CADTH is committed to supporting Canada’s health care decision-makers through this challenging and uncertain time.
For evidence, tools, and resources related to COVID-19, visit our COVID-19 Evidence Portal.

 

Begin main content

budesonide/ glycopyrronium /formoterol fumarate

Last Updated: March 15, 2021
Result type: Reports
Project Number: SR0675-000
Product Line: Reimbursement Review

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

  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 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 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
To
June 30, 2021
Draft recommendation posted for stakeholder feedback -