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 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 |