Stivarga (regorafenib)

Indications for Prior Authorization

Stivarga (regorafenib)
  • For diagnosis of Metastatic Colorectal Cancer (mCRC)
    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-VEGF therapy, and, if RAS wild- type, an anti-EGFR therapy.

  • For diagnosis of Gastrointestinal Stromal Tumor (GIST)
    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.

  • For diagnosis of Hepatocellular Carcinoma (HCC)
    Indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.

Criteria

Stivarga

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Metastatic Colorectal Cancer (mCRC) [1,2]

  • Diagnosis of metastatic colorectal cancer (mCRC)
Stivarga

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Gastrointestinal Stromal Tumor (GIST) [1,2]

  • Diagnosis of Gastrointestinal Stromal Tumor (GIST)
  • AND
  • Disease is one of the following:
    • Locally advanced
    • Unresectable
    • Metastatic
Stivarga

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Hepatocellular Carcinoma (HCC) [1,2]

  • Diagnosis of hepatocellular carcinoma (HCC)
Stivarga

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of All Indications Listed Above

  • Patient does not show evidence of progressive disease while on therapy
P & T Revisions

2024-05-20, 2023-07-05, 2023-05-24, 2023-05-04, 2022-05-22, 2021-08-02, 2021-05-11, 2020-06-02, 2019-11-24

  1. Stivarga Prescribing Information. Bayer HealthCare Pharmaceuticals Inc., December 2020.
  2. The NCCN Drugs and Biologics Compendium (NCCN Compendium™). Available at http://www.nccn.org/professionals/drug_compendium/content/contents.asp. Accessed April 19, 2022.

  • 2024-05-20: 2024 Annual Review
  • 2023-07-05: Removed specialist requirement
  • 2023-05-24: 2023 Annual Review
  • 2023-05-04: Program update to remove t/f criterion.
  • 2022-05-22: 2022 Annual Review.
  • 2021-08-02: 2021 UM Annual Review.
  • 2021-05-11: 2021 UM Annual Review.
  • 2020-06-02: Annual Review: updated references
  • 2019-11-24: Updated criteria

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