CADTH | Evidence Driven
CADTH | Evidence Driven

Opdivo for Metastatic Renal Cell Carcinoma – Details

Details

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Generic Name:
Nivolumab
Project Status:
Complete
Therapeutic Area:
Metastatic Renal Cell Carcinoma
Manufacturer:
Bristol Myers-Squibb Canada
Brand Name:
Opdivo
Project Line:
Reimbursement Review
Project Number:
PC0074-000
NOC Status at Filing:
Pre NOC
Strength:
40mg and 100mg vials
Tumour Type:
Genitourinary
Indications:
Metastatic Renal Cell Carcinoma
Funding Request:
For advanced or metastatic renal cell carcinoma in patients who have received prior systemic therapy
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:
Please note that the August pERC meeting was conducted over two days. The original target date for the posting of pERC Final Recommendation remains as September 1, 2016.
pERC Meeting:
Final Recommendation Issued:

Files

Provincial Funding Summary View PDF
Nivolumab (Opdivo) Metastatic Renal Cell Carcinoma – pERC Final Recommendation Final Recommendation September 1, 2016 View PDF
Nivolumab (Opdivo) Metastatic Renal Cell Carcinoma – Final Clinical Guidance Report Guidance Reports September 1, 2016 View PDF
Nivolumab (Opdivo) Metastatic Renal Cell Carcinoma – Final Economic Guidance Report Guidance Reports September 1, 2016 View PDF
Nivolumab (Opdivo) Metastatic Renal Cell Carcinoma – pERC Initial Recommendation Initial Recommendation June 30, 2016 View PDF
Nivolumab (Opdivo) Metastatic Renal Cell Carcinoma – PAG Feedback on Initial Recommendation Feedback September 1, 2016 View PDF
Nivolumab (Opdivo) Metastatic Renal Cell Carcinoma – Manufacturer Feedback on Initial Recommendation Feedback September 1, 2016 View PDF
Nivolumab (Opdivo) Metastatic Renal Cell Carcinoma – Patient Advocacy Group Feedback on Initial Recommendation Feedback September 1, 2016 View PDF
Nivolumab (Opdivo) Metastatic Renal Cell Carcinoma – Patient Advocacy Group COI Declarations COI Declarations September 1, 2016 View PDF

‡ 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.

Last Updated : September 19, 2016