letermovir

Details

Generic Name:
letermovir
Project Status:
Withdrawn
Therapeutic Area:
Cytomegalovirus infection (CMV), prophylaxis
Manufacturer:
Merck Canada Inc.
Call for patient/clinician input open:
Brand Name:
Prevymis
Project Line:
Reimbursement Review
Project Number:
SR0824-000
Call for patient/clinician input closed:
NOC Status at Filing:
Post NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Letermovir is indicated for the prophylaxis of CMV disease in adult kidney transplant recipients who are at high risk (donor CMV-seropositive [D+]/recipient CMV-seronegative [R-]).
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Letermovir is indicated for the prophylaxis of CMV disease in adult kidney transplant recipients who are at high risk (donor CMV-seropositive [D+]/recipient CMV-seronegative [R-]).
  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 openSeptember 15, 2023
Call for patient/clinician input closedNovember 14, 2023
Clarification:

- No patient input submission received

Submission receivedOctober 30, 2023
Submission acceptedNovember 14, 2023
Review initiatedNovember 15, 2023
Draft CADTH review report(s) provided to sponsor for commentFebruary 08, 2024
Clarification:

- Voluntarily withdrawn by the sponsor on 14-May-2024

Deadline for sponsors commentsFebruary 20, 2024
Clarification:

- Submission temporarily suspended

- Temporary suspension of the review has been lifted