budesonide/ glycopyrronium /formoterol fumarate


( Last Updated : September 15, 2021)
Generic Name:
budesonide/ glycopyrronium /formoterol fumarate
Project Status:
Active
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

Details


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:
  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/clinician input openDecember 23, 2020
Call for patient/clinician input closedFebruary 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 receivedJanuary 28, 2021
Submission acceptedFebruary 11, 2021
Review initiatedFebruary 12, 2021
Draft CADTH review report(s) provided to sponsor for commentMay 04, 2021
Deadline for sponsors commentsMay 13, 2021
CADTH responses on draft review report(s) provided to sponsorJune 04, 2021
Expert committee meeting (initial)June 16, 2021
Draft recommendation issued to sponsorJuly 21, 2021
Draft recommendation posted for stakeholder feedbackJuly 29, 2021
End of feedback periodAugust 13, 2021
Final recommendation issued to sponsor and drug plansAugust 26, 2021
Final recommendation postedSeptember 14, 2021
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)September 10, 2021
CADTH review report(s) posted