Last Updated : August 31, 2018
Details
FilesGeneric 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:
- 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 |
Files
Last Updated : August 31, 2018