abobotulinumtoxinA

Details

Files
Generic Name:
abobotulinumtoxinA
Project Status:
Complete
Therapeutic Area:
lower limb spasticity
Manufacturer:
Ipsen Biopharmaceuticals Canada Inc.
Call for patient/clinician input open:
Brand Name:
Dysport Therapeutic
Project Line:
Reimbursement Review
Project Number:
SR0556-000
Call for patient/clinician input closed:
NOC Status at Filing:
Post NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
For the treatment of lower limb spasticity in pediatric patients 2 years of aga and older.
Submission Type:
Initial
Fee Schedule:
Schedule B
Indications:
lower limb spasticity
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 Canada's Drug Agency. Reimbursement criteria from Canada's Drug Agency will be documented in the final recommendation, if applicable.

Key Milestones2

Call for patient input posted January 03, 2018
Patient group input closed February 22, 2018
Clarification:

- Patient input submission received

Patient input summary sent for review to patient input groups March 07, 2018
Patient group comments on input summary closed March 14, 2018
Clarification:

- Patient input submission received

Submission received February 07, 2018
Submission accepted for review February 22, 2018
Review initiated February 23, 2018
Draft CDR review report(s) sent to applicant May 11, 2018
Comments from applicant on draft CDR review report(s) received May 23, 2018
Redaction requests from applicant on draft CDR review report(s) received May 30, 2018
CDR review team's comments on draft CDR review report(s) sent to applicant July 06, 2018
Canadian Drug Expert Committee (CDEC) meeting July 18, 2018
CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plans July 30, 2018
Embargo period ended and validation of redacted CDR review report(s) received August 14, 2018
CDEC Final Recommendation issued to applicant and drug plans August 21, 2018
CDEC Final Recommendation posted August 23, 2018
Final CDR review report(s) and patient input posted August 31, 2018