DESCRIPTION
Breast conservation therapy (BCT) is a multi-modality alternative to mastectomy for treatment of early stage I or stage II breast cancer. Currently, most conventional BCT includes breast-conserving surgical excision of the tumor and whole breast radiotherapy delivered using external beam radiation. In addition, "boost" radiotherapy may be performed using brachytherapy; the interstitial or intracavitary implantation of radioactive material directly into the breast to target the segment of the breast surrounding the area where the tumor was removed.. Brachytherapy may also be given as the sole form of radiotherapy after surgical incision.
Various interstitial 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 of the older studies of local boost brachytherapy temporarily implanted needles, wires, or seeds after patients recovered from surgery and completed whole-breast radiation therapy. Since the 1990s, investigators have perioperatively implanted hollow needles or catheters that guide placement of the radioactive material. This can be done during the initial lumpectomy if brachytherapy has been selected already or at re-excision if the lumpectomy specimen has positive surgical margins. Intraoperative implantation avoids the need for a separate surgical procedure with anesthesia for brachytherapy.
Both low- and high-dose rate interstitial techniques are used, with high-dose rate techniques increasing in popularity. In the low-dose rate technique, radioactive seeds are temporarily implanted in hospitalized individuals. They deliver radiation continuously over 4 days and then are removed. In the high-dose rate technique, a computer-controlled device loads highly radioactive isotope sources into catheters that have been placed into the tumor bed. The individual is exposed to the radiation therapy for a brief period (e.g., 15 minutes) and then the radioactive sources are withdrawn. High-dose rate brachytherapy is typically administered to individuals on an outpatient basis as 8 fractions given twice daily over 4 days.
A balloon catheter system (e.g. the Mammosite™ RTS 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 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 partial-breast radiation therapy.
POLICY
Brachytherapy for the treatment of stage I or stage II breast cancer is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Brachytherapy for the treatment of stage I or stage II breast cancer as a local boost irradiation when combined with whole breast radiotherapy without surgical excision is considered investigational.
Any device utilized for this procedure must have FDA approval specific to the indication, otherwise it will be considered investigational.
MEDICAL APPROPRIATENESS
Brachytherapy for the treatment of Stage I or II breast cancer is considered medically appropriate if ANY ONE of the following criteria are met:
Initial treatment of stage I or II breast cancer and ALL of the following:
Therapy is a local boost to whole breast external beam radiation
Individual has had breast conserving surgery
Treatment of stage I or II breast cancer and ALL of the following:
As a sole form of radiation therapy
Individual has had surgical excision of tumor
The disease is invasive ductal or ductal carcinoma in situ
The total tumor size is less than or equal to 3 cm
Individual is at least 45 years or older
Surgical margins are microscopically negative
Axillary lymph nodes/sentinel lymph nodes are negative
IMPORTANT REMINDER
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
ADDITIONAL INFORMATION
The American Society of Breast Surgeons acknowledges that individuals should be carefully selected for accelerated partial breast irradiation (APBI) and properly informed of the benefits and risks of this type of treatment. In addition, surgeons, radiation oncologists and physicists who utilize the various APBI techniques should be adequately trained to allow for optimum radiation therapy planning and treatment.
There is a lack of published data to validate the efficacy of brachytherapy without surgical excision of the tumor .
SOURCES
American Brachytherapy Society. Breast brachytherapy task group. Retrieved October 18, 2011 from http://www.americanbrachytherapy.org/guidelines/abs_breast_brachytherapy_taskgroup.pdf.
American College of Radiology. (2010). Practice guideline for the performance of high-dose-rate brachytherapy. Retrieved October 19, 2011 from http://www.acr.org/SecondaryMainMenuCategories/quality_safety/guidelines/ro/high_dose_rate_brachytherapy.aspx.
American College of Radiology. (2011). ACR Appropriateness Criteria® conservative surgery and radiation – stage I and II breast cancer. Retrieved October 18, 2011 from http://www.guideline.gov/content.aspx?id=32631.
BlueCross BlueShield Association. Medical Policy Reference Manual. (4:2011) Accelerated breast irradiation after breast conserving surgery for early stage breast cancer and breast brachytherapy as boost with whole-breast irradiation. (8.01.13). Retrieved October 18, 2011 from BlueWeb. (39 articles and/or guidelines reviewed)
ECRI Institute. Health Technology Information Service. Emerging Technology Report. (2009, April). Accelerated partial breast irradiation using intracavitary brachytherapy to treat early stage breast cancer. Retrieved October 18, 2011 from ECRI Institute.
National Comprehensive Cancer Network. (2009). NCCN Clinical Practice Guidelines in Oncology™. Breast cancer. Retrieved October 18, 2011 from http://www.nccn.org/professionals/physician_gls/pdf/breast.pdf.
National Institute for Heath and Clinical Excellence. (July, 2008). Brachytherapy as the sole method of adjuvant radiotherapy for breast cancer after local excision. Retrieved October 18,2011 from http://www.nice.org.uk/nicemedia/live/11922/41277/41277.pdf.
Smith, B., Arthur, D., Buchholz, T., Haffty, B., Hahn, C., Hardenbergh, P., et al. (2009). Accelerated partial breast irradiation consensus statement from the American Society for Radiation Oncology (ASTRO). International Journal of Radiation Oncology, 74 (4), 987-1001.
Technology Evaluation Center. (2010, June). Gene expression profiling for managing breast cancer treatment. (Vol. 24, No. 9). Retrieved October 18, 2011 from http://www.bcbs.com/blueresources/tec/vols/24/24_09.pdf.
U. S. Food and Drug Administration. (2004, February). Center for Devices and Radiological Health. 510(k) Premarket Notification Database.K032067. Retrieved October 18, 2011 from http://www.accessdata.fda.gov/cdrh_docs/pdf3/K032067.pdf.
U. S. Food and Drug Administration. (2008, April). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K081079. Retrieved October 18, 2011 from http://www.accessdata.fda.gov/cdrh_docs/pdf8/K081079.pdf.
Winifred S. Hayes, Inc. Medical Technology Directory. (2011, March). Brachytherapy for breast cancer. Retrieved October 18, 2011 from www.Hayesinc.com/subscribers (99 articles and/or guidelines reviewed)
Yeo, S,G., Kim, J., Kwak, G.H., Kim, J.Y., Park, K., Kim, E.S., et al. (2010). Accelerated partial breast irradiation using multicatheter brachytherapy for the select early-stage breast cancer: local control and toxicity. Radiation Oncology, 5 (56) . (Level 3 Evidence - Independent study)
ORIGINAL EFFECTIVE DATE: 12/1/2002
MOST RECENT REVIEW DATE: 12/8/2011
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Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
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