LCD L40205: Irreversible Electroporation for Cancer

This is a NON-coverage Local Coverage Determination (LCD) for irreversible electroporation (IRE) as a means of managing cancer except as follows:

Favorable, Intermediate Risk Prostate Cancer, Grade Group 2

Intermediate-risk prostate cancer, Grade Group 2, coverage may be considered reasonable and necessary if all of the following criteria are met:

• Face to face discussion with the patient regarding risks of treatment with IRE versus other treatment options is documented.

• Options discussed should include active surveillance, radiation therapy, and radical prostatectomy.

• Providers should inform patients with intermediate risk prostate cancer considering whole gland or focal ablation that there is a lack of high-quality data comparing ablation outcomes to radiation therapy, surgery and active surveillance.

• Patients have not been previously treated with IRE.

• Patient counselling shall include:

• IRE is not U.S. Food and Drug Administration (FDA) approved or cleared for the treatment of prostate cancer

• Biopsy-detected cancer after focal therapy (FT) is common within 2 years post-treatment

• FT or whole gland ablative therapy may impact the safety and/or efficacy of subsequent local therapy

• Patients considering ablation should be counseled regarding side effects and recurrence risk and should be followed post-ablation with prostate surface antigen (PSA), digital rectal exam (DRE), magnetic resonance imaging (MRI), and biopsy tailored to their specific health and cancer characteristics.

Metastatic Colorectal Cancer to Liver

Metastatic colorectal cancer treatment with IRE to the liver may be considered reasonable and necessary if all of the following criteria are met:

• Patients that cannot be safely resected or ablated with margins due to proximity to central bile ducts or other structures that cannot be protected, IRE may be considered.

• Face-to-face discussion with patients regarding risks of treatment with IRE versus other treatment options is documented.

• Options discussed should include alternative treatment options and medical necessity of IRE over either radiofrequency ablation (RFA) or surgical excision.

• Providers should inform patients that there is a lack of high-quality data to support this treatment option.

• Patients should not have had previous failed IRE at the site to be treated as the incidence of higher adverse events (AEs) is unknown.

• Patient counselling shall include that IRE is not FDA cleared or approved for the treatment of liver cancer.

Irreversible electroporation (IRE) is a biophysical phenomenon in which cellular membranes exhibit increased permeability to ions and macromolecules when exposed to external electric fields. Although the exact mechanisms of electroporation have not been fully elucidated, the scientific community has mostly come to agreement that permeabilizing nanoscale defects or ‘‘nanopores’’ are formed in cellular membranes upon exposure to high-amplitude electric fields of sufficient duration. This phenomenon is manifested in 2 distinct forms: reversible electroporation, in which permeabilizing structures are transient and membrane integrity is quickly recovered; and IRE, in which permeabilization disrupts cellular homeostasis and leads to cell death. 1

In 2005, Davalos, et al. 2 proposed that IRE could be used as a stand-alone technique for soft tissue ablation. IRE delivers micro to millisecond electrical pulses to undesired tissue in order to produce cell necrosis through irreversible cell membrane permeabilization. IRE affects only the cell membrane and no other structure in the tissue. Over the ensuing years, IRE has been studied for its utility in cancer treatment, with and without combination of other modalities. There appears to be complete ablation to the margin of a treated lesion with several cell thickness of resolution. Thus, it was postulated that IRE could treat tumors without compromising nearby structures such as blood vessels, bile ducts, connective tissue, etc.

This minimally invasive procedure is performed under general anesthesia with ultrasound or computed tomography (CT) guidance and can be used during open or laparoscopic surgery or percutaneous procedures. IRE systems typically consist of a low-energy direct-current generator, a console with a monitor screen and control interface (e.g., keyboard and trackpad), a foot pedal to activate the system, and a set of needle electrode probes. During the procedure, 2 to 6 electrodes are placed around the target tumor, and a series of high-voltage, direct-current microsecond pulses create an electric field to induce cell electroporation.

There is limited literature to support such usage in cancers of the colon, pancreas, liver, prostate, kidney, and breast. This LCD will examine the evidence for the utility of IRE in the treatment of each of these 6 sites of cancer occurrences/metastases.