MEDICAL POLICY POLICY TITLE INTERSTITIAL OR BALLOON BREAST BRACHYTHERAPY AND RADIOTHERAPY POLICY NUMBER MP

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1 Original Issue Date (Created): July 1, 2002 Most Recent Review Date (Revised): Effective Date: October 27, 2009 November 30, RETIRED I. POLICY Interstitial or balloon brachytherapy may be considered medically necessary for the following indications: For patients undergoing initial treatment for stage I or II breast cancer when used as local boost irradiation in patients who are also treated with breast-conserving surgery and whole breast external beam radiotherapy. When used as the sole form of radiotherapy (i.e., accelerated partial-breast irradiation) after surgical excision, when patients meet ALL of the following criteria: Axillary lymph nodes/sentinel lymph nodes negative; AND Following breast conserving surgery with negative microscopic surgical margins of excision; AND Invasive ductal carcinoma or ductal carcinoma in situ; AND Patient aged 45 years or older; AND Stage 0, I, or stage II disease (total tumor size less than or equal to 3 cm). Interstitial or balloon brachytherapy is considered investigational for local boost irradiation when combined with whole-breast radiotherapy but without surgical excision, as there is insufficient evidence to support a conclusion concerning the health outcomes or benefits associated with this procedure. Accelerated partial breast irradiation using an electronic radiotherapy device is considered investigational, as there is insufficient evidence to support a conclusion concerning the health outcomes or benefits associated with this procedure. Page 1

2 II. PRODUCT VARIATIONS [N] = No product variation, policy applies as stated [Y] = Standard product coverage varies from application of this policy, see below [N] CHIP [N] PPO [N] HMO [N] SeniorBlue HMO [N] SeniorBlue PPO [N] Indemnity [N] SpecialCare [N] POS [Y] FEP PPO* * The FEP program dictates that all drugs, devices or biological products approved by the U.S. Food and Drug Administration (FDA) may not be considered investigational. Therefore, FDA-approved drugs, devices or biological products may be assessed on the basis of medical necessity. III. DESCRIPTION/BACKGROUND Breast conservation therapy (BCT) is a multi-modality alternative to mastectomy to treat early (stage I or II) breast cancer. In current practice, most conventional BCT includes breast-conserving surgical excision of the tumor (lumpectomy, segmentectomy, or quadrantectomy) and whole breast radiotherapy (WBRT), delivered using external beam radiation (EBR). In addition, boost radiotherapy more narrowly directed to the tumor bed is often added. Whole breast plus boost radiation therapy reduces local (i.e., inbreast) recurrence. It is hypothesized to eliminate residual cancer at the surgical site and treat undetected multicentric disease, if present. Breast brachytherapy uses radiation sources placed inside the breast. It has been investigated as an alternative to external beam radiation therapy in two settings: As the sole form of radiation therapy after breast-conserving surgery. To replace external beam for boost radiation therapy, in conjunction with whole breast radiation therapy and breast-conserving therapy. This more recent application of brachytherapy is based partly on the observation that most same side breast recurrences after breast-conserving surgery and radiation therapy occur at or near the tumor bed, with only a minority of recurrences located elsewhere in the breast. Additionally, in trials of breast-conserving surgery with radiation therapy versus without radiation therapy, most recurrences also occurred at or near the tumor bed, Page 2

3 suggesting that undetected multicentric disease may not be common. Together these findings suggested that tumor bed irradiation may provide the major benefit from external beam radiation therapy. Also, external beam radiation therapy typically is delivered in fractionated doses over a course of 5 to 7 weeks. This extended treatment course may be difficult for some patients, for example, those living in remote locations, or the elderly or disabled. Brachytherapy usually is delivered over a week. This shortened treatment course, which has been termed accelerated partial breast irradiation, may increase the proportion of patients choosing breast-conserving surgery. Various brachytherapy techniques have been investigated. They differ in the timing of implantation relative to other components of breast-conserving therapy, the radiation dose rate, the loading technique, the number and volumetric distribution of radioactive sources and the radioisotopes used. Most older studies of local boost brachytherapy temporarily implanted needles, wires, or seeds after patients recovered from surgery and completed whole breast radiation therapy. Investigators have also perioperatively implanted hollow needles or catheters that guide placement of the radioactive material. This can be done during the initial lumpectomy if the decision to use brachytherapy has already been made, or at the time of a re-excision if the lumpectomy specimen has positive surgical margins. Intraoperative implantation avoids the need for a separate surgical procedure with anesthesia for brachytherapy. Whether intra- or post-operative, these methods are collectively termed interstitial brachytherapy and use multiple radioactive sources placed to deliver a prescribed radiation dose to a defined target volume. Both low-dose and high-dose rate interstitial techniques have been used, with high-dose rate techniques increasing in popularity. In the low-dose rate technique, temporarily implanted radioactive seeds deliver radiation therapy continuously over a course of 4 days and then are removed. This treatment is generally an inpatient procedure. In the high-dose rate technique, a computer-controlled device pushes a highly radioactive isotope into a catheter that has been placed into the tumor bed. The patient is exposed to the radiation therapy for a brief period (5 to 15 minutes) and then the radioactive source is withdrawn. High-dose rate brachytherapy is typically administered on an outpatient basis in 8 fractions given twice daily over 4 days. A balloon catheter system (the MammoSite TM device; Cytyc Corp; Alpharetta, GA) is also available for brachytherapy. The device is implanted in the lumpectomy cavity during or shortly after breast-conserving surgery. The balloon is inflated with sterile solution of contrast media in saline solution, and its position is confirmed radiographically using computed tomography. A high-dose rate source of iridium-192 is then centrally positioned within the applicator by a remote afterloader. This system is used to deliver 34 Gy in 10 fractions over 5 days. Thus, balloon brachytherapy uses a Page 3

4 single radioactive source that delivers radiation to a spherical or elliptical target volume. Like interstitial brachytherapy, it can be used to deliver local boost or accelerated partialbreast radiation therapy. In December 2005, the U.S. Food and Drug Administration (FDA) approved the Axxent Electronic Radiotherapy device (Xoft, Inc., Fremont, CA) via 510(k) as substantially equivalent to the MammoSite and other brachytherapy systems. The Axxent device is a balloon brachytherapy system that uses a disposable, microminiature radiation source to deliver the radiation rather than radioisotopes. IV. DEFINITIONS BRACHYTHERAPY FOR BREAST CANCER is the implantation of radioactive material directly into the breast near a malignant tumor. BREAST CONSERVATION THERAPY (BCT) is a multi-treatment alternative to mastectomy for the treatment of early stage breast cancer. INTERSTITIAL refers to placed or lying between. INTRAOPERATIVE refers to occurring during surgery. MASTECTOMY is the surgical removal of one or both breasts, most commonly performed to remove a malignant tumor. PERIOPERATIVE refers to occurring in the period immediately before, during, and/or after surgery. RADIOISOTOPE refers to a form of an element, capable of spontaneous emission of alpha, beta, or gamma rays as a result of the disintegration of the nucleus of an atom. V. BENEFIT VARIATIONS The existence of this medical policy does not mean that this service is a covered benefit under the member's contract. Benefit determinations should be based in all cases on the applicable contract language. Medical policies do not constitute a description of benefits. A member s individual or group customer benefits govern which services are covered, which are excluded, and which are subject to benefit limits and which require preauthorization. Members and providers should consult the member s benefit information or contact Capital for benefit information. VI. DISCLAIMER Capital s medical policies are developed to assist in administering a member s benefits, do not constitute medical advice and are subject to change. Treating providers are solely responsible for medical advice and treatment of members. Members should discuss any medical policy related to their coverage or condition Page 4

5 with their provider and consult their benefit information to determine if the service is covered. If there is a discrepancy between this medical policy and a member s benefit information, the benefit information will govern. Capital considers the information contained in this medical policy to be proprietary and it may only be disseminated as permitted by law. VII. REFERENCES American Brachytherapy Society. Current applications of brachytherapy. [Website]: Accessed August 13, Bartelink H. Partial breast irradiation: Is it a valid option? Breast 2006; 15(3): BCBSA 2002, Volume 17, No. 18. TEC Assessment: Brachytherapy alone as the radiation component of breast conservation therapy for early stage breast cancer. BCBSA 2007 TEC Assessment. Accelerated Partial Breast Irradiation as Sole Radiotherapy after Breast-Conserving Surgery for Early Stage Breast Cancer. Benitez PR, et al. Partial breast irradiation in breast-conserving therapy by way of interstitial brachytherapy. Am J Surg 2004; 188: Chao KK, Vicini FA, Wallace M et al. Analysis of treatment efficacy, cosmesis, and toxicity using the MammoSite breast brachytherapy catheter to deliver accelerated partialbreast irradiation: The William Beaumont Hospital Experience. Int J Radiat Oncol Biol Phys 2007; 69(1): 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): Dickler A, Kirk MC, Choo J, et al. Cosmetic outcome and incidence of infection with the MammoSite breast brachytherapy applicator. Breast J2005; 11(5): DiFronzo LA, Tsai PI, Hwang JM, et al. Breast conserving surgery and accelerated partial breast irradiation using the MammoSite system: initial clinical experience. Arch Surg 2005; 140(8): Dragun AE, Aguero EG, Harmon JF, et al. Chest wall dose in MammoSite breast brachytherapy: radiobiologic estimations of late complication risk based on dosevolume considerations. Brachytherapy 2005; 4(4): ECRI. Target Report : Intracavitary balloon brachytherapy for early-stage breast cancer. 7/2007. Evans SB, Kaufman SA, Price LL, et al. Persistent seroma after intraoperative placement of MammoSite for accelerated partial breast irradiation: incidence, pathologic anatomy, and contributing factors. Int J Radiat Oncol Biol Phys 2006; 65(2): Page 5

6 Fentiman IS, Deshmane V, Tong D, Winter J, Mayles H, Chaudary MA. Caesium(137) implant as sole radiation therapy for operable breast cancer: a phase II trial. Radiother Oncol Jun; 71(3): 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 carcinomain-situ of the breast. Ann Surg Oncol 2006; 13(7): Kaufman SA, DiPetrillo TA, Price LL et al. Long-term outcome and toxicity in a Phase I/II trial using high-dose-rate multicatheter interstitial brachytherapy for T1/T2 breast cancer. Brachytherapy 2007; 6(4): Keisch M. Accelerated partial breast irradiation: the case for current use. Breast Cancer Research 2005; 7: Kuske RR, Winter K, Arthur DW, et al. Phase II trial of brachytherapy alone after lumpectomy for select breast cancer: toxicity analysis of RTOG Int J Radiat Oncol Biol Phys 2006; 65(1): 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; 3(3): Mosby s Medical, Nursing, & Allied Health Dictionary, 6 th edition. Munshi A. External hypofractionated whole-breast radiotherapy: now where does accelerated partial breast irradiation stand? J Cancer Res Ther 2007; 3(4): National Cancer Institute. Phase III Randomized Study of Adjuvant Whole Breast Versus Partial Breast Irradiation in Women With Ductal Carcinoma In Situ or Stage I or II Breast Cancer. [Website]: HealthProfessional&protocolsearchid= Accessed August 13, National Comprehensive Cancer Network. Breast Cancer. Clinical practice guidelines in oncology. v [Website]: Accessed August 13, Niehoff P, Ballardini B, Polgar C, et al. Early European experience with the MammoSite radiation therapy system for partial breast brachytherapy following breast conservation operation in low-risk breast cancer. Breast 2006; 15(3): Niehoff P, Polgar C, Ostertag H, et al. Clinical experience with the MammoSite radiation therapy system for brachytherapy of breast cancer: results from an international phase II trial. Radiother Oncol 2006; 79(3): Page 6

7 Ott OJ, Potter R, Hammer J, et al. Accelerated partial breast irradiation with iridium-192 multicatheter PDR/HDR brachytherapy. Preliminary results of the German-Austrian multicenter trial. Strahlenther Onkol 2004; 180(10): Polgar C, Major T, Fodor J, et al. High-dose-rate brachytherapy alone versus whole breast radiotherapy with or without tumor bed boost after breast-conserving surgery: seven-year results of a comparative study. Int J Radiat Oncol Biol Phys 2004; 60(4): Prosnitz LR, Marks LB. Partial breast irradiation: a cautionary note. Int J Radiat Oncol Biol Phys 2006; 65(2): Shah NM, Wazer DE. The MammoSite balloon brachytherapy catheter for accelerated partial breast irradiation. Semin Radiat Oncol 2005; 15(2): Stevens MJ, Cooper SG, Cross P, et al. Accelerated partial breast irradiation using interstitial high dose rate iridium brachytherapy: early Australian experience and review of the literature. Australas Radiol 2006; 50(2): Strnad V, Ott O, Potter R, et al. Interstitial brachytherapy alone after breast conserving surgery: interim results of a German-Austrian multicenter phase II trial. Brachytherapy 2004; 3(3): Swanson TA, Vicini FA. Overview of accelerated partial breast irradiation. Curr Oncol Rep 2008; 10(1): Tabers Cyclopedic Medical Dictionary, 19 th edition. The American Society of Breast Surgeons. Consensus statement for accelerated partial breast irradiation. [Website]: Accessed August 13, 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; 104(6): WazerDE, Kaufman S, Cuttino L, et al. Accelerated partial breast irradiation: an analysis of variables associated with late toxicity and long-term cosmetic outcome after highdose-rate interstitial brachytherapy. Int J Radiat Oncol Biol Phys 2006; 64(2): Zannis V, Beitsch P, Vicini F, et al. Descriptions and outcomes of insertion techniques of a breast brachytherapy balloon catheter in 1403 patients enrolled in the American Society of Breast Surgeons MammoSite breast brachytherapy registry trial. Am J Surg 2005; 190(4): Page 7

8 VIII. CODING INFORMATION Note: This list of codes may not be all-inclusive, and codes are subject to change at any time. The identification of a code in this section does not denote coverage as coverage is determined by the terms of member benefit information. In addition, not all covered services are eligible for separate reimbursement 0182T C1715 C1716 C1717 C1719 C1728 C2616 C2635 C2636 C2637 Q3001 IX. POLICY HISTORY MP CAC 1/28/03 CAC 1/25/05 CAC 1/31/06 CAC 2/28/06 CAC 2/27/07 CAC 11/27/07 CAC 11/25/08 CAC 9/29/09 Consensus Review Policy approved for retirement effective 11/30/2009. Information on Breast Brachytherapy was added into Policy Brachytherapy. Health care benefit programs issued or administered by Capital BlueCross and/or its subsidiaries, Capital Advantage Insurance Company and Keystone Health Plan Central. Independent licensees of the Blue Cross and Blue Shield Association. Communications issued by Capital BlueCross in its capacity as administrator of programs and provider relations for all companies. Page 8