CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Capecitabine (Xeloda) — Coverage Criteria for Oncology Indications

This policy governs coverage and authorization criteria for capecitabine (Xeloda) for cancer treatment and compendial uses for Neighborhood Health Plan of Rhode Island members when approval criteria are met.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyCapecitabine (Xeloda) — Coverage Criteria for Oncology Indications

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionPrior authorization is required and may be granted for up to 12 months for listed cancer indications when the member meets the stated criteria.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthstypical authorization period for covered indications

FDA + compendiaIndications basis

MultipleNumber of cancer types listed

references citedreference entries visible

Coverage Criteria for Capecitabine (Xeloda)

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FDA-approved Indications

Covered when ALL of the following are met for FDA-approved colorectal and breast indications:

Adjuvant colorectal (Dukes' C): Capecitabine used as a single agent for adjuvant treatment in patients with Dukes' C colon cancer after complete resection when treatment with fluoropyrimidine therapy alone is preferred.

First-line metastatic colorectal: Capecitabine indicated as first-line treatment for metastatic colorectal carcinoma when treatment with fluoropyrimidine therapy alone is preferred (may be used as single agent or as component of CAPEOX where specified).

Metastatic breast — combination: Capecitabine in combination with docetaxel for treatment of metastatic breast cancer after failure of prior anthracycline-containing chemotherapy.

Metastatic breast — monotherapy: Capecitabine monotherapy for metastatic breast cancer resistant to both paclitaxel and an anthracycline-containing regimen, or for patients resistant to paclitaxel when further anthracycline therapy is not indicated (for example cumulative doxorubicin exposure).

Compendial Uses and Specified Combination Regimens

Covered compendial uses when approval criteria are met (examples — list is extensive):

Compendial tumor types and regimen examples: Capecitabine may be authorized for compendial indications including, but not limited to: anal carcinoma (with concurrent mitomycin and radiation when specified); ampullary adenocarcinoma; additional breast cancer contexts; colorectal cancer including anal and appendiceal adenocarcinoma (single agent or as component of CAPEOX); CNS metastases from breast cancer; esophageal and esophagogastric junction cancers; gastric cancer; hepatobiliary cancers; ovarian, fallopian tube, and primary peritoneal cancers; occult primary tumors; pancreatic adenocarcinoma; penile cancer; thymomas and thymic carcinomas (e.g., with gemcitabine); neuroendocrine and adrenal tumors (e.g., with temozolomide or as component of CAPEOX); gestational trophoblastic neoplasia; small bowel adenocarcinoma; and squamous cell skin cancer when criteria met. Specified combination regimens include CAPEOX (capecitabine + oxaliplatin), capecitabine + docetaxel (breast), capecitabine + temozolomide (neuroendocrine), capecitabine + gemcitabine (thymic), and capecitabine + mitomycin with concurrent chemoradiation (anal carcinoma).

See listed compendial entries and regimen-specific language

Indication-specific criteria (example: squamous cell skin cancer)

Covered with additional criteria:

Squamous cell skin cancer specific: Disease is new regional disease, unresectable, inoperable or incompletely resected, locally advanced, recurrent, or metastatic; member is ineligible for or has progressed on immune checkpoint inhibitors and clinical trials; and capecitabine will be used as a single agent.

Squamous Cell Skin Cancer (cutaneous)

Covered when ALL of the following are met

Disease extent: Disease is new regional disease, unresectable, inoperable or incompletely resected, locally advanced, recurrent, or metastatic.

Prior therapy: Member is ineligible for or has progressed on immune checkpoint inhibitors and clinical trials.

Single-agent use: The requested medication will be used as a single agent.

Authorization duration: Authorization of 12 months may be granted for treatment of squamous cell skin cancer when criteria are met.

Continuation of Therapy / Reauthorization

Covered when ALL of the following are met

Continuation of Therapy: Authorization of 12 months may be granted for continued treatment in members requesting reauthorization for a listed indication when there is no evidence of unacceptable toxicity or disease progression while on the current regimen.

Regimen	Indication / Context	Coverage status
CAPEOX (capecitabine + oxaliplatin)
Colorectal cancer (including anal adenocarcinoma and appendiceal adenocarcinoma) — capecitabine may be used as a single agent or as a component of the CAPEOX regimen.

Provider Requirements and Authorization Guidance

Prior Authorization

Prior Authorization Required

Prior authorization is required and may be granted for up to 12 months for listed oncology indications when the member meets the stated criteria. Authorization of up to 12 months may be granted for specific indications (for example: colorectal cancer including anal and appendiceal adenocarcinoma; breast cancer per criteria; neuroendocrine and adrenal tumors; small bowel adenocarcinoma; ampullary adenocarcinoma; squamous cell skin cancer when criteria below are met). Documentation must support the indicated cancer type and relevant prior therapies or treatment intent.

Prior authorization required for covered oncology indications; authorizations may be granted for up to 12 months.
Documentation must support cancer type, treatment setting (adjuvant, metastatic, maintenance), and prior therapies as applicable.

Denial Risk

Experimental/Investigational Exclusion

Use according to labeled/compendial indications only. Use for indications that are not FDA‑approved or not listed as supported/compendial in this policy is considered experimental/investigational and therefore not medically necessary.

Step Therapy

Therapy Sequencing and Treatment Setting

Therapy sequencing and setting matter for coverage. Examples: adjuvant use for Dukes' C colon cancer is supported when fluoropyrimidine therapy alone is preferred; metastatic colorectal cancer may be treated when fluoropyrimidine therapy alone is preferred; breast cancer coverage depends on HER2 status, prior anthracycline/taxane exposure, and whether capecitabine is used as single agent or in combination (e.g., with docetaxel); neuroendocrine tumor regimens note combinations (with temozolomide or CAPEOX) where indicated.

Adjuvant Dukes' C colon cancer: supported when fluoropyrimidine alone is preferred.
Metastatic colorectal cancer: supported when fluoropyrimidine alone is preferred.
Breast cancer: sequencing depends on prior anthracycline/taxane exposure, HER2 status, and whether combination therapy (e.g., with docetaxel, trastuzumab + tucatinib, or ixabepilone) is intended.
Neuroendocrine tumors: may be used in combination with temozolomide or as part of CAPEOX where specified.

Documentation Required

Squamous Cell Skin Cancer — Prior Therapy and Documentation Requirements

For squamous cell skin cancer, authorization of up to 12 months may be granted when disease is new regional, unresectable, inoperable or incompletely resected, locally advanced, recurrent, or metastatic, AND the member is ineligible for or has progressed on immune checkpoint inhibitors and clinical trials, and the requested medication is to be used as a single agent.

Indication limited to unresectable/inoperable/incompletely resected/locally advanced/recurrent or metastatic disease.
Member must be ineligible for or have progressed on immune checkpoint inhibitors and clinical trials.
Requested use must be as a single agent.

Prior Authorization

Authorization Duration and Reauthorization Criteria

Reauthorization for continued treatment of a listed indication may be granted for up to 12 months when there is no evidence of unacceptable toxicity or disease progression on the current regimen. Reauthorization may be denied if there is unacceptable toxicity or disease progression while on therapy.

Reauthorization requires absence of unacceptable toxicity and no disease progression on current regimen.
Reauthorization period may be up to 12 months for listed indications.

Background on Capecitabine

Capecitabine (Xeloda) is an oral prodrug of 5‑fluorouracil that is used as a single agent or in combination regimens (for example, CAPEOX with oxaliplatin, combinations with docetaxel, or with temozolomide) across multiple solid tumor types. This policy defines the FDA‑approved and compendial indications for which prior authorization may be granted and specifies typical authorization durations and required documentation.

Definitions and Key Terms

Adjuvant treatment (Dukes' C colon cancer) — capecitabine (definition and related notes)

DefinitionUse of capecitabine as single‑agent postoperative (adjuvant) therapy for patients with Dukes' C colon cancer who have undergone complete resection of the primary tumor when fluoropyrimidine therapy alone is preferred.

Indication contextAdjuvant colorectal cancer (Dukes' C) — capecitabine indicated as single agent following complete resection when fluoropyrimidine alone is preferred.

Related metastatic colorectal useCapecitabine is also indicated as first‑line treatment in metastatic colorectal carcinoma when treatment with fluoropyrimidine therapy alone is preferred.

Breast cancer linkageCapecitabine has separate FDA indications in metastatic breast cancer (in combination with docetaxel after anthracycline failure, and as monotherapy for certain anthracycline/paclitaxel‑resistant settings), which may affect sequencing decisions relative to adjuvant colorectal use.

Authorization implicationWhen used in the adjuvant Dukes' C setting as defined, prior authorization may be sought under the FDA‑approved colorectal indication criteria in the policy.