nivolumab

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Generic Name:
nivolumab
Project Status:
Complete
Therapeutic Area:
Gastroesophageal junction or esophageal adenocarcinoma
Manufacturer:
Bristol-Myers Squibb
Brand Name:
Opdivo
Project Line:
Reimbursement Review
Project Number:
PC0259-000
Tumour Type:
Gastrointestinal
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
In combination with fluoropyrimidine- and platinum-containing chemotherapy, for the treatment of adult patients with advanced or metastatic gastric, gastroesophageal junction or esophageal adenocarcinoma.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
In combination with fluoropyrimidine- and platinum-containing chemotherapy, for the treatment of adult patients with advanced or metastatic gastric, gastroesophageal junction or esophageal adenocarcinoma.
Recommendation Type:
Reimburse with clinical criteria and/or conditions
Final Recommendation:
  1. The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of CADTH. Reimbursement criteria from CADTH will be documented in the final recommendation, if applicable.

Key Milestones2

Call for patient/clinician input open20-Jul-21
Call for patient/clinician input closed13-Sep-21
Clarification:

- Patient input submission received from My Gut Feeling - Stomach Cancer Foundation of Canada

Submission received18-Aug-21
Submission accepted01-Sep-21
Review initiated02-Sep-21
Draft CADTH review report(s) provided to sponsor for comment17-Nov-21
Deadline for sponsors comments26-Nov-21
CADTH review report(s) and responses to comments provided to sponsor23-Dec-21
Expert committee meeting (initial)12-Jan-22
Draft recommendation issued to sponsor25-Jan-22
Draft recommendation posted for stakeholder feedback03-Feb-22
End of feedback period17-Feb-22
Final recommendation issued to sponsor and drug plans04-Mar-22
Final recommendation posted22-Mar-22
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)18-Mar-22
CADTH review report(s) posted22-Jul-22