budesonide/ glycopyrronium /formoterol fumarate


( Last Updated : November 5, 2021)
Generic Name:
budesonide/ glycopyrronium /formoterol fumarate
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

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 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