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 | |
|---|---|
| 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 CDR review report(s) sent to applicant | November 07, 2017 |
| Comments from applicant on draft CDR review report(s) received | November 16, 2017 |
| Redaction requests from applicant on draft CDR review report(s) received | November 23, 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 |
| Embargo 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 posted | January 26, 2018 |
| Final CDR review report(s) and patient input posted | February 08, 2018 |
Tags
genetics, pediatrics, cysteamine, cystinosis, delayed-action preparations, Procysbi; cysteamine bitartrate; cystinosis; delayed release; sustained release; extended release; nephropathic; delayed action; controlled release; time release