nirmatrelvir/ritonavir

Details

Files
Generic Name:
nirmatrelvir/ritonavir
Project Status:
Active
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
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.
  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 openAugust 03, 2023
Call for patient/clinician input closedSeptember 25, 2023
Clarification:

- Patient input submission received from the Gastrointestinal Society, Lung Health Foundation, Save Your Skin Foundation and Sickle Cell Awareness Group of Ontario

Submission receivedSeptember 15, 2023
Submission acceptedSeptember 29, 2023
Review initiatedOctober 03, 2023
Draft CADTH review report(s) provided to sponsor for commentNovember 07, 2023
Deadline for sponsors commentsNovember 14, 2023
CADTH review report(s) and responses to comments provided to sponsorDecember 08, 2023
Expert committee meeting (initial)December 20, 2023
Draft recommendation issued to sponsorJanuary 09, 2024
Draft recommendation posted for stakeholder feedbackJanuary 18, 2024
End of feedback periodFebruary 02, 2024
Clarification:

- Reconsideration: major revisions requested by sponsor

Expert committee meetingMarch 27, 2024
Final recommendation issued to sponsor and drug plansApril 11, 2024
Final recommendation posted-
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)April 25, 2024
CADTH review report(s) posted-