Last Updated : June 25, 2020
Details
FilesGeneric Name:
teduglutide
Project Status:
Complete
Therapeutic Area:
Short Bowel Syndrome (SBS), pediatrics
Manufacturer:
Shire Pharmaceuticals Ireland Limited
Call for patient/clinician input open:
Brand Name:
Revestive
Project Line:
Reimbursement Review
Project Number:
SR0606-000
Call for patient/clinician input closed:
NOC Status at Filing:
Pre NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Revestive is proposed to be indicated for the treatment of pediatric patients 1 year of age and above with Short Bowel Syndrome (SBS) who are dependent on parenteral support.
Submission Type:
Initial
Fee Schedule:
Schedule B
Indications:
Short Bowel Syndrome (SBS), pediatrics
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 | March 04, 2019 |
| Patient group input closed | April 23, 2019 |
| Clarification:
- Patient input submission received from Gastrointestinal Society |
|
| Patient input summary sent for review to patient input groups | June 24, 2019 |
| Patient group comments on input summary closed | July 02, 2019 |
| Clarification:
- No patient input summary feedback received |
|
| Submission received | May 29, 2019 |
| Submission accepted | June 12, 2019 |
| Review initiated | June 17, 2019 |
| Draft CADTH review report(s) sent to sponsor | August 30, 2019 |
| Comments from sponsor on draft CADTH review report(s) received | September 11, 2019 |
| CADTH review team's comments on draft CADTH review report(s) sent to sponsor | October 03, 2019 |
| Canadian Drug Expert Committee (CDEC) meeting | October 16, 2019 |
| CDEC recommendation sent to sponsor and drug plans | October 29, 2019 |
| Embargo period ended | November 12, 2019 |
| CDEC Final Recommendation & CADTH review report(s) issued to sponsor and drug plans | November 19, 2019 |
| CDEC Final Recommendation posted | November 21, 2019 |
| Redaction requests from sponsor on draft CADTH review report(s) received | December 03, 2019 |
| Redacted CADTH review report(s) sent to sponsor and drug plans | December 13, 2019 |
| Validation of redacted CADTH review report(s) received | December 20, 2019 |
| Final CADTH review report(s) posted | January 22, 2020 |
Files
Last Updated : June 25, 2020