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Irreversible Electroporation (IRE)

Policy Number: MP-612

Latest Review Date: November 2024

Category: Surgery                                         

POLICY:

Irreversible electroporation (IRE) is considered 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. IRE achieves its action with no thermal effect. IRE appears to preserve vessels, nerves and the extracellular matrix.

KEY POINTS:

A literature review was conducted through August 8, 2024. 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 of Evidence

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.”

NICE (2021; updated in 2023) issued guidance on management for localized prostate cancer. Cryoablation and high-intensity ultrasound are not recommended for the treatment of localized prostate cancer because there is a lack of evidence on quality of life benefits and long-term survival. “Irreversible electroporation for treating prostate cancer should only be used with special arrangements for clinical governance, consent, and audit or research.”

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

National Comprehensive Cancer Network

The NCCN clinical practice guideline (Version 3.2024) for Pancreatic Adenocarcinoma states that "IRE is an ablative technique in which electric pulses are used to create nanopores to induce cell death. This technique has been used in individuals with locally advanced pancreatic cancer and may be considered safe and feasible and improve survival. However, due to concerns about complications and technical expertise, the panel does not currently recommend IRE for treatment of locally advanced pancreatic cancer.”

The NCCN clinical practice guideline (Version 2.2024) for Hepatocellular Carcinoma states that 'Irreversible electroporation (IRE) is an emerging modality for tumor ablation' and that 'Larger studies are needed to determine the effectiveness of IRE for local HCC treatment.'

The National Comprehensive Cancer Network (NCCN) guidelines for Biliary Tract Cancers (v3.2024), states that ablation is a reasonable alternative to surgical resection for intrahepatic CCA, particularly in patients with high-risk disease and 'Options for ablation include cryoablation, radiofrequency ablation, microwave ablation, and irreversible electroporation' for treatment of small, single intrahepatic cholangiocarcinoma tumors (<3cm) amenable to complete ablation, whether recurrent or primary.

The National Comprehensive Cancer Network (NCCN) guidelines for Kidney Cancer (v1.2025) do not refer to irreversible electroporation. The guidelines state that 'Thermal ablation (eg, cryosurgery, radiofrequency ablation, microwave ablation) is an option for the management of clinical stage T1 renal lesions. Thermal ablation is suitable for renal masses ≤3 cm. Thermal ablation is an option for clinical T1b masses in select patients not eligible for surgery.'

The National Comprehensive Cancer Network (NCCN) guidelines for Non-Small Cell Lung Cancer (v8.2024) do not refer to irreversible electroporation. With respect to ablation therapies, the guidelines state that:

  • 'Image-guided thermal ablation (IGTA) therapy (eg, cryotherapy, microwave, radiofrequency) may be an option for select patients' for initial treatment for stage 1A disease.
  • 'IGTA may be considered for those patients who are deemed “high risk”—those with tumors that are for the most part surgically resectable but rendered medically inoperable due to comorbidities. In cases where IGTA is considered for high-risk or borderline operable patients, a multidisciplinary evaluation is recommended.'
  • 'IGTA is an option for the management of NSCLC lesions <3 cm. Ablation for NSCLC lesions >3 cm may be associated with higher rates of local recurrence and complications.'
  • 'There is evidence on the use of IGTA for selected patients with stage 1A NSCLC, those who present with multiple lung cancers, or those who present with locoregional recurrence of symptomatic local thoracic disease.'
  • 'In the setting of progression at a limited number of sites on a given line of systemic therapy (oligoprogression), local ablative therapy to the
    oligoprogressive sites may extend the duration of benefit of the current line of systemic therapy.'

The NCCN guidelines for prostate cancer (v.1.2024) recommend only cryosurgery and high-intensity focused ultrasound (HIFU) as local therapy options for radiotherapy recurrence in the absence of metastatic disease (category 2B). Cryotherapy or other local therapies are not recommended as routine primary therapy for localized prostate cancer due to lack of long-term data comparing these treatments to radiation or radical prostatectomy.

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 TM (Angiodynamics) 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.  

CURRENT CODING: 

CPT Codes:

0600T

Ablation, irreversible electroporation; 1 or more tumors per organ, including imaging guidance, when performed, percutaneous

0601T

Ablation, irreversible electroporation; 1 or more tumors, including fluoroscopic and ultrasound guidance, when performed, open

 

REFERENCES:

  1. Angiodynamics. FDA grants prostate IDE approval for angiodynamics’nanoknife system. 2013 June. Website: investors.angiodynamics.com/releasedetail.cfm?ReleaseID=772028.
  2. AngioDynamics. NanoKnife Patient Guide. https://nanoknife.com/wp-content/uploads/2021/06/GL-ON-BR-911-REV-01-NanoKnife-Patient-Guide-WEB.pdf.
  3. Balaban EP, Mangu PB, Khorana AA, et al. Locally Advanced, Unresectable Pancreatic Cancer: American Society of Clinical Oncology Clinical Practice Guideline. J Clin Oncol. Aug 01 2016; 34(22): 2654-68.
  4. Belfiore MP, Reginelli A, Maggialetti N, et al. Preliminary results in unresectable cholangiocarcinoma treated by CT percutaneous irreversible electroporation: feasibility, safety and efficacy. Med Oncol. Apr 09 2020; 37(5): 45.
  5. Blaise L, Pereira H, Vilgrain V, et al. Percutaneous ablation for locally advanced hepatocellular carcinoma with tumor portal invasion. Clin Res Hepatol Gastroenterol. Nov 2021; 45(6): 101731.
  6. Blazevski A, Scheltema MJ, Amin A, Thompson JE, Lawrentschuk N, Stricker PD. Irreversible electroporation (IRE): a narrative review of the development of IRE from the laboratory to a prostate cancer treatment. BJU Int. 2020 Mar;125(3):369-378.
  7. Brar G, Greten TF, Graubard BI, et al. Hepatocellular Carcinoma Survival by Etiology: A SEER-Medicare Database Analysis. Hepatol Commun. Oct 2020; 4(10): 1541-1551.
  8. Buijs M, Zondervan PJ, de Bruin DM, et al. Feasibility and safety of irreversible electroporation (IRE) in patients with small renal masses: Results of a prospective study. Urol Oncol. Mar 2019; 37(3): 183.e1-183.e8. 
  9. 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.
  10. Centers for Disease Control and Prevention (CDC). Hepatocellular carcinoma - United States, 2001-2006. MMWR Morb Mortal Wkly Rep. May 07 2010; 59(17): 517-20.
  11. Centers for Disease Control and Prevention. Lung Cancer Risk Factors. www.cdc.gov/lung-cancer/risk-factors/index.html. 
  12. Charalambous P, Moris D, Karachaliou GS, et al. The efficacy and safety of the open approach irreversible electroporation in the treatment of pancreatic cancer: A systematic review. Eur J Surg Oncol. Sep 2020; 46(9): 1565-1572. 
  13. Cheung W, Kavnoudias H, Roberts S, et al. Irreversible electroporation for unresectable hepatocellular carcinoma: initial experience and review of safety and outcomes. Technol Cancer Res Treat. Jun 2013; 12(3): 233-41.
  14. Cheungpasitporn W, Thongprayoon C, O'Corragain OA, et al. The risk of kidney cancer in patients with kidney stones: a systematic review and meta-analysis. QJM. Mar 2015; 108(3): 205-12.
  15. Davis JM, Salibi PN, Motz BM, et al. Irreversible Electroporation-Assisted Resection for Locally Advanced Pancreas Cancer. Surg Innov. Jun 2023;30(3):332-339.
  16. Dhanasekaran R, Hemming AW, Zendejas I, et al. Treatment outcomes and prognostic factors of intrahepatic cholangiocarcinoma. Oncol Rep. Apr 2013; 29(4): 1259-67.
  17. Diehl SJ, Rathmann N, Kostrzewa M, et al. Irreversible Electroporation for Surgical Renal Masses in Solitary Kidneys: Short-Term Interventional and Functional Outcome. J Vasc Interv Radiol. Sep 2016; 27(9): 1407-1413. 
  18. 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.
  19. Ellis LM, Bernstein DS, Voest EE, et al. American Society of Clinical Oncology perspective: Raising the bar for clinical trials by defining clinically meaningful outcomes. J Clin Oncol. Apr 20 2014; 32(12): 1277-80.
  20. Food and Drug Administration website: www.accessdata.fda.gov/cdrh_docs/pdf10/k102329.pdf.
  21. Food and Drug Administration.  Smart Target FDA approval. www.accessdata.fda.gov/cdrh_docs/pdf17/k170250.pdf.
  22. Food and Drug Administration. NanoKnife System 510(k) Summary: K183385. www.accessdata.fda.gov/cdrh_docs/pdf18/K183385.pdf.
  23. Frühling P, Nilsson A, Duraj F, et al. Single-center nonrandomized clinical trial to assess the safety and efficacy of irreversible electroporation (IRE) ablation of liver tumors in humans: Short to mid-term results. Eur J Surg Oncol. Apr 2017; 43(4): 751-757.
  24. Gajewska-Naryniecka A, Szwedowicz U, Łapińska Z, et al. Irreversible Electroporation in Pancreatic Cancer-An Evolving Experimental and Clinical Method. Int J Mol Sci. 2023 Feb 23;24(5):4381.
  25. Geboers B, Scheffer HJ, Graybill PM, et al. High-Voltage Electrical Pulses in Oncology: Irreversible Electroporation, Electrochemotherapy, Gene Electrotransfer, Electrofusion, and Electroimmunotherapy. Radiology. May 2020; 295(2): 254-272.
  26. George AK, Miocinovic R, Patel AR, et al. A Description and Safety Overview of Irreversible Electroporation for ProstateTissue Ablation in Intermediate-Risk Prostate Cancer Patients: Preliminary Results from the PRESERVE Trial. Cancers(Basel). Jun 08 2024; 16(12).
  27. Granata V, Fusco R, Catalano O, et al. Percutaneous ablation therapy of hepatocellular carcinoma with irreversible electroporation: MRI findings. AJR Am J Roentgenol. May 2015; 204(5): 1000-7.
  28. Gupta P, Maralakunte M, Sagar S, Kumar-M P, Bhujade H, Chaluvashetty SB, Kalra N. Efficacy and safety of irreversible electroporation for malignant liver tumors: a systematic review and meta-analysis. Eur Radiol. 2021 Sep;31(9):6511-6521.
  29. Hilton A, Kourounis G, Georgiades F. Irreversible electroporation in renal tumours: A systematic review of safety and early oncological outcomes. Urologia. Aug 2022;89(3):329-337. 
  30. Hines, A, Goldberg SN, et al.  Radiofrequency ablation and cryoablation for renal cell carcinoma.  Up to Date.  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.
  31. Holland MM, Bhutiani N, Kruse EJ, et al. A prospective, multi-institution assessment of irreversible electroporation for treatment of locally advanced pancreatic adenocarcinoma: initial outcomes from the AHPBA pancreatic registry. HPB (Oxford). Aug 2019; 21(8): 1024-1031. 
  32. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
  33. Kim HS, El-Serag HB. The Epidemiology of Hepatocellular Carcinoma in the USA. Curr Gastroenterol Rep. Apr 11 2019; 21(4): 17.
  34. Klein AP. Pancreatic cancer epidemiology: understanding the role of lifestyle and inherited risk factors. Nat Rev Gastroenterol Hepatol. Jul 2021; 18(7): 493-502.
  35. Kluger MD, Epelboym I, Schrope BA, et al. Single-Institution Experience with Irreversible Electroporation for T4 Pancreatic Cancer: First 50 Patients. Ann Surg Oncol. May 2016; 23(5): 1736-43.
  36. Lafranceschina S, Brunetti O, Delvecchio A, Conticchio M, Ammendola M, Currò G, Piardi T, de'Angelis N, Silvestris N, Memeo R. Systematic Review of Irreversible Electroporation Role in Management of Locally Advanced Pancreatic Cancer. Cancers (Basel). 2019 Nov 3;11(11):1718. 
  37. Lee EW, Thai S, Kee ST. Irreversible electroporation; a novel image-guided cancer therapy. Gut liver 2010 Sep; 4(suppl 1): S99-S104.
  38. Leen E, Picard J, Stebbing J, et al. Percutaneous irreversible electroporation with systemic treatment for locally advanced pancreatic adenocarcinoma. J Gastrointest Oncol. Apr 2018; 9(2): 275-281.
  39. Liu B, Clark J, Domes T, et al. Percutaneous irreversible electroporation for the treatment of small renal masses: The first Canadian case series. Can Urol Assoc J. Sep 2019; 13(9): E263-E267. 
  40. Liu S, Qin Z, Xu J, et al. Irreversible electroporation combined with chemotherapy for unresectable pancreatic carcinoma: a prospective cohort study. Onco Targets Ther. 2019; 12: 1341-1350.
  41. Månsson C, Bergenfeldt M, Brahmstaedt R, et al. Safety and preliminary efficacy of ultrasound-guided percutaneous irreversible electroporation for treatment of localized pancreatic cancer. Anticancer Res. Jan 2014; 34(1): 289-93. 
  42. Martin RC 2nd, McFarland K, Ellis S, et al. Irreversible electroporation in locally advanced pancreatic cancer: Potential improved overall survival. Ann Surg Oncol. 2013 Dec; 20 Suppl3; S443-S449.
  43. Martin RC, McFarland K, Ellis S, et al. Irreversible electroporation therapy in the management of locally advanced pancreatic adenocarcinoma. J Am Coll Surg. Sep 2012; 215(3): 361-9.
  44. Martin RC, Kwon D, Chalikonda S, et al. Treatment of 200 locally advanced (stage III) pancreatic adenocarcinoma patients with irreversible electroporation: safety and efficacy. Ann Surg. Sep 2015; 262(3): 486-94; discussion 492-4.
  45. Martin RC, Durham AN, Besselink MG, et al. Irreversible electroporation in locally advanced pancreatic cancer: A call for standardization of energy delivery. J Surg Oncol. Dec 2016; 114(7): 865-871.
  46. McGlynn KA, Petrick JL, El-Serag HB. Epidemiology of Hepatocellular Carcinoma. Hepatology. Jan 2021; 73 Suppl 1(Suppl 1): 4-13.
  47. Nanoknife by AngioDynamics website: www.nanoknife.com.
  48. Narayanan G, Gentile NT, Eyshi J, et al. Irreversible Electroporation in Treating Colorectal Liver Metastases in Proximity to Critical Structures. J Vasc Interv Radiol. Aug 30 2024.
  49. Narayanan G, Hosein PJ, Arora G, et al. Percutaneous irreversible electroporation for downstaging and control of unresectable pancreatic adenocarcinoma. J Vasc Interv Radiol. Dec 2012; 23(12): 1613-21.
  50. Narayanan G, Hosein PJ, Beulaygue IC, et al. Percutaneous Image-Guided Irreversible Electroporation for the Treatment of Unresectable, Locally Advanced Pancreatic Adenocarcinoma. J Vasc Interv Radiol. Mar 2017; 28(3): 342-348.
  51. Narayanan, G. Irreversible electroporation for treatment of liver cancer. Gastroenterology & Hepatology. 2011 May; 7(5): 313-316.
  52. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Hepatocellular Carcinoma. Version 2.2024. www.nccn.org/professionals/physician_gls/pdf/hcc.pdf.
  53. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Biliary Tract Cancers. Version 3.2024. www.nccn.org/professionals/physician_gls/pdf/btc.pdf.
  54. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Pancreatic Adenocarcinoma. Version 3.2024. www.nccn.org/professionals/physician_gls/pdf/pancreatic.pdf.
  55. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Kidney Cancer. Version 1.2025. www.nccn.org/professionals/physician_gls/pdf/kidney.pdf. 
  56. National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Non-Small Cell Lung Cancer. Version 7.2024. www.nccn.org/professionals/physician_gls/pdf/nscl.pdf. 
  57. National Institute for Health and Care Excellence. Guideline: Irreversible electroporation for treating renal cancer. February 2013. www.nice.org.uk/guidance/ipg443.
  58. National Institute for Health and Care Excellence. Guideline: Irreversible electroporation for treating pancreatic cancer. Interventional procedures guidance [IPG579].  2017. www.nice.org.uk/guidance/ipg579.
  59. National Institute for Health and Care Excellence. Guideline: Irreversible electroporation for treating primary liver cancer. November 2019. www.nice.org.uk/guidance/ipg664.
  60. National Institute for Health and Care Excellence. Guideline: Irreversible electroporation for treating lung cancer. February 2013. www.nice.org.uk/guidance/ipg441.
  61. National Institute for Health and Care Excellence. Guideline: Irreversible electroporation for treating prostate cancer. July 2023. www.nice.org.uk/guidance/ipg768.
  62. National Institute for Health and Care Excellence (NICE). Interventional procedures guidance [IPG445]. Irreversible electroporation for treating liver metastases. February 23, 2013. London, UK, NICE. www.nice.org.uk/guidance/ipg445.
  63. 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.
  64. Niessen C, Beyer LP, Pregler B, et al. Percutaneous Ablation of Hepatic Tumors Using Irreversible Electroporation: A Prospective Safety and Midterm Efficacy Study in 34 Patients. J Vasc Interv Radiol. Apr 2016; 27(4): 480-6.
  65. Ong S, Chen K, Grummet J, et al. Guidelines of guidelines: focal therapy for prostate cancer, is it time for consensus?. BJU Int. 2023;131(1):20-31.
  66. Padia SA, Johnson GE, Yeung RS, et al. Irreversible Electroporation in Patients with Hepatocellular Carcinoma: Immediate versus Delayed Findings at MR Imaging. Radiology. Jan 2016; 278(1): 285-94.
  67. Pech M, Janitzky A, Wendler JJ, et al. Irreversible electroporation of renal cell carcinoma: a first-in-man phase I clinical study. Cardiovasc Intervent Radiol. Feb 2011; 34(1): 132-8. 
  68. Ricke J, Jürgens JH, Deschamps F, et al. Irreversible electroporation (IRE) fails to demonstrate efficacy in a prospective multicenter phase II trial on lung malignancies: the ALICE trial. Cardiovasc Intervent Radiol. Apr 2015; 38(2): 401-8. 
  69. Ruarus AH, Vroomen LGPH, Geboers B, van Veldhuisen E, Puijk RS, Nieuwenhuizen S, Besselink MG, Zonderhuis BM, Kazemier G, de Gruijl TD, van Lienden KP, de Vries JJJ, Scheffer HJ, Meijerink MR. Percutaneous Irreversible Electroporation in Locally Advanced and Recurrent Pancreatic Cancer (PANFIRE-2): A Multicenter, Prospective, Single-Arm, Phase II Study. Radiology. 2020 Jan;294(1):212-220. 
  70. Ruarus AH, Barabasch A, Catalano O, et al. Irreversible Electroporation for Hepatic Tumors: Protocol Standardization Using the Modified Delphi Technique. J Vasc Interv Radiol. Nov 2020; 31(11): 1765-1771.e15.
  71. Ruarus AH, Vroomen LGPH, Geboers B, et al. Percutaneous Irreversible Electroporation in Locally Advanced and Recurrent Pancreatic Cancer (PANFIRE-2): A Multicenter, Prospective, Single-Arm, Phase II Study. Radiology. Jan 2020; 294(1): 212-220
  72. Scheffer HJ, Vroomen LG, de Jong MC, et al. Ablation of Locally Advanced Pancreatic Cancer with Percutaneous Irreversible Electroporation: Results of the Phase I/II PANFIRE Study. Radiology. Feb 2017; 282(2): 585-597. 
  73. 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.
  74. Scheffer HJ, Nielsen K, van Tilborg AA, et al. Ablation of colorectal liver metastases by irreversible electroporation: results of the COLDFIRE-I ablate-and-resect study. Eur Radiol. Oct 2014; 24(10): 2467-75.
  75. 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.
  76. Scheltema MJ, van den Bos W, de Bruin DM, et al. Focal vs extended ablation in localized prostate cancer with irreversible electroporation; a multi-center randomized controlled trial. BMC Cancer. May 05 2016; 16: 299.
  77. Siegel RL, Giaquinto AN, Jemal A. Cancer statistics, 2024. CA Cancer J Clin. 2024; 74(1): 12-49.
  78. Silk M, Tahour D, et al. The state of irreversible electroporation in interventional oncology. Semin intervent radiol 2014 Jun; 31(2): 111-117.
  79. Silk MT, Wimmer T, Lee KS et al. Percutaneous ablation of peribiliary tumors with irreversible electroporation. J Vasc Interv Radiol 2014 Jan; 25(1):112-8.
  80. Sugimoto K, Kakimi K, Takeuchi H, et al. Irreversible Electroporation versus Radiofrequency Ablation: Comparison of Systemic Immune Responses in Patients with Hepatocellular Carcinoma. J Vasc Interv Radiol. Jun 2019; 30(6): 845-853.e6.
  81. Surveillance, Epidemiology, and End Results Program (SEER). SEER Stat Fact Sheets: Kidney and Renal Pelvis. seer.cancer.gov/statfacts/html/kidrp.html. 
  82. 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.
  83. Tasu J, Vessell G, Herpe G et al. Irreversible electroporation for locally advanced pancreatic cancer. Diagn Interv Imaging. 2016 Dec;97(12):1297-1304.
  84. Thomson KR, Cheung W, Ellis SJ, et al. Investigation of the safety of irreversible electroporation in humans. J Vasc Interv Radiol. May 2011; 22(5): 611-21.
  85. 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 (NEAT). Contemp Clin Trials. 2014Sep; 39(1); 57-65.
  86. 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.
  87. van Roessel S, Kasumova GG, Verheij J, et al. International Validation of the Eighth Edition of the American Joint Committee on Cancer (AJCC) TNM Staging System in Patients With Resected Pancreatic Cancer. JAMA Surg. Dec 01 2018; 153(12): e183617.
  88. Vroomen LGPH, Scheffer HJ, Melenhorst MCAM, et al. Irreversible Electroporation to Treat Malignant Tumor Recurrences Within the Pelvic Cavity: A Case Series. Cardiovasc Intervent Radiol. Oct 2017; 40(10): 1631-1640. 
  89. Wade R, South E, Anwer S, et al. Ablative and non-surgical therapies for early and very early hepatocellular carcinoma: a systematic review and network meta-analysis. Health Technol Assess. Dec 2023; 27(29): 1-172.
  90. Wendler JJ, Pech M, Fischbach F, et al. Initial Assessment of the Efficacy of Irreversible Electroporation in the Focal Treatment of Localized Renal Cell Carcinoma With Delayed-interval Kidney Tumor Resection (Irreversible Electroporation of Kidney Tumors Before Partial Nephrectomy [IRENE] Trial-An Ablate-and-Resect Pilot Study). Urology. Apr 2018; 114: 224-232. 
  91. Wendler JJ, Pech M, Köllermann J, et al. Upper-Urinary-Tract Effects After Irreversible Electroporation (IRE) of Human Localised Renal-Cell Carcinoma (RCC) in the IRENE Pilot Phase 2a Ablate-and-Resect Study. Cardiovasc Intervent Radiol. Mar 2018; 41(3): 466-476. 
  92. Xing M, Kokabi N, Zhang D, et al. Comparative Effectiveness of Thermal Ablation, Surgical Resection, and Active Surveillance for T1a Renal Cell Carcinoma: A Surveillance, Epidemiology, and End Results (SEER)-Medicare-linked Population Study. Radiology. Jul 2018; 288(1): 81-90. 
  93. Yaxley WJ, Gianduzzo T, Kua B, et al. Focal therapy for prostate cancer with irreversible electroporation: Oncological and functional results of a single institution study. Investig Clin Urol. 2022 May;63(3):285-293.
  94. Zhang K, Teoh J, Laguna P, et al. Effect of Focal vs Extended Irreversible Electroporation for the Ablation of Localized Low- or Intermediate-Risk Prostate Cancer on Early Oncological Control: A Randomized Clinical Trial. JAMA Surg. 2023;158(4):343–349.

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.

Medical Policy Group, June 2020: Quarterly coding update.  Added new CPT codes 0600T and 0601T to Current Coding.

Medical Policy Group, June 2021 (5): Reviewed by consensus. Updates to Key Points and References. Policy statement updated to remove “not medically necessary,” no change to policy intent. No new published peer-reviewed literature available that would alter the coverage statement in this policy.

Medical Policy Group, May 2022 (5): Reviewed by consensus. Updates to Key Points and References. No new published peer-reviewed literature available that would alter the coverage statement in this policy.

Medical Policy Group, May 2023 (11): Reviewed by consensus. Updates to Key Points, Benefit Application and References. No new published peer-reviewed literature available that would alter the coverage statement in this policy.

Medical Policy Group, May 2024 (11): Reviewed by consensus. Updates to Key Points, Benefit Application, Current Coding and References. No new published peer-reviewed literature available that would alter the coverage statement in this policy.

Medical Policy Group, September 2024 (11) Updates to Description, Key Points and References. No change to policy statement.

Medical Policy Group, November 2024 (11) Updates to Key Points, Approved By Governing Bodies and References. No change to policy statement.

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.