Generic Name: migalastat
Brand Name: Galafold
Manufacturer: Amicus Therapeutics
Indications: Fabry Disease
Submission Type: New
Project Status: Complete
Date Recommendation Issued: January 24, 2018
Recommendation Type: Reimburse with clinical criteria and/or conditions
Fee Schedule1: Schedule A
|Call for patient input posted3||May 05, 2017|
|Patient group input closed3||June 26, 2017|
- Patient input submission received
|Patient input summary sent for review to patient input groups||July 21, 2017|
|Patient group comments on input summary closed||July 28, 2017|
- Patient input summary feedback received
|Submission received||June 09, 2017|
|Submission accepted for review||June 23, 2017|
|Review initiated||July 05, 2017|
- Submission temporarily suspended pending receipt of information
- Additional information has been received and the temporary suspension of the review has been lifted
|Draft CDR review report(s) sent to applicant||October 23, 2017|
|Comments from applicant on draft CDR review report(s) received||November 01, 2017|
|Redaction requests from applicant on draft CDR review report(s) received||November 08, 2017|
|CDR review team's comments on draft CDR review report(s) sent to applicant||December 01, 2017|
|Canadian Drug Expert Committee (CDEC) meeting||December 13, 2017|
|CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plans||January 03, 2018|
|Embargo4 period ended and validation of redacted CDR review report(s) received||January 17, 2018|
|CDEC Final Recommendation issued to applicant and drug plans||January 24, 2018|
|CDEC Final Recommendation posted5||January 26, 2018|
|Final CDR review report(s) and patient input posted5||February 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.
genetics, nervous system, fabry disease, migalastat