abobotulinumtoxinA

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Generic Name:
abobotulinumtoxinA
Project Status:
Complete
Therapeutic Area:
Upper limb spasticity
Manufacturer:
IPSEN Biopharmaceuticals Canada, Inc.
Call for patient/clinician input open:
Brand Name:
Dysport Therapeutic
Project Line:
Reimbursement Review
Project Number:
SR0517-000
Call for patient/clinician input closed:
NOC Status at Filing:
Post NOC
Performance Metric:
Achieved
Biosimilar:
No
Submission Type:
Initial
Fee Schedule:
Schedule B
Indications:
Upper limb spasticity
Date NOC Issued:
Recommendation Type:
Reimburse with clinical criteria and/or conditions
Final Recommendation:

Key Milestones2

Call for patient input posted3 March 17, 2017
Patient group input closed3 May 08, 2017
Clarification:

-Patient input submission received

Patient input summary sent for review to patient input groups May 15, 2017
Patient group comments on input summary closed May 23, 2017
Clarification:

-Patient input summary feedback received

Submission received April 24, 2017
Submission accepted for review May 08, 2017
Review initiated May 09, 2017
Draft CDR review report(s) sent to applicant July 31, 2017
Comments from applicant on draft CDR review report(s) received August 10, 2017
Redaction requests from applicant on draft CDR review report(s) received August 17, 2017
CDR review team's comments on draft CDR review report(s) sent to applicant September 08, 2017
Canadian Drug Expert Committee (CDEC) meeting September 20, 2017
CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plans October 02, 2017
Embargo4 period ended and validation of redacted CDR review report(s) received October 17, 2017
CDEC Final Recommendation issued to applicant and drug plans October 24, 2017
CDEC Final Recommendation posted5 October 26, 2017
Final CDR review report(s) and patient input posted5 November 16, 2017