In vitro chemoresistance and chemosensitivity assays have been proposed as a means to provide information about the characteristics of an individual’s malignancy; such as predicting responsiveness of their cancer to specific drugs.
Although a variety of assays exist to examine chemosensitivity or chemoresistance, most are laboratory developed tests and a few are commercially available (e.g. Oncotech Extreme Drug Resistance (EDR) assay, ChemoFX® assay, BluePrint® 80-Gene Subtyping Assay). All the assays involve the same four basic steps:
Tumor tissue is sampled and tumor cells are isolated
Tumor cells are incubated with and without a chemotherapy drug
Cell death or survival is assessed
Tumor response to the drug is then classified as sensitive, resistant or intermediate.
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.
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.
The evidence is insufficient to determine the effects of the technology on health outcomes. The use of chemotherapy sensitivity and resistance assays to select chemotherapeutic agents for individuals is not recommended outside of the clinical trial setting.
American Society of Clinical Oncology. (2011). Clinical practice guideline update on the use of chemotherapy sensitivity and resistance assays. Journal of Clinical Oncology, 29 (24), 3328-3330.
American Society of Clinical Oncology. (October, 2014). Chemotherapy and targeted therapy for women with human epidermal growth factor receptor 2-negative (or unknown) advanced breast cancer: American Society of Clinical Oncology clinical practice guideline. Retrieved March 18, 2016 from the National Guideline Clearinghouse (NGC: 10558).
BlueCross BlueShield Association. Medical Policy Reference Manual. (9:2017). In vitro chemoresistance and chemosensitivity assays (2.03.01). Retrieved February 15, 2018 from BlueWeb. (57 articles and/or guidelines reviewed)
Jenks, S. (2012). Chemosensitivity assays: still eyeing the clinic. Journal of the National Cancer Institute, 104 (23), 1775-1777. (Level 5 evidence)
Kim, J., Kim, S., Cho, D., Ha, Y., Choi, E., Kim, C., et al. (2011). Novel chemosensitive single-nucleotide polymorphism markers to targeted regimens in metastatic colorectal cancer. Clinical Cancer Research. 17 (5); 1200-1209. (Level 3 evidence)
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)
Li, S., Zeng, A., Hu, Q., Yan, W., Liu, Y., & You, Y. (2017). MiR-423-5p contributes to a malignant phenotype and temozolomide chemoresistance in glioblastomas. Neuro Oncology, 19 (1), 55-65. Abstract retrieved February 16, 2017 from PubMed database.
National Comprehensive Cancer Network (2018, February) NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Ovarian cancer including fallopian tube cancer and primary peritoneal cancer. Retrieved February 15, 2018 from www.nccn.org.
Winifred S. Hayes, Inc. Genetic Technology Evaluation (GTE) Report (2014, December). BluePrint molecular subtyping profile for breast cancer. Retrieved December 14, 2015 from www.HayesInc.com/subscribers. (45 articles and/or guidelines reviewed)
Wisconsin Physician Services Corporation. (2017, December). Local Coverage Determination (LCD): Special histochemical stains and immunohistochemical stains (L36805). Retrieved February 15, 2018 from https://www.cms.gov.
ORIGINAL EFFECTIVE DATE: 3/1/2005
MOST RECENT REVIEW DATE: 3/8/2018
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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