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Last Updated: July 3, 2019
Result type: Reports
Project Number: SR0595-000
Product Line: Reimbursement Review

Generic Name: cysteamine

Brand Name: Cystadrops

Manufacturer: Recordati Rare Diseases Canada Inc.

Therapeutic Area: Corneal cystine crystal deposits

Indications: Corneal cystine crystal deposits

Manufacturer Requested Reimbursement Criteria1: For the treatment of corneal cystine crystal deposits in adults and children from 2 years of age with cystinosis.

Submission Type: Initial

Project Status: Complete

Biosimilar: No

Companion Diagnostics: No

Date Recommendation Issued: June 18, 2019

Recommendation Type: Reimburse with clinical criteria and/or conditions

Fee Schedule: Schedule A

  1. The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of CADTH. Reimbursement criteria from CADTH will be documented in the final recommendation, if applicable.

Key Milestones2

Call for patient input postedNovember 02, 2018
Patient group input closedDecember 20, 2018

- No patient input submission received

Submission receivedDecember 10, 2018
Submission accepted for reviewDecember 24, 2018
Review initiatedJanuary 02, 2019
Draft CADTH review report(s) sent to applicantMarch 25, 2019
Comments from applicant on draft CADTH review report(s) receivedApril 03, 2019
Redaction requests from applicant on draft CADTH review report(s) receivedApril 10, 2019
CADTH review team's comments on draft CADTH review report(s) sent to applicantMay 03, 2019
Canadian Drug Expert Committee (CDEC) meetingMay 15, 2019
CDEC recommendation & redacted CADTH review report(s) sent to applicant and drug plansMay 28, 2019
Embargo period ended and validation of redacted CADTH review report(s) receivedJune 11, 2019
CDEC Final Recommendation issued to applicant and drug plansJune 18, 2019
CDEC Final Recommendation postedJune 20, 2019
Final CADTH review report(s) postedJuly 03, 2019