CurrentAmbetter NevadaPolicy CP.MP.145

Electric Tumor Treating Fields (Optune)

Defines medical necessity and coverage criteria for tumor treating fields (TTF) therapy delivered by the Optune device for adults with supratentorial glioblastoma, including initial and continuation authorization requirements and contraindications.

Policy Summary

PayerAmbetter Nevada

PolicyElectric Tumor Treating Fields (Optune)

Policy CodePolicy CP.MP.145

Change TypeCriteria revisions and additions (KPS threshold, age limit, device wear/compliance)

Effective Date

Next Review Date

Key ActionObtain prior authorization and document patient meets KPS ≥ 60, agrees to wear device ≥18 hours/day, and meets indication criteria.

SourceLink

POLICY UPDATE CHANGES

Changed Karnofsky Performance Status requirement multiple times, most recently set to ≥ 60.

Added age restriction requiring adults > 22 years.

Added requirement that the member agrees to wear the TTF device for 18 hours per day and, for continuation, documented compliance during prior authorization period.

18h/dayrequired device wear time

≥60KPS minimum

90dinitial auth

90dcontinuation auth

Policy Summary

PayerAmbetter Nevada

PolicyElectric Tumor Treating Fields (Optune)

Policy CodePolicy CP.MP.145

Change TypeCriteria revisions and additions (KPS threshold, age limit, device wear/compliance)

Effective Date

Next Review Date

Key ActionObtain prior authorization and document patient meets KPS ≥ 60, agrees to wear device ≥18 hours/day, and meets indication criteria.

SourceLink

On This Page

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Coverage Criteria for Tumor Treating Fields (Optune)

Initial Therapy (first 90 days)

Covered when ALL of the following are met

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

Continuation Therapy (additional 90 days)

Covered when ALL of the following are met

Continuation criteria: 1) There has been no disease progression in the most recent 90 days of TTF therapy; 2) Member agrees to wear the TTF device for ≥ 18 hours per day and demonstrated compliance with device wear during the prior authorization period.

Other indications

Not supported

Insufficient evidence: There is insufficient evidence to support the use of TTF therapy for indications other than those specified (newly diagnosed or recurrent supratentorial glioblastoma).

The policy lists specific contraindicated conditions that preclude coverage of Tumor Treating Fields (TTF) therapy. Contraindications include implanted electronic medical devices such as deep brain stimulators, spinal cord stimulators, vagus nerve stimulators, pacemakers, defibrillators, or programmable shunts. Coverage is also excluded for members with a skull defect (for example, a missing bone without replacement or the presence of a bullet fragment), for pregnancy, and for individuals with a known sensitivity to conductive hydrogels (for example, gels used with ECG stickers or TENS electrodes).

The policy explicitly states that there is insufficient evidence to support the use of TTF therapy for any indications beyond those listed for newly diagnosed or recurrent supratentorial glioblastoma. Additionally, the policy indicates there is insufficient evidence to establish the efficacy of the NovoTal™ computer mapping software for planning TTF therapy.

Regimens and Treatment Contexts

Regimen	Indication	Coverage status
Optune (Tumor Treating Fields) delivered concurrently with temozolomide following completion of standard surgical and/or radiation therapies
Newly diagnosed, histologically confirmed supratentorial glioblastoma in adults (>22 years) with Karnofsky Performance Status ≥ 60; member agrees to wear device ≥ 18 hours/day
Covered

Regimen	Indication	Coverage status
Optune (Tumor Treating Fields) as monotherapy after prior standard treatments (chemotherapy, surgery, and/or radiation)
Recurrent glioblastoma, histologically- or radiologically-confirmed supratentorial tumor in adults (>22 years) with Karnofsky Performance Status ≥ 60; member agrees to wear device ≥ 18 hours/day
Covered with criteria

Coding and Performance Status

Referenced HCPCSHCPCS

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: Karnofsky Performance Status — ≥ 60

ThresholdKarnofsky Performance Status (KPS) ≥ 60 is required for eligibility.

Definition contextKPS is a performance-status scale used to assess functional status; policy specifies ≥ 60 as 'good performance status'.

Applicable settingsRequired for both initial 90-day and additional 90-day TTF therapy requests for newly diagnosed and recurrent supratentorial glioblastoma.

Revision historyKPS requirement was revised multiple times in the policy history and most recently finalized as ≥ 60.

inv-08: Device wear time — >= 18 hours per day

Daily wear time>= 18 hours per day (member agrees to wear the TTF device for 18 hours/day).

Provider Requirements, Authorization, and Documentation

Prior Authorization

Prior authorization required for initial and continuation TTF therapy

Prior authorization is required for both the initial 90-day course of Tumor Treating Fields (TTF) therapy and for any additional 90-day continuation period. The policy references the device and transducer HCPCS codes for billing and authorization (E0766 for the electrical stimulation device and A4555 for electrode/transducer replacement).

Initial authorization: initial 90 days of TTF therapy.
Continuation authorization: additional 90-day periods as requested.
Referenced codes: E0766 (device) and A4555 (electrode/transducer replacement).

Step Therapy

Therapy sequencing — TTF with temozolomide for newly diagnosed GBM

For newly diagnosed supratentorial glioblastoma, TTF must be delivered in conjunction with temozolomide after standard surgical and/or radiation therapies have been completed; for recurrent glioblastoma, TTF is used as monotherapy after standard chemotherapy, surgery, and/or radiation.

Line of Therapy Designations

first-line

First-line use

Newly diagnosed use: TTF (Optune) is used in conjunction with temozolomide after completion of standard surgical and/or radiation therapies for newly diagnosed supratentorial glioblastoma; supported by the EF-14 trial showing improved progression-free and overall survival when added to temozolomide.

salvage

Salvage (recurrent disease) use

Recurrent disease use: TTF may be used as monotherapy for recurrent supratentorial glioblastoma after standard treatment with chemotherapy, surgery, and/or radiation; phase III trial data demonstrate comparable activity to chemotherapy with favorable toxicity and quality-of-life profile.

Definitions

inv-14: Definition of Tumor Treating Fields (TTF) / Optune — alternating electric field therapy description

TermTumor Treating Fields (TTF) — alternating electric field therapy delivered by the Optune system.

MechanismLow-intensity, intermediate-frequency (≈100–300 kHz; ~200 kHz for GBM) alternating electric fields applied to the brain via transducer arrays on the scalp to disrupt mitosis in dividing tumor cells.

DeliveryFields are generated by a portable device (Optune/Optune Gio) and applied through electrodes/transducer arrays attached to the scalp.

SelectivityTTF primarily affects dividing tumor cells and is not expected to significantly affect nondividing normal brain cells; field intensities are low and do not raise tissue temperature.

inv-15: Karnofsky Performance Status — performance-status scale; KPS ≥ 60 defined as 'good performance status'

Scale

Background on Tumor Treating Fields

Tumor Treating Fields (TTF) are an alternating electric field therapy used to treat glioblastoma by delivering low-intensity, intermediate-frequency electric fields to the scalp via transducer arrays. The policy describes TTF (Optune) as therapy that disrupts dividing tumor cells and is used as an adjunct to temozolomide in newly diagnosed supratentorial glioblastoma or as monotherapy in recurrent disease. For coverage, the policy requires clinical elements that reflect the TTF mechanism and intended use, including tumor location in the supratentorial region, adequate performance status (KPS ≥ 60), appropriate sequencing with temozolomide for newly diagnosed disease, and compliance with device wear-time requirements.