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Last Updated: October 25, 2019
Result type: Reports
Project Number: SR0531-000
Product Line: Reimbursement Review

Generic Name: nitisinone

Brand Name: Orfadin

Manufacturer: Sobi Canada Inc.

Therapeutic Area: Hereditary tyrosinemia type 1

Indications: Hereditary tyrosinemia type 1

Submission Type: Initial

Project Status: Complete

Biosimilar: No

Date Recommendation Issued: February 21, 2018

Recommendation Type: Reimburse with clinical criteria and/or conditions

Fee Schedule: Schedule A

Key Milestones2

Call for patient input postedJuly 28, 2017
Patient group input closedSeptember 19, 2017

- Patient input submission received

Patient input summary sent for review to patient input groupsOctober 05, 2017
Patient group comments on input summary closedOctober 13, 2017

- Patient input summary feedback received

Submission receivedAugust 29, 2017
Submission accepted for reviewSeptember 13, 2017
Review initiatedSeptember 14, 2017
Draft CADTH review report(s) sent to sponsorNovember 27, 2017
Comments from sponsor on draft CADTH review report(s) receivedDecember 06, 2017
Redaction requests from sponsor on draft CADTH review report(s) receivedDecember 13, 2017
CADTH review team's comments on draft CADTH review report(s) sent to sponsorJanuary 05, 2018
Canadian Drug Expert Committee (CDEC) meetingJanuary 17, 2018
CDEC recommendation & redacted CADTH review report(s) sent to sponsor and drug plansJanuary 30, 2018
Embargo period ended and validation of redacted CADTH review report(s) receivedFebruary 13, 2018
CDEC Final Recommendation issued to sponsor and drug plansFebruary 21, 2018
CDEC Final Recommendation postedFebruary 23, 2018
Final CADTH review report(s) and patient input postedApril 18, 2018