Subject: Stivarga 1809-A SGM P2022a
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
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; and
2. An anti-vascular endothelial growth factor (VEGF) therapy; and
3. 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 for locally advanced, unresectable, recurrent/progressive, or metastatic GIST following
disease progression on imatinib and either sunitinib or dasatinib
2. The requested medication will be used for treatment of unresectable, recurrent/progressive, or 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 unresectable succinate dehydrogenase (SDH)-deficient GIST as a single agent.
4. The requested medication will be used for palliation of symptoms if previously tolerated and effective.
C. Hepatocellular carcinoma
Authorization of 12 months may be granted for treatment of 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 glioblastoma 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 2022 National Comprehensive Cancer Network, Inc. Available at: http://www.nccn.org. Accessed July 11, 2022.
- NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines): Anal Carcinoma. Version 1.2022. Accessed July 12, 2022. https://www.nccn.org/professionals/physician_gls/pdf/anal.pdf
- NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines): Colon Cancer. Version 1.2022. Accessed September 12, 2022. 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.
January 28, 2023
