Last Updated : October 23, 2019
Details
FilesGeneric Name:
telotristat
Project Status:
Complete
Therapeutic Area:
carcinoid syndrome
Manufacturer:
Ipsen Biopharmaceuticals Canada Inc.
Call for patient/clinician input open:
Brand Name:
Xermelo
Project Line:
Reimbursement Review
Project Number:
SR0580-000
Call for patient/clinician input closed:
NOC Status at Filing:
Pre NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
For the treatment of refractory carcinoid syndrome diarrhea, in combination with somatostatin analogue (SSA) therapy, in patients inadequately controlled by SSA therapy alone.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
carcinoid syndrome
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 | August 29, 2018 |
| Patient group input closed | October 19, 2018 |
| Clarification:
- Patient input submission received from the Carcinoid Neuroendocrine Tumour Society - Canada |
|
| Patient input summary sent for review to patient input groups | October 29, 2018 |
| Patient group comments on input summary closed | November 05, 2018 |
| Clarification:
- Patient input summary feedback received |
|
| Submission received | September 27, 2018 |
| Submission accepted for review | October 12, 2018 |
| Review initiated | October 15, 2018 |
| Draft CADTH review report(s) sent to sponsor | January 07, 2019 |
| Comments from sponsor on draft CADTH review report(s) received | January 16, 2019 |
| Redaction requests from sponsor on draft CADTH review report(s) received | January 23, 2019 |
| CADTH review team's comments on draft CADTH review report(s) sent to sponsor | February 07, 2019 |
| Canadian Drug Expert Committee (CDEC) meeting | February 20, 2019 |
| CDEC recommendation & redacted CADTH review report(s) sent to sponsor and drug plans | March 06, 2019 |
| Embargo period ended and validation of redacted CADTH review report(s) received | March 22, 2019 |
| Clarification:
- Request for extension to embargo period received from the manufacturer - Embargo extension request granted - Reconsideration requested - Target CDEC reconsideration meeting date to be determined |
|
| Sponsor's request for reconsideration placed on CDEC agenda | June 19, 2019 |
| CDEC Final Recommendation issued to sponsor and drug plans | June 26, 2019 |
| CDEC Final Recommendation posted | July 03, 2019 |
| Final CADTH review report(s) posted | July 25, 2019 |
Files
Last Updated : October 23, 2019