Last Updated : November 15, 2021
Details
FilesGeneric Name:
givosiran
Project Status:
Complete
Therapeutic Area:
Acute hepatic porphyria (AHP) in adults
Manufacturer:
Alnylam Netherlands B.V.
Call for patient/clinician input open:
Brand Name:
Givlaari
Project Line:
Reimbursement Review
Project Number:
SR0679-000
Call for patient/clinician input closed:
NOC Status at Filing:
Post NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Treatment of acute hepatic porphyria (AHP) in adults
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Treatment of acute hepatic porphyria (AHP) in adults
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/clinician input open | January 25, 2021 |
| Call for patient/clinician input closed | March 19, 2021 |
| Clarification: - Patient input submission received from American Porphyria Foundation | |
| Submission received | February 23, 2021 |
| Submission accepted | March 09, 2021 |
| Review initiated | March 10, 2021 |
| Draft CADTH review report(s) provided to sponsor for comment | June 03, 2021 |
| Deadline for sponsors comments | June 14, 2021 |
| CADTH responses on draft review report(s) provided to sponsor | July 09, 2021 |
| Expert committee meeting (initial) | July 21, 2021 |
| Draft recommendation issued to sponsor | August 03, 2021 |
| Draft recommendation posted for stakeholder feedback | August 12, 2021 |
| End of feedback period | August 26, 2021 |
| Final recommendation issued to sponsor and drug plans | September 08, 2021 |
| Final recommendation posted | September 24, 2021 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | September 22, 2021 |
| CADTH review report(s) posted | November 15, 2021 |
Files
Last Updated : November 15, 2021