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Last Updated: October 24, 2019
Result type: Reports
Project Number: SR0582-000
Product Line: Reimbursement Review

Generic Name: doravirine

Brand Name: Pifeltro

Manufacturer: Merck Canada Inc.

Therapeutic Area: HIV-1 infection

Indications: HIV-1 infection

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

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 A

  1. 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 postedSeptember 14, 2018
Patient group input closedNovember 05, 2018

- Patient input submission received

Patient input summary sent for review to patient input groupsDecember 14, 2018
Patient group comments on input summary closedDecember 21, 2018
Submission receivedNovember 16, 2018
Submission accepted for reviewNovember 30, 2018
Review initiatedDecember 03, 2018
Draft CADTH review report(s) sent to sponsorFebruary 22, 2019
Comments from sponsor on draft CADTH review report(s) receivedMarch 05, 2019
Redaction requests from sponsor on draft CADTH review report(s) receivedMarch 12, 2019
CADTH review team's comments on draft CADTH review report(s) sent to sponsorMarch 29, 2019
Canadian Drug Expert Committee (CDEC) meetingApril 10, 2019
CDEC recommendation & redacted CADTH review report(s) sent to sponsor and drug plansApril 23, 2019
Embargo period ended and validation of redacted CADTH review report(s) receivedMay 07, 2019
CDEC Final Recommendation issued to sponsor and drug plansMay 14, 2019
CDEC Final Recommendation postedMay 16, 2019
Final CADTH review report(s) postedJune 12, 2019