Subject: Xeloda 1993-A SGM P2021a
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. Anal carcinoma
2. Breast cancer
3. Central nervous system (CNS) metastases from breast cancer
4. Colorectal Cancer
5. Esophageal and esophagogastric junction cancer
6. Gastric cancer
7. Head and neck cancers (including very advanced head and
neck cancer)
8. Hepatobiliary cancers (including extrahepatic and intra-hepatic
cholangiocarcinoma and gallbladder cancer)
9. Occult primary tumors (cancer of unknown primary)
10. Ovarian cancer, fallopian tube cancer, and primary peritoneal
cancer: Epithelial ovarian cancer, fallopian tube cancer, primary
peritoneal cancer, mucinous cancer, carcinosarcoma (malignant
mixed Mullerian tumors), clear cell carcinoma, grade 1
endometrioid carcinoma, low-grade serious carcinoma/ovarian
borderline epithelial tumor (low malignant potential) with
invasive implants
11. Pancreatic adenocarcinoma
12. Penile cancer
13. Neuroendocrine and adrenal tumors
14. Thymomas and Thymic Carcinomas
15. Gestational Trophoblastic Neoplasia
16. Small bowel adenocarcinoma
17. 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.
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 or metastatic disease, as a single agent or in
combination with docetaxel; or
2. Member has early-stage HER2 negative postoperative residual
disease, as a single agent
3. Member has HER2 positive advanced, recurrent, unresectable, or
metastatic disease, in combination with a HER2 inhibitor (e.g.,
margetuximab-cmkb [Margenza], trastuzumab [Herceptin],
lapatinib [Tykerb], or neratinib [Nerlynx]), as subsequent
therapy; or
4. Member has HER2 positive recurrent, advanced unresectable, or
metastatic disease, in combination with trastuzumab and
tucatinib, when one or more prior anti-HER2-based regimens
were received in the metastatic setting; or
5. Xeloda will be used in combination with ixabepilone for treatment
of metastatic or locally advanced disease; or
6. Xeloda will be used as adjuvant therapy.
C. Neuroendocrine and Adrenal Tumors
Authorization of 12 months may be granted for treatment of ANY of
the following:
1. Member has neuroendocrine and adrenal tumors of the
gastrointestinal tract, lung, or thymus (carcinoid tumors); or
2. Member has neuroendocrine and adrenal tumors of the pancreas;
or
3. Member has poorly differentiated (high grade)/large or small cell
disease, in combination with temozolomide; 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, grade 1 endometrioid carcinoma, low-grade serious
carcinoma/ovarian borderline epithelial tumor (low malignant
potential) with invasive implants; or
2. Member has mucinous carcinoma and when either of the
following criteria are met:
a. Xeloda will be used in combination with oxaliplatin as adjuvant
treatment; or
b. Xeloda will be used as a single agent or in combination with
oxaliplatin for treatment of persistent or 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.
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.
O. Small Bowel Adenocarcinoma
Authorization of 12 months may be granted for treatment of small
bowel adenocarcinoma, including advanced ampullary cancer.
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 unresectable/inoperable, locally advanced, recurrent,
or metastatic
2. Member is ineligible for or has progressed on immune checkpoint
inhibitors and clinical trials
3. Xeloda will be used as a single agent.
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.
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.
April 23, 2022
