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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
Clarification:

- No patient input submission received

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

- Reconsideration requested

- Request for Clarification received from CDR Participating Drug Plans

Applicant's request for reconsideration placed on CDEC agendaApril 10, 2019
Drug plans' request for clarification placed on CDEC agendaApril 10, 2019
CDEC recommendation & redacted CADTH review report(s) sent to applicant and drug plansApril 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) receivedMay 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 plansMay 23, 2019
CDEC Final Recommendation posted-
Final CADTH review report(s) posted-