CADTH is committed to supporting Canada’s health care decision-makers through this challenging and uncertain time.
For evidence, tools, and resources related to COVID-19, visit our COVID-19 Evidence Portal.


Begin main content


Last Updated: August 31, 2018
Result type: Reports
Project Number: SR0554-000
Product Line: Reimbursement Review

Generic Name: nitisinone

Brand Name: Nitisinone

Manufacturer: Cycle Pharmaceuticals Ltd.

Therapeutic Area: Hereditary tyrosinemia type 1

Indications: Hereditary tyrosinemia type 1

Manufacturer Requested Reimbursement Criteria1: Hereditary tyrosinemia type 1

Submission Type: Initial

Project Status: Complete

Biosimilar: No

Date Recommendation Issued: August 23, 2018

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 postedDecember 14, 2017
Patient group input closedFebruary 09, 2018

- Patient input submission received

Patient input summary sent for review to patient input groupsFebruary 27, 2018
Patient group comments on input summary closedMarch 06, 2018

- Patient input summary feedback received

Submission receivedJanuary 25, 2018
Submission accepted for reviewFebruary 08, 2018
Review initiatedFebruary 09, 2018

- Temporary suspension due to non-payment of the application fee

- Temporary suspension of the review has been lifted

Draft CDR review report(s) sent to applicantMay 31, 2018
Comments from applicant on draft CDR review report(s) receivedJune 11, 2018
Redaction requests from applicant on draft CDR review report(s) receivedJune 18, 2018

- No redactions requested by the applicant

CDR review team's comments on draft CDR review report(s) sent to applicantJuly 06, 2018
Canadian Drug Expert Committee (CDEC) meetingJuly 18, 2018
CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plansJuly 30, 2018
Embargo period ended and validation of redacted CDR review report(s) receivedAugust 14, 2018
CDEC Final Recommendation issued to applicant and drug plansAugust 21, 2018
CDEC Final Recommendation postedAugust 23, 2018
Final CDR review report(s) and patient input postedAugust 31, 2018