nitisinone

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Generic 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
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:
  1. The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of CADTH. Reimbursement criteria from CADTH 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