Last Updated : July 9, 2024
Details
FilesGeneric Name:
nirmatrelvir/ritonavir
Project Status:
Complete
Therapeutic Area:
Mild-to-moderate COVID-19, treatment
Manufacturer:
Pfizer Canada ULC
Call for patient/clinician input open:
Brand Name:
Paxlovid
Project Line:
Reimbursement Review
Project Number:
SR0808-000
Call for patient/clinician input closed:
NOC Status at Filing:
Post NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
For the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults 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:
For the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults 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 | 03-Aug-23 |
|---|---|
| Call for patient/clinician input closed | 25-Sep-23 |
| Clarification: - Patient input submission received from the Gastrointestinal Society, Lung Health Foundation, Save Your Skin Foundation and Sickle Cell Awareness Group of Ontario | |
| Submission received | 15-Sep-23 |
| Submission accepted | 29-Sep-23 |
| Review initiated | 03-Oct-23 |
| Draft CADTH review report(s) provided to sponsor for comment | 07-Nov-23 |
| Deadline for sponsors comments | 14-Nov-23 |
| CADTH review report(s) and responses to comments provided to sponsor | 08-Dec-23 |
| Expert committee meeting (initial) | 20-Dec-23 |
| Draft recommendation issued to sponsor | 09-Jan-24 |
| Draft recommendation posted for stakeholder feedback | 18-Jan-24 |
| End of feedback period | 02-Feb-24 |
| Clarification: - Reconsideration: major revisions requested by sponsor | |
| Expert committee meeting | 27-Mar-24 |
| Final recommendation issued to sponsor and drug plans | 11-Apr-24 |
| Final recommendation posted | 30-Apr-24 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | 25-Apr-24 |
| CADTH review report(s) posted | 09-Jul-24 |
Files
Last Updated : July 9, 2024