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patisiran

Last Updated: February 11, 2019
Result type: Reports
Project Number: SR0598-000
Product Line: Common Drug Review

Generic Name: patisiran

Brand Name: Onpattro

Manufacturer: Alnylam Netherlands BV

Indications: Polyneuropathy in hereditary transthyretin-mediated amyloidosis

Manufacturer Requested Reimbursement Criteria1: Treatment of hATTR amyloidosis with polyneuropathy in adults.

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 postedDecember 20, 2018
Patient group input closedFebruary 15, 2019
Patient input summary sent for review to patient input groups-
Patient group comments on input summary closed-
Submission receivedJanuary 25, 2019
Submission accepted for reviewFebruary 08, 2019
Review initiatedFebruary 11, 2019
Draft CDR review report(s) sent to applicantApril 26, 2019
Comments from applicant on draft CDR review report(s) receivedMay 07, 2019
Redaction requests from applicant on draft CDR review report(s) receivedMay 14, 2019
CDR review team's comments on draft CDR review report(s) sent to applicantJune 07, 2019
Canadian Drug Expert Committee (CDEC) meetingJune 19, 2019
CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plansJuly 02, 2019
To
July 04, 2019

Tags

genetics, nervous system