Xeloda - NC Standard

Restricted Product(s)

Restriction applies to brand and generic products

• Xeloda® (capecitabine)

FDA Approved Use

• Colorectal Cancer 
  • For the adjuvant treatment of patients with Stage III colon cancer as a single agent or as a component of a combination chemotherapy regimen. 
  • For the perioperative treatment of adults with locally advanced rectal cancer as a component of chemoradiotherapy. 
  • For the treatment of patients with unresectable or metastatic colorectal cancer as a single agent or as a component of a combination chemotherapy regimen. 
• Breast Cancer 
  • For the treatment of patients with advanced or metastatic breast cancer as a single agent if an anthracycline- or taxane-containing chemotherapy is not indicated.
  • For the treatment of patients with advanced or metastatic breast cancer in combination with docetaxel after disease progression on prior anthracycline-containing chemotherapy. 
  • For the treatment of adult patients with advanced unresectable or metastatic HER2-positive breast cancer in combination with trastuzumab and tucatinib, including patients with brain metastases, who have received one or more prior anti-HER2-based regimens in the metastatic setting. 
• Gastric, Esophageal, or Gastroesophageal Junction Cancer 
  • For the treatment of adults with unresectable or metastatic gastric, esophageal, or gastroesophageal junction cancer as a component of a combination chemotherapy regimen. 
  • For the treatment of adults with HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma who have not received prior treatment for metastatic disease as a component of a combination regimen. 
• Pancreatic Cancer 
  • For adjuvant treatment of adults with pancreatic adenocarcinoma as a component of a combination chemotherapy regimen. 

Criteria for Approval of Restricted Product(s)

1. The patient is currently taking the requested medication for a cancer diagnosis; AND 
   1. The patient will utilize the generic formulation of this product (if available); OR 
2. The patient is 18 years of age or older; AND 
3. Dose requested is according to FDA approved labeling; AND 
4. The patient is being managed by or in consultation with an oncologist; AND 
5. If the request is for brand Xeloda, a. The patient has tried and failed, is intolerant to, or has a clinical contraindication to generic capecitabine (medical record documentation required); AND 
6. ONE of the following: 
   1. The patient has been diagnosed with COLORECTAL CANCER (medical record documentation required); AND 
      1. Xeloda will be used as adjuvant treatment for Stage III colon cancer as a single agent or as a component of a combination chemotherapy regimen; OR 
      2. Xeloda will be used for the perioperative treatment of locally advanced rectal cancer as a component of chemoradiotherapy; OR 
      3. Xeloda will be used for unresectable or metastatic colorectal cancer as a single agent or as a component of a combination chemotherapy regimen; OR 
   2. The patient has been diagnosed with advanced or metastatic BREAST CANCER (medical record documentation required); AND 
      1. Xeloda will be used as monotherapy if an anthracycline- or taxane-containing chemotherapy is not indicated; OR 
      2. Xeloda will be used in combination with docetaxel after disease progression on prior anthracycline-containing chemotherapy; OR 
      3. Xeloda will be used in combination with trastuzumab and tucatinib for the treatment of advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received one or more prior anti-HER2- based regimens in the metastatic setting; OR 
   3. The patient has been diagnosed with GASTRIC, ESOPHAGEAL, or GASTROESOPHAGEAL JUNCTION CANCER (medical record documentation required; AND 
      1. Xeloda will be used as a component of a combination chemotherapy regimen in unresectable or metastatic gastric, esophageal, or gastroesophageal junction cancer; OR 
      2. Xeloda will be used as a component of a combination regimen for the treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma who have not received prior treatment; OR
   4. The patient has been diagnosed with PANCREATIC CANCER (medical record documentation required); AND 
      1. Xeloda will be used as adjuvant treatment in a combination chemotherapy regimen; AND 
7. Indications outside of FDA labeling will be subject to medical necessity review in accordance with specific strong endorsement or support by nationally recognized compendia, when such recommendation is based on strong/high levels of evidence, and/or uniform consensus of clinical appropriateness has been reached. Medical records and references / evidence must be provided; AND 
8. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies.
   
   Duration of Approval: 365 days (1 year)

References

All information referenced is from FDA package insert unless otherwise noted below.

Policy Implementation/Update Information

Criteria and treatment protocols are reviewed annually by the Blue Cross NC P&T Committee, regardless of change. This policy is reviewed in Q3 annually.

September 2023: Criteria change: Added expanded FDA approved indication shared within Tukysa (tucatinib) label for breast cancer.
December 2022: Criteria change: Added expanded FDA approved indications.
July 2022: Criteria change: Require usage of generic medication unless patient has tried and failed, is intolerant to, or has a clinical contraindication to generic medication. Added medical record documentation required for diagnosis.
July 2020: Criteria update: Allow for approval if currently taking for a cancer diagnosis and utilizing the generic (if available).
November 2019: Criteria update: Reformatted criteria.
October 2018: Annual review; No change.
January 2017: Original utilization management criteria issued.