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|Strength||40mg/4mL and 100mg/10mL vials|
|Tumour Type||Skin and Melanoma|
|Funding Request||For the treatment of both first-line and previously-treated advanced adult melanoma patients, regardless of BRAF status|
|Pre Noc Submission||Yes|
|NOC Date||September 25, 2015|
|Manufacturer||Bristol-Myers Squibb Canada|
|Sponsor||Bristol-Myers Squibb Canada|
|Submission Date||August 13, 2015|
|Submission Deemed Complete||September 1, 2015|
|Prioritization Requested||Requested and Granted|
|Stakeholder Input Deadline ‡||August 27, 2015|
|Check-point meeting||November 18, 2015|
|pERC Meeting||January 21, 2016|
|Clarification||An expanded scope of review has been granted for nivolumab (Opdivo). In accordance with the pCODR Procedures, the pCODR Provincial Advisory Group (PAG) requested additional information on nivolumab (Opdivo) which extends beyond the submitted scope of the review. Revision of review scope may be considered by pCODR in very limited instances, based on jurisdictional input, feasibility to conduct the revised review and clinical importance. All three criteria for scope modification were met in this case. The timeline of the review was temporarily stopped, pending receipt of the additional information. The timeline of the review has resumed as the additional information has now been provided and a new target pERC date has been set by pCODR.|
|Initial Recommendation Issued||February 4, 2016|
|Feedback Deadline ‡||February 19, 2016|
|pERC Reconsideration Meeting||March 17, 2016|
|Final Recommendation Issued||April 1, 2016|
|Notification to Implement Issued||April 18, 2016|
|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.