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insulin degludec + liraglutide

Last Updated: October 29, 2019
Result type: Reports
Project Number: SR0599-000
Product Line: Common Drug Review

Generic Name: insulin degludec + liraglutide

Brand Name: Xultophy

Manufacturer: Novo Nordisk Canada Inc.

Indications: Diabetes mellitus, Type 2

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: New Combination

Project Status: Active

Biosimilar: No

Date Recommendation Issued: October 24, 2019

Recommendation Type: Reimburse with clinical criteria and/or conditions

Fee Schedule: Schedule A

  1. The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of CADTH. Reimbursement criteria from CADTH will be documented in the final recommendation, if applicable.

Key Milestones2

Call for patient input postedJanuary 02, 2019
Patient group input closedFebruary 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 groupsFebruary 27, 2019
Patient group comments on input summary closedMarch 06, 2019
Clarification:

- Patient input summary feedback received

Submission receivedJanuary 30, 2019
Submission accepted for reviewFebruary 13, 2019
Review initiatedFebruary 14, 2019
Draft CADTH review report(s) sent to sponsorMay 03, 2019
Comments from sponsor on draft CADTH review report(s) receivedMay 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) receivedMay 22, 2019
CADTH review team's comments on draft CADTH review report(s) sent to sponsorSeptember 06, 2019
Canadian Drug Expert Committee (CDEC) meetingSeptember 18, 2019
CDEC recommendation & redacted CADTH review report(s) sent to sponsor and drug plansOctober 02, 2019
Embargo period ended and validation of redacted CADTH review report(s) receivedOctober 17, 2019
CDEC Final Recommendation issued to sponsor and drug plansOctober 24, 2019
CDEC Final Recommendation postedOctober 28, 2019
Final CADTH review report(s) posted-