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
- 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 |
| Patient input summary sent for review to patient input groups | - |
| Patient group comments on input summary closed | - |
| Submission received | January 25, 2019 |
| Submission accepted for review | February 08, 2019 |
| Review initiated | February 11, 2019 |
| Draft CDR review report(s) sent to applicant | April 26, 2019 |
| Comments from applicant on draft CDR review report(s) received | May 07, 2019 |
| Redaction requests from applicant on draft CDR review report(s) received | May 14, 2019 |
| CDR review team's comments on draft CDR review report(s) sent to applicant | June 07, 2019 |
| Canadian Drug Expert Committee (CDEC) meeting | June 19, 2019 |
| CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plans | July 02, 2019 To July 04, 2019 |
Tags
genetics, nervous system