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patisiran

Last Updated: March 26, 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
Clarification:

- Patient input submission received from the Canadian Organization for Rare Disorders

Patient input summary sent for review to patient input groupsFebruary 26, 2019
Patient group comments on input summary closedMarch 05, 2019
Clarification:

- No patient input summary feedback received

Submission receivedJanuary 25, 2019
Submission accepted for reviewFebruary 08, 2019
Review initiatedFebruary 11, 2019
Clarification:

- Selected for participation in CADTH/INESSS Clinical Engagement Pilot

Draft CADTH review report(s) sent to applicantMay 02, 2019
Comments from applicant on draft CADTH review report(s) receivedMay 13, 2019
Redaction requests from applicant on draft CADTH review report(s) receivedMay 21, 2019
CADTH review team's comments on draft CADTH review report(s) sent to applicantJune 07, 2019
Canadian Drug Expert Committee (CDEC) meetingJune 19, 2019
CDEC recommendation & redacted CADTH review report(s) sent to applicant and drug plansJuly 02, 2019
To
July 04, 2019