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abobotulinumtoxinA

Last Updated: November 22, 2017
Result type: Reports
Project Number: SR0517-000
Product Line: Common Drug Review

Generic Name: abobotulinumtoxinA

Brand Name: Dysport Therapeutic

Manufacturer: IPSEN Biopharmaceuticals Canada, Inc.

Indications: Upper limb spasticity

Submission Type: New Indication

Project Status: Complete

Biosimilar: No

Date Recommendation Issued: October 24, 2017

Recommendation Type: Reimburse with clinical criteria and/or conditions

Fee Schedule1: Schedule B

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
  1. Refer to Appendix 1 of the Procedure for the CADTH Common Drug Review for details regarding CDR application fee schedules.
  2. Please refer to the Procedure for the CADTH Common Drug Review for complete details regarding the CDR process and targeted time frames for key milestones.
  3. The call for patient group input is posted 20 business days in advance of the applicant's anticipated date of filing the CDR application. Patient groups have a total of 35 business days for preparing and submitting patient input.
  4. The embargoed CDEC recommendation is held in confidence by all stakeholders and not acted upon until after CADTH has issued the notice of CDEC Final Recommendation.The applicant may make a request for reconsideration or resubmission based on reduced price during the embargo period, and the drug plans may make a request for clarification, as applicable (see section 8 of the Procedure for the CADTH Common Drug Review).
  5. The timing for posting the CDEC Final Recommendation and CDR review report(s) depends on several factors including the need for consultation with the applicant regarding redaction issues.
  6. The time frame required to address a request for clarification at the drug plans' request or request for reconsideration at the applicant's request depends on the amount of work required to address the request and the available dates for CDEC meetings.

Tags

nervous system, botulinum toxins, type a, muscle hypertonia, muscle hypotonia, upper extremity, botulinum neurotoxin; botulinum neurotoxins; botulinum toxin a; Spasticity; upper extremities; upper limbs