Last Updated : December 21, 2018
Details
FilesGeneric Name:
bictegravir/emtricitabine/tenofovir alafenamide
Project Status:
Complete
Therapeutic Area:
HIV-1 infection
Manufacturer:
Gilead Sciences Canada, Inc.
Brand Name:
Biktarvy
Project Line:
Reimbursement Review
Project Number:
SR0567-000
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
A complete regimen for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adults with no known substitution associated with resistance to the individual components of TBD (bictegravir/emtricitabine/tenofovir alafenamide).
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 | April 02, 2018 |
| Patient group input closed | May 22, 2018 |
| Clarification: - Patient input submission received | |
| Patient input summary sent for review to patient input groups | June 07, 2018 |
| Patient group comments on input summary closed | June 14, 2018 |
| Clarification: - Patient input summary feedback received | |
| Submission received | April 30, 2018 |
| Submission accepted for review | May 14, 2018 |
| Review initiated | May 16, 2018 |
| Draft CDR review report(s) sent to applicant | July 31, 2018 |
| Comments from applicant on draft CDR review report(s) received | August 10, 2018 |
| Redaction requests from applicant on draft CDR review report(s) received | August 17, 2018 |
| CDR review team's comments on draft CDR review report(s) sent to applicant | September 07, 2018 |
| Canadian Drug Expert Committee (CDEC) meeting | September 19, 2018 |
| CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plans | October 03, 2018 |
| Embargo period ended and validation of redacted CDR review report(s) received | October 18, 2018 |
| CDEC Final Recommendation issued to applicant and drug plans | October 25, 2018 |
| CDEC Final Recommendation posted | October 29, 2018 |
| Final CDR review report(s) and patient input posted | October 29, 2018 |
Files
Last Updated : December 21, 2018