BlueCross BlueShield of Tennessee Medical Policy Manual

Capecitabine

NDC CODE(S)

Xeloda 150 mg tablets - 00004-1100-xx (Roche Pharmaceuticals)

 

Xeloda 500 mg tablets - 00004-1101-xx (Roche Pharmaceuticals)

 

Generics available from various manufacturers

DESCRIPTION

Capecitabine, a fluoropyrimidine carbamate, is an oral prodrug that is enzymatically converted to the active antineoplastic drug 5-fluoruracil (5-FU) in the body.  5-FU is metabolized by normal and tumor cells into metabolites that cause cell injury by both inhibiting cell division through interference with the formation of precursors of DNA synthesis and causing a metabolic error in RNA synthesis, interfering in RNA processing and protein synthesis.

REFER TO DECISION SUPPORT TREE

POLICY

RENEWAL CRITERIA

INDICATION(S) DOSAGE & ADMINISTRATION
Breast Cancer 1,250 mg/m2 PO twice daily for 14 days, every 21 days
Central Nervous System Cancers 1,000 mg/m2 PO twice daily for 14 days, every 21 days
Colorectal Cancer 1,250 mg/m2 PO twice daily for 14 days, every 21 days
Esophageal and Esophagogastric Junction Cancers 1,000 mg/m2 PO twice daily for 14 days, every 21 days
Gastric Cancer 1,000 mg/m2 PO twice daily for 14 days, every 21 days
Head and Neck Cancers 1,250 mg/m2 PO twice daily for 14 days, every 21 days
Hepatobiliary Cancers 650-1,250 mg/m2 PO twice daily for 14 days, every 21 days
Neuroendocrine Tumors of the Pancreas (Islet Cell Tumors) 750 mg/m2 PO twice daily for 14 days, every 28 days
Occult Primary Cancers 850 - 1,000 mg/m2 PO twice daily for 14 days, every 21 days
Ovarian Cancer 1,000 mg/m2 PO twice daily for 14 days, every 21 days
Pancreatic Adenocarcinoma 650-1,000 mg/m2 PO twice daily for 14 days, every 21 days

APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS

BlueCross BlueShield of Tennessee’s Medical Policy complies with Tennessee Code Annotated Section 56-7-2352 regarding coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is recognized in one of the statutorily recognized standard reference compendia or in the published peer-reviewed medical literature.

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 

For appropriate chemotherapy regimens, dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) published by the National Comprehensive Cancer Network®, Drugdex Evaluations of Micromedex Solutions at Truven Health, or The American Hospital Formulary Service Drug Information).

No controlled studies were found in the published literature that validate the use of capecitabine for the treatment of other conditions or diseases.

SOURCES

Lexicomp Online. (2016). AHFS DI. Capecitabine. Retrieved August 26, 2016 from Lexicomp Online with AHFS.

MICROMEDEX Healthcare Series. Drugdex Evaluations. (2016, August). Capecitabine. Retrieved August 26, 2016 from MICROMEDEX Healthcare Series.

National Comprehensive Cancer Network. (2016). NCCN Drugs & Biologics Compendium®. Capecitabine. Retrieved August 26, 2016 from the National Comprehensive Cancer Network.

U. S. Food and Drug Administration. (2015, March). Center for Drug Evaluation and Research. Xeloda® (capecitabine)tablets, for oral use. Retrieved August 26, 2016 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020896s037lbl.pdf.

ORIGINAL EFFECTIVE DATE:  12/1/2016

MOST RECENT REVIEW DATE:  2/27/2018

ID_MRx

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.

Pharmaceutical Decision Support Tree

Capecitabine (Xeloda®)

  1. Is this the initial request for capecitabine for this individual?

If yes, go to question #2

If no, go to question #4

  1. Does the individual have a diagnosis of ANY ONE of the following?

If yes, go to question #3

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Was the request for a 6 month supply based on the following dosage chart and billing unit (1 billing unit = 150 mg tablet or 500 mg tablet)?

INDICATION(S) DOSAGE & ADMINISTRATION
Breast Cancer 1,250 mg/m2 PO twice daily for 14 days, every 21 days
Central Nervous System Cancers 1,000 mg/m2 PO twice daily for 14 days, every 21 days
Colorectal Cancer 1,250 mg/m2 PO twice daily for 14 days, every 21 days
Esophageal and Esophagogastric Junction Cancers 1,000 mg/m2 PO twice daily for 14 days, every 21 days
Gastric Cancer 1,000 mg/m2 PO twice daily for 14 days, every 21 days
Head and Neck Cancers 1,250 mg/m2 PO twice daily for 14 days, every 21 days
Hepatobiliary Cancers 650-1,250 mg/m2 PO twice daily for 14 days, every 21 days
Neuroendocrine Tumors of the Pancreas (Islet Cell Tumors) 750 mg/m2 PO twice daily for 14 days, every 28 days
Occult Primary Cancers 850 - 1,000 mg/m2 PO twice daily for 14 days, every 21 days
Ovarian Cancer 1,000 mg/m2 PO twice daily for 14 days, every 21 days
Pancreatic Adenocarcinoma 650-1,000 mg/m2 PO twice daily for 14 days, every 21 days

 

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Does the individual show evidence of tumor response with stabilization of disease or decrease in size of tumor or tumor size?

If yes, go to question #5

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Was there absence of unacceptable toxicity from the agent, e.g., severe coagulopathy and hematologic effects (neutrophil counts <1.5 x 109/L or thrombocyte counts <100 x 109/L), hyperbilirubinemia (grade 2 or 4), hand-and-foot syndrome?

If yes, go to question #6

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is the request for a 6 month supply as indicated in the dosage chart in #3?

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, this does not meet medical necessity and/or medical appropriateness criteria

This document has been classified as public information.