CurrentNeighborhood Health Plan of Rhode IslandPolicy Xeloda 1993-A SGM P2022

Xeloda_Indications_and_Authorization_Criteria

Defines covered FDA-approved and compendial indications for capecitabine (Xeloda), authorization durations (usually 12 months), continuation/reauthorization criteria, and eligibility conditions for specific tumor types. Applies to coverage determinations when approval criteria are met and no member exclusions exist.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyXeloda_Indications_and_Authorization_Criteria

Policy CodePolicy Xeloda 1993-A SGM P2022

Change TypeClarified / No material change

Effective Date

Next Review Date

Key ActionAuthorization may be granted (typically for 12 months) only when the requested indication matches an FDA-approved or listed compendial use and the specific indication criteria are met; continuation requires no unacceptable toxicity or disease progression.

POLICY UPDATE CHANGES

No material clinical or coverage changes documented; policy retains reference number 1993-A.

18Listed Compendial Indications

12 monthsTypical Authorization Duration

Coverage Summary

Xeloda is covered_with_criteria: it is covered for FDA-approved indications and specified compendial uses when all approval criteria are met and the member has no exclusions to the prescribed therapy. General coverage requires that the requested indication is an FDA-approved indication or a listed compendial use, all specific approval criteria for the indication are met, and the member has no exclusions to the prescribed therapy.

General Coverage Statement

Xeloda is covered for FDA-approved indications and specified compendial uses when all approval criteria are met and the member has no exclusions to the prescribed therapy.

ALL of the following

General requirements: Requested indication is an FDA-approved indication or a listed compendial use
Specific approval criteria: All specific approval criteria for the indication (see indication-specific nodes) are met
Member exclusions: Member has no exclusions to the prescribed therapy

FDA-Approved Indications

Covered when the following indication-specific conditions are met:

FDA-approved uses

Colorectal cancer - adjuvant: Colorectal cancer: as a single agent for adjuvant treatment in patients with Dukes' C colon cancer after complete resection when fluoropyrimidine therapy alone is preferred
Colorectal cancer - metastatic first-line: Colorectal cancer: as first-line treatment in metastatic colorectal carcinoma when fluoropyrimidine therapy alone is preferred
Breast cancer - with docetaxel: Breast cancer: in combination with docetaxel for metastatic breast cancer after failure of prior anthracycline-containing chemotherapy
Breast cancer - monotherapy: Breast cancer: monotherapy for metastatic breast cancer resistant to both paclitaxel and an anthracycline-containing regimen or resistant to paclitaxel and further anthracycline therapy is not indicated (e.g., cumulative doxorubicin dose >= 400 mg/m2)

Compendial Uses (Covered When Criteria Met)

Compendial Uses (covered when criteria met)

Authorization of 12 months may be granted for the following compendial indications when approval criteria are met. Many indications have indication-specific criteria detailed below.

Compendial indications

Ampullary adenocarcinoma
Anal carcinoma
Breast cancer (see detailed): Breast cancer (see detailed breast cancer criteria)
CNS metastases from breast cancer
Colorectal cancer (includes anal/appendiceal): Colorectal cancer (including anal adenocarcinoma and appendiceal adenocarcinoma)
Esophageal/esophagogastric junction: Esophageal and esophagogastric junction cancer
Gastric cancer
Head and neck cancers (including very advanced head and neck cancer)
Hepatobiliary cancers (including extrahepatic and intrahepatic cholangiocarcinoma and gallbladder cancer)
Occult primary tumors (cancer of unknown primary)
Ovarian/fallopian tube/primary peritoneal: Ovarian cancer, fallopian tube cancer, and primary peritoneal cancer (specific histologies listed in policy)
Pancreatic adenocarcinoma
Penile cancer
Neuroendocrine and adrenal tumors (see detailed): Neuroendocrine and adrenal tumors (see detailed criteria)
Thymomas/thymic carcinomas: Thymomas and Thymic Carcinomas (in combination with gemcitabine)
Gestational trophoblastic neoplasia: Gestational Trophoblastic Neoplasia
Small bowel adenocarcinoma
Squamous cell skin cancer (conditional)
- SCC criterion: disease state: Disease is new regional disease, unresectable, inoperable or incompletely resected, locally advanced, recurrent, or metastatic
- SCC criterion: IO ineligible/progressed: Member is ineligible for or has progressed on immune checkpoint inhibitors and clinical trials
- SCC criterion: single agent: The requested medication will be used as a single agent

Authorization Durations and Continuation Criteria

Authorization Durations and Repeat/Continuation

Authorization length and reauthorization rules

Authorization and continuation rules

Colorectal & CAPEOX: Authorization of 12 months may be granted for colorectal cancer, including anal adenocarcinoma and appendiceal adenocarcinoma, used as single agent or as part of CAPEOX12 months
Breast cancer authorization: Authorization of 12 months may be granted for breast cancer when any one of the listed breast cancer criteria (1–6) is met12 months
Neuroendocrine/adrenal authorization: Authorization of 12 months may be granted for neuroendocrine/adrenal tumors when any one of the listed neuroendocrine criteria (1–4) is met12 months
Other indications authorization: Authorization of 12 months may be granted for pancreatic adenocarcinoma, esophageal cancers, gastric cancer, hepatobiliary cancers, ovarian/fallopian tube/primary peritoneal cancers, thymomas/thymic carcinomas (with gemcitabine), gestational trophoblastic neoplasia, small bowel adenocarcinoma, penile cancer, ampullary adenocarcinoma, anal carcinoma (with scenario-specific criteria)12 months
Continuation/Reauthorization: Authorization of 12 months may be granted for continued treatment when there is no evidence of unacceptable toxicity or disease progression while on the current regimen12 months

Authorization duration12 months

Doxorubicin cumulative dose threshold>= 400 mg/m2

Breast Cancer — Detailed Criteria

Breast Cancer - Detailed Criteria

Authorization of 12 months for breast cancer requires at least one of the following:

Breast cancer detailed criteria

HER2-negative recurrent/metastatic or no response preop: Member has HER2-negative recurrent unresectable or metastatic disease or no response to preoperative systemic therapy, for use as single agent or with docetaxel
Early-stage HER2-negative postop residual: Member has early-stage HER2-negative postoperative residual disease, for use as a single agent
HER2-positive subsequent therapy combos: Member has HER2-positive advanced/recurrent/metastatic disease or no response to preoperative systemic therapy and requested medication will be used as subsequent therapy in combination with trastuzumab and tucatinib or with a HER2 inhibitor (examples listed)
Combination with ixabepilone: Requested medication will be used in combination with ixabepilone for metastatic or locally advanced disease
Triple negative disease options
- Triple negative - adjuvant: The requested medication will be used as adjuvant therapy
- Triple negative - maintenance: The requested medication will be used as maintenance therapy following adjuvant chemotherapy
Brain metastases: Member has brain metastases in breast cancer and medication will be used as initial therapy or for recurrent/relapsed disease

Neuroendocrine & Adrenal Tumors — Detailed Criteria

Neuroendocrine and Adrenal Tumors - Detailed Criteria

Authorization of 12 months may be granted when any of the following are present:

Neuroendocrine/adrenal criteria

GI/lung/thymus carcinoid tumors: Member has neuroendocrine tumors of the gastrointestinal tract, lung, or thymus (carcinoid tumors)
Pancreatic NETs with temozolomide/CAPEOX: Member has neuroendocrine and adrenal tumors of the pancreas, in combination with temozolomide or as part of CAPEOX
Extrapulmonary poorly differentiated disease: Member has extrapulmonary poorly differentiated disease/large or small cell disease/mixed neuroendocrine-non-neuroendocrine neoplasm, in combination with temozolomide or with concurrent or sequential radiation
Well differentiated grade 3 NETs: Member has well differentiated grade 3 neuroendocrine tumors, in combination with temozolomide or as part of CAPEOX

Anal Carcinoma — Detailed Criteria

Anal Carcinoma - Detailed Criteria

Authorization of 12 months may be granted when either of the following is met:

Anal carcinoma options

Concurrent chemoradiation with mitomycin: Requested drug will be used with concurrent chemoradiation in combination with mitomycin
Radiation after primary treatment (single agent): Requested drug will be used with radiation after primary treatment of metastatic disease, as a single agent

Ovarian / Fallopian Tube / Primary Peritoneal Cancer — Detailed Criteria

Ovarian / Fallopian Tube / Primary Peritoneal Cancer - Detailed Criteria

Authorization of 12 months may be granted for any of the following uses:

Ovarian/fallopian tube/primary peritoneal uses

Single agent for persistent or recurrent epithelial and select histologies: As single agent therapy for persistent or recurrent epithelial ovarian cancer, fallopian tube cancer, primary peritoneal cancer, carcinosarcoma, clear cell carcinoma, or grade 1 endometrioid carcinoma
Low-grade serous/borderline: Member has low-grade serous carcinoma/borderline epithelial tumor and requested medication will be used as single agent for platinum-sensitive or platinum-resistant recurrence
Mucinous carcinoma options
- Mucinous - adjuvant with oxaliplatin: Requested medication will be used in combination with oxaliplatin as adjuvant treatment
- Mucinous - single agent or with oxaliplatin for recurrent disease: Requested medication will be used as single agent or in combination with oxaliplatin for treatment of persistent or relapsed/recurrent disease

Provider Actions & Prior Authorization

Prior Authorization

Prior authorization required for covered uses

Authorization may be granted (typically for 12 months) only when the requested indication matches an FDA-approved or listed compendial use and the specific indication criteria are met; continuation requires no unacceptable toxicity or disease progression.

Documentation Required

Document histology and prior treatments where required

Providers must document tumor type, relevant receptor status (e.g., HER2, triple-negative), prior therapies (e.g., anthracycline, paclitaxel), eligibility for combinations (e.g., with docetaxel, temozolomide, oxaliplatin, mitomycin, gemcitabine), and lack of unacceptable toxicity or progression for reauthorization.

Denial Risk

Not covered if not listed or if other criteria not met

Uses not listed in the FDA-approved indications or the compendial uses section are considered experimental/investigational and not medically necessary and may be denied.

Background & Clinical Evidence

This policy summarizes FDA-approved indications for capecitabine (Xeloda) and lists compendial uses referenced to NCCN and other sources. FDA-approved indications include use as a single agent for adjuvant treatment of Dukes' C colon cancer after complete resection and as first-line treatment for metastatic colorectal carcinoma when fluoropyrimidine therapy alone is preferred, and breast cancer indications including combination with docetaxel after anthracycline failure and monotherapy for certain anthracycline- and paclitaxel-resistant metastatic breast cancers. The policy provides indication-specific authorization guidance and continuation/reauthorization criteria.

Primary references include the Xeloda package insert (May 2021) and the NCCN Drugs & Biologics Compendium 2022.