amifampridine phosphate

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Generic Name:

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:

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:

June 16, 2022

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

Last Updated : August 29, 2022