Last Updated : April 26, 2021
Details
FilesGeneric 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:
- 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 |
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) posted | July 20, 2021 |
Files
Last Updated : April 26, 2021