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Opdivo in combo with Yervoy for Metastatic Melanoma – Details

Project Number PC0098-000
Brand Name Opdivo & Yervoy in combo
Generic Name Nivolumab & Ipilimumab in combo
Strength 40 mg & 100 mg single-use vials
Tumour Type Skin and Melanoma
Indication Metastatic Melanoma
Funding Request In combination, for treatment-naïve adult patients with advanced (unresectable or metastatic) melanoma, regardless of BRAF status
Review Status Complete
Pre Noc Submission No
NOC Date October 26, 2016
Manufacturer Bristol-Myers Squibb Canada
Sponsor Bristol-Myers Squibb Canada
Submission Date November 30, 2016
Submission Deemed Complete December 14, 2016
Submission Type Initial
Prioritization Requested Requested and Not Granted
Stakeholder Input Deadline ‡ December 14, 2016
Check-point meeting February 1, 2017
pERC Meeting September 21, 2017
Clarification The pCODR Expert Review Committee (pERC) Recommendation was deferred on April 20, 2017 pending additional information from the submitter. The timeline of the review has resumed as the additional information has now been provided and a new pERC date has been set by pCODR.
Initial Recommendation Issued October 5, 2017
Feedback Deadline ‡ October 20, 2017
pERC Reconsideration Meeting November 16, 2017
Final Recommendation Issued November 30, 2017
Notification to Implement Issued December 15, 2017
Therapeutic Area Metastatic Melanoma
Recommendation Type Reimburse with clinical criteria and/or conditions

‡ 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.