Generic Name: cerliponase alfa
Brand Name: Brineura
Manufacturer: Biomarin Pharmaceutical (Canada) Inc.
Indications: Neuronal Ceroid Lipofuscinosis Type 2
Manufacturer Requested Reimbursement Criteria1: Indicated for patients with CLN2 disease, also known as tripeptidyl peptidase 1 (TPP1) deficiency or Neuronal Ceroid Lipofuscinosis type 2.
Submission Type: New
Project Status: Active
Biosimilar: No
Companion Diagnostics: No
Fee Schedule: Schedule A
- 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 | June 04, 2018 |
| Patient group input closed | July 24, 2018 |
| Clarification: - No patient input submission received | |
| Submission received | July 31, 2018 |
| Submission accepted for review | August 15, 2018 |
| Review initiated | August 16, 2018 |
| Draft CADTH review report(s) sent to applicant | November 14, 2018 |
| Comments from applicant on draft CADTH review report(s) received | November 23, 2018 |
| Redaction requests from applicant on draft CADTH review report(s) received | November 30, 2018 |
| CADTH review team's comments on draft CADTH review report(s) sent to applicant | January 04, 2019 |
| Canadian Drug Expert Committee (CDEC) meeting | January 16, 2019 |
| CDEC recommendation & redacted CADTH review report(s) sent to applicant and drug plans | January 30, 2019 |
| Embargo period ended and validation of redacted CADTH review report(s) received | February 13, 2019 |
| Clarification: - Reconsideration requested - Request for Clarification received from CDR Participating Drug Plans | |
| Applicant's request for reconsideration placed on CDEC agenda | April 10, 2019 |
| Drug plans' request for clarification placed on CDEC agenda | April 10, 2019 |
| CDEC recommendation & redacted CADTH review report(s) sent to applicant and drug plans | April 17, 2019 |
| Clarification: - Embargoed CDEC recommendation issued in accordance with CADTH Pharmaceutical Reviews Update - Issue 7 | |
| Embargo period ended and validation of redacted CADTH review report(s) received | May 02, 2019 |
| Clarification: - Request for Clarification received from CDR Participating Drug Plans - Drug plans' request for clarification placed on the May 15, 2019 CDEC agenda | |
| Response to request for clarification and CDEC Final Recommendation sent to applicant and drug plans | May 23, 2019 |
| CDEC Final Recommendation posted | - |
| Final CADTH review report(s) posted | - |