Last Updated : February 7, 2019
Details
FilesGeneric Name:
ertugliflozin and metformin hydrochloride
Project Status:
Complete
Therapeutic Area:
Diabetes mellitus, Type 2
Manufacturer:
Merck Canada Inc.
Call for patient/clinician input open:
Brand Name:
Segluromet
Project Line:
Reimbursement Review
Project Number:
SR0566-000
Call for patient/clinician input closed:
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Added on to metformin for patients who have inadequate glycemic control on metformin and have a contraindication or intolerance to a sulfonylurea, or To replace the individual components of ertugliflozin and metformin for those patients who are on both therapies
Submission Type:
Initial
Fee Schedule:
Schedule C
Indications:
Diabetes mellitus, Type 2
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 | April 02, 2018 |
| Patient group input closed | May 22, 2018 |
| Clarification:
- Patient input submission received |
|
| Patient input summary sent for review to patient input groups | May 31, 2018 |
| Patient group comments on input summary closed | June 07, 2018 |
| Clarification:
- Patient input summary feedback received |
|
| Submission received | April 30, 2018 |
| Submission accepted for review | May 14, 2018 |
| Review initiated | May 15, 2018 |
| Draft CDR review report(s) sent to applicant | August 07, 2018 |
| Comments from applicant on draft CDR review report(s) received | August 16, 2018 |
| Redaction requests from applicant on draft CDR review report(s) received | August 23, 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 03, 2018 |
| Embargo period ended and validation of redacted CDR review report(s) received | October 29, 2018 |
| Clarification:
- Request for extension to embargo period received from the manufacturer - Embargo extension request granted - Reconsideration requested |
|
| Applicant's request for reconsideration placed on CDEC agenda | January 16, 2019 |
| CDEC Final Recommendation issued to applicant and drug plans | January 23, 2019 |
| CDEC Final Recommendation posted | January 25, 2019 |
| Final CDR review report(s) posted | February 07, 2019 |
Files
Last Updated : February 7, 2019