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 |