givosiran


( Last Updated : May 4, 2021)
Generic Name:
givosiran
Project Status:
Active
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:

Details


Manufacturer Requested Reimbursement Criteria1:
Treatment of acute hepatic porphyria (AHP) in adults
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
‚ÄčTreatment of acute hepatic porphyria (AHP) in adults
  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 openJanuary 25, 2021
Call for patient/clinician input closedMarch 19, 2021
Clarification:

- Patient input submission received from American Porphyria Foundation

Submission receivedFebruary 23, 2021
Submission acceptedMarch 09, 2021
Review initiatedMarch 10, 2021
Draft CADTH review report(s) provided to sponsor for commentJune 03, 2021
Deadline for sponsors commentsJune 14, 2021
CADTH responses on draft review report(s) provided to sponsorJuly 09, 2021
Expert committee meeting (initial)July 21, 2021
Draft recommendation issued to sponsorAugust 03, 2021
To
August 05, 2021
Draft recommendation posted for stakeholder feedback-