fecal microbiota

Details

Files
Generic Name:
fecal microbiota
Project Status:
Active
Therapeutic Area:
Clostridioides difficile infection, prevention
Manufacturer:
Ferring Canada Inc.
Call for patient/clinician input open:
Brand Name:
TBC
Project Line:
Reimbursement Review
Project Number:
SR0850-000
Call for patient/clinician input closed:
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Indicated to prevent recurrence of Clostridioides difficile infection (CDI) in adults following antibiotic treatment for recurrent CDI.
Submission Type:
Initial
Fee Schedule:
Schedule E
Indications:
​Indicated to prevent recurrence of Clostridioides difficile infection (CDI) in adults following antibiotic treatment for recurrent CDI.
  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 open15-Nov-24
Call for patient/clinician input closed17-Jan-25
Submission received03-Jan-25
Submission accepted17-Jan-25
Review initiated20-Jan-25
Draft CADTH review report(s) provided to sponsor for comment07-Apr-25
Deadline for sponsors comments16-Apr-25
CADTH review report(s) and responses to comments provided to sponsor15-May-25
Expert committee meeting (initial)28-May-25
Draft recommendation issued to sponsorJune 09, 2025
To
June 11, 2025
Draft recommendation posted for stakeholder feedback19-Jun-25
End of feedback period04-Jul-25