CurrentCignaPolicy N/A

Capecitabine Coverage Policy

Defines prior authorization and preferred product management for capecitabine tablets (generic preferred; Xeloda non-preferred) including exception criteria for non-preferred product coverage and documentation requirements. Applies to Cigna-administered health benefit plans as described.

Policy Summary

PayerCigna

PolicyCapecitabine Coverage Policy

Policy CodePolicy N/A

Change TypeClarified (no criteria changes)

Effective Date

Next Review DateJun 18, 2025

Key ActionFollow the Oncology - Capecitabine Prior Authorization Policy; submit documentation when requesting Xeloda due to formulation differences and note approvals are for 1 year.

SourceLink

POLICY UPDATE CHANGES

Annual revisions listed with 'No criteria changes' for review dates 08/23/2023, 06/19/2024, and 06/18/2025.

1Non-preferred product requiring exception for coverage

1 yearStandard approval duration

Coverage Summary

This policy implements a Preferred Specialty Management program in which generic capecitabine tablets are the Preferred Product and Xeloda (brand capecitabine) is designated as Non-Preferred. The program requires patients to meet the standard Oncology - Capecitabine Prior Authorization criteria and directs use of the Preferred Product prior to approval of the Non-Preferred product. Coverage guidance and exception review apply to health benefit plans administered by Cigna companies.

Non-Preferred Product Exception Criteria

Non-Preferred Product Exception Criteria (Xeloda)

Approve for 1 year if the patient meets ALL of the following (A, B, and C):

ALL of the following

A: Patient meets the standard Oncology - Capecitabine Prior Authorization (PA) Policy criteria
See separate Oncology - Capecitabine PA Policy for clinical necessity criteria; documentation required where noted
B: Patient has tried generic capecitabine tablets
Treatment attempt with preferred product required before non-preferred approval
C: Patient cannot continue to use generic capecitabine tablets due to a formulation difference in the inactive ingredient(s)
Must result, per prescriber, in a significant allergy or serious adverse reaction; documentation required (e.g., difference in dyes, fillers, preservatives)

Default Coverage when Exception Not Met

Default Coverage if Exception Not Met

For patients who meet Oncology - Capecitabine PA Policy criteria but do not meet exception criteria (1B and/or 1C):

ALL of the following

Approve generic capecitabine tablets for 1 year
Generic is the Preferred Product and will be authorized when exception for non-preferred is not met

Provider Actions & Requirements

Prior Authorization

Prior authorization required

All medications (Preferred and Non-Preferred) require meeting the standard Oncology - Capecitabine Prior Authorization Policy criteria; requests for non-preferred products are reviewed under the exception criteria. Note: both preferred (generic capecitabine tablets) and non-preferred (Xeloda) require meeting the Oncology - Capecitabine PA Policy criteria.

Documentation Required

Documentation for exception

When requesting Xeloda due to a formulation difference, submit documentation showing the prescriber’s assertion that an inactive ingredient difference would result in a significant allergy or serious adverse reaction.

Chart notes
Prescription claims records
Prescription receipts

Billing Rule

Approval duration

Approvals are provided for 1 year for both preferred generic capecitabine tablets and non-preferred products when approved under the exception criteria.

Background

Background: Capecitabine is an oral nucleoside metabolic inhibitor with antineoplastic activity indicated for multiple solid tumors including breast, colorectal, gastric/esophageal, and pancreatic cancers. This policy implements a Preferred Specialty Management program to encourage use of generic capecitabine tablets as the Preferred Product; Xeloda is Non-Preferred and is subject to exception criteria for coverage.

Preferred Productgeneric capecitabine tablets

Non-Preferred ProductXeloda (brand capecitabine)

Revision History

2023-08-23review

Annual revision: No clinical policy statement changes; non-material.

2024-06-19review

Annual revision: No clinical policy statement changes; non-material.

2025-06-18reviewLatest

Annual revision: No clinical policy statement changes; non-material.

Policy Summary

PayerCigna

PolicyCapecitabine Coverage Policy

Policy CodePolicy N/A

Change TypeClarified (no criteria changes)

Effective Date

Next Review DateJun 18, 2025

Key ActionFollow the Oncology - Capecitabine Prior Authorization Policy; submit documentation when requesting Xeloda due to formulation differences and note approvals are for 1 year.

SourceLink

On This Page

OpenPayer

Capecitabine Coverage Policy

Coverage Summary

Non-Preferred Product Exception Criteria

Default Coverage when Exception Not Met

Provider Actions & Requirements

Applicable Codes / Drug References

Clinical Evidence & References

Background

Revision History

generic capecitabine tablets	Preferred Product (generic capecitabine tablets) — no specific NDCs listed
Xeloda	Non-Preferred Product (brand capecitabine)