Product Details

Stivarga

Regorafenib
40 mg
Tablet


DIN/PIN/NPN

02403390

Manufacturer

Bayer Inc., Health Care Division

Formulary Listing Date

2015-02-26  

Unit Price

72.6200

Amount MOH Pays

72.6200

Coverage Status

Exceptional Access Program Product

ODB Formulary Therapeutic Classification

Therapeutic Note

NO

ATC Code

L01EX05

Interchangeable Products

NO  

LU Clinical Criteria

NO  

EAP Criteria

Therapeutic Class Reimbursement Criteria
Oncology Drugs

Regorafenib

  • Brand(s): Stivarga
  • Dosage Form/Strength: 40 mg tablets
  • Updated November 18, 2020

For the treatment of metastatic and/or unresectable gastrointestinal stromal tumors (GIST) in patients who have had disease progression on, or intolerance to, imatinib and sunitinib

Dosage: 160 mg once daily for 3 weeks followed by 1 week of no therapy to comprise a cycle of 4 weeks. 

Duration of Approval: 6 Months

Reimbursement of Stivarga will be considered as long as benefit is observed or until unacceptable toxicity occurs.

Renewals will be considered in patients who continue to derive benefit from therapy.

Duration of Approval: 6 Months

Initial Criteria:

For the treatment of unresectable, advanced hepatocellular carcinoma (HCC) in patients who meet ALL the following criteria prior to starting treatment with regorafenib:

  1. Patient is 18 years of age or older; AND

  2. Regorafenib will be used as monotherapy for HCC; AND

  3. Regorafenib will be used as second line therapy in a patient who has experienced disease progression during treatment with sorafenib or lenvatinib for HCC; AND

  4. If prior treatment was sorafenib, patient must have tolerated at least 400 mg a day for 20 days or more in the 28 days before stopping treatment with sorafenib; AND

  5. Has an Eastern Cooperative Oncology Group (ECOG) Performance status less than or equal to 1; AND

  6. Has a Child-Pugh class A liver function. 

Exclusion Criteria: Patients meeting any of the following criteria will not be funded. 

  • Regorafenib will not be funded in the first line setting. 

  • Patients with Child-Pugh score greater than 6 (i.e. Child-Pugh class B or C) will not be funded. 

Recommended Dosage: 160 mg once daily for 3 weeks followed by 1 week of no therapy to comprise a cycle of 4 weeks. 

Renewal Criteria:
Renewals will be considered until disease progression1 or until patient develops unacceptable toxicity. Please provide radiographic and/or scan results indicating no progression1 with requests for renewal of funding. 

1Evaluation according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) or RECIST 1.1 criteria.

Approval duration for initials and renewals: 3 months

EAP Drug Request Form:

Standard Form for EAP Drug Requests

Product Monograph

View Monograph