CurrentKaiser PermanentePolicy N/A

Tumor‑treating fields (TTF) therapy (Optune) — clinical review criteria for primary supratentorial glioblastoma

Clinical review criteria governing medical necessity and authorization of tumor‑treating fields (TTF) therapy (Optune) for adults with primary supratentorial glioblastoma, including initiation and reauthorization requirements within Kaiser Permanente Washington plans.

Policy Summary

PayerKaiser Permanente

PolicyTumor‑treating fields (TTF) therapy (Optune) — clinical review criteria for primary supratentorial glioblastoma

Policy CodePolicy N/A

Change TypeRevised and clarified

Effective DateNov 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization; standard authorizations are issued for 90 days and reauthorizations require updated clinical notes and follow-up imaging.

SourceLink

POLICY UPDATE CHANGES

Criteria were updated to align with RANO 2.0 for distinguishing true progression from pseudo-progression and to require starting TTF no later than 60 days from the end of chemoradiation.

Reauthorization language clarified to allow limited reauthorization when pseudo-progression is favored and RANO 2.0 criteria are not met; durations specified (3 months standard, 1 month limited).

90 daysstandard authorization period

60 daysmax time to start TTF

KPS ≥ 70%required KPS

≥ 18

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Coverage Criteria

Initial therapy (newly diagnosed primary supratentorial GBM)

Covered when ALL of the following are met:

Initial eligibility: Patient is 18 years of age or older; Karnofsky Performance Status (KPS) >= 70%; histologically confirmed primary supratentorial glioblastoma multiforme (GBM); patient has completed standard concomitant chemoradiation with temozolomide (TMZ); disease did not progress through chemoradiation (pseudo-progression does not exclude eligibility when RANO 2.0 or magnetic resonance spectroscopy favors pseudo-progression); TTF is expected to be administered concurrently with temozolomide unless TMZ is ineffective, not tolerated, or contraindicated; TTF must be started no later than 60 days from the end of chemoradiation.

Model follows effective Nov 1, 2025 updates aligning to RANO 2.0.

Reauthorization / Continued use

Covered when ALL of the following are met:

Standard reauthorization: No radiological progression or clinical deterioration while on TTF; TTF continued in conjunction with temozolomide unless TMZ is ineffective, not tolerated, or contraindicated; authorizations for continued use will be issued for 3 months on reauthorization with required updated clinical notes and follow-up imaging.

Reauthorization contingent on completion or imminent scheduling of follow-up imaging.

Limited reauthorization after equivocal imaging: Limited reauthorization (1 month) is allowed when pseudo-progression is favored and RANO 2.0 criteria for true progression are not met, or when magnetic resonance spectroscopy (MRS) is consistent with post-treatment necrosis rather than true progression.

Additional reauthorizations require completion or imminent scheduling of follow-up imaging and documentation.

Historically, Kaiser Permanente's Medical Technology Assessment Committee (MTAC) reviewed tumor-treating fields (TTFields) for recurrent glioblastoma (GBM) and concluded that the technology did not meet MTAC criteria. The MTAC review (August 2013) summarized the available literature at that time, which included a small pilot study and a larger pivotal randomized trial, and recorded that the use of TTFields therapy for recurrent GBM was not supported for routine adoption within the health system.

The pivotal randomized phase III trial compared NovoTTF-100A (TTFields) as a standalone treatment to physician’s choice (best standard of care) chemotherapy in patients with recurrent GBM. The trial’s primary endpoint was overall survival (OS) in the intent-to-treat population. At a median follow-up of 39 months, the study did not demonstrate superiority of NovoTTF-100A over chemotherapy for OS; MTAC noted overall survival with TTFields was not superior to active chemotherapy.

MTAC’s evaluation also reported secondary outcomes and safety: progression-free survival and one-year survival were measured, and TTFields treatment showed lower rates of systemic chemotherapy-type adverse events but a slightly higher incidence of neurological adverse events and device-related mild-to-moderate skin irritation beneath electrode arrays. These efficacy and safety findings contributed to MTAC’s historical conclusion that TTFields alone for recurrent GBM did not show superior overall survival versus physician’s choice chemotherapy.

Coding and Clinical Thresholds

Listed HCPCS/CPT codes for deviceHCPCSCovered

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.

Karnofsky Performance Status (KPS) — eligibility threshold

Required KPS for eligibilityKarnofsky Performance Status (KPS) ≥ 70%

Context in initial eligibilityKPS ≥ 70% is required for initial requests for TTF in newly diagnosed primary supratentorial GBM

Reauthorization implicationKPS must remain ≥ 70% to avoid common authorization failure triggers on continuation requests

Time from end of chemoradiation to TTF start — operational threshold

Maximum interval allowedTTF must be started no later than 60 days from the end of chemoradiation

Applies toInitial initiation of TTF for newly diagnosed primary supratentorial GBM

Provider Actions and Authorization Rules

Prior Authorization

Prior Authorization Required

Prior authorization is required for Tumor-Treating Fields (TTF). Standard authorizations are issued for 90 days. Reauthorization is required for continued coverage.

Authorization length: 90 days
Reauthorization required for continued coverage

Note

Concurrent Chemotherapy Expectation

TTF is expected to be administered concurrently with temozolomide (TMZ) unless TMZ has been ineffective, not tolerated, or is contraindicated.

Concurrent chemotherapy expectation: TTF + TMZ (unless contraindicated)

Background

Glioblastoma (GBM) is an aggressive primary brain tumor most often arising in the supratentorial cerebral hemispheres and carries a poor prognosis. Median survival with standard therapy is limited (on the order of about 15 months for newly diagnosed disease), and the disease is generally considered incurable. Clinical management commonly includes maximal safe surgical resection when feasible, followed by concurrent chemoradiation with temozolomide and subsequent adjuvant therapy.

Tumor-treating fields (TTFields) are a portable, noninvasive therapy delivered transcranially via scalp transducer arrays that generate low-intensity, intermediate-frequency (about 200 kHz) alternating electric fields intended to disrupt cancer cell mitosis. While TTFields have regulatory approval in certain settings, their role in GBM treatment depends on the clinical context and evidence; historically, evidence for benefit as monotherapy in recurrent GBM was not demonstrated for overall survival, and current policy criteria focus on defined indications, performance status thresholds, and timing relative to chemoradiation for newly diagnosed supratentorial GBM.

Definitions

Tumor‑treating fields (TTF) — device definition and mechanism

Device identificationTumor‑treating fields (TTF; NovoTTF‑100A/Optune) — a portable, noninvasive, battery‑operated, wearable device

Mechanism overviewDelivers low‑intensity, intermediate‑frequency (200 kHz) alternating electric fields via scalp transducer arrays to disrupt mitosis (inhibits cytokinesis and microtubule assembly) and reduce cancer cell proliferation

Application methodTransducer arrays affixed to the scalp with hydrogel and hypoallergenic disks to transmit alternating electric fields transcranially

RANO progression (per RANO 2.0) — definition used for reauthorization

RANO progression — core imaging criteria≥25% increase in enhancing lesions despite stable or increasing steroid dose; significant increase in non‑enhancing FLAIR/T2 lesions not attributable to other causes; any new lesions