CurrentCignaPolicy N/A

Oncology -Capecitabine Prior Authorization

Cigna prior authorization policy for capecitabine (Xeloda® and generics) for outpatient prescription benefit coverage, listing FDA-approved indications and other uses with supportive evidence and approval durations/age criteria. Applies to Cigna-administered health benefit plans unless a client's plan document or delegated vendor guidance dictates otherwise.

Policy Summary

PayerCigna

PolicyOncology -Capecitabine Prior Authorization

Policy CodePolicy N/A

Change TypeAnnual revisions (non-material)

Effective Date

Next Review Date

Key ActionPrior Authorization is recommended/required for prescription benefit coverage of capecitabine; approvals are provided for 1 year when criteria are met.

SourceLink

POLICY UPDATE CHANGES

Biliary Tract Cancer condition of approval was changed from 'hepatobiliary cancer' to 'biliary tract cancer'.

Cervical, Endometrial, Vaginal, and Vulvar Cancers were added to Other Uses With Supportive Evidence in prior revisions.

5FDA-Approved Indications

18Other Uses with Supportive Evidence

1yrTypical Approval Duration

Coverage Summary & Criteria

Coverage Criteria - FDA-Approved Indications

Approve for 1 year if the patient is ≥ 18 years of age.

ALL of the following

Any FDA-approved indication
- Breast Cancer - treatment of advanced or metastatic disease (including in combination with docetaxel after progression on anthracycline-containing chemotherapy, or as single agent if anthracycline- or taxane-containing chemotherapy is not indicated)
- Colon Cancer - adjuvant treatment of Stage III colon cancer as single agent or component of combination chemotherapy; treatment of unresectable or metastatic colorectal cancer
- Esophageal and Esophagogastric Junction Cancers - treatment of adults
- Gastric Cancer - treatment of adults with unresectable or metastatic disease; HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma in patients not previously treated for metastatic disease as component of combination regimen
- Pancreatic Adenocarcinoma - adjuvant treatment as component of combination chemotherapy regimen
Patient is ≥ 18 years of age>= 18 years
Approval duration contingent on age criterion

Coverage Criteria - Other Uses with Supportive Evidence

Approve for 1 year if the patient is ≥ 18 years of age.

ALL of the following

Any listed supportive-evidence indication
- Ampullary Adenocarcinoma
- Anal Carcinoma
- Biliary Tract Cancer
- Central Nervous System Cancers
- Cervical Cancer
- Endometrial Carcinoma
- Gestational Trophoblastic Neoplasia
- Head and Neck Cancers
- Neuroendocrine and Adrenal Tumors
- Occult Primary Tumors
- Ovarian Cancer / Fallopian Tube Cancer / Primary Peritoneal Cancer
- Penile Cancer
- Rectal Cancer
- Small Bowel Adenocarcinoma
- Squamous Cell Skin Cancer
- Thymomas and Thymic Carcinomas
- Vaginal Cancer
- Vulvar Cancer
Patient is ≥ 18 years of age>= 18 years
Approval duration contingent on age criterion

Prior Authorization Requirement

Prior Authorization is recommended for prescription benefit coverage of capecitabine.

ALL of the following

Prior Authorization required/recommended before dispensing for coverage determination
All approvals are provided for the duration noted (1 year when criteria met)

Authorization, Documentation & Billing

Prior Authorization

Prior Authorization required

Prior Authorization is recommended/required for prescription benefit coverage of capecitabine; approvals are provided for 1 year when criteria are met.

Documentation Required

Indication documentation

Provider must document the specific cancer indication (FDA-approved or listed supportive-evidence indication) and patient age to support approval.

Billing Rule

Use appropriate codes

Claims must be submitted with covered diagnosis and/or procedure codes consistent with the coverage policy; services billed for conditions not covered under this policy will be denied.

Clinical Evidence & References

Prescribing information: Xeloda tablets prescribing information, Genentech; December 2022

Guideline source: NCCN Drugs & Biologics Compendium (accessed June 11, 2025)

Background

Capecitabine is an oral nucleoside metabolic inhibitor indicated for multiple cancers per FDA labeling, including breast, colorectal, gastric, esophageal/gastroesophageal junction, and pancreatic adenocarcinoma; NCCN compendium recommendations support use for these and other listed indications. This policy guides prior authorization for outpatient prescription benefit coverage under Cigna-administered plans.

Approval Thresholds and Duration

Age thresholdPatient is >= 18 years

Typical Approval Duration1 year

Applies toAll listed FDA-approved and supportive-evidence indications when criteria met

Policy Revision History

Recorded in Annual Revision history.

Biliary Tract Cancer condition of approval was changed from 'hepatobiliary cancer' to 'biliary tract cancer'.

Recorded in Annual Revision history; no criteria changes for 06/19/2024 update.

Cervical, Endometrial, Vaginal, and Vulvar Cancers were added to Other Uses With Supportive Evidence in prior revisions.

Policy Summary

PayerCigna

PolicyOncology -Capecitabine Prior Authorization

Policy CodePolicy N/A

Change TypeAnnual revisions (non-material)

Effective Date

Next Review Date

Key ActionPrior Authorization is recommended/required for prescription benefit coverage of capecitabine; approvals are provided for 1 year when criteria are met.

SourceLink

On This Page

OpenPayer

Oncology -Capecitabine Prior Authorization

Coverage Summary & Criteria

Authorization, Documentation & Billing

Applicable Codes

Clinical Evidence & References

Background

Policy Revision History