glucagon

Details

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Generic Name:

glucagon

Project Status:

Complete

Therapeutic Area:

Severe hypoglycemic reactions

Manufacturer:

Eli Lilly Canada Inc.

Call for patient/clinician input open:

June 25, 2019

Brand Name:

Baqsimi

Project Line:

Reimbursement Review

Project Number:

SR0626-000

Call for patient/clinician input closed:

August 15, 2019

NOC Status at Filing:

Pre NOC

Performance Metric:

Achieved

Biosimilar:

Manufacturer Requested Reimbursement Criteria¹:

For the treatment of severe hypoglycemic reactions which may occur in the management of insulin treated patients with diabetes mellitus, when impaired consciousness precludes oral carbohydrates.

Submission Type:

Initial

Fee Schedule:

Schedule A

Indications:

Severe hypoglycemic reactions

Recommendation Type:

Reimburse with clinical criteria and/or conditions

Final Recommendation/Report:

January 22, 2020

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	June 25, 2019
Patient group input closed	August 15, 2019
Clarification: - Patient input submission received from Diabetes Canada and Type 1 Together/Ensemble
Patient input summary sent for review to patient input groups	September 12, 2019
Patient group comments on input summary closed	September 19, 2019
Clarification: - Patient input summary feedback received
Submission received	July 24, 2019
Submission accepted	August 08, 2019
Review initiated	August 09, 2019
Draft Canada's Drug Agency review report(s) sent to sponsor	October 24, 2019
Comments from sponsor on draft Canada's Drug Agency review report(s) received	November 04, 2019
Canada's Drug Agency review team's comments on draft Canada's Drug Agency review report(s) sent to sponsor	November 29, 2019
Canadian Drug Expert Committee (CDEC) meeting	December 11, 2019
CDEC recommendation sent to sponsor and drug plans	December 24, 2019
CDEC Final Recommendation & Canada's Drug Agency review report(s) issued to sponsor and drug plans	January 22, 2020
CDEC Final Recommendation posted	January 24, 2020
Redaction requests from sponsor on draft Canada's Drug Agency review report(s) received	February 05, 2020
Redacted Canada's Drug Agency review report(s) sent to sponsor and drug plans	February 18, 2020
Validation of redacted Canada's Drug Agency review report(s) received	February 25, 2020
Final Canada's Drug Agency review report(s) posted	March 09, 2020