nitisinone


( Last Updated : January 14, 2019)
Generic Name:
nitisinone
Project Status:
Complete
Therapeutic Area:
Hereditary tyrosinemia type 1
Manufacturer:
MendeliKABS Inc
Call for patient/clinician input open:
Brand Name:
MDK-Nitisinone
Project Line:
Reimbursement Review
Project Number:
SR0538-000
Call for patient/clinician input closed:

Details

Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Hereditary tyrosinemia type 1
Date NOC Issued:
Recommendation Type:
Reimburse with clinical criteria and/or conditions
Final Recommendation:

Key Milestones2

Call for patient input postedAugust 31, 2017
Patient group input closedOctober 23, 2017
Clarification:

- Patient input submission received

Submission receivedSeptember 29, 2017
Submission accepted for reviewOctober 16, 2017
Review initiatedOctober 20, 2017
Draft CDR review report(s) sent to applicantJanuary 24, 2018
Comments from applicant on draft CDR review report(s) receivedFebruary 02, 2018
Redaction requests from applicant on draft CDR review report(s) receivedFebruary 09, 2018
Canadian Drug Expert Committee (CDEC) meetingMarch 21, 2018
CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plansApril 04, 2018
Embargo period ended and validation of redacted CDR review report(s) receivedApril 18, 2018
CDEC Final Recommendation issued to applicant and drug plansApril 25, 2018
CDEC Final Recommendation postedApril 27, 2018
Final CDR review report(s) and patient input postedApril 27, 2018

Files

Recommendations and Reasons

Clinical Report

Pharmacoeconomic Report

Patient Group Input Submissions