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
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 CADTH. Reimbursement criteria from CADTH will be documented in the final recommendation, if applicable.

Key Milestones2

Call for patient input openSeptember 08, 2020
Call for patient input closedOctober 28, 2020
Clarification:

- Patient input submission received from individual patient

Submission receivedOctober 05, 2020
Submission acceptedOctober 20, 2020
Review initiatedOctober 21, 2020
Clarification:

- Selected for CADTH/INESSS Joint Clinician Engagement

Draft CADTH review report(s) provided to sponsor for commentJanuary 11, 2021
Deadline for sponsors commentsJanuary 20, 2021
CADTH responses on draft review report(s) provided to sponsorMarch 05, 2021
Expert committee meeting (initial)March 17, 2021
Draft recommendation issued to sponsorMarch 29, 2021
End of embargo periodApril 13, 2021
Final recommendation issued to sponsor and drug plansApril 20, 2021
Final recommendation postedApril 23, 2021
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)May 04, 2021
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) postedJuly 20, 2021