nitisinone

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Generic Name:
nitisinone
Project Status:
Complete
Therapeutic Area:
Hereditary tyrosinemia type 1
Manufacturer:
Sobi Canada Inc.
Call for patient/clinician input open:
Brand Name:
Orfadin
Project Line:
Reimbursement Review
Project Number:
SR0531-000
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
Recommendation Type:
Reimburse with clinical criteria and/or conditions
Final Recommendation:

Key Milestones2

Call for patient input posted July 28, 2017
Patient group input closed September 19, 2017
Clarification:

- Patient input submission received

Patient input summary sent for review to patient input groups October 05, 2017
Patient group comments on input summary closed October 13, 2017
Clarification:

- Patient input summary feedback received

Submission received August 29, 2017
Submission accepted for review September 13, 2017
Review initiated September 14, 2017
Draft CADTH review report(s) sent to sponsor November 27, 2017
Comments from sponsor on draft CADTH review report(s) received December 06, 2017
Redaction requests from sponsor on draft CADTH review report(s) received December 13, 2017
CADTH review team's comments on draft CADTH review report(s) sent to sponsor January 05, 2018
Canadian Drug Expert Committee (CDEC) meeting January 17, 2018
CDEC recommendation & redacted CADTH review report(s) sent to sponsor and drug plans January 30, 2018
Embargo period ended and validation of redacted CADTH review report(s) received February 13, 2018
CDEC Final Recommendation issued to sponsor and drug plans February 21, 2018
CDEC Final Recommendation posted February 23, 2018
Final CADTH review report(s) and patient input posted April 18, 2018