Last Updated : June 18, 2020
Details
FilesGeneric Name:
insulin degludec + liraglutide
Project Status:
Complete
Therapeutic Area:
Diabetes mellitus, Type 2
Manufacturer:
Novo Nordisk Canada Inc.
Call for patient/clinician input open:
Brand Name:
Xultophy
Project Line:
Reimbursement Review
Project Number:
SR0599-000
Call for patient/clinician input closed:
NOC Status at Filing:
Post NOC
Performance Metric:
N/A delay outside our control - Temporary suspension and/or submission of new information by sponsor
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
To be reimbursed as an adjunct to lifestyle modifications to improve glycemic control in adults with type 2 diabetes mellitus when oral glucose-lowering medications combined with basal insulin, or basal insulin alone do not provide adequate glycemic control.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Diabetes mellitus, Type 2
Date NOC Issued:
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 | January 02, 2019 |
| Patient group input closed | February 21, 2019 |
| Clarification:
- Patient input submission received from Diabetes Canada and Type 2 Diabetes Experience Exchange |
|
| Patient input summary sent for review to patient input groups | February 27, 2019 |
| Patient group comments on input summary closed | March 06, 2019 |
| Clarification:
- Patient input summary feedback received |
|
| Submission received | January 30, 2019 |
| Submission accepted | February 13, 2019 |
| Review initiated | February 14, 2019 |
| Draft CADTH review report(s) sent to sponsor | May 03, 2019 |
| Comments from sponsor on draft CADTH review report(s) received | May 14, 2019 |
| Clarification:
- Submission temporarily suspended pending receipt of information - Additional information has been received and the temporary suspension of the review has been lifted |
|
| Redaction requests from sponsor on draft CADTH review report(s) received | May 22, 2019 |
| CADTH review team's comments on draft CADTH review report(s) sent to sponsor | September 06, 2019 |
| Canadian Drug Expert Committee (CDEC) meeting | September 18, 2019 |
| CDEC recommendation & redacted CADTH review report(s) sent to sponsor and drug plans | October 02, 2019 |
| Embargo period ended and validation of redacted CADTH review report(s) received | October 17, 2019 |
| CDEC Final Recommendation issued to sponsor and drug plans | October 24, 2019 |
| CDEC Final Recommendation posted | October 28, 2019 |
| Final CADTH review report(s) posted | December 05, 2019 |
Files
Last Updated : June 18, 2020