Last Updated : September 6, 2019
Details
FilesGeneric Name:
patisiran
Project Status:
Complete
Therapeutic Area:
Polyneuropathy in hereditary transthyretin-mediated amyloidosis
Manufacturer:
Alnylam Netherlands BV
Call for patient/clinician input open:
Brand Name:
Onpattro
Project Line:
Reimbursement Review
Project Number:
SR0598-000
Call for patient/clinician input closed:
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Treatment of polyneuropathy in adult patients with hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis).
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Polyneuropathy in hereditary transthyretin-mediated amyloidosis
Recommendation Type:
Reimburse with clinical criteria and/or conditions
Final Recommendation:
- The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of Canada's Drug Agency. Reimbursement criteria from Canada's Drug Agency 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 Canada's Drug Agency/INESSS Clinical Engagement Pilot | |
| Draft Canada's Drug Agency review report(s) sent to sponsor | May 02, 2019 |
| Comments from sponsor on draft Canada's Drug Agency review report(s) received | May 13, 2019 |
| Redaction requests from sponsor on draft Canada's Drug Agency review report(s) received | May 21, 2019 |
| Canada's Drug Agency review team's comments on draft Canada's Drug Agency review report(s) sent to sponsor | June 07, 2019 |
| Canadian Drug Expert Committee (CDEC) meeting | June 19, 2019 |
| CDEC recommendation & redacted Canada's Drug Agency review report(s) sent to sponsor and drug plans | July 04, 2019 |
| Embargo period ended and validation of redacted Canada's Drug Agency 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 Canada's Drug Agency review report(s) posted | August 27, 2019 |
Files
Last Updated : September 6, 2019