Generic Name: budesonide/ glycopyrronium /formoterol fumarate
Brand Name: TBC
Manufacturer: AstraZeneca Canada Inc.
Therapeutic Area: chronic obstructive pulmonary disease (COPD)
Indications: budesonide/ glycopyrronium /formoterol fumarate 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 to relieve symptoms in patients with COPD, including chronic bronchitis and/or emphysema.
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
NOC Status at Filing: Pre NOC
Project Status: Active
Companion Diagnostics: No
Fee Schedule: Schedule A
- 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.
|Call for patient/clinician input open||December 23, 2020|
|Call for patient/clinician input closed||February 22, 2021|
- 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||April 29, 2021|
|Deadline for sponsors comments||May 10, 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||June 28, 2021
June 30, 2021
|Draft recommendation posted for stakeholder feedback||-|