Last Updated : October 29, 2019
Details
FilesGeneric 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
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 |
Files
Last Updated : October 29, 2019