporting criteria
Tumor treating fields (TTF) used with maintenance temozolomide (TMZ) for newly diagnosed supratentorial GBM
Covered when all initial ndGBM criteria are met
Coverage based on EF-14 trial evidence showing improved PFS and OS when TTFields is added to maintenance TMZ; initial approval is for 3 months if criteria (surgery, completed radiation, receiving TMZ as sole cancer drug, KPS ≥60/ECOG ≤2, counselled to wear ≥18 hours/day) are met

Regimen	Coverage stance	Notes / supporting criteria
Optune (TTFields) in combination with maintenance temozolomide for newly diagnosed supratentorial glioblastoma after radiochemotherapy
Covered when EF-14–based criteria are met
Supplemental FDA approval and randomized EF-14 evidence support use as adjunct to maintenance TMZ after completion of standard radiochemotherapy; coverage requires completion of surgery and radiation, receiving TMZ as only cancer drug, performance status threshold, and counselling about ≥18 hours/day wear; initial approval: 3 months

Regimen	Coverage stance	Notes / supporting criteria
TTFields delivered to the thorax in combination with systemic chemotherapy (LUNAR, STELLAR trials) for metastatic NSCLC or unresectable malignant pleural mesothelioma
Experimental / investigational
Phase II (STELLAR) and phase III (LUNAR) trials evaluated TTFields to the thorax with systemic chemotherapy; evidence is emerging but insufficient for routine coverage and considered investigational in non-GBM tumors

Regimen	Coverage stance	Notes / supporting criteria
Tumor treating fields (Optune) plus adjuvant (maintenance) temozolomide for newly diagnosed supratentorial GBM in selected patients with good performance status
Covered with criteria
Policy aligns with FDA supplemental approval and guideline context (NCCN, ASCO/SNO) recommending adjunctive use in selected patients with good PS; coverage requires completion of surgery and radiation, ongoing TMZ as sole cancer drug, KPS ≥60/ECOG ≤2, and counselling regarding ≥18 hours/day wear

Regimen	Coverage stance	Notes / supporting criteria
Tumor treating fields (Optune) as monotherapy or as clinically indicated for recurrent GBM
Covered \| mixed
Policy covers TTF as sole therapy for rGBM when coverage criteria are met (device used as only treatment, KPS ≥60/ECOG ≤2, counselled to wear ≥18 hours/day); evidence for rGBM shows similar OS to best standard care with different toxicity profiles and coverage may depend on individual factors and guideline interpretation

Definitions and Terms

Karnofsky Performance Status (KPS) definition

DefinitionKarnofsky Performance Status (KPS) is a 0–100 scale measuring ability to perform ordinary tasks; higher scores indicate greater independence

Example score interpretationKPS 60 = requires occasional assistance but is able to care for most personal needs; KPS 70 = cares for self but unable to do normal activity or active work

Use in policyKPS is used to determine eligibility for TTFields coverage (policy requires KPS ≥ 60)

ECOG Performance Status definition

DefinitionECOG Performance Status is a 0–5 scale assessing functional status; lower scores indicate better functioning

Key scoresECOG 0 = fully active; ECOG 1 = restricted in strenuous activity but ambulatory; ECOG 2 = ambulatory and capable of self‑care but unable to work; ECOG 5 = dead

Line of Therapy Context

inv-38: first-line

first-line: After maximal safe resection (or biopsy) and completion of concomitant radiotherapy with temozolomide, TTFields may be used concurrently with maintenance temozolomide as first-line adjunctive therapy in selected patients meeting coverage criteria

Initial approval 3 months; continuation requires MRI stability and ongoing TMZ.

inv-39: salvage

salvage: For recurrent supratentorial GBM, TTFields may be used as salvage therapy as the sole treatment modality in patients with radiologically confirmed recurrence who meet performance and counseling criteria

Initial approval 3 months; continuation requires MRI stability and device as sole therapy.

inv-40: first-line (alternate reference)

Biomarker and Clinical Thresholds

PTEN mutation

MarkerPTEN mutation

Evidence noteRetrospective institutional series reported improved post‑progression survival (PPS) with TTFields in PTEN‑mutant rGBM versus PTEN‑wildtype, but data are exploratory and from small samples

Coverage implicationPTEN mutation is not required for coverage; may be considered informational in case review

Dexamethasone dose

ThresholdDexamethasone dose ≤ 4.1 mg has been associated with longer median overall survival in analyses of TTFields-treated patients

Evidence sourceSystematic review/meta‑analysis identified dexamethasone ≤ 4.1 mg as an influencing factor on TTFields efficacy

Background

Tumor treating fields (TTFields) are a noninvasive therapy that deliver low‑intensity, intermediate‑frequency alternating electric fields to the tumor region via transducer arrays placed on the scalp. These fields disrupt cell division processes and are delivered by portable systems (for example, Optune) that require frequent array replacement and prolonged daily wear. Standard management of newly diagnosed glioblastoma typically includes maximal safe resection when feasible, followed by radiotherapy with concurrent temozolomide and then adjuvant (maintenance) temozolomide; pivotal trial evidence evaluating TTFields (for example, EF‑14) examined adding TTF to maintenance temozolomide after completion of radiochemotherapy.

OpenPayer

Electric Tumor Treatment Field Therapy (for New Mexico Only)