remdesivir

Details

Generic 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
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
  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 openJanuary 08, 2024
Call for patient/clinician input closedMarch 04, 2024
Clarification:

- Patient input submission received from the Gastrointestinal Society

Submission receivedMarch 01, 2024
Submission acceptedMarch 18, 2024
Review initiatedMarch 19, 2024
Draft CADTH review report(s) provided to sponsor for commentMay 13, 2024
Deadline for sponsors commentsMay 23, 2024
CADTH review report(s) and responses to comments provided to sponsorJune 14, 2024
Expert committee meeting (initial)June 26, 2024
Draft recommendation issued to sponsorJuly 09, 2024
To
July 11, 2024
Draft recommendation posted for stakeholder feedbackJuly 18, 2024
End of feedback periodAugust 01, 2024