cenegermin


( Last Updated : September 13, 2022)
Generic Name:
cenegermin
Project Status:
Complete
Therapeutic Area:
Neurotrophic keratitis
Manufacturer:
Dompé Farmaceutici S.p.A
Brand Name:
Oxervate
Project Line:
Reimbursement Review
Project Number:
SR0704-000
NOC Status at Filing:
Post NOC

Details


Manufacturer Requested Reimbursement Criteria1:
For the treatment of moderate (persistent epithelial defect) or severe (corneal ulcer) neurotrophic keratitis in adults who have failed conventional non-surgical treatments.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
For the treatment of moderate (persistent epithelial defect) or severe (corneal ulcer) neurotrophic keratitis in adults.
Recommendation Type:
Reimburse with clinical criteria and/or conditions
Final Recommendation:
  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 02-Sep-21
Call for patient/clinician input closed 25-Oct-21
Clarification:

- Patient input submission received from the Canadian Organization for Rare Disorders

Submission received 29-Oct-21
Submission accepted 15-Nov-21
Review initiated 16-Nov-21
Draft CADTH review report(s) provided to sponsor for comment 08-Feb-22
Deadline for sponsors comments 17-Feb-22
CADTH review report(s) and responses to comments provided to sponsor 14-Apr-22
Expert committee meeting (initial) 27-Apr-22
Draft recommendation issued to sponsor 09-May-22
Draft recommendation posted for stakeholder feedback 26-May-22
End of feedback period 09-Jun-22
Final recommendation issued to sponsor and drug plans 23-Jun-22
Final recommendation posted 12-Jul-22
Deadline for sponsor to submit redaction requests on draft CADTH review report(s) 08-Jul-22
CADTH review report(s) posted 13-Sep-22