givosiran

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Generic Name:

givosiran

Project Status:

Complete

Therapeutic Area:

Acute hepatic porphyria (AHP) in adults

Manufacturer:

Alnylam Netherlands B.V.

Call for patient/clinician input open:

January 25, 2021

Brand Name:

Givlaari

Project Line:

Reimbursement Review

Project Number:

SR0679-000

Call for patient/clinician input closed:

March 19, 2021

NOC Status at Filing:

Post NOC

Biosimilar:

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:

September 8, 2021

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	November 15, 2021

Last Updated : November 15, 2021