Last Updated : October 29, 2019
Details
FilesGeneric Name:
doravirine
Project Status:
Complete
Therapeutic Area:
HIV-1 infection
Manufacturer:
Merck Canada Inc.
Call for patient/clinician input open:
Brand Name:
Pifeltro
Project Line:
Reimbursement Review
Project Number:
SR0582-000
Call for patient/clinician input closed:
NOC Status at Filing:
Post NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
In combination with other antiretroviral medicinal products, for the treatment of adults infected with HIV-1 without past or present evidence of viral resistance to doravirine.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
HIV-1 infection
Recommendation Type:
Reimburse with clinical criteria and/or conditions
Final Recommendation:
- 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 input posted | September 14, 2018 |
| Patient group input closed | November 05, 2018 |
| Clarification:
- Patient input submission received |
|
| Patient input summary sent for review to patient input groups | December 14, 2018 |
| Patient group comments on input summary closed | December 21, 2018 |
| Submission received | November 16, 2018 |
| Submission accepted for review | November 30, 2018 |
| Review initiated | December 03, 2018 |
| Draft CADTH review report(s) sent to sponsor | February 22, 2019 |
| Comments from sponsor on draft CADTH review report(s) received | March 05, 2019 |
| Redaction requests from sponsor on draft CADTH review report(s) received | March 12, 2019 |
| CADTH review team's comments on draft CADTH review report(s) sent to sponsor | March 29, 2019 |
| Canadian Drug Expert Committee (CDEC) meeting | April 10, 2019 |
| CDEC recommendation & redacted CADTH review report(s) sent to sponsor and drug plans | April 23, 2019 |
| Embargo period ended and validation of redacted CADTH review report(s) received | May 07, 2019 |
| CDEC Final Recommendation issued to sponsor and drug plans | May 14, 2019 |
| CDEC Final Recommendation posted | May 16, 2019 |
| Final CADTH review report(s) posted | June 12, 2019 |
Files
Last Updated : October 29, 2019