Last Updated : May 14, 2024
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Withdrawn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-]).
- 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.
| Call for patient/clinician input open | September 15, 2023 |
|---|---|
| Call for patient/clinician input closed | November 14, 2023 |
| Clarification: - No patient input submission received | |
| Submission received | October 30, 2023 |
| Submission accepted | November 14, 2023 |
| Review initiated | November 15, 2023 |
| Draft CADTH review report(s) provided to sponsor for comment | February 08, 2024 |
| Clarification: - Voluntarily withdrawn by the sponsor on 14-May-2024 | |
| Deadline for sponsors comments | February 20, 2024 |
| Clarification: - Submission temporarily suspended - Temporary suspension of the review has been lifted | |
Last Updated : May 14, 2024