Canada’s Drug Agency | Drugs, Health Technologies and Systems.

bulevirtide

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Generic Name:
bulevirtide
Project Status:
Active
Therapeutic Area:
chronic hepatitis delta virus (HDV) infection
Manufacturer:
Gilead Sciences Canada, Inc.
Call for patient/clinician input open:
Brand Name:
Hepcludex
Project Line:
Reimbursement Review
Project Number:
SR0881-000
Call for patient/clinician input closed:
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Bulevirtide is anticipated to be indicated for the treatment of chronic hepatitis delta virus (HDV) infection in adults with compensated liver disease.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
​Bulevirtide is anticipated to be indicated for the treatment of chronic hepatitis delta virus (HDV) infection in adults with compensated liver disease.
  1. 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 open22-Jan-25
Call for patient/clinician input closed18-Mar-25
Submission received09-Apr-25
Submission accepted25-Apr-25
Review initiated28-Apr-25
Draft CADTH review report(s) provided to sponsor for comment11-Jul-25
Deadline for sponsors comments22-Jul-25
CDA-AMC review report(s) and responses to comments provided to sponsor15-Aug-25
Expert committee meeting (initial)27-Aug-25
Draft recommendation issued to sponsorSeptember 09, 2025
To
September 11, 2025
Draft recommendation posted for stakeholder feedback18-Sep-25
End of feedback period03-Oct-25

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Patient and Clinician Group input View PDF
Last Updated : April 28, 2025