Last Updated : August 31, 2018
Details
FilesGeneric Name:
nitisinone
Project Status:
Complete
Therapeutic Area:
Hereditary tyrosinemia type 1
Manufacturer:
Cycle Pharmaceuticals Ltd.
Call for patient/clinician input open:
Brand Name:
Nitisinone
Project Line:
Reimbursement Review
Project Number:
SR0554-000
Call for patient/clinician input closed:
NOC Status at Filing:
Post NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Hereditary tyrosinemia type 1
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:
- The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of Canada's Drug Agency. Reimbursement criteria from Canada's Drug Agency will be documented in the final recommendation, if applicable.
Key Milestones2 |
|
|---|---|
| Call for patient input posted | December 14, 2017 |
| Patient group input closed | February 09, 2018 |
| Clarification:
- Patient input submission received |
|
| Patient input summary sent for review to patient input groups | February 27, 2018 |
| Patient group comments on input summary closed | March 06, 2018 |
| Clarification:
- Patient input summary feedback received |
|
| Submission received | January 25, 2018 |
| Submission accepted for review | February 08, 2018 |
| Review initiated | February 09, 2018 |
| Clarification:
- Temporary suspension due to non-payment of the application fee - Temporary suspension of the review has been lifted |
|
| Draft CDR review report(s) sent to applicant | May 31, 2018 |
| Comments from applicant on draft CDR review report(s) received | June 11, 2018 |
| Redaction requests from applicant on draft CDR review report(s) received | June 18, 2018 |
| Clarification:
- No redactions requested by the applicant |
|
| CDR review team's comments on draft CDR review report(s) sent to applicant | July 06, 2018 |
| Canadian Drug Expert Committee (CDEC) meeting | July 18, 2018 |
| CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plans | July 30, 2018 |
| Embargo period ended and validation of redacted CDR review report(s) received | August 14, 2018 |
| CDEC Final Recommendation issued to applicant and drug plans | August 21, 2018 |
| CDEC Final Recommendation posted | August 23, 2018 |
| Final CDR review report(s) and patient input posted | August 31, 2018 |
Files
Last Updated : August 31, 2018