Last Updated : January 14, 2019
Details
FilesGeneric 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:
- 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 |
Files
Last Updated : January 14, 2019