Subject: Xeloda 1993-A SGM P2022
Policy:
I. INDICATIONS
The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy.
A. FDA-Approved Indications
1. Colorectal Cancer
a. Xeloda is indicated as a single agent for adjuvant treatment in patients with Dukes’ C colon cancer who have undergone complete
resection of the primary tumor when treatment with fluoropyrimidine therapy alone is preferred.
b. Xeloda is indicated as first-line treatment in patients with metastatic colorectal carcinoma when treatment with fluoropyrimidine
therapy alone is preferred.
2. Breast Cancer
a. Xeloda in combination with docetaxel is indicated for the treatment of patients with metastatic breast cancer after failure of
prior anthracycline-containing chemotherapy.
b. Xeloda monotherapy is also indicated for the treatment of patients with metastatic breast cancer resistant to both paclitaxel and
an anthracycline-containing chemotherapy regimen or resistant to paclitaxel and for whom further anthracycline therapy is not
indicated, for example, patients who have received cumulative doses of 400 mg/m2 of doxorubicin or doxorubicin equivalents.
B. Compendial Uses
1. Ampullary Adenocarcinoma
2. Anal carcinoma
3. Breast cancer
4. Central nervous system (CNS) metastases from breast cancer
5. Colorectal Cancer (including anal adenocarcinoma and appendiceal adenocarcinoma)
6. Esophageal and esophagogastric junction cancer
7. Gastric cancer
8. Head and neck cancers (including very advanced head and neck cancer)
9. Hepatobiliary cancers (including extrahepatic and intra-hepatic cholangiocarcinoma and gallbladder cancer)
10. Occult primary tumors (cancer of unknown primary)
11. Ovarian cancer, fallopian tube cancer, and primary peritoneal cancer: Epithelial ovarian cancer, fallopian tube cancer, primary
peritoneal cancer, mucinous cancer, arcinosarcoma (malignant mixed Mullerian tumors), clear cell carcinoma, grade 1 endometrioid
carcinoma, low-grade serious carcinoma/ovarian borderline epithelial tumor
12. Pancreatic adenocarcinoma
13. Penile cancer
14. Neuroendocrine and adrenal tumors
15. Thymomas and Thymic Carcinomas
16. Gestational Trophoblastic Neoplasia
17. Small bowel adenocarcinoma
18. Squamous cell skin cancer
All other indications are considered experimental/investigational and not medically necessary.
II. CRITERIA FOR INITIAL APPROVAL
A. Colorectal Cancer (CRC)
Authorization of 12 months may be granted for treatment of colorectal cancer, including anal adenocarcinoma and appendiceal adenocarcinoma,
as a single agent or as a component of CAPEOX (capecitabine and oxaliplatin) regimen.
B. Breast Cancer
Authorization of 12 months may be granted for treatment of breast cancer in members when any of the following criteria are met:
1. Member has human epidermal growth factor receptor 2 (HER2) negative recurrent unresectable, or metastatic disease or member had no
response to preoperative systemic therapy, as a single agent or in combination with docetaxel; or
2. Member has early-stage HER2 negative postoperative residual disease, as a single agent; or
3. Member has HER2 positive advanced, recurrent unresectable, or metastatic disease or member had no response to preoperative
systemic therapy, and the requested medication will be used as subsequent therapy in combination with trastuzumab and tucatinib or
in combination with a HER2 inhibitor (e.g., margetuximab-cmkb [Margenza], trastuzumab [Herceptin], lapatinib [Tykerb], neratinib [Nerlynx]); or
4. The requested medication will be used in combination with ixabepilone for treatment of metastatic or locally advanced disease; or
5. Member has triple negative disease and meets one of the following criteria:
a. The requested medication will be used as adjuvant therapy; or
b. The requested medication will be used as maintenance therapy following adjuvant chemotherapy
6. Member has brain metastases in breast cancer and the requested medication will be used as initial therapy or for recurrent or relapsed disease.
C. Neuroendocrine and Adrenal Tumors
Authorization of 12 months may be granted for treatment of ANY of the following:
1. Member has neuroendocrine tumors of the gastrointestinal tract, lung, or thymus (carcinoid tumors); or
2. Member has neuroendocrine and adrenal tumors of the pancreas, in combination with temozolomide or as a component of
CAPEOX (capecitabine and oxaliplatin) regimen; or
3. 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; or
4. Member has well differentiated grade 3 neuroendocrine tumors, in combination with temozolomide or as a component of CAPEOX
(capecitabine and oxaliplatin) regimen
D. Pancreatic Adenocarcinoma
Authorization of 12 months may be granted for treatment of pancreatic adenocarcinoma.
E. Esophageal and Esophagogastric Junction Cancers
Authorization of 12 months may be granted for treatment of esophageal and esophagogastric junction cancers.
F. Gastric Cancer
Authorization of 12 months may be granted for treatment of gastric cancer.
G. Hepatobiliary Cancers
Authorization of 12 months may be granted for treatment of hepatobiliary cancers (including extrahepatic and intrahepatic
cholangiocarcinoma and gallbladder cancer).
H. Ovarian Cancer, Fallopian Tube Cancer, and Primary Peritoneal Cancer
Authorization of 12 months may be granted for treatment of ANY of the following:
1. As a single agent therapy for persistent or recurrent epithelial ovarian cancer, fallopian tube cancer, primary peritoneal cancer,
carcinosarcoma (malignant mixed Mullerian tumors), clear cell carcinoma, or grade 1 endometrioid carcinoma; or
2. Member has low-grade serous carcinoma/borderline epithelial tumor and the requested medication will be used as a single agent for
platinum-sensitive or platinum-resistant recurrence
3. Member has mucinous carcinoma and either of the following criteria are met:
a. The requested medication will be used in combination with oxaliplatin as adjuvant treatment; or
b. The requested medication will be used as a single agent or in combination with oxaliplatin for treatment of persistent or
relapsed/recurrent disease.
I. Head and Neck Cancers
Authorization of 12 months may be granted for treatment of head and neck cancers (including very advanced head and neck
cancer), as a single agent.
J. Occult Primary Tumors (cancer of unknown primary)
Authorization of 12 months may be granted for treatment of occult primary tumors, as a single agent or as a component of
CAPEOX (capecitabine and oxaliplatin) regimen.
K. Penile Cancer
Authorization of 12 months may be granted for treatment of penile cancer, as a single agent.
L. Anal Carcinoma
Authorization of 12 months may be granted for treatment of anal carcinoma when any of the following criteria are met:
1. The requested drug will be used with concurrent chemoradiation in combination with mitomycin.
2. The requested drug will be used with radiation after primary treatment of metastatic disease, as a single agent.
M. Thymomas and Thymic Carcinomas
Authorization of 12 months may be granted for treatment of thymomas and thymic carcinomas in combination with gemcitabine.
N. Gestational Trophoblastic Neoplasia
Authorization of 12 months may be granted for treatment of gestational trophoblastic neoplasia, as a single agent.
O. Small Bowel Adenocarcinoma
Authorization of 12 months may be granted for treatment of small bowel adenocarcinoma.
P. Squamous Cell Skin Cancer
Authorization of 12 months may be granted for treatment of squamous cell skin cancer when all of the following criteria are met:
1. Disease is new regional disease, unresectable, inoperable or incompletely resected, locally advanced, recurrent, or metastatic
2. Member is ineligible for or has progressed on immune checkpoint inhibitors and clinical trials
3. The requested medication will be used as a single agent.
Q. Ampullary Adenocarcinoma
Authorization of 12 months may be granted for treatment of ampullary adenocarcinoma.
III. CONTINUATION OF THERAPY
Authorization of 12 months may be granted for continued treatment in members requesting reauthorization for an indication listed in Section II when there is no evidence of unacceptable toxicity or disease progression while on the current regimen.
Place of Service:
Outpatient
The above policy is based on the following references:
- Xeloda [package insert]. South San Francisco, CA: Genentech, Inc.; May 2021.
- The NCCN Drugs & Biologics Compendium 2022 National Comprehensive Cancer Network, Inc. http://www.nccn.org. Accessed July 6, 2022.
- Clinical Pharmacology powered by ClinicalKey [database online]. Tampa, FL. Elsevier; https://www.clinicalkey.com/pharmacology/ [available with subscription]. Accessed July 6, 2022.
- Ixempra [package insert]. Princeton, NJ: Bristol-Myers Squibb Company; January 2016.
- Lexicomp [database online]. Hudson, OH: Lexi-Comp, Inc.; http://online.lexi.com/lco/action/index/dataset/complete_ashp [available with subscription]. Accessed July 6, 2022.
- Micromedex Solutions [database online]. Ann Arbor, MI: Truven Health Analytics Inc. Updated periodically. www.micromedexsolutions.com [available with subscription]. Accessed July 6, 2022.
- National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: Gestational Trophoblastic Neoplasia. Version 2.2021. https://www.nccn.org/professionals/physician_gls/pdf/gtn.pdf. Accessed July 14, 2021.
- National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: Anal Carcinoma. Version 1.2022. https://www.nccn.org/professionals/physician_gls/pdf/anal.pdf. Accessed June 30, 2022.
Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.
January 28, 2023
