Generic Name: nitisinone
Brand Name: Orfadin
Manufacturer: Sobi Canada Inc.
Indications: Hereditary tyrosinemia type 1
Submission Type: New
Project Status: Active
Fee Schedule1: Schedule A
|Call for patient input posted3||July 28, 2017|
|Patient group input closed3||September 19, 2017|
- 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|
- Patient input summary feedback received
|Submission received||August 29, 2017|
|Submission accepted for review||September 13, 2017|
|Review initiated||September 14, 2017|
|Draft CDR review report(s) sent to applicant||November 27, 2017|
|Comments from applicant on draft CDR review report(s) received||December 06, 2017|
|Redaction requests from applicant on draft CDR review report(s) received||December 13, 2017|
|CDR review team's comments on draft CDR review report(s) sent to applicant||January 05, 2018|
|Canadian Drug Expert Committee (CDEC) meeting||January 17, 2018|
|CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plans||January 30, 2018|
|Embargo4 period ended and validation of redacted CDR review report(s) received||February 13, 2018|
|CDEC Final Recommendation issued to applicant and drug plans||February 21, 2018|
|CDEC Final Recommendation posted5||-|
|Final CDR review report(s) and patient input posted5||-|
- Refer to Appendix 1 of the Procedure for the CADTH Common Drug Review for details regarding CDR application fee schedules.
- Please refer to the Procedure for the CADTH Common Drug Review for complete details regarding the CDR process and targeted time frames for key milestones.
- The call for patient group input is posted 20 business days in advance of the applicant's anticipated date of filing the CDR application. Patient groups have a total of 35 business days for preparing and submitting patient input.
- The embargoed CDEC recommendation is held in confidence by all stakeholders and not acted upon until after CADTH has issued the notice of CDEC Final Recommendation.The applicant may make a request for reconsideration or resubmission based on reduced price during the embargo period, and the drug plans may make a request for clarification, as applicable (see section 8 of the Procedure for the CADTH Common Drug Review).
- The timing for posting the CDEC Final Recommendation and CDR review report(s) depends on several factors including the need for consultation with the applicant regarding redaction issues.
- The time frame required to address a request for clarification at the drug plans' request or request for reconsideration at the applicant's request depends on the amount of work required to address the request and the available dates for CDEC meetings.
digestive system, genetics, pediatrics, tyrosinemias, nitisinone; tyrosinemia