Radiotherapy is the standard care for individuals with breast cancer undergoing breast-conserving surgery because it reduces recurrences and lengthens survival. The conventional radiotherapy regimen consists of approximately 25 treatments of 2 gray (a measure of absorbed radiation dose) delivered over 5 - 6 weeks. Accelerated radiotherapy approaches have been proposed to make the regimen less burdensome for individuals with early-stage breast cancer at low risk of recurrence. Accelerated (also called hypofractionated) whole-breast irradiation reduces the number of fractions and the duration of treatment to about three weeks. Accelerated whole-breast irradiation is delivered using external beam radiation.
An alternative approach to reducing radiotherapy treatment time is accelerated partial breast irradiation. It differs from conventional whole breast irradiation by only targeting the segment of the breast surrounding the area where the tumor was removed rather than the entire breast. The duration of treatment is 4 – 5 days. Several methods can be used to deliver APBI, including brachytherapy, focused external-beam radiotherapy, or intraoperative radiotherapy, which occurs at the time of surgery.
Brachytherapy is a type of radiation therapy (either low or high dose) that uses radioactive materials implanted temporarily or permanently into tissue. The implants can be solid or liquid isotopes. They can be implanted interstitially (needles or seeds), intracavitary (balloon) or as intraluminal therapy. When used in combination or as an adjunct to whole-breast irradiation it is referred to as local ‘boost’ therapy (e.g., MammoSite® Radiation Therapy System).
A new technology using external applicators to deliver radiation to targeted locations, without implanting radioactive materials, is being investigated. This procedure is known as non-invasive brachytherapy (e.g. AccuBoost®).
Accelerated whole-breast irradiation for the treatment of breast cancer may be considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below)
Brachytherapy may be considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below)
Accelerated partial-breast irradiation (APBI), including external beam APBI, interstitial APBI, balloon APBI and intra-operative radiation for the treatment of breast cancer is considered investigational.
Non-invasive brachytherapy (e.g. AccuBoost®) for the treatment of breast cancer is considered investigational.
Any device utilized for this procedure must have FDA approval specific to the indication, otherwise it will be considered investigational.
Radiotherapy after breast-conserving surgery is considered medically appropriate for ANY ONE of the following:
Accelerated whole-breast irradiation if ALL of the following are met:
Invasive carcinoma of the breast
Technically clear surgical margins (i.e. no ink on tumor or invasive carcinoma or ductal carcinoma in situ)
Tumors 5 cm or less in diameter
Negative lymph nodes
Brachytherapy if ALL of the following are met:
Individual is undergoing initial treatment for stage I or II breast cancer
Used as an adjunct to whole-breast external beam radiotherapy (standard or accelerated schedule)
ANY ONE of the following types of brachytherapy are used:
Any specific products referenced in this policy are just examples and are intended for illustrative purposes only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available. These examples are contained in the parenthetical e.g. statement.
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.
Staging of the disease is determined by tumor size, the degree of invasiveness, lymph node involvement, and axillary lymph node involvement. Stage I describes invasive breast cancer in which the tumor measures up to 2 cm and no lymph nodes are involved. Stage IIB describes invasive breast cancer that the tumor is larger than 5 cm across but does not grow into the chest wall or skin. The cancer has not spread to the lymph nodes or to distant sites. For the purposes of this policy, Stages I to IIB are considered early-stage breast cancer.
Evidence for noninvasive breast brachytherapy to provide boost radiation to the tumor bed is very limited at this time.
American Society for Radiation Oncology (ASTRO). (2016, September). Accelerated partial breast irradiation: executive summary for the update of an ASTRO evidence-based consensus statement. Retrieved January 25, 2017 from https://www.astro.org.
BlueCross BlueShield Association. Medical Policy Reference Manual. (1:2017). Accelerated breast irradiation and brachytherapy boost after breast-conserving surgery for early-stage breast cancer. (8.01.13). Retrieved January 24, 2017 from BlueWeb. (52 articles and/or guidelines reviewed)
Budach, W., Bölke, E., & Mtuschek, C. (2015). Hypofractionated radiotherapy as adjuvant treatment in early breast cancer. A review and meta-analysis of randomized controlled trials. Breast Care, 10, 240-245. (Level 1 evidence)
Christoudias, M., Collett, A., Stull, T, Gracely, E., Frazier, T., & Barrio, A. (2013). Are the American society for radiation oncology guidelines accurate predictors of recurrence in early stage breast cancer patients treated with balloon-based brachytherapy? International Journal of Surgical Oncology. Vol. 2013, ID 829050. (Level 4 evidence)
Garsa, A., Ferraro, D., DeWees, T., Deshields, T., Margenthaler, J., Cyr, A., et al. (2013). A prospective longitudinal clinical trial evaluating quality of life after breast conserving surgery and high-dose-rate interstitial brachytherapy for early-stage breast cancer. International Journal of Radiation Oncology, 87 (5), 1043–1050. (Level 3 Evidence)
Genebes, C., Chand, M., Gal, J., Gautier, M., Raoust, I., Ihrai, T. et al. (2014). Accelerated partial breast irradiation in the elderly: 5-year results of high-dose rate multi-catheter brachytherapy. Radiation Oncology. 9,115. (Level 3 evidence)
Harness, J.K., Davies, K., Via, C., Brooks, E., Zambelli-Weiner, A., & Vicini, F. (2018). Meta-analysis of local invasive breast cancer recurrence after electron intraoperative radiotherapy. Annals of Surgical Oncology, 25 (1), 137-147. (Level 2 evidence)
Marta, G., Macedo, C., Carvalho, H., Hanna, S., da Silva, J., & Riera, R. (2015). Accelerated partial irradiation for breast cancer: systematic review and meta-analysis of 8653 women in eight randomized trials. Radiotherapy Oncology. 114 (1), 42-49. Abstract retrieved from PubMed database January 24, 2017.
National Comprehensive Cancer Network. (2017). NCCN Clinical Practice Guidelines in Oncology®. Breast cancer V 3.2017. Retrieved January 23, 2018 from the National Comprehensive Cancer Network.
National Institute for Heath and Clinical Excellence. (2008, July). Brachytherapy as the sole method of adjuvant radiotherapy for breast cancer after local excision. Retrieved January 24, 2017 from: http://www.nice.org.
Polo, A., Polgar, C., Hannoun-Levi, J.M., Guinot, J.L., Gutierrez, C., Galalae, R., et al. (2017). Risk factors and state-of-the-art indications for boost irradiation in invasive breast carcinoma. Brachytherapy, 16 (3), 552-564. Abstract retrieved February 13, 2018 from PubMed database.
Smith, G., Jiang, J., Buchholz, T., Xu, Y., Hoffman, K., Giordano, S., et al. (2014). Benefit of adjuvant brachytherapy versus external beam radiation for early breast cancer: Impact of patient stratification on breast preservation. International Journal of Radiation Oncology, 88 (2), 274–284. (Level 4 evidence)
Smith, G., Xu, Y., Buchholz, T., Giordano, S., Jiang, J., Shih, Y., et al. (2012). Association between treatment with brachytherapy vs whole- breast irradiation and subsequent mastectomy, complications, and survival among older women with invasive breast cancer. Journal of the American Medical Association. 307 (17), 1827–1837 (Level 4 evidence)
Strnad, V., Ott, O., Hildebrandt, G., Kauer-Dorner, D., Knauerhase, H., Major, T., et al. (2016). 5-year results of accelerated partial breast irradiation using sole interstitial multicatheter brachytherapy versus whole-breast irradiation with boost after breast-conserving surgery for low-risk invasive and in-situ carcinoma of the female breast: a randomised, phase 3, non-inferiority trial. Lancet. 387 (10015), 229-238. Abstract retrieved from PubMed database January 24, 2017.
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Winifred S. Hayes, Inc. Medical Technology Directory. (2016, December; last update search September 2017). Accelerated partial breast irradiation for breast cancer using brachytherapy. Retrieved January 23, 2018 from www.Hayesinc.com/subscribers. (72 articles and/or guidelines reviewed)
Winifred S. Hayes, Inc. Medical Technology Directory. (2016, December; last update search September 2017). Brachytherapy as an adjunct to other types of radiation therapy for breast cancer. Retrieved January 23, 2018 from www.Hayesinc.com/subscribers. (64 articles and/or guidelines reviewed)
ORIGINAL EFFECTIVE DATE: 12/1/2002
MOST RECENT REVIEW DATE: 8/1/2018
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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