Irreversible Electroporation of Tumors Located in the Liver, Pancreas, Kidney or Lung

Policy Number: MA 1.162

Effective Date 9/1/2025

Policy

Irreversible electroporation is considered investigational for treatment of primary or metastatic solid tumors including, but not limited to, tumors of the liver, pancreas, kidney or lung. There is insufficient evidence to support a general conclusion concerning the health outcomes or benefits associated with this procedure.

Cross-references

• MP 4.043 Treatments of the Prostate

Product variations

This policy is only applicable to certain programs and products administered by Capital Blue Cross and subject to benefit variations as discussed in Section VI. Please see additional information below.

FEP PPO – Refer to FEP Medical Policy Manual. The FEP Medical Policy manual can be found at: https://www.fepblue.org/benefit-plans/medical-policies-and-utilization-management-guidelines/medical-policies

Description/background

Irreversible electroporation

Electroporation generates high-frequent electric pulses between two or more electrodes which produces an electric current that damages the cell membrane and allows molecules to pass into the cell passively. Electroporation can be temporary (reversible electroporation) or permanent (irreversible electroporation or IRE). In IRE the cell membrane is permanently damaged causing cell death due to the inability to maintain homeostasis. IRE achieves its action with no thermal effect. IRE appears to preserve vessels, nerves and the extracellular matrix.

Rationale

Summary of evidence

For individuals being treated with locoregional therapy for tumors in the liver who receive irreversible electroporation, the evidence includes primarily single-arm studies. Relevant outcomes are overall survival, disease-specific survival, symptoms, morbid events, functional outcomes, quality of life. Irreversible electroporation may be an option for locoregional therapy that is less damaging to nearby blood vessels, bile ducts, and nerves than thermal ablation therapies. Most studies of IRE for liver tumors lack a comparator arm. One comparative study was identified reporting health outcomes but the study is retrospective and included 18 patients treated with IRE. Therefore, there is insufficient data to determine how survival or adverse events compare to other methods for locoregional therapy. There is a lack of standardization on appropriate use. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals with locally advanced pancreatic cancer who receive irreversible electroporation, the evidence includes single-arm studies. Relevant outcomes are overall survival, disease-specific survival, symptoms, morbid events, functional outcomes, quality of life. Thermal ablation therapies are not commonly used to treat pancreatic cancer due to the increased risk of trauma to the adjacent major anatomical structures. IRE may be alternative that does not cause thermal injury to nearby sensitive structures. However, there is a lack of consensus on the optimal IRE treatment protocol. Studies of IRE for pancreatic tumors are single-arm. There is insufficient data to determine whether survival is improved with chemotherapy followed by IRE compared to chemotherapy alone. Two RCTs are underway. Prospective, single arm studies suggest a high complication rate. There are no studies reporting functional or quality of life outcomes. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals being treated with locoregional therapy for tumors in the kidneys who receive irreversible electroporation, the evidence includes single-arm studies. Relevant outcomes are overall survival, disease-specific survival, symptoms, morbid events, functional outcomes, quality of life. Studies of IRE for kidney tumors are single-arm. Only one study has included more than 10 participants. No comparative data are available. Therefore, there is no data to determine how survival or adverse events compare to other methods for locoregional therapy. There are no studies reporting functional or quality of life outcomes. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals being treated with locoregional therapy for tumors in the lungs who receive irreversible electroporation, the evidence includes single-arm studies. Relevant outcomes are overall survival, disease-specific survival, symptoms, morbid events, functional outcomes, quality of life. Irreversible electroporation may be an option for locoregional therapy that is less damaging to nearby bronchovascular structures. Studies of IRE for lung tumors are single-arm. The ALICE study was a prospective, single-arm study conducted at two centers that was stopped early (n=23) due to failing to meet expected efficacy at an interim analysis based on high recurrence rates of 61% at a median follow-up of 1 year. No comparative data are available. Therefore, there is no data to determine how survival or adverse events compare to other methods for locoregional therapy. There are no studies reporting functional or quality of life outcomes. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Definitions

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Disclaimer

Capital Blue Cross’ medical policies are used to determine coverage for specific medical technologies, procedures, equipment, and services. These medical policies do not constitute medical advice and are subject to change as required by law or applicable clinical evidence from independent treatment guidelines. Treating providers are solely responsible for medical advice and treatment of members. These policies are not a guarantee of coverage or payment. Payment of claims is subject to a determination regarding the member’s benefit program and eligibility on the date of service, and a determination that the services are medically necessary and appropriate. Final processing of a claim is based upon the terms of contract that applies to the members’ benefit program, including benefit limitations and exclusions. If a provider or a member has a question concerning this medical policy, please contact Capital Blue Cross’ Provider Services or Member Services.

Coding Information

Note: This list of codes may not be all-inclusive, and codes are subject to change at any time. The identification of a code in this section does not denote coverage as coverage is determined by the terms of member benefit information. In addition, not all covered services are eligible for separate reimbursement. The codes need to be in numerical order.

Investigational; therefore, not covered:

References

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Policy History

• MA 1.162 - 3/24/2025 Policy Creation; Full Adoption

Health care benefit programs issued or administered by Capital Blue Cross and/or its subsidiaries, Capital Advantage Insurance Company^®, Capital Advantage Assurance Company^® and Keystone Health Plan^® Central. Independent licensees of the Blue Cross BlueShield Association. Communications issued by Capital Blue Cross in its capacity as administrator of programs and provider relations for all companies