cysteamine

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Generic Name:

cysteamine

Project Status:

Complete

Therapeutic Area:

Corneal cystine crystal deposits

Manufacturer:

Recordati Rare Diseases Canada Inc.

Call for patient/clinician input open:

November 2, 2018

Brand Name:

Cystadrops

Project Line:

Reimbursement Review

Project Number:

SR0595-000

Call for patient/clinician input closed:

December 20, 2018

Biosimilar:

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

Fee Schedule:

Schedule A

Indications:

Corneal cystine crystal deposits

Recommendation Type:

Reimburse with clinical criteria and/or conditions

Final Recommendation:

June 18, 2019

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 posted	November 02, 2018
Patient group input closed	December 20, 2018
Clarification: - No patient input submission received
Submission received	December 10, 2018
Submission accepted for review	December 24, 2018
Review initiated	January 02, 2019
Draft CADTH review report(s) sent to applicant	March 25, 2019
Comments from applicant on draft CADTH review report(s) received	April 03, 2019
Redaction requests from applicant on draft CADTH review report(s) received	April 10, 2019
CADTH review team's comments on draft CADTH review report(s) sent to applicant	May 03, 2019
Canadian Drug Expert Committee (CDEC) meeting	May 15, 2019
CDEC recommendation & redacted CADTH review report(s) sent to applicant and drug plans	May 28, 2019
Embargo period ended and validation of redacted CADTH review report(s) received	June 11, 2019
CDEC Final Recommendation issued to applicant and drug plans	June 18, 2019
CDEC Final Recommendation posted	June 20, 2019
Final CADTH review report(s) posted	July 03, 2019