Medical Policy

Effective Date:01/01/2012 Title:Xeloda (Capecitabine)
Revision Date:06/01/2018 Document:BI340:00
CPT Code(s):None
Public Statement

Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

1)    Xeloda (Capecitabine) requires prior authorization.

2)    Xeloda is considered a specialty medication and must be obtained through the designated specialty pharmacy. Only the generic product is covered.

3)    Xeloda is used to treat breast cancer and colorectal cancer.

Medical Statement

Xeloda is considered medically necessary for members who meet the following criteria:

a)    Diagnosis of metastatic colorectal cancer, OR

b)    Diagnosis of Dukes’ C colon cancer and has undergone a complete resection of the primary tumor, OR

c)    Diagnosis of metastatic breast cancer and Capecitabine is being used:

1)    In combination with docetaxel after failure of prior anthracycline-containing therapy, OR

2)    As adjuvant therapy for patients who have triple-negative breast cancer and are found (after surgery) to have residual invasive cancer despite standard neoadjuvant treatment with taxane, alkylator and anthracycline-based chemotherapy, OR

3)    As monotherapy in patients resistant to both paclitaxel and an anthracycline-containing regiment (or for whom further anthracycline therapy is not indicated)

d) Patient’s creatinine clearance is greater than or equal to 30mL/minute, AND

e)  Patient does not have a known deficiency of dihydropyrimidine dehydrogenase (DPD).
Intentially left empty


1)    Xeloda Product Information. 

2)    Clinical Pharmacology Online. “Capecitabine”, retrieved November 2011.

3)    NCCN Drugs & Biologic Compendium.  Accessed online September 2014.

Application to Products
This policy applies to all health plans administered by QualChoice, both those insured by QualChoice and those that are self-funded by the sponsoring employer, unless there is indication in this policy otherwise or a stated exclusion in your medical plan booklet. Consult the individual plan sponsor Summary Plan Description (SPD) for self-insured plans or the specific Evidence of Coverage (EOC) for those plans insured by QualChoice. In the event of a discrepancy between this policy and a self-insured customer’s SPD or the specific QualChoice EOC, the SPD or EOC, as applicable, will prevail. State and federal mandates will be followed as they apply.

Changes: QualChoice reserves the right to alter, amend, change or supplement benefit interpretations as needed.