Tapentadol Hydrochloride


( Last Updated : December 21, 2018)
Generic 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:

Details


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:
  1. The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of CADTH. Reimbursement criteria from CADTH 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