CDA | Evidence Driven
CDA | Evidence Driven

amifampridine

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Generic Name:
amifampridine
Project Status:
Complete
Therapeutic Area:
Lambert-Eaton myasthenic syndrome
Manufacturer:
Médunik Canada Inc.
Brand Name:
Ruzurgi
Project Line:
Reimbursement Review
Project Number:
SR0660-000
NOC Status at Filing:
Post NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Indicated for the symptomatic treatment of Lambert-Eaton myasthenic syndrome (LEMS) in patients 6 years of age and older.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Indicated for the symptomatic treatment of Lambert-Eaton myasthenic syndrome (LEMS) in patients 6 years of age and older.
Date NOC Issued:
Recommendation Type:
Reimburse with clinical criteria and/or conditions
Final Recommendation:
  1. 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 input open08-Sep-20
Call for patient input closed28-Oct-20
Clarification:

- Patient input submission received from individual patient

Submission received05-Oct-20
Submission accepted20-Oct-20
Review initiated21-Oct-20
Clarification:

- Selected for CADTH/INESSS Joint Clinician Engagement

Draft CADTH review report(s) provided to sponsor for comment11-Jan-21
Deadline for sponsors comments20-Jan-21
CADTH responses on draft review report(s) provided to sponsor05-Mar-21
Expert committee meeting (initial)17-Mar-21
Draft recommendation issued to sponsor29-Mar-21
End of embargo period13-Apr-21
Final recommendation issued to sponsor and drug plans20-Apr-21
Final recommendation posted23-Apr-21
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)04-May-21
Clarification:

Submission temporarily suspended at the request of the sponsor

- Additional information has been received and the temporary suspension of the review has been lifted

CADTH review report(s) posted20-Jul-21

Files

Recommendation and Reasons View PDF
Clinical Report View PDF
Pharmacoeconomic Report View PDF
Last Updated : July 23, 2024