CurrentArizona Complete HealthPolicy CP.MP.145

Electric Tumor Treating Fields (Optune)

Criteria and coverage stance for use of Tumor Treating Fields (Optune/Optune Gio) in adults with glioblastoma for initial and continuation therapy; includes exclusions, documentation, authorization intervals, and coding.

Policy Summary

PayerArizona Complete Health

PolicyElectric Tumor Treating Fields (Optune)

Policy CodePolicy CP.MP.145

Change TypeMaterial updates to age, KPS threshold history, and wear-time compliance added

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and document histologic/radiologic confirmation, KPS ≥ 60, supratentorial GBM, agreement to wear device ≥18 hours/day.

SourceLink

POLICY UPDATE CHANGES

Added age restriction of > 22 years.

Karnofsky Performance Status requirement changed between ≥ 60 and ≥ 70 in prior revisions; current criteria use KPS ≥ 60.

Requirement that member/enrollee agrees to wear the TTF device for 18 hours per day (initial and continuation) and compliance for continuation.

18h/dayminimum device wear time required

>22minimum age for coverage

KPS≥60required performance status

Initial + additional 90d

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Coverage Criteria for Tumor Treating Fields (Optune)

Initial Therapy (90 days)

Covered when ALL of the following are met for an initial 90-day course:

Initial 90 days criteria: 1) Patient is > 22 years old; 2) One of the following indications: (a) Newly diagnosed glioblastoma, histologically confirmed, located in the supratentorial region, and Karnofsky Performance Status ≥ 60, with TTF to be delivered in conjunction with temozolomide after standard surgical and/or radiation therapies are completed; OR (b) Recurrent glioblastoma, histologically- or radiologically-confirmed, located in the supratentorial region, and Karnofsky Performance Status ≥ 60, with TTF to be used as monotherapy after standard treatment with chemotherapy, surgery, and/or radiation; 3) None of the following contraindications: implanted medical device (e.g., deep brain stimulator, spinal cord stimulator, vagus nerve stimulator, pacemaker, defibrillator, programmable shunt), skull defect without replacement or bullet fragment, pregnancy, known sensitivity to conductive hydrogels; 4) Member agrees to wear the TTF device for 18 hours per day.

Matches policy I.A.

Continuation Therapy (additional 90 days)

Covered when ALL of the following are met for an additional 90-day course:

Continuation 90 days criteria: 1) There has been no disease progression in the prior 90 days of TTF therapy; 2) The member/enrollee agrees to wear the TTF device for 18 hours per day and was compliant with this requirement during the prior authorization period.

Matches policy I.B.

Insufficient Evidence / Not Established

Not covered/insufficient evidence:

Other indications: Use of TTF therapy for all indications beyond those specified for supratentorial glioblastoma is considered to have insufficient evidence to support coverage.

Matches policy II.

NovoTal planning software: Insufficient evidence to establish the efficacy of the NovoTal computer mapping/planning software for TTF array placement.

Matches policy III and NovoTal section.

Contraindications that preclude coverage of Tumor Treating Fields (TTF) include implanted electronic or programmable medical devices and other specific anatomic or physiologic conditions. Specifically, TTF is not covered for members with implanted devices such as a deep brain stimulator, spinal cord stimulator, vagus nerve stimulator, pacemaker, defibrillator, or programmable shunt. Coverage is also excluded for members with a skull defect (missing bone without replacement) or a retained bullet fragment, for pregnancy, and for those with a known sensitivity to conductive hydrogels (for example, gels used with ECG stickers or TENS electrodes).

The policy states there is insufficient evidence to support the use of Tumor Treating Fields (TTF) for any indications beyond the specific glioblastoma criteria described for initial and continuation therapy. In addition, the efficacy of the NovoTal computer mapping/planning software for TTF has not been established and is considered to have insufficient evidence to support coverage.

Regimen	Indication	Coverage status
Optune (Tumor Treating Fields) delivered concurrently with temozolomide	Newly diagnosed glioblastoma (histologically confirmed), supratentorial location; used as an adjunct to standard surgery and/or radiation therapy plus temozolomide	Covered with criteria

Regimen	Indication	Coverage status
Optune (Tumor Treating Fields) monotherapy	Recurrent glioblastoma (histologically- or radiologically-confirmed), supratentorial location; used as monotherapy after standard treatments (chemotherapy, surgery, and/or radiation)	Covered with criteria

Coding, Wear Time, Age, and Performance Status

Referenced HCPCS codes for device and transducersHCPCSCovered

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

inv-07: Minimum daily wear time — 18 hours/day

Minimum daily wear timeMember agrees to wear the TTF device for 18 hours per day (required for initial and continuation authorization)

Compliance for continuationFor additional 90-day courses, member must have been compliant with 18 hours/day wear during the prior authorization period

Documented agreementProvider documentation must record the member's agreement to wear the device 18 hours/day

inv-08: Minimum age — > 22 years

Minimum age for coverage> 22 years

Applies to initial and continuation therapyAge requirement is specified in initial 90-day and continuation criteria

Provider Requirements and Authorization Procedures

Prior Authorization

Prior Authorization Required

Prior authorization is required for initial and additional 90-day courses of Tumor Treating Fields (TTF) therapy.

Initial authorization: first 90-day course
Reauthorization: additional 90-day course — must document no disease progression in prior 90 days

Step Therapy

Step Therapy Guidance

This policy defines eligibility criteria rather than a sequential step-therapy progression. Clinicians should document that the member meets the policy-defined clinical eligibility (diagnosis, location, KPS, prior treatments) rather than attempting trials of alternative therapies as a step requirement.

Policy uses clinical criteria (e.g., histologic/radiologic confirmation, supratentorial location, KPS ≥ 60) to determine coverage
Do not interpret as requiring failure of specific prior systemic or surgical therapies beyond those specified in the criteria

Indication by Line of Therapy

first-line | second-line

Newly diagnosed: TTF used in conjunction with temozolomide after standard surgery and/or radiation (adjunct to standard therapy); supported by the EF-14 trial showing improved progression-free and overall survival when added to temozolomide.

First-line (newly diagnosed) per EF-14.

Recurrent: TTF may be used as monotherapy for recurrent glioblastoma after standard treatments (chemotherapy, surgery, and/or radiation); initial FDA approval was based on a phase III trial in recurrent GBM.

Second-line (recurrent) per Stupp et al. and FDA approval.

Biomarker and Molecular Status

inv-18: MGMT promoter methylation status — methylated or unmethylated/indeterminate noted as eligible per NCCN

MGMT promoter methylation statusBoth methylated and unmethylated/indeterminate statuses are considered eligible per NCCN guidance

Not required for coverage determinationMGMT status is not required to meet policy criteria; eligibility includes either status

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

Terms and Device Definitions

inv-15: TTF — Tumor Treating Fields definition

DefinitionTumor Treating Fields (TTF) are low‑intensity, intermediate-frequency alternating electric fields delivered to the brain via transducer arrays placed on the scalp to disrupt mitosis in dividing tumor cells

MechanismTTF exert physical forces on electrically charged cellular components, preventing normal mitotic process and causing cancer cell death

ApplicationDelivered continuously via a wearable device attached to the head using electrodes/transducer arrays

inv-16: Optune/Optune Gio — device definition and generation notes

Device familyOptune and Optune Gio (NovoTTF systems) — wearable medical devices that generate Tumor Treating Fields delivered to the scalp via transducer arrays

Generation note

Background on Tumor Treating Fields

Tumor Treating Fields (TTF) are a locoregional cancer therapy that deliver low‑intensity, alternating electric fields to the head via scalp transducer arrays. The fields disrupt mitosis in dividing tumor cells and are applied through a portable device (commercially available as Optune/Optune Gio) worn by the patient with transducer arrays placed on the scalp. Delivery requires adherence to device wear-time goals and consistent placement of arrays; clinical trials and regulatory approvals supporting TTF use for glioblastoma demonstrate that efficacy correlates with device compliance.

Policy Revision History

02/20policy_revision

Added age restriction of > 22 years to eligibility criteria.

12/21policy_revision

Added requirement that member/enrollee agrees to wear the TTF device for 18 hours per day for initial therapy and that continuation requires prior compliance with wearing the device.

11/23policy_revision

Karnofsky Performance Status requirement was changed from ≥ 60 to ≥ 70 (subsequently revised).