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
- 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.
|Call for patient input open||September 08, 2020|
|Call for patient input closed||October 28, 2020|
- Patient input submission received from individual patient
|Submission received||October 05, 2020|
|Submission accepted||October 20, 2020|
|Review initiated||October 21, 2020|
- 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||-|