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 CDR review report(s) sent to applicant | November 14, 2018 |
| Comments from applicant on draft CDR review report(s) received | November 23, 2018 |
| Redaction requests from applicant on draft CDR review report(s) received | November 30, 2018 |
| CDR review team's comments on draft CDR review report(s) sent to applicant | January 04, 2019 |
| Canadian Drug Expert Committee (CDEC) meeting | January 16, 2019 |
| CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plans | January 30, 2019 |
| Embargo period ended and validation of redacted CDR review report(s) received | February 13, 2019 |
| Clarification: - Reconsideration requested - Reconsideration request under assessment by CADTH | |
Tags
genetics, nervous system, lipid metabolism disorders, neuronal ceroid lipofuscinosis; neuronal ceroid lipofuscinoses; ceroid storage disease; Batten disease; cln2; Batten diseases; ceroid storage diseases; brineura; cerliponase alfa; cerliponase alpha