Last Updated : August 9, 2024
Details
Generic Name:
pegcetacoplan
Project Status:
Active
Therapeutic Area:
Geographic atrophy secondary to age-related macular degeneration
Manufacturer:
Apellis Canada, Inc.
Call for patient/clinician input open:
Brand Name:
TBC
Project Line:
Reimbursement Review
Project Number:
SR0810-000
Call for patient/clinician input closed:
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
For the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD) in adults.
Submission Type:
Initial
Fee Schedule:
Schedule E
Indications:
Pegcetacoplan solution
for injection is indicated in adults for the treatment of geographic atrophy
(GA) secondary to age-related macular degeneration (AMD).
- 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.
| Call for patient/clinician input open | 23-May-24 |
|---|---|
| Clarification: - CDA-AMC initially posted the call for patient from Dec 13 to Feb 12 . The pending submission was subsequently delayed and CDA-AMC re-posted the call for patient input when the revised filing date was received. | |
| Call for patient/clinician input closed | 12-Jul-24 |
| Clarification: - Patient input submission received from Fighting Blindness Canada, The Canadian Council of the Blind, CNIB, International Federation on Ageing, Vision Loss Rehabilitation Canada, Association Québécoise de la dégénérescence maculaire | |
| Submission received | 23-Jul-24 |
| Submission accepted | 07-Aug-24 |
| Review initiated | 08-Aug-24 |
| Draft CADTH review report(s) provided to sponsor for comment | 24-Oct-24 |
| Deadline for sponsors comments | 04-Nov-24 |
| CADTH review report(s) and responses to comments provided to sponsor | 06-Dec-24 |
| Expert committee meeting (initial) | 18-Dec-24 |
| Draft recommendation issued to sponsor | - |
| Draft recommendation posted for stakeholder feedback | - |
| End of feedback period | - |
Last Updated : August 9, 2024