BlueCross BlueShield of Tennessee Medical Policy Manual

In Vitro Chemosensitivity and Chemoresistance Assays

DESCRIPTION

In vitro chemosensitivity and chemoresistance assays have been proposed as a method to provide information about the characteristics of an individual’s malignancy to predict potential responsiveness of their cancer to specific drugs.

A variety of chemoresistance and chemosensitivity assays have been clinically evaluated. All assays use characteristics of cell physiology to distinguish between viable and nonviable cells to quantify cell kill following exposure to a drug of interest. With few exceptions, drug doses used in the assays vary highly depending on tumor type and drug class. Although a variety of assays exist to examine chemosensitivity or chemoresistance, only 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:

POLICY

IMPORTANT REMINDERS

ADDITIONAL INFORMATION  

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.

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.

BlueCross BlueShield Association. Evidence Positioning System. (7:2018). In vitro chemoresistance and chemosensitivity assays (2.03.01). Retrieved December 7, 2018 from https://www.evidencepositioningsystem.com/. (57 articles and/or guidelines reviewed)

CMS.gov. Centers for Medicare & Medicaid Services. Palmetto GBA. (2018, February). Special histochemical stains and immunohistochemical stains. (LCD ID L35922). Retrieved December 7, 2018 from https://www.cms.gov.

Krivak, T.C., Lele, S., Richard, S., Secord, A.A., Leath, C.A., Brower, S.L., et al. (2014). A chemoresponse assay for prediction of platinum resistance in primary ovarian cancer. American Journal of Obstetrics and Gynecology, 211 (1), 68. e1-8. Abstract retrieved December 7, 2018 from PubMed database.

National Comprehensive Cancer Network. (2018, March). NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). Ovarian cancer including fallopian tube cancer and primary peritoneal cancer, v. 2.2018. Retrieved February 15, 2018 from the National Comprehensive Cancer Network.

Rutherford, T., Orr, J., Grendys, E., Edwards, R., Krivak, T.C., Holloway, R., et al. (2013). A prospective study evaluating the clinical relevance of a chemoresponse assay for treatment of patients with persistent or recurrent ovarian cancer. Gynecological Oncology, 131 (2), 362-367. Abstract retrieved December 7, 2018 from PubMed database.

ORIGINAL EFFECTIVE DATE:  3/1/2005

MOST RECENT REVIEW DATE:  1/10/2019  

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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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