Last Updated : April 5, 2024
Details
Generic Name:
letermovir
Project Status:
Active
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 CADTH. Reimbursement criteria from CADTH will be documented in the final recommendation, if applicable.
| Call for patient/clinician input open | 15-Sep-23 |
|---|---|
| Call for patient/clinician input closed | 14-Nov-23 |
| Clarification: - No patient input submission received | |
| Submission received | 30-Oct-23 |
| Submission accepted | 14-Nov-23 |
| Review initiated | 15-Nov-23 |
| Draft CADTH review report(s) provided to sponsor for comment | 08-Feb-24 |
| Deadline for sponsors comments | 20-Feb-24 |
| Clarification: - Submission temporarily suspended - Temporary suspension of the review has been lifted | |
| CADTH review report(s) and responses to comments provided to sponsor | 14-Jun-24 |
| Expert committee meeting (initial) | 26-Jun-24 |
| Draft recommendation issued to sponsor | July 09, 2024 To July 11, 2024 |
| Draft recommendation posted for stakeholder feedback | 18-Jul-24 |
| End of feedback period | 01-Aug-24 |
Last Updated : April 5, 2024