Levodopa / carbidopa (Drug Plan Submission)

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Generic Name:
Levodopa / carbidopa (Drug Plan Submission)
Project Status:
Complete
Therapeutic Area:
Parkinson's disease
Manufacturer:
AbbVie Corporation
Call for patient/clinician input open:
Brand Name:
Duodopa
Project Line:
Reimbursement Review
Project Number:
SR0557-000
Call for patient/clinician input closed:
NOC Status at Filing:
Post NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Not applicable. Drug plan submission.
Submission Type:
Drug Plan Initiated
Indications:
Parkinson's disease
Date NOC Issued:
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 11, 2018
Patient group input closed March 02, 2018
Clarification:

- Patient input submission received

Patient input summary sent for review to patient input groups March 14, 2018
Patient group comments on input summary closed March 21, 2018
Clarification:

- Patient input summary feedback received

Submission received February 08, 2018
Submission accepted for review February 23, 2018
Review initiated February 26, 2018
Draft CDR review report(s) sent to applicant May 10, 2018
Comments from applicant on draft CDR review report(s) received May 22, 2018
Redaction requests from applicant on draft CDR review report(s) received May 29, 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 31, 2018
Embargo period ended and validation of redacted CDR review report(s) received August 15, 2018
CDEC Final Recommendation issued to applicant and drug plans August 22, 2018
CDEC Final Recommendation posted August 24, 2018
Final CDR review report(s) and patient input posted September 18, 2018