WHA

XELODA (capecitabine)

Self-Administration – oral

 

Diagnosis considered for coverage:

 

  • Colorectal Cancer
    • Xeloda is indicated as a single agent for adjuvant treatment in patients with Dukes' C colon cancer who have undergone complete resection of the primary tumor when treatment with fluoropyrimidine therapy alone is preferred. Xeloda was non-inferior to 5-fluorouracil and leucovorin (5-FU/LV) for disease-free survival (DFS). Physicians should consider results of combination chemotherapy trials, which have shown improvement in DFS and OS, when prescribing single-agent Xeloda in the adjuvant treatment of Dukes' C colon cancer.
    • Xeloda is indicated as first-line treatment of patients with metastatic colorectal carcinoma when treatment with fluoropyrimidine therapy alone is preferred. Combination chemotherapy has shown a survival benefit compared to 5-FU/LV alone. A survival benefit over 5-FU/LV has not been demonstrated with Xeloda monotherapy. Use of Xeloda instead of 5-FU/LV in combinations has not been adequately studied to assure safety or preservation of the survival advantage.
  • Breast Cancer
    • Xeloda in combination with docetaxel is indicated for the treatment of patients with metastatic breast cancer after failure of prior anthracycline-containing chemotherapy.
    • Xeloda monotherapy is also indicated for the treatment of patients with metastatic breast cancer resistant to both paclitaxel and an anthracycline-containing chemotherapy regimen or resistant to paclitaxel and for whom further anthracycline therapy is not indicated (e.g., patients who have received cumulative doses of 400 mg/m2 of doxorubicin or doxorubicin equivalents). Resistance is defined as progressive disease while on treatment, with or without an initial response, or relapse within 6 months of completing treatment with an anthracycline-containing adjuvant regimen.

 

Coverage Criteria:

 

For diagnosis of colorectal cancer:

  • Dose does not exceed 1250 mg/m2 twice daily for 2 weeks followed by a 1-week rest period given as 3-week cycles, AND
  • Patient is 18 years of age or older, AND
  • Prescribed by or in consultation with an oncologist, AND
  • Chart note documentation provided confirms one of the following (A or B):
    • A. Diagnosis of metastatic colorectal cancer, or
    • B. Both of the following (I and II):
      • I. Diagnosis of Dukes’ C colon cancer, and
      • II. Patient has undergone complete resection of the primary tumor, AND
  • For Dukes’ C colon cancer: used for up to 8 cycles, AND
  • For brand Xeloda tablets only: Trial and failure, contraindication, or intolerance to generic Xeloda (capecitabine) tablet.

 

For diagnosis of breast cancer:

  • Dose does not exceed 1250 mg/m2 twice daily for 2 weeks followed by a 1-week rest period given as 3-week cycles, AND
  • Patient is 18 years of age or older, AND
  • Prescribed by or in consultation with an oncologist, AND
  • Chart note documentation provided confirms diagnosis of breast cancer, AND
  • For brand Xeloda tablets only: Trial and failure, contraindication, or intolerance to generic Xeloda (capecitabine) tablets. 

 

For diagnosis of metastatic gastric adenocarcinoma, esophageal adenocarcinoma or gastroesophageal junction (GEJ) cancer (off-label):

  • Dose does not exceed 1000 mg/m2 twice daily for 2 weeks followed by a 1-week rest period given as 3-week cycles, AND
  • Patient is 18 years of age or older, AND
  • Chart note documentation provided confirms diagnosis of advanced or metastatic gastric adenocarcinoma, esophageal adenocarcinoma or GEJ cancer, AND
  • Will be administered with oxaliplatin and nivolumab, AND
  • Used for up to 24 months in patients without disease progression, AND
  • For brand Xeloda tablets only: Trial and failure, contraindication, or intolerance to generic Xeloda (capecitabine) tablets.

 

For diagnosis of GEJ cancer (off-label):

  • Dose does not exceed 1000 mg/m2 twice daily for 2 weeks followed by a 1-week rest period given as 3-week cycles, AND
  • Patient is 18 years of age or older, AND
  • Chart note documentation provided confirms diagnosis of HER2-positive locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma, AND
  • Used as first-line treatment in combination with oxaliplatin, trastuzumab and pembrolizumab, AND
  • Used for up to 24 months in patients without disease progression, AND
  • For brand Xeloda tablets only: Trial and failure, contraindication, or intolerance to generic Xeloda (capecitabine) tablets.

 

For diagnosis of gastric cancer or GEJ adenocarcinoma (off-label):

  • Dose does not exceed:
    • GEJ ca:1000 mg/m2 twice daily for 2 weeks followed by a 1-week rest period given as 3-week cycles, AND
  • Patient is 18 years of age or older, AND
  • Member is previously untreated, AND
  • Chart note documentation provided confirms diagnosis of previously untreated metastatic gastric or GEJ adenocarcinoma, AND
  • Will be administered with cisplatin and trastuzumab, AND
  • Used for up to a maximum of 6 cycles, AND
  • For brand Xeloda tablets only: Trial and failure, contraindication, or intolerance to generic Xeloda (capecitabine) tablets.

 

For diagnosis of gastric cancer (off-label):

  • Dose does not exceed:
    • When used in combination with cisplatin: 1000 mg/m2 twice daily for 2 weeks followed by a 1-week rest period given as 3-week cycles
    • When used in combination with epirubicin and cisplatin or oxaliplatin: 625 mg/m2 twice daily on days 1 to 21 as part of 3-week cycles, AND
  • Patient is 18 years of age or older, AND
  • Chart note documentation provided confirms diagnosis advanced gastric cancer, AND
  • One of the following (A or B):
    • A) Will be used in combination with cisplatin, or
    • B) Will be used in combination with epirubicin and cisplatin or oxaliplatin and will be used for a maximum of 8 cycles, AND
  • For brand Xeloda tablets only: Trial and failure, contraindication, or intolerance to generic Xeloda (capecitabine) tablets.

 

For diagnosis of pancreatic cancer (off-label):

  • Dose does not exceed 1660 mg/m2 daily on days 1 to 21 followed by 1-week rest period given as 28-day cycles, AND
  • Patient is 18 years of age or older, AND
  • Chart note documentation provided confirms diagnosis of pancreatic cancer (ductal adenocarcinoma), AND
  • Will be administered with gemcitabine, AND
  • Used for a maximum of 6 cycles, AND
  • For brand Xeloda tablets only: Trial and failure, contraindication, or intolerance to generic Xeloda (capecitabine) tablets.

 

Reauthorization Criteria:

 

For diagnosis of:  metastatic colorectal carcinoma cancer, breast cancer, advanced or metastatic gastric/esophageal or GEJ cancer (off-label), HER2-positive locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma (off-label), OR advanced gastric cancer (off-label):

  • Dose does not exceed maximum doses as listed above, AND
  • Patient does not show evidence of progressive disease while on therapy. 

 

Coverage Duration: 

 

  • Initial: 
    • Dukes' C colon cancer: 6 months (8 cycles)
    • Metastatic colorectal carcinoma or breast cancer: 1 year
    • Advanced or metastatic gastric adenocarcinoma, esophageal adenocarcinoma or GEJ cancer used in combination with oxaliplatin and nivolumab (off-label): 1 year
    • First line treatment of HER2-positive locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma used in combination with oxaliplatin, trastuzumab and pembrolizumab (off-label): 1 year
    • Previously untreated metastatic gastric or GEJ adenocarcinoma used in combination with cisplatin and trastuzumab (off-label): 5 months (6 cycles)
    • Advanced gastric cancer used in combination with cisplatin (off-label): 1 year
    • Advanced gastric cancer used in combination with epirubicin and cisplatin or oxaliplatin (off-label): 6 months (8 cycles)
    • Pancreatic cancer used in combination with gemcitabine (off-label): 6 months (6 cycles)

 

  • Reauthorization: 
    • Metastatic colorectal carcinoma or breast cancer: 1 year
    • Advanced or Metastatic gastric adenocarcinoma, esophageal adenocarcinoma or GEJ cancer in combination with oxaliplatin and nivolumab (off-label): 1 year
    • First line treatment of HER2-positive locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma used in combination with oxaliplatin, trastuzumab and pembrolizumab (off-label): 1 year
    • Advanced gastric cancer used in combination with cisplatin (off-label): 1 year

 

Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

 

Additional Information: 
  • Dukes' staging is a pathological staging system based on resection of the tumor and measures the depth of invasion through the mucosa and bowel wall.  Dukes’ C Stage describes locally advanced disease (Stage III) with regional lymph node metastasis.
  • Xeloda (capecitabine) is contraindicated in patients with severe renal impairment (creatinine clearance below 30 mL/min [Cockroft and Gault]).
  • Xeloda (capecitabine) is contraindicated in patients with known hypersensitivity to capecitabine or to any of its components.  Xeloda is contraindicated in patients who have a known hypersensitivity to 5-fluorouracil.
  • Adjuvant treatment in patients with Dukes' C colon cancer is recommended for a total of 6 months [ie, Xeloda 1250 mg/m2 orally twice daily for 2 weeks followed by a 1-week rest period, given as 3-week cycles for a total of 8 cycles (24 weeks)].

 

Policy Updates:
  • 08/16/2022 – New policy approved by P&T.

 

References:

 

  1. Xeloda prescribing information. Genentech, Inc. South San Francisco, CA. June 2021. 
  2. National Comprehensive Cancer Network Drugs and Biologics Compendium. Available at www.nccn.org. Accessed July 2022.
  3. Clinical Pharmacology. Available at https://www.clinicalpharmacology-ip.com/. Accessed July 2022.

Last review date: August 16, 2022