BlueCross BlueShield of Tennessee Medical Policy Manual

In Vitro Chemosensitivity and Chemoresistance Assays

DESCRIPTION

Although a variety of assays exist to examine chemosensitivity or chemoresistance, only a few are commercially available (i.e. Oncotech EDR assay, ChemoFX® assay, BluePrint® 80-Gene Subtyping Assay). 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.

Although a variety of assays exist to examine chemosensitivity or chemoresistance, only a few are commercially available (i.e. Oncotech EDR assay, ChemoFX® assay, BluePrint® 80-Gene Subtyping Assay). 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.

POLICY

IMPORTANT REMINDERS

ADDITIONAL INFORMATION

The use of chemotherapy sensitivity and resistance assays to select chemotherapeutic agents for individuals is not recommended outside of the clinical trial setting. Oncologists should make recommendations for chemotherapy treatment recommendations on the basis of published clinical evidence and clinical trials plus an individual’s health status and treatment preferences.

SOURCES

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. (7:2016). In vitro chemoresistance and chemosensitivity assays (2.03.01). Retrieved February 16, 2017 from BlueWeb. (53 articles and/or guidelines reviewed)

Centers for Medicare & Medicaid Services. CMS.gov. NCD for human tumor stem cell drug sensitivity assays (190.7). Retrieved February 16, 2017 from https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?ncdid=253&ve.

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.

Paiva, B., Corchete, L., Vidriales, M., Puig, N., Maiso, P., Rodriguez, I., et al. (2016). Phenotypic and genomic analysis of multiple myeloma minimal residual disease tumor cells: a new model to understand chemoresistance. Blood, 127 (4), 1896-1906. Abstract retrieved February 16, 2017 from PubMed database.

Qian, L., Zhang, W., Lei, B., He, A., Ye, L., Li, X., et al. (2016). MicroRNA-101 regulates T-cell acute lymphoblastic leukemia progression and chemotherapeutic sensitivity by targeting Notch1. Oncology Reports, 36 (5), 2511-2516. Abstract retrieved February 16, 2017 from PubMed database.

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)

ORIGINAL EFFECTIVE DATE:  3/1/2005

MOST RECENT REVIEW DATE:  4/13/2017   

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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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