givosiran


( Last Updated : September 27, 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:
NOC Status at Filing:
Post NOC

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
Recommendation Type:
Reimburse with clinical criteria and/or conditions
  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 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