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Irreversible Electroporation (IRE)

Policy Number: MP-612

Latest Review Date: October 2019

 

Category:  Surgery                                                     

Policy Grade:  B

POLICY:

Irreversible Electroporation (IRE) is considered not medically necessary and investigational for all indications, including but not limited to, the surgical ablation of soft tissue and/or solid organs.

 

DESCRIPTION OF PROCEDURE OR SERVICE:

Irreversible electroporation (IRE) is a non-invasive ablation technique that uses non-thermal energy (i.e., electrical pulses) to disrupt cellular homeostasis leading to cell death. Because the device is non-thermal, it is proposed to allow the ability to ablate tumors in locations previously contraindicated for thermal ablation such as tumors located near blood vessels.

 

IRE uses electrical currents delivered through thin needles to treat tumors. The needles are placed in certain locations around the tumor. The electrical pulses disrupt the cell membrane which triggers cancer cells to die and destroys the tumor.  Because the electrical pulses are contained between the electrodes placed around the tumor, damage to surrounding tissue, vessels, etc., is contained to the tumor.

 

KEY POINTS:

A literature review was conducted through October 11, 2019. The published evidence to date on irreversible electroporation consists of smaller studies with only short term follow up; however, there are clinical trials in progress.

 

Summary

Irreversible electroporation is an emerging technology aimed at focal therapy of tumors. Based on the small studies available, there is not adequate evidence for proof of effectiveness. Larger studies with long term outcomes are needed to determine the net health outcomes related to this procedure.

 

PRACTICE GUIDELINES AND POSITION STATEMENTS

National Institute for Health and Care Excellence

In 2013, NICE guidelines regarding renal, primary liver, primary lung, lung metastases, and pancreatic cancer state that current evidence on the safety and efficacy of irreversible electroporation is inadequate in quantity and quality. Therefore, this procedure should only be used in the context of research. In particular, studies should report the effect of the procedure on local tumour control and patient survival.”

 

In 2016, NICE guidelines regarding prostate cancer states that,“Current evidence on the safety and efficacy of irreversible electroporation for treating prostate cancer is inadequate in quantity and quality. Therefore, this procedure should only be used in the context of research. Studies should include randomised controlled trials comparing the procedure with current standards of care. They should report details of patient selection and short- and long-term outcomes, including patient-reported outcomes and the effect on any future prostate surgery.”

 

In 2017, NICE guidelines reaffirmed the guidelines for pancreatic cancer.

 

The NCCN does not address IRE for the treatment of prostate, pancreatic or hepatobiliary cancer.

 

U.S. PREVENTIVE SERVICES TASK FORCE RECOMMENDATIONS

Not Applicable.

 

 

KEY WORDS:

Nanoknife, Irreversible Electroporation, IRE, SmartTarget

 

APPROVED BY GOVERNING BODIES:

In 2011, the Nanoknife System received FDA 510k clearance for the surgical ablation of soft tissue.  The FDA further clarified in 2011, that it has not been cleared for treatment for a specific disease or condition.

 

In May 2017, the SmartTarget received FDA 510k clearance for treatment of the prostate.  The device is “intended as an accessory for image guided interventional and diagnostic procedures involving the prostate gland…..Example procedures include, but are not limited to: needle biopsy in which tissue samples are removed from the prostate…..irreversible electroporation…”

 

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits.  Group specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply.

FEP:  Special benefit consideration may apply.  Refer to member’s benefit plan.  FEP does not consider investigational if FDA approved and will be reviewed for medical necessity.

 

CURRENT CODING: 

CPT Codes:

There are no specific codes for IRE.  Procedures will likely come in on an unlisted code related to the specific body area being treated.

32999              Unlisted procedure, lungs and pleura
47399              Unlisted procedure, liver
48999    Unlisted procedure, pancreas
53899              Unlisted procedure, urinary system

 

REFERENCES:

  1. Angiodynamics. FDA grants prostate IDE approval for angiodynamics’nanoknife system. 2013 June. Website: investors.angiodynamics.com/releasedetail.cfm?ReleaseID=772028.
  2. Cannon R, Ellis S, Hayes D, et al. Safety and early efficacy of irreversible electroporation for hepatic tumors in proximity to vital structures. J Surg Oncol 2013 Apr; 107(5):544-9.
  3. Distelmaier M, Barabasch A, Heil P, et al. Midterm safety and efficacy of irreversible electroporation of malignant liver tumors located close to major portal or hepatic veins. Radiology. 2017 Dec; 285(3): 1023-1031.
  4. Food and Drug Administration website: www.accessdata.fda.gov/cdrh_docs/pdf10/k102329.pdf.
  5. Food and Drug Administration.  Smart Target FDA approval. https://www.accessdata.fda.gov/cdrh_docs/pdf17/k170250.pdf.  Accessed February 2017.
  6. Hines, A, Goldberg SN, et al.  Radiofrequency ablation and cryoablation for renal cell carcinoma.  Up to Date.  https://www.uptodate.com/contents/radiofrequency-ablation-and-cryoablation-for-renal-cell-carcinoma?search=irreversible%20electroporation&source=search_result&selectedTitle=2~7&usage_type=default&display_rank=2.  Accessed January 31, 2018.
  7. Lee EW, Thai S, Kee ST. Irreversible electroporation; a novel image-guided cancer therapy. Gut liver 2010 Sep; 4(suppl 1): S99-S104.
  8. Martin RC,
  9. McFarland K, Ellis S, et al. Irreversible electroporation in locally advanced pancreatic cancer: Potential  improved overall survival. Ann Surg Oncol. 2013; 20 Suppl3; S443-S449.
  10. Nanoknife by AngioDynamics website: www.nanoknife.com.
  11. Narayanan, G. Irreversible electroporation for treatment of liver cancer. Gastroenterology & Hepatology. 2011 May; 7(5): 313-316.
  12. National Institute for Health and Care Excellence. Guideline: Irreversible electroporation for treating renal cancer. February 2013. Accessed February 2018.
  13. National Institute for Health and Care Excellence. Guideline: Irreversible electroporation for treating pancreatic cancer. May 2017. Accessed February 2018.
  14. National Institute for Health and Care Excellence. Guideline: Irreversible electroporation for treating liver cancer. February 2013. Accessed February 2018.
  15. National Institute for Health and Care Excellence. Guideline: Irreversible electroporation for treating lung cancer. February 2013. Accessed February 2018.
  16. National Institute for Health and Care Excellence. Guideline: Irreversible electroporation for treating prostate cancer. December 2016. Accessed February 2018.
  17. Niessen C, Thuman S, Beyer L, et al. Percutaneous irreversible electroporation: long term survival analysis of 71 patients with inoperable malignant hepatic tumors. Sci Rep. 2017 Mar 7;7:43687.
  18. Scheffer HJ, Nielsen K, de Jong MC. Irreversible electroporation for the nonthermal tumor ablation in the clinical setting: a systematic review of safety and efficacy. J Vasc Interv Radiol 2014 Jul;25(7);997-1011.
  19. Scheltema MJ, van den Bos W, Siriwardana AR, et al. Feasibility and safety of focal irreversible electroporation as salvage treatment for localized radio-recurrent prostate cancer.  BJU Int. 2017 Nov; 120 Suppl 3:51-58.
  20. Silk M, Tahour D, et al. The state of irreversible electroporation in interventional oncology. Semin intervent radiol 2014. 2014 Jun; 31(2): 111-117.
  21. Silk MT, Wimmer T, Lee KS et al. Percutaneous ablation of peribiliary tumors with irreversible electroporation. J Vasc Interv Radiol 2014 Jan; 25(10:112-8.
  22. Sutter O, Calvo J, N’Kontchou G, et al. Safety and efficacy of irreversible electroporation for the treatment of hepatocellular carcinoma not amenable to thermal ablation techniques: a retrospective single center case series. Radiology. 2017 Sep;284(3):877-886.
  23. Valerio M, Dickinson L, Ali A, et al. A prospective development study investigating focal irreversible electroporation in men with localised prostate cancer: Nanoknife Electroporation Ablation Trial (NEST). Contemp Clin Trials. 2014Sep; 39(1); 57-65.
  24. Valerio M, Stricker PD, Ahmed HU, et al. Initial assessment of safety and clinical feasibility of irreversible electroporation in the focal treatment of prostate cancer. Prostate Cancer Prostatic Dis. 2014 Dec; 17(4); 343-7.

 

POLICY HISTORY:

Medical Policy Group, September 2015

Medical Policy Administration Committee, October 2015

Available for comment September 29 through November 12, 2015

Medical Policy Group, February 2017(4): Updates to Description, Key Points, Key Words and References.  No change to policy statement.

Medical Policy Group, October 2019 (5): Reviewed by consensus. Updates to Key Points. No new published peer-reviewed literature available that would alter the coverage statement in this policy.                                                                                                                                                                   

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

 

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

 

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.