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amifampridine

Last Updated: April 23, 2021
Result type: Reports
Project Number: SR0660-000
Product Line: Reimbursement Review

Generic Name: amifampridine

Brand Name: Ruzurgi

Manufacturer: Médunik Canada Inc.

Therapeutic Area: Lambert-Eaton myasthenic syndrome

Indications: Indicated for the symptomatic treatment of Lambert-Eaton myasthenic syndrome (LEMS) in patients 6 years of age and older.

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

NOC Status at Filing: Post NOC

Project Status: Active

Companion Diagnostics: No

Date Recommendation Issued: April 20, 2021

Recommendation Type: Reimburse with clinical criteria and/or conditions

Fee Schedule: Schedule A

  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 input open September 08, 2020
Call for patient input closed October 28, 2020
Clarification:

- Patient input submission received from individual patient

Submission received October 05, 2020
Submission accepted October 20, 2020
Review initiated October 21, 2020
Clarification:

- Selected for CADTH/INESSS Joint Clinician Engagement

Draft CADTH review report(s) provided to sponsor for comment January 11, 2021
Deadline for sponsors comments January 20, 2021
CADTH responses on draft review report(s) provided to sponsor March 05, 2021
Expert committee meeting (initial) March 17, 2021
Draft recommendation issued to sponsor March 29, 2021
End of embargo period April 13, 2021
Final recommendation issued to sponsor and drug plans April 20, 2021
Final recommendation posted April 23, 2021
Deadline for sponsor to submit redaction requests on draft CADTH review report(s) May 04,2021
CADTH review report(s) posted -