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Last Updated: January 13, 2020
Result type: Reports
Project Number: SR0603-000
Product Line: Common Drug Review

Generic Name: inotersen

Brand Name: Tegsedi

Manufacturer: Akcea Therapeutics Inc.

Indications: hereditary transthyretin amyloidosis

Manufacturer Requested Reimbursement Criteria1: For the treatment of stage 1 or stage 2 polyneuropathy in adult patients with hereditary transthyretin amyloidosis (hATTR).

Submission Type: New

Project Status: Complete

Biosimilar: No

Companion Diagnostics: No

Date Recommendation Issued: December 18, 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 postedJanuary 24, 2019
Patient group input closedMarch 15, 2019

- Patient input submission received from Hereditary Amyloidosis Canada

Patient input summary sent for review to patient input groupsMarch 21, 2019
Patient group comments on input summary closedMarch 28, 2019

- No patient input summary feedback received

Submission receivedFebruary 22, 2019
Submission acceptedMarch 08, 2019
Review initiatedMarch 11, 2019

- Selected for participation in CADTH/INESSS Clinical Engagement Pilot

Draft CADTH review report(s) sent to sponsorJune 04, 2019
Comments from sponsor on draft CADTH review report(s) receivedJune 13, 2019
Redaction requests from sponsor on draft CADTH review report(s) receivedJune 20, 2019
CADTH review team's comments on draft CADTH review report(s) sent to sponsorJuly 05, 2019
Canadian Drug Expert Committee (CDEC) meetingJuly 17, 2019
CDEC recommendation & redacted CADTH review report(s) sent to sponsor and drug plansJuly 31, 2019
Embargo period ended and validation of redacted CADTH review report(s) receivedSeptember 13, 2019

- Request for extension to embargo period received from the manufacturer

- Embargo extension request granted

- Reconsideration requested

Sponsor's request for reconsideration placed on CDEC agendaNovember 20, 2019
CDEC recommendation sent to sponsor and drug plansNovember 27, 2019
Embargo period endedDecember 11, 2019
CDEC Final Recommendation issued to sponsor and drug plansDecember 18, 2019
CDEC Final Recommendation postedDecember 20, 2019
Final CADTH review report(s) postedJanuary 10, 2020