amifampridine phosphate


( Last Updated : November 29, 2021)
Generic Name:
amifampridine phosphate
Project Status:
Active
Therapeutic Area:
Lambert-Eaton Myasthenic Syndrome, adults
Manufacturer:
KYE Pharmaceuticals Inc.
Call for patient/clinician input open:
Brand Name:
Firdapse
Project Line:
Reimbursement Review
Project Number:
SR0664-000
Call for patient/clinician input closed:
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 Milestones

Call for patient/clinician input open October 18, 2021
Call for patient/clinician input closed December 09, 2021
Submission received November 15, 2021
Submission accepted November 29, 2021
Review initiated November 30, 2021
Draft CADTH review report(s) provided to sponsor for comment February 18, 2022
Deadline for sponsors comments March 02, 2022
CADTH review report(s) and responses to comments provided to sponsor April 14, 2022
Expert committee meeting (initial) April 27, 2022
Draft recommendation issued to sponsor May 09, 2022
To
May 11, 2022
Draft recommendation posted for stakeholder feedback May 19, 2022
End of feedback period June 03, 2022