amifampridine phosphate


( Last Updated : June 16, 2022)
Generic Name:
amifampridine phosphate
Project Status:
Active
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

Details


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.
  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 open18-Oct-21
Call for patient/clinician input closed09-Dec-21
Clarification:

- No patient input submission received

Submission received15-Nov-21
Submission accepted29-Nov-21
Review initiated30-Nov-21
Draft CADTH review report(s) provided to sponsor for comment22-Feb-22
Deadline for sponsors comments03-Mar-22
CADTH review report(s) and responses to comments provided to sponsor14-Apr-22
Expert committee meeting (initial)27-Apr-22
Draft recommendation issued to sponsor11-May-22
Draft recommendation posted for stakeholder feedback19-May-22
End of feedback period03-Jun-22
Draft recommendation posted for stakeholder feedback19-May-22
End of feedback period03-Jun-22
Draft recommendation posted for stakeholder feedback19-May-22
End of feedback period03-Jun-22
Final recommendation issued to sponsor and drug plans16-Jun-22
Final recommendation posted
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)30-Jun-22
CADTH review report(s) posted