Generic Name: cysteamine bitartrate
Brand Name: Procysbi
Manufacturer: Horizon Pharma
Therapeutic Area: Nephropathic cystinosis
Indications: Nephropathic cystinosis
Submission Type: Initial
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 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 |