Stivarga for Unresectable Hepatocellular Carcinoma (HCC) – Details

Details

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Generic Name:
Regorafenib
Project Status:
Complete
Therapeutic Area:
Unresectable Hepatocellular Carcinoma (HCC)
Manufacturer:
Bayer Inc.
Brand Name:
Stivarga
Project Line:
Reimbursement Review
Project Number:
PC0119-000
NOC Status at Filing:
Post NOC
Strength:
40 mg
Tumour Type:
Gastrointestinal
Indications:
Unresectable Hepatocellular Carcinoma (HCC)
Funding Request:
For treatment of patients with unresectable hepatocellular carcinoma (HCC) who have been previously treated with sorafenib
Sponsor:
Bayer Inc.
Submission Date:
Submission Deemed Complete:
Prioritization Requested:
Requested and Granted
Stakeholder Input Deadline ‡:
Check-point meeting:
pERC Meeting:
Initial Recommendation Issued:
Feedback Deadline ‡:
Notification to Implement Issued:
Recommendation Type:
Reimburse with clinical criteria and/or conditions
pERC Meeting:
Final Recommendation Issued:

‡ Patient Advocacy Groups (or individual patients and caregivers when there is no patient group) and Clinicians who are registered with pCODR are eligible to provide Input and Feedback. Deadlines for Input and Feedback are by the end of the pCODR business day (5P.M. Eastern Time) of the date noted.