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givosiran

Last Updated: April 5, 2021
Result type: Reports
Project Number: SR0679-000
Product Line: Reimbursement Review

Generic Name: givosiran

Brand Name: Givlaari

Manufacturer: Alnylam Netherlands B.V.

Therapeutic Area: Acute hepatic porphyria (AHP) in adults

Indications: ​Treatment of acute hepatic porphyria (AHP) in adults

Manufacturer Requested Reimbursement Criteria1: Treatment of acute hepatic porphyria (AHP) in adults

Submission Type: Initial

NOC Status at Filing: Post NOC

Project Status: Active

Companion Diagnostics: No

Fee Schedule: Schedule A

  1. 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/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 May 25, 2021
Deadline for sponsors comments June 03, 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
To
August 05, 2021
Draft recommendation posted for stakeholder feedback -