cysteamine bitartrate


( Last Updated : May 8, 2019)
Generic Name:
cysteamine bitartrate
Project Status:
Complete
Therapeutic Area:
Nephropathic cystinosis
Manufacturer:
Horizon Pharma
Call for patient/clinician input open:
Brand Name:
Procysbi
Project Line:
Reimbursement Review
Project Number:
SR0526-000
Call for patient/clinician input closed:

Details

Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Nephropathic cystinosis
Recommendation Type:
Reimburse with clinical criteria and/or conditions
Final Recommendation:

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

Files

Recommendation and Reasons

Clinical Report

Pharmacoeconomic Report

Patient Group Input Submissions

Implementation Advice