Last Updated : June 28, 2019
Details
FilesGeneric Name:
cerliponase alfa
Project Status:
Complete
Therapeutic Area:
Neuronal Ceroid Lipofuscinosis Type 2
Manufacturer:
Biomarin Pharmaceutical (Canada) Inc.
Call for patient/clinician input open:
Brand Name:
Brineura
Project Line:
Reimbursement Review
Project Number:
SR0574-000
Call for patient/clinician input closed:
NOC Status at Filing:
Pre NOC
Performance Metric:
Achieved
Biosimilar:
No
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:
Initial
Fee Schedule:
Schedule A
Indications:
Neuronal Ceroid Lipofuscinosis Type 2
Recommendation Type:
Reimburse with clinical criteria and/or conditions
Final Recommendation:
- The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of Canada's Drug Agency. Reimbursement criteria from Canada's Drug Agency 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 | May 27, 2019 |
| Final CADTH review report(s) posted | June 28, 2019 |
Files
Last Updated : June 28, 2019