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cerliponase alfa

Last Updated: December 21, 2018
Result type: Reports
Project Number: SR0574-000
Product Line: Common Drug Review

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

  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 postedJune 04, 2018
Patient group input closedJuly 24, 2018

- No patient input submission received

Submission receivedJuly 31, 2018
Submission accepted for reviewAugust 15, 2018
Review initiatedAugust 16, 2018
Draft CDR review report(s) sent to applicantNovember 14, 2018
Comments from applicant on draft CDR review report(s) receivedNovember 23, 2018
Redaction requests from applicant on draft CDR review report(s) receivedNovember 30, 2018
CDR review team's comments on draft CDR review report(s) sent to applicantJanuary 04, 2019
Canadian Drug Expert Committee (CDEC) meetingJanuary 16, 2019
CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plansJanuary 30, 2019
Embargo period ended and validation of redacted CDR review report(s) receivedFebruary 13, 2019

- Reconsideration requested

- Reconsideration request under assessment by CADTH


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