Generic Name: Darunavir/cobicistat/emtricitabine/tenofovir alafenamide
Brand Name: TBC
Manufacturer: Janssen Inc.
Indications: HIV-1 infection
Submission Type: New
Project Status: Active
Fee Schedule1: Schedule CSubmit Feedback
|Call for patient input posted3||November 24, 2017|
|Patient group input closed3||January 22, 2018|
|Patient input summary sent for review to patient input groups||-|
|Patient group comments on input summary closed||-|
|Submission received||December 22, 2017|
|Submission accepted for review||January 15, 2018|
|Review initiated||January 16, 2018|
|Draft CDR review report(s) sent to applicant||April 02, 2018|
|Comments from applicant on draft CDR review report(s) received||April 11, 2018|
|Redaction requests from applicant on draft CDR review report(s) received||April 18, 2018|
|CDR review team's comments on draft CDR review report(s) sent to applicant||June 08, 2018|
|Canadian Drug Expert Committee (CDEC) meeting||June 20, 2018|
|CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plans||July 03, 2018|
July 05, 2018
- Refer to Appendix 1 of the Procedure for the CADTH Common Drug Review for details regarding CDR application fee schedules.
- Please refer to the Procedure for the CADTH Common Drug Review for complete details regarding the CDR process and targeted time frames for key milestones.
- The call for patient group input is posted 20 business days in advance of the applicant's anticipated date of filing the CDR application. Patient groups have a total of 35 business days for preparing and submitting patient input.
- The embargoed CDEC recommendation is held in confidence by all stakeholders and not acted upon until after CADTH has issued the notice of CDEC Final Recommendation.The applicant may make a request for reconsideration or resubmission based on reduced price during the embargo period, and the drug plans may make a request for clarification, as applicable (see section 8 of the Procedure for the CADTH Common Drug Review).
- The timing for posting the CDEC Final Recommendation and CDR review report(s) depends on several factors including the need for consultation with the applicant regarding redaction issues.
- The time frame required to address a request for clarification at the drug plans' request or request for reconsideration at the applicant's request depends on the amount of work required to address the request and the available dates for CDEC meetings.
infectious diseases, hiv/aids