Last Updated : September 4, 2024
Details
FilesGeneric Name:
remdesivir
Project Status:
Active
Therapeutic Area:
COVID-19 in non-hospitalized patients
Manufacturer:
Gilead Sciences Canada, Inc
Call for patient/clinician input open:
Brand Name:
Veklury
Project Line:
Reimbursement Review
Project Number:
SR0834-000
Call for patient/clinician input closed:
NOC Status at Filing:
Post NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Non-hospitalized patients 12 years of age (weighing at least 40 kg) with positive results of direct severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Non-hospitalized patients ≥12 years of age (weighing at least 40 kg) with positive results of direct severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death
Recommendation Type:
Reimburse with clinical criteria and/or conditions
Final Recommendation:
- 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 | 08-Jan-24 |
|---|---|
| Call for patient/clinician input closed | 04-Mar-24 |
| Clarification: - Patient input submission received from the Gastrointestinal Society | |
| Submission received | 01-Mar-24 |
| Submission accepted | 18-Mar-24 |
| Review initiated | 19-Mar-24 |
| Draft CADTH review report(s) provided to sponsor for comment | 13-May-24 |
| Deadline for sponsors comments | 23-May-24 |
| CADTH review report(s) and responses to comments provided to sponsor | 14-Jun-24 |
| Expert committee meeting (initial) | 26-Jun-24 |
| Draft recommendation issued to sponsor | 09-Jul-24 |
| Draft recommendation posted for stakeholder feedback | 18-Jul-24 |
| End of feedback period | 01-Aug-24 |
| Final recommendation issued to sponsor and drug plans | 16-Aug-24 |
| Final recommendation posted | 04-Sep-24 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | 30-Aug-24 |
| CADTH review report(s) posted | - |
Files
Last Updated : September 4, 2024