Generic Name: cysteamine bitartrate
Brand Name: Procysbi
Manufacturer: Horizon Pharma
Indications: Nephropathic cystinosis
Submission Type: New
Project Status: Complete
Biosimilar: No
Date Recommendation Issued: January 24, 2018
Recommendation Type: Reimburse with clinical criteria and/or conditions
Fee Schedule: Schedule A
Key Milestones2 |
|
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Call for patient input posted | June 05, 2017 |
Patient group input closed | July 25, 2017 |
Clarification:
- Patient input submission received |
|
Patient input summary sent for review to patient input groups | September 12, 2017 |
Patient group comments on input summary closed | September 18, 2017 |
Clarification:
- Patient input summary feedback received |
|
Submission received | August 08, 2017 |
Submission accepted for review | August 22, 2017 |
Review initiated | August 23, 2017 |
Draft CADTH review report(s) sent to applicant | November 07, 2017 |
Comments from applicant on draft CADTH review report(s) received | November 16, 2017 |
Redaction requests from applicant on draft CADTH review report(s) received | November 23, 2017 |
CADTH review team's comments on draft CADTH review report(s) sent to applicant | December 01, 2017 |
Canadian Drug Expert Committee (CDEC) meeting | December 13, 2017 |
CDEC recommendation & redacted CADTH review report(s) sent to applicant and drug plans | January 03, 2018 |
Embargo period ended and validation of redacted CADTH review report(s) received | January 17, 2018 |
CDEC Final Recommendation issued to applicant and drug plans | January 24, 2018 |
CDEC Final Recommendation posted | January 26, 2018 |
Final CADTH review report(s) and patient input posted | February 08, 2018 |