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 |
| 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 applicant | May 02, 2019 |
| Comments from applicant on draft CADTH review report(s) received | May 13, 2019 |
| Redaction requests from applicant on draft CADTH review report(s) received | May 21, 2019 |
| CADTH review team's comments on draft CADTH review report(s) sent to applicant | June 07, 2019 |
| Canadian Drug Expert Committee (CDEC) meeting | June 19, 2019 |
| CDEC recommendation & redacted CADTH review report(s) sent to applicant and drug plans | July 02, 2019 To July 04, 2019 |