Subject: Stivarga 1809-A SGM P2021
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
e. Solitary fibrous tumor
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 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)
B. Gastrointestinal stromal tumor (GIST)
Authorization of 12 months may be granted for treatment of progressive GIST when either of the following criteria are met:
1. Stivarga will be used following disease progression after single-agent therapy with imatinib and sunitinib; or
2. Stivarga will be used in combination with everolimus for members who have failed at least four FDA-approved therapies (e.g., imatinib, sunitinib, ripretinib, avapritinib)
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, undifferentiated pleomorphic sarcoma (UPS),
solitary fibrous tumor, 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 2021 National Comprehensive Cancer Network, Inc. Available at: http://www.nccn.org. Accessed July 7, 2021.
- Lexicomp [database online]. Hudson, OH: Lexi-Comp, Inc.; http://online.lexi.com/lco/action/index/dataset/complete_ashp [available with subscription]. Accessed July 7, 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 30, 2021
