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Last Updated: September 4, 2019
Result type: Reports
Project Number: SR0598-000
Product Line: Reimbursement Review

Generic Name: patisiran

Brand Name: Onpattro

Manufacturer: Alnylam Netherlands BV

Indications: Polyneuropathy in hereditary transthyretin-mediated amyloidosis

Manufacturer Requested Reimbursement Criteria1: Treatment of polyneuropathy in adult patients with hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis).

Submission Type: Initial

Project Status: Complete

Biosimilar: No

Companion Diagnostics: No

Date Recommendation Issued: July 25, 2019

Recommendation Type: Reimburse with clinical criteria and/or conditions

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 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

- No patient input summary feedback received

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

- Selected for participation in CADTH/INESSS Clinical Engagement Pilot

Draft CADTH review report(s) sent to sponsorMay 02, 2019
Comments from sponsor on draft CADTH review report(s) receivedMay 13, 2019
Redaction requests from sponsor on draft CADTH review report(s) receivedMay 21, 2019
CADTH review team's comments on draft CADTH review report(s) sent to sponsorJune 07, 2019
Canadian Drug Expert Committee (CDEC) meetingJune 19, 2019
CDEC recommendation & redacted CADTH review report(s) sent to sponsor and drug plansJuly 04, 2019
Embargo period ended and validation of redacted CADTH review report(s) receivedJuly 18, 2019
CDEC Final Recommendation issued to sponsor and drug plansJuly 25, 2019
CDEC Final Recommendation postedJuly 29, 2019
Final CADTH review report(s) postedAugust 27, 2019