Generic Name: doravirine lamuvidine tenofovir disoproxil fumarate
Brand Name: Delstrigo
Manufacturer: Merck Canada Inc.
Indications: HIV-1 infection
Manufacturer Requested Reimbursement Criteria1: For the treatment of adults infected with HIV-1 without past or present evidence of viral resistance to doravirine, lamivudine, or tenofovir.
Submission Type: New
Project Status: Complete
Biosimilar: No
Companion Diagnostics: No
Date Recommendation Issued: May 14, 2019
Recommendation Type: Reimburse with clinical criteria and/or conditions
Fee Schedule: Schedule C
- The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of CADTH. Reimbursement criteria from CADTH 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 applicant | February 22, 2019 |
| Comments from applicant on draft CADTH review report(s) received | March 05, 2019 |
| Redaction requests from applicant on draft CADTH review report(s) received | March 12, 2019 |
| CADTH review team's comments on draft CADTH review report(s) sent to applicant | March 29, 2019 |
| Canadian Drug Expert Committee (CDEC) meeting | April 10, 2019 |
| CDEC recommendation & redacted CADTH review report(s) sent to applicant 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 applicant and drug plans | May 14, 2019 |
| CDEC Final Recommendation posted | May 16, 2019 |
| Final CADTH review report(s) posted | June 14, 2019 |