nitisinone

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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:
NOC Status at Filing:
Post NOC
Performance Metric:
Achieved
Biosimilar:
No
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 posted August 31, 2017
Patient group input closed October 23, 2017
Clarification:

- Patient input submission received

Submission received September 29, 2017
Submission accepted for review October 16, 2017
Review initiated October 20, 2017
Draft CDR review report(s) sent to applicant January 24, 2018
Comments from applicant on draft CDR review report(s) received February 02, 2018
Redaction requests from applicant on draft CDR review report(s) received February 09, 2018
Canadian Drug Expert Committee (CDEC) meeting March 21, 2018
CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plans April 04, 2018
Embargo period ended and validation of redacted CDR review report(s) received April 18, 2018
CDEC Final Recommendation issued to applicant and drug plans April 25, 2018
CDEC Final Recommendation posted April 27, 2018
Final CDR review report(s) and patient input posted April 27, 2018