cerliponase alfa


( Last Updated : June 28, 2019)
Generic 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

Details


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:
  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 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