Last Updated : October 23, 2019
Details
FilesGeneric Name:
dolutegravir / lamivudine
Project Status:
Complete
Therapeutic Area:
HIV-1 infection
Manufacturer:
ViiV Healthcare
Call for patient/clinician input open:
Brand Name:
Dovato
Project Line:
Reimbursement Review
Project Number:
SR0601-000
Call for patient/clinician input closed:
NOC Status at Filing:
Pre NOC
Performance Metric:
N/A delay outside our control - Application held awaiting decision by Health Canada
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Indicated as a complete regimen for the treatment of Human Immunodeficiency Virus type 1 (HIV-1) infection in adults and adolescents 12 years of age and older and weighing at least 40 kg.
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 | January 23, 2019 |
| Patient group input closed | March 14, 2019 |
| Clarification:
- Patient input submission received from the Canadian Treatment Action Council (CTAC) |
|
| Patient input summary sent for review to patient input groups | March 21, 2019 |
| Patient group comments on input summary closed | March 28, 2019 |
| Clarification:
- Patient input summary feedback received |
|
| Submission received | February 21, 2019 |
| Submission accepted for review | March 07, 2019 |
| Review initiated | March 08, 2019 |
| Draft CADTH review report(s) sent to sponsor | May 23, 2019 |
| Comments from sponsor on draft CADTH review report(s) received | June 03, 2019 |
| Redaction requests from sponsor on draft CADTH review report(s) received | June 10, 2019 |
| CADTH review team's comments on draft CADTH review report(s) sent to sponsor | July 05, 2019 |
| Canadian Drug Expert Committee (CDEC) meeting | July 17, 2019 |
| Clarification:
CDEC recommendation held pending receipt of NOC and evaluation of the finalized submission requirements. |
|
| CDEC recommendation & redacted CADTH review report(s) sent to sponsor and drug plans | September 09, 2019 |
| Embargo period ended and validation of redacted CADTH review report(s) received | September 23, 2019 |
| CDEC Final Recommendation issued to sponsor and drug plans | September 30, 2019 |
| CDEC Final Recommendation posted | October 02, 2019 |
| Final CADTH review report(s) posted | October 23, 2019 |
Files
Last Updated : October 23, 2019