DESCRIPTION
In vitro chemosensitivity and chemoresistance assays are being offered as a means of predicting tumor response to various chemotherapies. The results of the assays may then be used for guiding choices of chemotherapy regimens. A variety of assays have been developed that differ in their processing and in the technique used to measure the sensitivity or resistance. However, all the assays involve the same 4 basic steps. The steps are: 1) the tumor is sampled and tumor cells are isolated; 2) the tumor cells are incubated with and without a chemotherapy drug; 3) cell death or survival is assessed; and 4) the tumor's response to the drug is then classified as sensitive, resistant or intermediate. If the tumor is identified as drug sensitive, the drug is thought to be potentially effective in vivo chemotherapy. If the tumor is identified as drug resistant, the drug is thought to be potentially ineffective in vivo chemotherapies. Chemoresistance assays are most commonly used.
A variety of assays are available. Examples of these assays include the: differential staining cytotoxicity (DiSC) assay, thymidine incorporation assay, fluorescent cytoprint assay, extreme drug resistance (EDR) assay, histoculture drug response assay, capillary cloning system (CCS) assay, adenosine triphosphate (ATP) assay and the methyl-thiazolyl-diphenyl-tetrazolium bromide (MTT) assay
POLICY
In vitro chemosensitivity assays performed as a means of predicting tumor response to chemotherapy is considered investigational.
In vitro chemoresistance assays performed as a means of predicting tumor response to chemotherapy is considered investigational.
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
A search of peer-reviewed literature did not provide data to demonstrate that there is improved survival among individuals in whom chemosensitivity assays is used to guide the selection of chemotherapy regimens. Likewise, a literature search did not provide published data that clinical trials have been done to demonstrate that there is improved survival among individuals in whom chemoresistance assays were used to exclude chemotherapy regimens. Conclusions concerning the effect of this technology on health outcomes cannot be made, and it is not known if the technology improves health outcomes.
SOURCES
BlueCross BlueShield Association. Medical Policy Reference Manual. (4:2011). In vitro chemoresistance and chemosensitivity assays (2.03.01). Retrieved November 14, 2011 from BlueWeb. ( 36 articles and/or guidelines reviewed)
Burstein, H., Mangu, P., Somerfield, M., Schrag, D., Samson, D., Holt, L. et al. (2011). American Society of Clinical Oncology clinical practice guideline update on the use of chemotherapy sensitivity and resistance assays. Journal of Clinical Oncology, 29 (24), 3328- 3330.
Complete Guide to Medicare Coverage Issues [Computer software]. (2011, November). Human tumor stem cell drug sensitivity assays (NCD 190.7, p. 2-92). The Ingenix.
Kim, J., Lee, K., Kim, Y., Lee, K., Oh, D., Kim, J., et al. (2010). Individualized tumor response testing for prediction of response to Paclitaxel and Cisplatin chemotherapy in patients with advanced gastric cancer. Journal of Korean Medical Science, 25 (5), 684-690. (Level 4 Evidence - Independent study)
National Comprehensive Cancer Network. (2011, November). Clinical practice guidelines in oncology. Ovarian cancer (V.1.2012).Retrieved November 14, 2011 from http://www.nccn.org/professionals/physician_gls/pdf/ovarian.pdf.
Technology Evaluation Center. (2002, October). Chemotherapy sensitivity and resistance assays. (Vol. 17, No.12). Chicago: BlueCross BlueShield Association. (37 articles and/or guidelines reviewed)
ORIGINAL EFFECTIVE DATE: 3/1/2005
MOST RECENT REVIEW DATE: 1/12/2012
ID_BA
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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