Generic Name: inotersen
Brand Name: Tegsedi
Manufacturer: Akcea Therapeutics Inc.
Therapeutic Area: hereditary transthyretin amyloidosis
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: Initial
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
- 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 | January 24, 2019 |
| Patient group input closed | March 15, 2019 |
| Clarification:
- Patient input submission received from Hereditary Amyloidosis Canada |
|
| Patient input summary sent for review to patient input groups | March 21, 2019 |
| Patient group comments on input summary closed | March 28, 2019 |
| Clarification:
- No patient input summary feedback received |
|
| Submission received | February 22, 2019 |
| Submission accepted | March 08, 2019 |
| Review initiated | March 11, 2019 |
| Clarification:
- Selected for participation in CADTH/INESSS Clinical Engagement Pilot |
|
| Draft CADTH review report(s) sent to sponsor | June 04, 2019 |
| Comments from sponsor on draft CADTH review report(s) received | June 13, 2019 |
| Redaction requests from sponsor on draft CADTH review report(s) received | June 20, 2019 |
| CADTH review team's comments on draft CADTH review report(s) sent to sponsor | July 05, 2019 |
| Canadian Drug Expert Committee (CDEC) meeting | July 17, 2019 |
| CDEC recommendation & redacted CADTH review report(s) sent to sponsor and drug plans | July 31, 2019 |
| Embargo period ended and validation of redacted CADTH review report(s) received | September 13, 2019 |
| Clarification:
- Request for extension to embargo period received from the manufacturer - Embargo extension request granted - Reconsideration requested |
|
| Sponsor's request for reconsideration placed on CDEC agenda | November 20, 2019 |
| CDEC recommendation sent to sponsor and drug plans | November 27, 2019 |
| Embargo period ended | December 11, 2019 |
| CDEC Final Recommendation issued to sponsor and drug plans | December 18, 2019 |
| CDEC Final Recommendation posted | December 20, 2019 |
| Final CADTH review report(s) posted | January 10, 2020 |