budesonide/ glycopyrronium /formoterol fumarate

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Generic Name:

Project Status:

Complete

Therapeutic Area:

chronic obstructive pulmonary disease (COPD)

Manufacturer:

AstraZeneca Canada Inc.

Brand Name:

Breztri Aerosphere

Project Line:

Reimbursement Review

Project Number:

SR0675-000

NOC Status at Filing:

Pre NOC

Performance Metric:

Achieved

Biosimilar:

Manufacturer Requested Reimbursement Criteria¹:

For the long-term maintenance treatment to reduce exacerbations of COPD, and to relieve symptoms in patients with COPD, including chronic bronchitis and/or emphysema.

Submission Type:

Initial

Fee Schedule:

Schedule A

Indications:

Breztri Aerosphere is a combination of an inhaled corticosteroid (ICS), long-acting muscarinic antagonist (LAMA), and a long-acting beta2-adrenergic agonist (LABA), indicated for the long-term maintenance treatment to reduce exacerbations of chronic obstructive pulmonary disease (COPD) and treat airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema who are not adequately treated by a combination of an ICS/LABA or a combination of a LAMA/LABA.

Recommendation Type:

Reimburse with clinical criteria and/or conditions

Final Recommendation:

September 14, 2021

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 Milestones
Call for patient/clinician input open	December 23, 2020
Call for patient/clinician input closed	February 22, 2021
Clarification: - Patient input submission received from British Columbia Lung Groups, Chronic Obstructive Pulmonary Disease Association and Lung Health Foundation / The Ontario Lung Association
Submission received	January 28, 2021
Submission accepted	February 11, 2021
Review initiated	February 12, 2021
Draft CADTH review report(s) provided to sponsor for comment	May 04, 2021
Deadline for sponsors comments	May 13, 2021
CADTH responses on draft review report(s) provided to sponsor	June 04, 2021
Expert committee meeting (initial)	June 16, 2021
Draft recommendation issued to sponsor	July 21, 2021
Draft recommendation posted for stakeholder feedback	July 29, 2021
End of feedback period	August 13, 2021
Final recommendation issued to sponsor and drug plans	August 26, 2021
Final recommendation posted	September 14, 2021
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)	September 10, 2021
CADTH review report(s) posted	November 05, 2021