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abobotulinumtoxinA

Last Updated: August 31, 2018
Result type: Reports
Project Number: SR0556-000
Product Line: Common Drug Review

Generic Name: abobotulinumtoxinA

Brand Name: Dysport Therapeutic

Manufacturer: Ipsen Biopharmaceuticals Canada Inc.

Indications: lower limb spasticity

Manufacturer Requested Reimbursement Criteria1: For the treatment of lower limb spasticity in pediatric patients 2 years of aga and older.

Submission Type: New Indication

Project Status: Complete

Biosimilar: No

Companion Diagnostics: No

Date Recommendation Issued: August 23, 2018

Recommendation Type: Reimburse with clinical criteria and/or conditions

Fee Schedule: Schedule B

  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 postedJanuary 03, 2018
Patient group input closedFebruary 22, 2018
Clarification:

- Patient input submission received

Patient input summary sent for review to patient input groupsMarch 07, 2018
Patient group comments on input summary closedMarch 14, 2018
Clarification:

- Patient input submission received

Submission receivedFebruary 07, 2018
Submission accepted for reviewFebruary 22, 2018
Review initiatedFebruary 23, 2018
Draft CDR review report(s) sent to applicantMay 11, 2018
Comments from applicant on draft CDR review report(s) receivedMay 23, 2018
Redaction requests from applicant on draft CDR review report(s) receivedMay 30, 2018
CDR review team's comments on draft CDR review report(s) sent to applicantJuly 06, 2018
Canadian Drug Expert Committee (CDEC) meetingJuly 18, 2018
CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plansJuly 30, 2018
Embargo period ended and validation of redacted CDR review report(s) receivedAugust 14, 2018
CDEC Final Recommendation issued to applicant and drug plansAugust 21, 2018
CDEC Final Recommendation postedAugust 23, 2018
Final CDR review report(s) and patient input postedAugust 31, 2018

Tags

nervous system, pediatrics, cerebral palsy, muscle spasticity, Spasticity; cerebral palsies; Pediatric; Children