Last Updated : January 29, 2025
Details
FilesGeneric Name:
nivolumab
Project Status:
Complete
Therapeutic Area:
Gastric, 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/Report:
- The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of Canada's Drug Agency. Reimbursement criteria from Canada's Drug Agency will be documented in the final recommendation, if applicable.
| Call for patient/clinician input open | July 20, 2021 |
|---|---|
| Call for patient/clinician input closed | September 13, 2021 |
| Clarification: - Patient input submission received from My Gut Feeling - Stomach Cancer Foundation of Canada | |
| Submission received | August 18, 2021 |
| Submission accepted | September 01, 2021 |
| Review initiated | September 02, 2021 |
| Draft CADTH review report(s) provided to sponsor for comment | November 17, 2021 |
| Deadline for sponsors comments | November 26, 2021 |
| CADTH review report(s) and responses to comments provided to sponsor | December 23, 2021 |
| Expert committee meeting (initial) | January 12, 2022 |
| Draft recommendation issued to sponsor | January 25, 2022 |
| Draft recommendation posted for stakeholder feedback | February 03, 2022 |
| End of feedback period | February 17, 2022 |
| Final recommendation issued to sponsor and drug plans | March 04, 2022 |
| Final recommendation posted | March 22, 2022 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | March 18, 2022 |
| CADTH review report(s) posted | July 22, 2022 |
Files
Last Updated : January 29, 2025