Last Updated : August 29, 2022
Details
FilesGeneric Name:
amifampridine phosphate
Project Status:
Complete
Therapeutic Area:
Lambert-Eaton Myasthenic Syndrome, adults
Manufacturer:
KYE Pharmaceuticals Inc.
Brand Name:
Firdapse
Project Line:
Reimbursement Review
Project Number:
SR0664-000
NOC Status at Filing:
Post NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
For the symptomatic treatment of Lambert-Eaton Myasthenic Syndrome (LEMS) in adults.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
For the symptomatic treatment of Lambert-Eaton Myasthenic Syndrome (LEMS) in adults.
Recommendation Type:
Reimburse with clinical criteria and/or conditions
Final Recommendation:
- 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 open | 18-Oct-21 |
| Call for patient/clinician input closed | 09-Dec-21 |
| Clarification: - No patient input submission received | |
| Submission received | 15-Nov-21 |
| Submission accepted | 29-Nov-21 |
| Review initiated | 30-Nov-21 |
| Draft CADTH review report(s) provided to sponsor for comment | 22-Feb-22 |
| Deadline for sponsors comments | 03-Mar-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 | 11-May-22 |
| Draft recommendation posted for stakeholder feedback | 19-May-22 |
| End of feedback period | 03-Jun-22 |
| Final recommendation issued to sponsor and drug plans | 16-Jun-22 |
| Final recommendation posted | 05-Jul-22 |
| Deadline for sponsor to submit redaction requests on draft CADTH review report(s) | 30-Jun-22 |
| CADTH review report(s) posted | 25-Aug-22 |
Files
Last Updated : August 29, 2022