ModifiedCentenePolicy CP MP.145

Electric Tumor Treating Fields (Optune)

Defines medical necessity and coverage criteria for use of Tumor Treating Fields (TTF) delivered by the Optune device for adults with supratentorial glioblastoma, including initial and continuation authorization requirements and contraindications for Centene-affiliated health plans.

Policy Summary

PayerCentene

PolicyElectric Tumor Treating Fields (Optune)

Policy CodePolicy CP MP.145

Change TypeCriteria updates (age, KPS) and wear-time compliance added

Effective Date

Next Review Date

Key ActionObtain prior authorization for an initial 90-day TTF course and document histologic/radiologic diagnosis, supratentorial tumor location, KPS 63; 70, and agreement to wear the device 63; 18 hours/day.

SourceLink

POLICY UPDATE CHANGES

Added age restriction of 63; 22 years.

Changed Karnofsky Performance Status requirement from 63; 60 to 63; 70.

Added requirement that the member agrees to wear the TTF device for 18 hours per day and demonstrate compliance for continuation of therapy.

90 daysInitial authorization period

18 hr/dayRequired device wear time

KPS 63;70Minimum KPS

SupratentorialTumor location required

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Coverage Criteria for Tumor Treating Fields (Optune)

Initial Therapy — Covered when ALL of the following are met for initial 90-day therapy

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

Initial Therapy Criteria: Age ≥ 22 years; histologically confirmed glioblastoma located in the supratentorial region; Karnofsky Performance Status ≥ 70; member agrees to wear the TTF device ≥ 18 hours per day; no contraindications (e.g., implanted medical devices such as deep brain stimulators, spinal cord stimulators, vagus nerve stimulators, pacemakers, defibrillators, programmable shunts; skull defect such as missing bone without replacement or presence of bullet fragment; pregnancy; known sensitivity to conductive hydrogels); for newly diagnosed GBM, TTF delivered in conjunction with temozolomide after completion of standard surgical and/or radiation therapies; for recurrent GBM, TTF may be used as monotherapy after standard treatments.

Initial authorization length = 90 days

Continuation Therapy — Covered for additional 90 days (continuation) when ALL of the following are met

Covered for additional 90 days (continuation) when ALL of the following are met:

Continuation Therapy Criteria: No disease progression during the prior 90 days of TTF therapy; member agrees to wear the TTF device ≥ 18 hours per day and was compliant with this wear-time during the authorization period; clinical benefit is implied by lack of progression.

Continuation authorization = additional 90 days

Insufficient Evidence — Not supported / Insufficient Evidence for other indications

Not supported / Insufficient Evidence

Other Indications / NovoTal: Insufficient evidence to support use of TTF therapy for indications other than supratentorial glioblastoma; insufficient evidence to establish the efficacy of NovoTal computer mapping software for planning TTF therapy.

Policy stance: not covered outside specified indications

Contraindications that preclude coverage include implanted medical devices such as deep brain stimulators, spinal cord stimulators, vagus nerve stimulators, pacemakers, defibrillators, or programmable shunts; skull defect such as a missing bone without replacement or the presence of a bullet fragment; pregnancy; and known sensitivity to conductive hydrogels (e.g., those used with ECG stickers or TENS electrodes).

Coverage and administration of benefits are subject to all terms, conditions, exclusions and limitations in the member’s coverage documents (for example, evidence of coverage, certificate of coverage, policy, or contract of insurance), as well as applicable state and federal requirements and Health Plan-level administrative policies and procedures. Any discrepancies are governed by law and the Health Plan’s effective dates and procedures.

This policy finds insufficient evidence to support the use of Tumor Treating Fields (TTF) for indications other than supratentorial glioblastoma. The policy also concludes there is insufficient evidence to establish the efficacy of the NovoTal computer planning software for placement of transducer arrays to guide TTF therapy.

Coding and Key Parameters

Device and accessory HCPCS codes referencedHCPCS

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.

Device wear time — required parameter (wear time)

Required daily wear timeMember/enrollee agrees to wear the TTF device for ≥ 18 hours per day

Compliance for continuationContinuation authorization requires documented compliance with ≥ 18 hours/day during the prior authorization period

Authorization implicationAgreement to wear ≥ 18 hours/day is a required element of initial and continuation authorization criteria

Karnofsky Performance Status — minimum threshold

Minimum KPS for eligibilityKarnofsky Performance Status ≥ 70

Change historyRequirement revised from ≥ 60 to ≥ 70 in recent policy update

Provider Actions, Authorization and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for initial and continuation Tumor Treating Fields (TTF) therapy requests. Initial requests are for the first 90 days of TTF therapy and must meet the medical necessity criteria for either newly diagnosed or recurrent supratentorial glioblastoma. Continuation (additional 90-day) requests require documentation of no disease progression in the prior authorization period and demonstrated member compliance with wearing the TTF device ≥18 hours per day during that period.

Initial authorization: first 90 days — documentation must demonstrate diagnosis, tumor location (supratentorial), histologic or radiologic confirmation as applicable, and Karnofsky Performance Status ≥ 70.
Continuation authorization: additional 90 days — documentation must show no disease progression in the last 90 days and evidence the member was compliant with device wear (≈18 hours/day) during the prior authorization period.
Requests that do not meet these prior authorization requirements are at risk for denial.

Note

Therapy Context

TTF therapy is intended for use in adults (≥ 22 years per source text) with supratentorial glioblastoma. For newly diagnosed glioblastoma, TTF is used in conjunction with temozolomide following standard surgical and/or radiation therapy. For recurrent glioblastoma, TTF may be used as monotherapy after prior standard treatment (chemotherapy, surgery, and/or radiation). The policy states TTF is medically necessary only for these indications; other uses are considered unsupported by sufficient evidence.

Background

Tumor Treating Fields (TTF) are low‑intensity, alternating electric fields delivered to the scalp via transducer arrays (Optune systems) that produce alternating fields in the approximate frequency range used to disrupt mitosis of dividing tumor cells while sparing nondividing brain cells. Optune systems, including the second‑generation Optune Gio, are designed to be worn by patients and require application of scalp transducer arrays and coupling gels to deliver the electric fields for prolonged daily use to achieve therapeutic effect.

Definitions

Electric tumor treating fields (TTF) / Optune — definition

DefinitionElectric tumor treating fields (TTF) — low‑intensity alternating electric fields delivered to the scalp via transducer arrays (Optune) that disrupt mitosis in dividing tumor cells

Device exampleOptune GioTM — a portable, second‑generation system that generates TTF for treatment of glioblastoma

MechanismTTF alter tumor cell polarity at intermediate frequencies (~100–300 kHz) to interfere with cell division while sparing nondividing brain cells

NovoTal — definition and evidence

DefinitionNovoTal — a computer software‑planning tool to assist placement of transducer arrays for TTF therapy

Evidence statementFew studies have evaluated outcomes using NovoTal; available data are limited and authors often had ties to the manufacturer