insulin degludec + liraglutide

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Generic 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:
  1. 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