remdesivir

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Generic Name:
remdesivir
Project Status:
Complete
Therapeutic Area:
COVID-19 in hospitalized patients
Manufacturer:
Gilead Sciences Canada, Inc.
Call for patient/clinician input open:
Brand Name:
Veklury
Project Line:
Reimbursement Review
Project Number:
SR0833-000
Call for patient/clinician input closed:
NOC Status at Filing:
Post NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Hospitalized patients 12 years of age (weighing at least 40 kg) with pneumonia requiring supplemental oxygen.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Hospitalized patients ≥12 years of age (weighing at least 40 kg) with pneumonia requiring supplemental oxygen.
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 Canada's Drug Agency. Reimbursement criteria from Canada's Drug Agency 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:

- No patient input submission received

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
Draft recommendation posted for stakeholder feedbackJuly 18, 2024
End of feedback periodAugust 01, 2024
Final recommendation issued to sponsor and drug plansAugust 16, 2024
Final recommendation postedSeptember 04, 2024
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)August 30, 2024
CADTH review report(s) postedJanuary 08, 2025