Subject: Stivarga 1809-A SGM P2023b
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
Stivarga is indicated for the treatment of patients with
metastatic colorectal cancer (CRC) who have been
previously treated with fluoropyrimidine-, oxaliplatin- and
irinotecan-based chemotherapy, an anti-vascular
endothelial growth factor (VEGF) therapy, and, if RAS wild
type, an anti-epidermal growth factor receptor (EGFR)
therapy.
2. Gastrointestinal stromal tumors
Stivarga is indicated for the treatment of patients with
locally advanced, unresectable or metastatic
gastrointestinal stromal tumor (GIST) who have been
previously treated with imatinib mesylate and sunitinib
malate.
3. Hepatocellular carcinoma
Stivarga is indicated for the treatment of patients with
hepatocellular carcinoma (HCC) who have been
previously treated with sorafenib.
B. Compendial Uses
1. Advanced or metastatic colorectal cancer
2. Gastrointestinal stromal tumors (GIST)
3. Soft tissue sarcoma
a. Non-adipocytic sarcoma
b. Retroperitoneal/Intra-abdominal
c. Rhabdomyosarcoma
d. Angiosarcoma
4. Hepatocellular carcinoma
5. Osteosarcoma
6. Glioblastoma
7. Ewing sarcoma
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
advanced or metastatic colorectal cancer, including
appendiceal adenocarcinoma and anal adenocarcinoma, as a
single agent when the member has progressed on previous
treatment with all the following regimens unless the member
has a contraindication or intolerance:
1. Fluoropyrimidine-, oxaliplatin- and irinotecan-based
chemotherapy (with or without bevacizumab); and
2. If RAS wild type, an anti-epidermal growth factor receptor
(EGFR) therapy, such as Erbitux (cetuximab) or Vectibix
(panitumumab), for rectal cancer, appendiceal
adenocarcinoma, anal adenocarcinoma, or left-sided
colon cancer.
B. Gastrointestinal stromal tumor (GIST)
Authorization of 12 months may be granted for treatment of
GIST when any of the following criteria are met:
1. The requested medication will be used as a single agent
for locally advanced, residual, unresectable, tumor
rupture, or recurrent/metastatic GIST following disease
progression on imatinib and either sunitinib or ripretinib
2. The requested medication will be used for treatment of
residual, unresectable, tumor rupture or
recurrent/metastatic GIST in combination with everolimus
for disease progression after the member has failed at
least four FDA-approved therapies (e.g., imatinib,
sunitinib, ripretinib, avapritinib)
3. The requested medication will be used for treatment of
residual, unresectable, tumor rupture or
recurrent/metastatic succinate dehydrogenase (SDH)-
deficient GIST as a single agent.
C. Hepatocellular carcinoma
Authorization of 12 months may be granted for treatment of
unresectable/inoperable, metastatic, or extensive liver tumor
burden hepatocellular carcinoma as subsequent treatment as
a single agent.
D. Soft tissue sarcomas
Authorization of 12 months may be granted for treatment of
angiosarcoma, retroperitoneal/intra-abdominal soft tissue
sarcoma, rhabdomyosarcoma, and non-adipocytic sarcoma,
as a single agent.
E. Osteosarcoma
Authorization of 12 months may be granted for second-line
treatment of relapsed/refractory or metastatic osteosarcoma
as a single agent.
F. Glioblastoma
Authorization of 12 months may be granted for treatment of
recurrent or progressive glioblastoma as a single agent.
G. Ewing sarcoma
Authorization of 12 months may be granted for subsequent
treatment of relapsed (with or without radiation), progressive
or metastatic Ewing sarcoma 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:
- Stivarga [package insert]. Whippany, NJ: Bayer HealthCare Pharmaceuticals Inc.; December 2020.
- The NCCN Drugs & Biologics Compendium 2023 National Comprehensive Cancer Network, Inc. Available at: http://www.nccn.org. Accessed November 24, 2023.
- NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines): Anal Carcinoma. Version 2.2023. Accessed July 6, 2023. https://www.nccn.org/professionals/physician_gls/pdf/anal.pdf
- NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines): Colon Cancer. Version 4.2023. Accessed November 24, 2023. https://www.nccn.org/professionals/physician_gls/pdf/colon.pdf
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.
February 06, 2024
