Humana Commercial Clinical Policy

Humana Irreversible Electroporation (NanoKnife) Form

Effective Date

04/27/2023

Last Reviewed

NA

Original Document

  Reference



Description

Irreversible electroporation (IRE) (eg, NanoKnife), is a nonthermal ablative technique that is designed to target a tumor while sparing surrounding critical structures such as vessels, nerves and ducts. IRE can be performed percutaneously or with an open procedure. During the procedure, conducted under general anesthesia, two to six electrodes are positioned in or around the tumor. High-voltage, direct current microsecond pulses are applied, creating an electric field. This purportedly generates cell electroporation causing numerous nanoscale-sized holes in the cell membrane, which leads to permanent damage and eventually cell death. The ablated tissue is supposedly naturally eliminated.

Coverage Determination

Humana members may NOT be eligible under the Plan for IRE (eg, NanoKnife) for ANY indication including, but may not be limited to:

  • Cholangiocarcinoma; OR
  • Colon cancer; OR
  • Liver cancer (eg, hepatocellular carcinoma); OR
  • Lung cancer (eg, non-small cell lung cancer); OR
  • Pancreatic cancer; OR
  • Prostate cancer; OR
  • Rectal cancer; OR
  • Renal cell carcinoma; OR
  • Skeletal metastases

This is considered experimental/investigational as it is not identified as widely used and generally accepted for the proposed use as reported in nationally recognized peer-reviewed medical literature published in the English language.

Background

Additional information about cancer may be found from the following websites:

  • American Cancer Society
  • National Cancer Institute
  • National Comprehensive Cancer Network
  • National Library of Medicine
Medical Alternatives

Alternatives to IRE include, but may not be limited to:

  • Chemotherapy
  • Hormone therapy
  • Prescription drug therapy
  • Radiation therapy (also known as radiotherapy, X-ray therapy or irradiation)

    (For information regarding other forms of radiation therapy, please refer to Brachytherapy, Intensity Modulated Radiation Therapy (IMRT), Proton Beam, Neutron Beam and Carbon Ion Radiation Therapy, or Stereotactic Radiosurgery and Stereotactic Body Radiation Therapy Medical Coverage Policies).

    Physician consultation is advised to make an informed decision based on an individual's health needs.

    Any CPT, HCPCS or ICD codes listed on this medical coverage policy are for informational purposes only. Do not rely on the accuracy and inclusion of specific codes. Inclusion of a code does not guarantee coverage and or reimbursement for a service or procedure.

    References

    1. ClinicalKey.

    Clinical Overview

    Hepatocellular carcinoma. https://www.clinicalkey.com. Updated July 28, 2022. Accessed March 22, 2023.

    ClinicalKey. Herman JM, Moreno AC, Crane CH et al. Pancreatic cancer. In: Tepper JE, Foote RL, Michalski JM. Gunderson & Tepper's Clinical Radiation Oncology. Elsevier; 2021:946-972.e8. https://www.clinicalkey.com. Accessed March 22, 2023.

    Irreversible Electroporation (NanoKnife) Effective Date: 04/27/2023 Revision Date: 04/27/2023 Review Date: 04/27/2023 Policy Number: HUM-0588-003 Page: 4 of 6

    Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

    ClinicalKey. Parakh A, Noda Y, Kambadakone A, Sahani D. Pancreatic ductal adenocarcinoma. In: Silverman P. Oncologic Imaging: A Multidisciplinary Approach. Elsevier; 2023:160-176. https://www.clinicalkey.com. Accessed March 22, 2023.

    ECRI Institute. Clinical Evidence Assessment. NanoKnife system (AngioDynamics, Inc.) for treating liver cancer. https://www.ecri.org. Published May 7, 2013. Updated April 5, 2023. Accessed April 5, 2023.

    1. ECRI Institute. Clinical Evidence Assessment. NanoKnife system (AngioDynamics, Inc.) for treating pancreatic cancer. https://www.ecri.org. Published February 5, 2016. Updated April 11, 2023. Accessed April 12, 2023.
    2. ECRI Institute. Clinical Evidence Assessment. NanoKnife system (AngioDynamics, Inc.) for treating prostate cancer. https://www.ecri.org. Published September 14, 2022. Accessed March 22, 2023.
    3. Hayes, Inc. Health Technology Brief (ARCHIVED). NanoKnife system for irreversible electroporation treatment of locally advanced pancreatic cancer. https://evidence.hayesinc.com. Published September 1, 2016. Updated August 13, 2018. Accessed March 22, 2023.
    4. Hayes, Inc. Health Technology Brief (ARCHIVED). NanoKnife system for irreversible electroporation treatment of primary and metastatic liver tumors. https://evidence.hayesinc.com. Published September 15, 2016. Updated September 18, 2018. Accessed March 22, 2023.
    5. National Cancer Institute (NCI). Adult primary liver cancer treatment (PDQ) – health professional version. https://www.cancer.gov. Updated January 20, 2023. Accessed April 5, 2023.
    6. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology. Colon cancer. https://www.nccn.org. Updated January 20, 2023. Accessed April 5, 2023.
    7. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology. Hepatobiliary cancer. https://www.nccn.org. Updated March 10, 2023. Accessed April 5, 2023.
    8. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology. Pancreatic adenocarcinoma. https://www.nccn.org. Updated December 6, 2022. Accessed April 6, 2023.
    9. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology. Rectal cancer. https://www.nccn.org. Updated March 29, 2023. Accessed April 6, 2023.
    10. Ohaegbulam K, Koethe Y, Fung A, et al. The multidisciplinary management of cholangiocarcinoma. Cancer. 2023;129:184-214.
    11. UpToDate, Inc. Clinical features and diagnosis of hepatocellular carcinoma. https://www.uptodate.com. Updated February 2023. Accessed March 22, 2023.
    12. UpToDate, Inc. Image-guided ablation of lung tumors. https://www.uptodate.com. Updated February 2023. Accessed March 22, 2023.
    1. UpToDate, Inc. Image-guided ablation of skeletal metastases. https://www.uptodate.com. Updated February 2023. Accessed March 22, 2023.
    2. UpToDate, Inc. Localized hepatocellular carcinoma: liver-directed therapies for nonsurgical candidates who are eligible for local ablation. https://www.uptodate.com. Updated February 2023. Accessed March 22, 2023.
    3. UpToDate, Inc. Management of stage I and stage II non-small cell lung cancer. https://www.uptodate.com. Updated February 21, 2023. Accessed March 22, 2023.

    Irreversible Electroporation (NanoKnife) Effective Date: 04/27/2023 Revision Date: 04/27/2023 Review Date: 04/27/2023 Policy Number: HUM-0588-003 Page: 6 of 6

    Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing.

    1. UpToDate, Inc. Radiofrequency ablation, cryoablation and other ablative techniques for renal cell carcinoma. https://www.uptodate.com. Updated March 3, 2023. Accessed March 22, 2023.
    2. US Food & Drug Administration (FDA). 510(k) summary: NanoKnife system. https://www.fda.gov. Published October 24, 2011. Accessed May 14, 2020.