nirmatrelvir/ritonavir

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Generic 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
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:
  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 open03-Aug-23
Call for patient/clinician input closed25-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 received15-Sep-23
Submission accepted29-Sep-23
Review initiated03-Oct-23
Draft CADTH review report(s) provided to sponsor for comment07-Nov-23
Deadline for sponsors comments14-Nov-23
CADTH review report(s) and responses to comments provided to sponsor08-Dec-23
Expert committee meeting (initial)20-Dec-23
Draft recommendation issued to sponsor09-Jan-24
Draft recommendation posted for stakeholder feedback18-Jan-24
End of feedback period02-Feb-24
Clarification:

- Reconsideration: major revisions requested by sponsor

Expert committee meeting27-Mar-24
Final recommendation issued to sponsor and drug plans11-Apr-24
Final recommendation posted30-Apr-24
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)25-Apr-24
CADTH review report(s) posted09-Jul-24