CADTH is committed to supporting Canada’s health care decision-makers through this challenging and uncertain time.
For evidence, tools, and resources related to COVID-19, visit our COVID-19 Evidence Portal.


Begin main content

Opdivo for Melanoma Adjuvant Therapy – Details

Project Number PC0147-000
Brand Name Opdivo
Generic Name Nivolumab
Strength 40 mg & 100 mg
Tumour Type Skin & Melanoma
Indication Melanoma Adjuvant Therapy
Funding Request For the adjuvant treatment of adult patients after complete resection of melanoma with regional lymph node involvement, in transit metastases/satellites without metastatic nodes, or distant metastases
Review Status Notification to Implement Issued
Pre Noc Submission Yes
NOC Date November 15, 2018
Manufacturer Bristol-Myers Squibb Canada
Sponsor Bristol-Myers Squibb Canada
Submission Date August 27, 2018
Submission Deemed Complete September 11, 2018
Submission Type Initial
Prioritization Requested Requested and Granted
Stakeholder Input Deadline ‡ September 11, 2018
Check-point meeting October 17, 2018
pERC Meeting December 13, 2018
Initial Recommendation Issued January 4, 2019
Feedback Deadline ‡ January 18, 2019
pERC Reconsideration Meeting February 21, 2019
Final Recommendation Issued March 7, 2019
Notification to Implement Issued March 22, 2019
Therapeutic Area Melanoma Adjuvant Therapy
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.