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Opdivo for Hepatocellular Carcinoma – Details

Project Number PC0134-000
Brand Name Opdivo
Generic Name Nivolumab
Strength 10 mg/mL
Tumour Type Gastrointestinal
Indication Hepatocellular Carcinoma (HCC)
Funding Request For the treatment of adult patients with advanced (not amenable to curative therapy or local therapeutic measures) or metastatic hepatocellular carcinoma who are intolerant to or have progressed on sorafenib therapy
Review Status Complete
Pre Noc Submission No
NOC Date March 23, 2018
Manufacturer Bristol-Myers Squibb Canada
Sponsor Bristol-Myers Squibb Canada
Submission Date May 8, 2018
Submission Deemed Complete May 15, 2018
Submission Type Initial
Prioritization Requested Not Requested
Stakeholder Input Deadline ‡ May 23, 2018
Check-point meeting July 10, 2018
pERC Meeting September 20, 2018
Initial Recommendation Issued October 4, 2018
Feedback Deadline ‡ October 19, 2018
pERC Reconsideration Meeting November 15, 2018
Final Recommendation Issued November 29, 2018
Notification to Implement Issued December 14, 2018
Therapeutic Area Metastatic Hepatocellular Carcinoma (HCC)
Recommendation Type Do not reimburse

‡ 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.