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doravirine

Last Updated: May 22, 2019
Result type: Reports
Project Number: SR0582-000
Product Line: Common Drug Review

Generic Name: doravirine

Brand Name: Pifeltro

Manufacturer: Merck Canada Inc.

Indications: HIV-1

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: New

Project Status: Active

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 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 -