Generic Name: patisiran
Brand Name: Onpattro
Manufacturer: Alnylam Netherlands BV
Therapeutic Area: Polyneuropathy in hereditary transthyretin-mediated amyloidosis
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
- 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 | December 20, 2018 |
| Patient group input closed | February 15, 2019 |
| Clarification: - Patient input submission received from the Canadian Organization for Rare Disorders | |
| Patient input summary sent for review to patient input groups | February 26, 2019 |
| Patient group comments on input summary closed | March 05, 2019 |
| Clarification: - No patient input summary feedback received | |
| Submission received | January 25, 2019 |
| Submission accepted for review | February 08, 2019 |
| Review initiated | February 11, 2019 |
| Clarification: - Selected for participation in CADTH/INESSS Clinical Engagement Pilot | |
| Draft CADTH review report(s) sent to sponsor | May 02, 2019 |
| Comments from sponsor on draft CADTH review report(s) received | May 13, 2019 |
| Redaction requests from sponsor on draft CADTH review report(s) received | May 21, 2019 |
| CADTH review team's comments on draft CADTH review report(s) sent to sponsor | June 07, 2019 |
| Canadian Drug Expert Committee (CDEC) meeting | June 19, 2019 |
| CDEC recommendation & redacted CADTH review report(s) sent to sponsor and drug plans | July 04, 2019 |
| Embargo period ended and validation of redacted CADTH review report(s) received | July 18, 2019 |
| CDEC Final Recommendation issued to sponsor and drug plans | July 25, 2019 |
| CDEC Final Recommendation posted | July 29, 2019 |
| Final CADTH review report(s) posted | August 27, 2019 |