Generic Name: nitisinone
Brand Name: MDK-Nitisinone
Manufacturer: MendeliKABS Inc
Indications: Hereditary tyrosinemia type 1
Project Status: Active
Fee Schedule1: Schedule A
|Call for patient input posted3||August 31, 2017|
|Patient group input closed3||October 23, 2017|
- Patient input submission received
|Submission received||September 29, 2017|
|Submission accepted for review||October 16, 2017|
|Review initiated||October 20, 2017|
|Draft CDR review report(s) sent to applicant||January 24, 2018|
|Comments from applicant on draft CDR review report(s) received||February 02, 2018|
|Redaction requests from applicant on draft CDR review report(s) received||February 09, 2018|
|CDR review team's comments on draft CDR review report(s) sent to applicant||March 09, 2018|
|Canadian Drug Expert Committee (CDEC) meeting||March 21, 2018|
|CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plans||April 03, 2018|
April 05, 2018
- 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