Description
Breast conserving surgery and adjuvant radiotherapy is commonly used to treat early-stage breast cancer. A marker may be placed in the tumor bed during the surgery to mark the area for follow-up with subsequent clinical imaging and/or postoperative radiation.

To date, the standard method to mark a tumor bed and define the region targeted for radiation treatment is with individual surgical clips. Studies have shown the effectiveness of surgical clips in localizing the target volume for radiation purposes, with minimal clip movement and ease of identification on various imaging modalities. Other means of identifying a tumor bed postoperatively include use of the surgical scar site or the presence of post-surgical tissue changes or seroma. However, none of these methods produces a standardized target that is reliable during the postoperative period of tissue healing and associated changes to the breast.

A newer technique is BioZorb^®, an implantable, three-dimensional (3D), spiral-shaped bioabsorbable tissue marker that contains titanium clips, and is inserted and sutured in the surgical cavity after a lumpectomy.

Biozorb^® Tissue Marker has received 510(k) clearance from the FDA.

***Note: This Medical Policy is complex and technical. For questions concerning the technical language and/or specific clinical indications for its use, please consult your physician.

Policy 
BioZorb^® three-dimensional (3D) bioabsorbable tissue marker is investigational and/or unproven and therefore considered NOT MEDICALLY NECESSARY for all applications.

Rationale 
The published evidence consists of a review article, cost-effectiveness analysis of surgical clips versus BioZorb and radiation planning studies.

Rashad and colleagues conducted a comprehensive literature review to compare the traditional placement of surgical clips and the BioZorb marker in the surgical tumor bed in the context of oncoplastic breast surgery. They identified five studies that met their literature inclusion criteria, pooling a total of 359 patients. Clinical outcomes reported included effectiveness in marking the tumor bed and postoperative pain and infection. The authors concluded that there was little clinical data noting any advantage favoring BioZorb over the standard practice of surgical clip placement and that, in the absence of comparative data showing clinical benefit of BioZorb, traditional surgical clips provide a more cost-effective technique.

Weins and colleagues evaluated the effect of BioZorb on radiation boost clinical and planning target volumes (CTV and PTV, respectively), and radiation dose to adjacent organs in early stage breast cancer treated by partial mastectomy. The authors conducted a retrospective cohort study of BioZorb versus no BioZorb placement in 143 patients stratified by age, tumor laterality and cancer stage. The BioZorb arm showed statistically significant reductions in CTV and PTV but not ipsilateral lung or heart radiation. There was a statistically significant increase in the amount of radiation to the ipsilateral lung in the BioZorb arm. The long-term impact of these findings on clinical outcomes is unknown.

Cross and colleagues evaluated the impact of BioZorb on radiation planning in 108 patients undergoing breast conserving surgery. The outcomes measured included post-operative infection rate, impact on ability to perform surgical re-excision and utility for radiation boost planning. No post-operative infections occurred and no impact on surgical margin re-excision was noted. The authors concluded that the marker was easily visible and proved “useful” for radiation planning.

In summary, no prospective, comparative studies of BioZorb versus standard methods of marking a tumor bed were identified nor were studies reporting long-term clinical outcomes such as local tumor recurrence or radiation effects on adjacent organs using BioZorb versus conventional surgical site markers. The evidence is insufficient to determine the effects of BioZorb on health outcomes.

References  

1. Cross MJ, Lebovic GS, Ross J, et al. Impact of a Novel Bioabsorbable Implant on Radiation Treatment Planning for Breast Cancer. World J Surg. 2017 Feb;41(2):464-471.
2. Foster B, Sindhu K, Hepel J, et al. Three-Dimensional Bioabsorbable Tissue Marker Placement is Associated with Decreased Tumor Bed Volume Among Patients Receiving Radiation Therapy for Breast Cancer. Pract Radiat Oncol. 2019 Mar;9(2):e134-e141.
3. Rashad R, Huber K, Chatterjee A. (2018). Cost-Effectiveness of the BioZorb Device for Radiation Planning in Oncoplastic Surgery. 7. 23. 10.5539/cco.v7n2p23.
4. Wiens N, Torp L, Wolff B, et al. Effect of BioZorb® surgical marker placement on post-operative radiation boost target volume. J Radiat Oncol. 2018;7(2):175-179.
5. U.S. Food and Drug Administration (FDA). Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf14/K143484.pdf
6. Medical Director review 6/2019

Coding Codes 

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all inclusive.

This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community, Blue Cross Blue Shield Association technology assessment program (TEC) and other nonaffiliated technology evaluation centers, reference to federal regulations, other plan medical policies and accredited national guidelines.

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