Electronic Brachytherapy

» Summary» Procedure Codes
» Description» Selected References
» Prior Approval» Policy History
» Policy
 

Medical Policy: 08.01.11 
Original Effective Date: February 2005 
Reviewed: February 2015 
Revised: March 2014 


Benefit Application
Benefit determinations are based on the applicable contract language in effect at the time the services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary based on contract, and individual member benefits must be verified. Wellmark determines medical necessity only if the benefit exists and no contract exclusions are applicable. This medical policy may not apply to FEP. Benefits are determined by the Federal Employee Program.

This Medical Policy document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy will be reviewed regularly and be updated as scientific and medical literature becomes available.


Description: 

Electronic brachytherapy (EBT) has been developed to offer advantages over standard radioactive brachytherapy in the areas of radiation safety both to the patient as well as the personnel administering the treatment. EBT uses X-ray radiation sources to deliver electronically generated ionizing radiation. Therefore, it can be used in controlled settings without a specially shielded vault, such as in the office of an authorized user or in an operating room. Electronic brachytherapy is a treatment modality being utilized to treat breast, skin, gynecological and other cancers.

 

EBT uses a disposable miniature low energy (50Kv) X-ray tube into a pre-positioned applicator within body/tumor cavities to rapidly deliver high doses of radiotherapy. Through the manipulation of radiation intensity and dose distribution, EBT delivers more intense therapy directly to cancer sites with minimal radiation exposure to surrounding healthy tissue.

 

Electronic brachytherapy (EBT) for skin application (surface brachytherapy) uses a direct contact applicator and a flexible clamp. The lightweight surface applicator (less than 150g) can be precisely oriented to the desired location on the patient i.e. the target lesion. Surface applicators range in size from 10mm to 50mm providing flexibility in treating a variety of lesion sizes. A miniaturized X-ray source is placed in the applicator and energized to deliver radiation for a few minutes. With the reduced shielding requirement, the physician can remain near the patient. Furthermore, faster dose fall-off of the low-energy miniaturized X-ray source minimizes exposure to healthy adjacent tissues.     

 

Summary
There is insufficient evidence in peer reviewed scientific literature to support electronic brachytherapy for the treatment of breast cancer to include all other cancer related indications. Studies are small, mostly single center studies with limited follow up. Furthermore, studies comparing health outcomes of electronic brachytherapy with health outcomes of conventional radioactive source brachytherapy are lacking. Randomized trials or comparison studies demonstrating improvements in health outcomes and long term assessments of treatment efficacy and effects are warranted. Therefore, electronic brachytherapy is considered investigational for all indications.  

 

Practice Guideline and Position Statements
American Society for Radiation Oncology (ASTRO)
The American Society for Therapeutic Radiology and Oncology (ASTRO) Emerging Technology Committee's report on EBT (Park et al, 2010) stated that "advantages of EBT over existing technologies are as yet unproven in terms of efficacy or patient outcomes".  The report explains the impact of clinical use of electronic brachytherapy could be far-reaching, and if used improperly, potentially harmful to patients.  The report explains that electronic brachytherapy is currently an unregulated treatment delivery modality for cancer therapy, with minimal clinical data available from small single institution, studies, none with significant follow-up.  It also noted that there are currently no accepted calibration standards for EBT.  Thus, there can be large uncertainties associated with absorbed dose measurement at low energies.  Furthermore, the report stated that the effects of EBT on tumor and normal tissues are not yet well understood, given the paucity of clinical studies.


Thus, electronic brachytherapy is a widely unregulated method of delivering cancer treatment. Randomized trials or comparison studies demonstrating improvement in health outcomes and long-term assessments of treatment efficacy and effects are warranted. 

 

Regulatory Status
The Axxent eBx system (produced by Xoft, Inc)
received marketing clearance under the 510(k) process from the U.S. Food and Drug Administration (FDA) in 2005 for “delivery of intracavitary or interstitial radiation to the surgical margins following lumpectomy for breast cancer.” In 2008, FDA cleared expanded indications to include “lesions, tumors and conditions in or on the body where radiation is indicated,” and Xoft received marketing clearance for Axxent Vaginal Applicator for use with the Axxent eBx system to deliver intracavity brachytherapy (BT) in the vagina and rectum. In 2009, FDA granted marketing clearance for the Axxent Surface Applicator for use with the Axxent eBX system to deliver surface BT (e.g., for treating skin or oral cancers).

 

This system consists of three components: a high dose radiation (HDR) controller, balloon applicators, and a disposable HDR x-ray source kit. To perform electronic brachytherapy using this system, the surgeon fills the balloon applicator with saline to approximate the surgically created lumpectomy cavity or natural cavity. The surgeon then inserts the x-ray source attached to a flexible cable into the central lumen of the appropriately filled balloon applicator, permitting the delivery of radiation to the target site via a disposable micro-minature x-ray tube. The balloon applicator can be safely left in place between treatments.

 

For skin application the Axxdent eBx system enables the clinical to administer surface brachytherapy without the use of radioactive isotope or a megavoltage linear accelerator, making surface treatments more accessible. eBx simplifies the surface  radiation process by targeting the tumor site using a direct contact applicator and a flexible clamp.

   

Zeiss Intrabeam Sytem is another electronic brachytherapy device . This system is similar to Axxent eBx system produced by Xoft, Inc in that is uses low energy x-ray system. It has been used most often in the application of radiation directly to the tumor bed exposed surgically in the operating room (intra-operative radiation therapy [IORT]).

 

The Zeiss system is described the manufacturer as a mobile Photon Radio Surgery Systerm (PRS), not to be confused with stereotactic radio surgery system that used a highly precise beam of photon or proton radiation. The radiation source in a stereotactic radio surgery system is typically a gamma-knife linear accelerator, or cyclotron. Whereas, the PRS system produces an electron beam in the main housing unit that is accelerated before entering a drift tube where the beam is directed to the x-ray target located at the end (tip) of the drift tube. Target is 50kV peak, maximum current is 40 uA.   


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Prior Approval: 

 

Not applicable


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Policy: 

Electronic brachytherapy is considered investigational in all care settings and for all indications.

 

There is insufficient evidence in peer reviewed scientific literature to support electronic brachytherapy for the treatment of breast cancer to include all other cancer related indications. Studies are small, mostly single center studies with limited follow up. Furthermore, studies comparing health outcomes of electronic brachytherapy with health outcomes of conventional radioactive source brachytherapy are lacking. Randomized trials or comparison studies demonstrating improvements in health outcomes and long term assessments of treatment efficacy and effects are warranted. Therefore, electronic brachytherapy is considered investigational for all indications.  





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Procedure Codes and Billing Guidelines: 

To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or diagnosis codes.

The following codes or code ranges may be used to report brachytherapy:

  • 0182T High dose rate electronic brachytherapy, per fraction  

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Selected References: 

  • Edmundson GK et al. Accelerated treatment of breast cancer: dosimetric comparisons between interstitial HDR brachytherapy, MammoSite balloon brachytherapy, and external beam quadrant radiation. Int J Radiat Oncol Biol Phys 2003 Oct 1;57(2Suppl):S307-8.
  • Fisher B, Anderson S, Bryant J et al. Twenty-year follow-up of a randomized trial comparing total mastectomy, lumpectomy, and lumpectomy plus irradiation for the treatment of invasive breast cancer. NEJM 2002 Oct 17;347(16):1233-41.
  • King TA, et al. Long-term results of wide-field brachytherapy as the sole method of radiation therapy after segmental mastectomy for T1,2 breast cancer. AM J Surg 2000 Oct;180(4):299-304.
  • Pawlik TM, et al. Potential applicability of balloon catheter-based accelerated partial breast irradiation after conservative surgery for breast carcinoma. Cancer 2004 Feb 1;100(3):490-8.
  • Huang E, Buchholz TA, Meric F et al.  Classifying local disease recurrences after breast conservation therapy based on location and histology. Cancer 2002; 95(10): 2059-67.
  • Dragun AE, Aguero EG, Harmon JF et al. Chest wall dose in MammositeTM  breast brachytherapy: radiobiologic estimations of late complication risk based on dose-volume considerations. Brachytherapy. 2005; 4(4):259-63.
  • Vicini FA< Beitsch PD, Quiet CA et al. First analysis of patient demographics, technical reproducibility, cosmesis, and early toxicity: results of the American Society of Breast Surgeons MammoSite breast brachytherapy trial. Cancer. 2005 Sep 15; 104(6):1138-48.
  • McCormick B. Partial-breast radiation for early staged breast cancers: hypothesis, existing data, and a planned phase III trial. J Natl Compr Canc Netw. 2005 May;3(3):301-7.
  • Chen PY, Vicini FA, Benitez P et al. Long-term cosmetic results and toxicity after accelerated partial-breast irradiation: a method of radiation delivery by interstitial brachytherapy for the treatment of early-stage breast carcinoma. Cancer 2006; 106(5):991-9.
  • Jeruss JS, Vicini FA, Beitsch PD et al. Initial outcomes for patients treated on the American Society of Breast Surgeons MammoSite clinical trial for ductal carcinoma-in-situ of the breast. Ann Surg Oncol 2006; 13(7):967-76.
  • Kuske RR, Winter K, Arthur DW et al. Phase II trial of brachytherapy alone after lumpectomy for select breast cancer: toxicity analysis of RTOG 95-17. Int J Radiat Oncol Biol Phys 2006; 65(1):45-51.
  • The American Society of Breast Surgeons. Consensus Statement for Accelerated Partial Breast Irradiation. October 2008.
  • Blue Cross Blue Shield Association Technology Evaluation Center. Accelerated Partial Breast Irradiation as Sole Radiotherapy After Breast-Conserving Surgery for Early Stage Breast Cancer. 2007 TEC Assessment.
  • Benitez P, Keisch M, Vicini F et al. Five-year results: the initial clinical trial of Mammosite balloon brachytherapy for partial breast irradiation in early-stage breast cancer. Am J Surg 2007;194(4):456-62.
  • Ko EC, Koprowski CD, Dickson-Witmer D et al. Partial vs. whole breast irradiation in a community hospital: A retrospective cohort analysis of 200 patients. Brachytherapy. 2010 Feb 12 [Epub ahead of print]
  • Harper JL, Watkins JM, Zauls AJ et al. Six-year experience: long-term disease control outcomes for partial breast irradiation using MammoSite balloon brachytherapy. Am J Surg. 2010 Feb; 199(2): 204-9. Epub 2009 Oct 17.
  • Nelson JC, Beitsch PD, Vicini FA et al. Four-year clinical update from the American Society of Breast Surgeons MammoSite brachytherapy trial. Am J Surg. 2009 Jul; 198(1):83-91. Epub 2009 Mar 6.
  • Antonucci JV, Wallace M, Goldstein NS et al. Differences in patterns of failure in patients treated with accelerated partial breast irradiation versus whole-breast irradiation: a matched-pair analysis with 10-year follow-up. Int J Radiat Oncol Biol Phys. 2009 Jun 1; 74(2): 447-52. Epub 2008 Dec 6.
  •  Sher DJ, Wittenberg E, Suh WW et al. Partial-breast irradiation versus whole-breast irradiation for early-stage breast cancer: a cost-effectiveness analysis. Int J Radait Oncol Biol Phys. 2009 Jun 1; 74(2): 440-6. Epub 2008 Oct 27.
  • ECRI Institute. Electronic Brachytherapy. Plymouth Meeting (PA): ECRI Institute; 2009 Jun 12. 6 p. [ECRI hotline response].
  • Park CC, Yom SS, Podgorsak MB et al. American Society for Therapeutic Radiology and Oncology (ASTRO) Emerging Technology Committee report on electronic brachytherapy. Int J Radiat Oncol Biol Phys. 2010 Mar 15; 76(4): 963-72.
  • Dickler A, Ivanov O, Francescatti D. Intraoperative radiation therapy in the treatment of early-stage breast cancer utilizing xoft axxent electronic brachytherapy. World J Surg Oncol. 2009 Mar 2; 7:24.
  • Dickler A, Kirk MC, Coon A et al. A dosimetric comparison of Xoft Axxent electronic brachytherapy and iridium-192 high-dose-rate brachytherapy in the treatment of endometrial cancer. Brachytheapy. 2008 Oct-Dec; 7(4):351-4. Epub 2008 Sep 9.
  • ECRI Institute. Electronic Brachytherapy. Plymouth Meeting (PA): ECRI Institute; 2011 August 9. 8 p. [ECRI hotline response].
  • Dooley WC, Wurzer JC, Megahy M et al. Electronic  brachytherapy as adjuvant therapy for early stage breast cancer: a retrospective analysis. OncoTargets Ther. 2011 Jan 12; 4:13-20.
  • Dooley WC, Algan O, Dowlatshahi K et al. Surgical perspectives from a prospective, nonrandomized, multicenter study of breast conserving surgery and adjuvant electronic brachytherapy for the treatment of breast cancer. World J Surg Oncol. 2011 Mar 7; 9:30.
  • Ivanov O, Dickler A, Lum BY et al. Twelve-month follow-up results of a trial utilizing Axxent electronic brachytherapy to deliver intraoperative radiation therapy for early-stage breast cancer. Ann Surg Oncol. 2011 Feb; 18(2):453-8. Epub 2010 Aug 25.
  • Mehta VK, ALgan O, Griem KL et al. Experience with an electronic brachytherapy technique for intracavitary accelerated partial breast irradiation. Am J Clin Oncol. 2010 Aug; 33(4):327-35.
  • Njeh CF, Saunders MW, Langton CM. Accelerated Partial Breast Irradiation (APBI): A review of available techniques. Radiat Oncol. 2010 Oct 4; 5:90.
  • Vicini F, Arthur D, Wazer D et al. Limitations of the American Society of Therapeutic Radiology and Oncology Consensus Panel Guidelines on the use of accelerated partial breast irradiation. Int J Radiat Oncol Biol Phys 2011; 79(4):977-84.
  • Shaitelman SF, Vicini FA, Beitsch P et al. Five-year outcome of patients classified using the American Society for Radiation Oncology Consensus Statement Guidelines for the application of accelerated partial breast irradiation. Cancer 2010; 116(20):4677-85.
  • Beitsch P, Vicini F, Keisch M et al. Five-year outcome of patients classified in the “unsuitable” category using the American Society of Therapeutic Radiology and Oncology (ASTRO) Consensus Panel Guidelines for the Applications of Accelerated Partial Breast Irradiation: An Analysis of Patients Treated on the American Society of Breast Surgeons MammoSite® Registry Trial. Ann Surg Oncol 2010; 17(Suppl 3):S219-25.
  • American Society of Breast Surgeons. Consensus Statement for Accelerated Partial Breast Irradiationpdf. Revised August, 2011.
  • ECRI Institute. Contura Multi-lumen Balloon Catheter (SenoRx, Inc.) for Accelerated Partial Breast Irradiation. Plymouth Meeting (PA): Dec 8, 2011. Custom Hotline Product Brief. Available at: http://www.ecri.org
  • American College of Radiology. Expert Panel on Radiation Oncology-Breast; Moran MS, Bai HX, Haffty BG et al. ACR Appropriateness Criteria®. Ductal Carcinoma In Situ. 2011.
  • American College of Radiology. Expert Panel on Radiation Oncology-Breast; Bellon JR, Haffty BG, Harris EER et al. ACR Appropriateness Criteria®. Conservative Surgery and Radiation-Stage I and II Breast Carcinoma. 2011.
  • Wilder RB, Curcio LD, Khanijou RK et al. Preliminary results in 173 breast cancer patients treated with post-lumpectomy MammoSite Single-lumen brachytherapy or multi-catheter brachytherapy. Breast J. 2010 Nov-Dec; 16(6):581-6.
  • Yashar C, Scanderbeg D, Kuske R et al. Initial clinical experience with the strut-adjusted volume implant (SAVI) breast brachytherapy device for accelerated partial-breast irradiation (APBI): First 100 patients with more than 1 year of follow-up. Int J Radiat Oncol Biol Phys. 2011 Jul 1;80(3):765-70.
  • Smith GL, Xu y, Buchholz TA et al. Association between treatment with brachytherapy vs whole-breast irradiation and subsequent mastectomy, complications, and survival among older women with invasive breast cancer. JAMA. 2012;307(17):1827-37.
  • ECRI Institute. Product Brief. Axxent Electronic Brachytherapy System (Xoft, Inc) for Adjuvant Treatment of Breast, Vaginal and Skin Cancers. December 2012.
  • Conference of Radiation Control Program Directors, Inc. (CRCPD). Technical White Paper: Guidance for State Programs that Regulate the New Therapy Modality Electronic Brachytherapy. January 2011.
  • American Society for Radiation Oncology (ASTRO) Brachytherapy Model Policy. January 2012.
  • American Socity of Radiation Oncology (ASTRO), Emerging Technology Committee Report on Electronic Brachytherapy, May 23, 2008, Catherine C. Park, M.D. et al.  
  •  Xoft, Inc.

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Policy History: 

 

Date                                        Reason                              Action

June 2011                               Annual review                    Policy renewed

June 2012                               Annual review                    Policy renewed

May 2013                               Annual review                    Policy revised

March 2014                            Annual review                    Policy revised

February 2015                        Annual review                    Policy renewed


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Wellmark medical policies address the complex issue of technology assessment of new and emerging treatments, devices, drugs, etc.   They are developed to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. Wellmark medical policies contain only a partial, general description of plan or program benefits and do not constitute a contract. Wellmark does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Wellmark or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. Our medical policies may be updated and therefore are subject to change without notice.

*Current Procedural Terminology © 2012 American Medical Association. All Rights Reserved.

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