Electric Tumor Treating Fields (Optune)
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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.
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.
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:
Matches policy I.A.
Continuation Therapy (additional 90 days)
Covered when ALL of the following are met for an additional 90-day course:
Matches policy I.B.
Insufficient Evidence / Not Established
Not covered/insufficient evidence:
Matches policy II.
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
Provider Requirements and Authorization Procedures
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 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
Required Documentation to Support Medical Necessity
Submit documentation to support medical necessity with the prior authorization request. Incomplete documentation is a common cause of delay or denial.
- Histologic or radiologic confirmation of glioblastoma (pathology report or imaging with report)
- Documentation of tumor location — supratentorial (operative note, imaging report)
- Karnofsky Performance Status (KPS) score ≥ 60 documented in clinical notes
- For initial therapy: documentation that TTF will be delivered in conjunction with temozolomide after completion of standard surgical and/or radiation therapies (for new diagnosis) or that TTF will be used as monotherapy after standard treatments for recurrent disease
- For reauthorization: documentation of no disease progression during the prior 90 days of TTF therapy
- Documentation of device wear-time agreement and prior compliance (member attestation, device logs) — device worn ≥ 18 hours per day
- Contraindications assessment: absence of implanted medical devices (DBS, spinal cord stimulator, VNS, pacemaker, defibrillator, programmable shunt), no skull defects without replacement, not pregnant, and no known sensitivity to conductive hydrogels
Denial Triggers for Not Meeting Coverage Criteria
Denials are commonly triggered when requests do not meet the explicit coverage criteria below — verify each element before submission.
- Age: member must be > 22 years
- Diagnosis: glioblastoma must be histologically or radiologically confirmed as specified
- Tumor location: tumor must be in the supratentorial region
- Performance status: KPS must be documented and ≥ 60
- Device wear-time: member must agree to and be compliant with wearing the device ≥ 18 hours per day; lack of documented compliance may lead to denial for reauthorization
- Contraindications: presence of excluded implanted devices, skull defect without replacement, pregnancy, or known hydrogel sensitivity will result in denial
- Reauthorization criteria: evidence of disease progression during prior 90 days or failure to document no progression will result in denial for additional 90-day therapy
Indication by Line of Therapy
first-line | second-line
First-line (newly diagnosed) per EF-14.
Second-line (recurrent) per Stupp et al. and FDA approval.
Biomarker and Molecular Status
Terms and Device Definitions
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
Added age restriction of > 22 years to eligibility criteria.
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.
Karnofsky Performance Status requirement was changed from ≥ 60 to ≥ 70 (subsequently revised).
Changed KPS requirement in I.A.1.a.ii and I.A.1.b.ii from ≥ 60 to ≥ 70 (recorded in revision log).
Karnofsky Performance Status requirement restored from ≥ 70 back to ≥ 60 in I.A.1.a.ii and I.A.1.b.ii.
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