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:
Tumor tissue is sampled and tumor cells are isolated
Tumor cells are incubated with various drugs
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.
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
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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