Last Updated : April 18, 2019
Details
FilesGeneric Name:
buprenorphine hydrochloride
Project Status:
Complete
Therapeutic Area:
Opioid drug dependence, treatment
Manufacturer:
Knight Therapeutics Inc.
Call for patient/clinician input open:
Brand Name:
Probuphine
Project Line:
Reimbursement Review
Project Number:
SR0550-000
Call for patient/clinician input closed:
NOC Status at Filing:
Pre NOC
Biosimilar:
No
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Opioid drug dependence, treatment
Recommendation Type:
Reimburse with clinical criteria and/or conditions
Final Recommendation:
Key Milestones2 |
|
|---|---|
| Call for patient input posted | November 22, 2017 |
| Patient group input closed | January 18, 2018 |
| Clarification:
- No patient input submission received |
|
| Submission received | December 21, 2017 |
| Submission accepted for review | January 12, 2018 |
| Review initiated | January 15, 2018 |
| Draft CADTH review report(s) sent to applicant | April 03, 2018 |
| Comments from applicant on draft CADTH review report(s) received | April 12, 2018 |
| Redaction requests from applicant on draft CADTH review report(s) received | April 19, 2018 |
| Clarification:
- No redactions requested by the applicant |
|
| CADTH review team's comments on draft CADTH review report(s) sent to applicant | May 04, 2018 |
| Canadian Drug Expert Committee (CDEC) meeting | May 16, 2018 |
| CDEC recommendation & redacted CADTH review report(s) sent to applicant and drug plans | May 29, 2018 |
| Embargo period ended and validation of redacted CADTH review report(s) received | June 12, 2018 |
| Clarification:
- Reconsideration requested |
|
| Applicant's request for reconsideration placed on CDEC agenda | August 15, 2018 |
| CDEC Final Recommendation issued to applicant and drug plans | August 22, 2018 |
| CDEC Final Recommendation posted | August 24, 2018 |
| Final CADTH review report(s) and patient input posted | September 17, 2018 |
Files
Last Updated : April 18, 2019