Generic Name: letermovir
Brand Name: Prevymis
Manufacturer: Merck Canada Inc.
Therapeutic Area: Cytomegalovirus infection, prophylaxis
Indications: Cytomegalovirus infection, prophylaxis
Submission Type: Initial
Project Status: Complete
Biosimilar: No
Date Recommendation Issued: June 20, 2018
Recommendation Type: Reimburse with clinical criteria and/or conditions
Fee Schedule: Schedule A
Key Milestones2 | |
|---|---|
| Call for patient input posted | November 03, 2017 |
| Patient group input closed | December 22, 2017 |
| Clarification: - Patient input submission received | |
| Patient input summary sent for review to patient input groups | January 10, 2018 |
| Patient group comments on input summary closed | January 17, 2018 |
| Clarification: - Patient input summary feedback received | |
| Submission received | December 07, 2017 |
| Submission accepted for review | December 21, 2017 |
| Review initiated | December 22, 2017 |
| Draft CDR review report(s) sent to applicant | March 15, 2018 |
| Comments from applicant on draft CDR review report(s) received | March 26, 2018 |
| Redaction requests from applicant on draft CDR review report(s) received | April 03, 2018 |
| CDR review team's comments on draft CDR review report(s) sent to applicant | May 04, 2018 |
| Canadian Drug Expert Committee (CDEC) meeting | May 16, 2018 |
| CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plans | May 30, 2018 |
| Embargo period ended and validation of redacted CDR review report(s) received | June 13, 2018 |
| CDEC Final Recommendation issued to applicant and drug plans | June 20, 2018 |
| CDEC Final Recommendation posted | June 22, 2018 |
| Final CDR review report(s) and patient input posted | July 09, 2018 |