Opdivo for Metastatic Melanoma - Details


( Last Updated : April 18, 2016)
Generic Name:
Nivolumab
Project Status:
Complete
Therapeutic Area:
Metastatic Melanoma
Manufacturer:
Bristol-Myers Squibb Canada
Brand Name:
Opdivo
Project Line:
Reimbursement Review
Project Number:
PC0063-000
NOC Date:

Details


Strength:
40mg/4mL and 100mg/10mL vials
Tumour Type:
Skin and Melanoma
Indications:
Metastatic Melanoma
Funding Request:
For the treatment of both first-line and previously-treated advanced adult melanoma patients, regardless of BRAF status
Review Status:
Complete
Pre Noc Submission:
Yes
Sponsor:
Bristol-Myers Squibb Canada
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
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.
pERC Meeting:
Final Recommendation Issued:

Files

‡ 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.