INTRACAVITARY BALLOON BRACHYTHERAPY FOR MALIGNANT AND METASTATIC BRAIN TUMORS

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METASTATIC BRAIN TUMORS Non-Discrimination Statement and Multi-Language Interpreter Services information are located at the end of this document. Coverage for services, procedures, medical devices and drugs are dependent upon benefit eligibility as outlined in the member's specific benefit plan. This Medical Coverage Guideline must be read in its entirety to determine coverage eligibility, if any. This Medical Coverage Guideline provides information related to coverage determinations only and does not imply that a service or treatment is clinically appropriate or inappropriate. The provider and the member are responsible for all decisions regarding the appropriateness of care. Providers should provide BCBSAZ complete medical rationale when requesting any exceptions to these guidelines. The section identified as Description defines or describes a service, procedure, medical device or drug and is in no way intended as a statement of medical necessity and/or coverage. The section identified as Criteria defines criteria to determine whether a service, procedure, medical device or drug is considered medically necessary or experimental or investigational. State or federal mandates, e.g., FEP program, may dictate that any drug, device or biological product approved by the U.S. Food and Drug Administration (FDA) may not be considered experimental or investigational and thus the drug, device or biological product may be assessed only on the basis of medical necessity. Medical Coverage Guidelines are subject to change as new information becomes available. For purposes of this Medical Coverage Guideline, the terms "experimental" and "investigational" are considered to be interchangeable. BLUE CROSS, BLUE SHIELD and the Cross and Shield Symbols are registered service marks of the Blue Cross and Blue Shield Association, an association of independent Blue Cross and Blue Shield Plans. All other trademarks and service marks contained in this guideline are the property of their respective owners, which are not affiliated with BCBSAZ. Description: Brachytherapy describes the delivery of radiation therapy via radioactive ribbons or seeds, radioactive stents, or radioactive filled catheter balloons. The radioactive source (gamma, beta or alpha radioisotopes) is implanted within, or close to, the targeted site, allowing a high dose of radiation with less exposure to normal cells. Implants may be intracavitary, interstitial or intraluminal and permanent or temporary. O750.6.docx Page 1 of 6

Description: (cont.) Intracavitary balloon brachytherapy for brain tumors is localized radiation therapy that involves placement of an inflatable balloon catheter in the surgical cavity to remove or debulk a malignant brain mass. The balloon catheter is placed in the surgical cavity before closing the craniotomy of a resection. A radiation source is then placed in the balloon to expose surrounding brain tissue to radiation, either continuously or in a series of brief treatments. After the individual completes therapy, the radiation source is permanently removed and the balloon catheter is surgically removed. Electronic brachytherapy uses a miniature X-ray tube rather than radioactive material to deliver intracavitary radiation. It can be used with balloon and interstitial brachytherapy and with intraoperative brachytherapy. Intrabeam Photon Radiosurgery Device is an electronic brachytherapy device that is used for intraoperative radiotherapy. Criteria: For breast cancer, see BCBSAZ Medical Coverage Guideline #O830, Brachytherapy for Treatment of Breast Cancer. For endobronchial brachytherapy, see BCBSAZ Medical Coverage Guideline #O698, Endobronchial Brachytherapy. For brachytherapy for prostate cancer, see BCBSAZ Medical Coverage Guideline #O773, Brachytherapy for Clinically Localized Prostate Cancer Using Permanently Implanted Seeds. For high-dose brachytherapy for prostate cancer, see BCBSAZ Medical Coverage Guideline #O774 High-Dose Rate Temporary Prostate Brachytherapy. For brachytherapy for miscellaneous cancers, see BCBSAZ Medical Coverage Guideline #O231 Brachytherapy for Treatment of Miscellaneous Cancers. O750.6.docx Page 2 of 6

Criteria: (cont.) Intracavitary balloon catheter brachytherapy alone or as part of a multimodality treatment regimen for the following indications is considered experimental or investigational based upon: 1. Insufficient scientific evidence to permit conclusions concerning the effect on health outcomes, and 2. Insufficient evidence to support improvement of the net health outcome, and 3. Insufficient evidence to support improvement of the net health outcome as much as, or more than, established alternatives, and 4. Insufficient evidence to support improvement outside the investigational settings. These indications include, but are not limited to: Primary or recurrent malignant brain tumors Metastasis to the brain from primary solid tumors outside the brain Electronic brachytherapy for the treatment of brain cancer is considered experimental or investigational based upon: 1. Insufficient scientific evidence to permit conclusions concerning the effect on health outcomes, and 2. Insufficient evidence to support improvement of the net health outcome, and 3. Insufficient evidence to support improvement of the net health outcome as much as, or more than, established alternatives, and 4. Insufficient evidence to support improvement outside the investigational settings. Resources: Resources prior to 05/22/13 may be requested from the BCBSAZ Medical Policy and Technology Research Department. Literature reviewed 08/21/18. We do not include marketing materials, poster boards and nonpublished literature in our review. The BCBS Association Medical Policy Reference Manual (MPRM) policy is included in our guideline review. References cited in the MPRM policy are not duplicated on this guideline. 1. 8.01.45 BCBS Association Medical Policy Reference Manual. Intracavitary Balloon Catheter Brain Brachytherapy for Malignant Gliomas or Metastasis to the Brain. Re-issue date 07/12/2018, issue date 02/15/2007. O750.6.docx Page 3 of 6

Resources: (cont.) 2. Barani IJ, Larson DA. Radiation therapy of glioblastoma. Cancer Treat Res. 2015;163:49-73. 3. El Majdoub F, Rezk E, Hunsche S, Buhrle C, Sturm V, Maarouf M. Intracranial ganglioglioma WHO I: results in a series of eight patients treated with stereotactic interstitial brachytherapy. J Neurooncol. Jun 2014;118(2):345-350. 4. Kickingereder P, Hamisch C, Suchorska B, et al. Low-dose rate stereotactic iodine-125 brachytherapy for the treatment of inoperable primary and recurrent glioblastoma: single-center experience with 201 cases. J Neurooncol. Dec 2014;120(3):615-623. 5. UpToDate. Adjuvant radiation therapy for high-grade gliomas. 09/26/2014. 6. UpToDate. Management of recurrent high-grade gliomas. 02/23/2015. 7. UpToDate. Treatment of brain metastases in favorable prognosis patients. 03/13/2015. O750.6.docx Page 4 of 6

Non-Discrimination Statement: Blue Cross Blue Shield of Arizona (BCBSAZ) complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability or sex. BCBSAZ provides appropriate free aids and services, such as qualified interpreters and written information in other formats, to people with disabilities to communicate effectively with us. BCBSAZ also provides free language services to people whose primary language is not English, such as qualified interpreters and information written in other languages. If you need these services, call (602) 864-4884 for Spanish and (877) 475-4799 for all other languages and other aids and services. If you believe that BCBSAZ has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability or sex, you can file a grievance with: BCBSAZ s Civil Rights Coordinator, Attn: Civil Rights Coordinator, Blue Cross Blue Shield of Arizona, P.O. Box 13466, Phoenix, AZ 85002-3466, (602) 864-2288, TTY/TDD (602) 864-4823, crc@azblue.com. You can file a grievance in person or by mail or email. If you need help filing a grievance BCBSAZ s Civil Rights Coordinator is available to help you. You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at https://ocrportal.hhs.gov/ocr/portal/lobby.jsf, or by mail or phone at: U.S. Department of Health and Human Services, 200 Independence Avenue SW., Room 509F, HHH Building, Washington, DC 20201, 1 800 368 1019, 800 537 7697 (TDD). Complaint forms are available at http://www.hhs.gov/ocr/office/file/index.html Multi-Language Interpreter Services: O750.6.docx Page 5 of 6

Multi-Language Interpreter Services: (cont.) O750.6.docx Page 6 of 6