Last Updated : December 21, 2018
Details
FilesGeneric Name:
tapentadol hydrochloride
Project Status:
Complete
Therapeutic Area:
pain, severe
Manufacturer:
Paladin Labs Inc.
Call for patient/clinician input open:
Brand Name:
Nucynta
Project Line:
Reimbursement Review
Project Number:
SR0563-000
Call for patient/clinician input closed:
NOC Status at Filing:
Post NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
For the management of pain severe enough to require daily, continuous, long-term opioid treatment, and: that is opioid-responsive; and for which alternative treatment options are inadequate.
Submission Type:
Initial
Fee Schedule:
Schedule B
Indications:
pain, severe
Date NOC Issued:
Recommendation Type:
Do not reimburse
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 | March 19, 2018 |
| Patient group input closed | May 08, 2018 |
| Clarification:
- Patient input submission received |
|
| Patient input summary sent for review to patient input groups | May 14, 2018 |
| Patient group comments on input summary closed | May 22, 2018 |
| Clarification:
- Patient input summary feedback received |
|
| Submission received | April 17, 2018 |
| Submission accepted for review | May 01, 2018 |
| Review initiated | May 02, 2018 |
| Draft CDR review report(s) sent to applicant | July 20, 2018 |
| Comments from applicant on draft CDR review report(s) received | July 31, 2018 |
| Redaction requests from applicant on draft CDR review report(s) received | August 08, 2018 |
| CDR review team's comments on draft CDR review report(s) sent to applicant | September 07, 2018 |
| Canadian Drug Expert Committee (CDEC) meeting | September 19, 2018 |
| CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plans | October 01, 2018 |
| Embargo period ended and validation of redacted CDR review report(s) received | October 16, 2018 |
| CDEC Final Recommendation issued to applicant and drug plans | October 23, 2018 |
| CDEC Final Recommendation posted | October 25, 2018 |
| Final CDR review report(s) and patient input posted | October 29, 2018 |
Files
Last Updated : December 21, 2018