CDA | Evidence Driven
CDA | Evidence Driven

Indacaterol glycopyrronium mometasone furoate

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Generic Name:
indacaterol glycopyrronium mometasone furoate
Project Status:
Complete
Therapeutic Area:
Asthma maintenance, adults
Manufacturer:
Novartis Pharmaceuticals Canada Inc.
Call for patient/clinician input open:
Brand Name:
Enerzair Breezhaler
Project Line:
Reimbursement Review
Project Number:
SR0645-000
Call for patient/clinician input closed:
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Indicated as a maintenance treatment of asthma in adult patients not adequately controlled with a maintenance combination of a long-acting beta2-agonist and a medium or high dose of an inhaled corticosteroid who experienced one or more asthma exacerbations in the previous 12 months.
Submission Type:
Initial
Fee Schedule:
Schedule A
Indications:
Indicated as a maintenance treatment of asthma in adult patients not adequately controlled with a maintenance combination of a long-acting beta2-agonist and a medium or high dose of an inhaled corticosteroid who experienced one or more asthma exacerbations in the previous 12 months.
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 Canada's Drug Agency. Reimbursement criteria from Canada's Drug Agency will be documented in the final recommendation, if applicable.

Key Milestones2
Call for patient input open March 31, 2020
Call for patient input closed May 21, 2020
Clarification:

- Patient input submission received from Asthma Canada and Lung Health Foundation
Submission received May 19, 2020
Submission accepted June 02, 2020
Review initiated June 03, 2020
Draft CADTH review report(s) provided to sponsor for comment August 18, 2020
Deadline for sponsors comments August 27, 2020
CADTH responses on draft review report(s) provided to sponsor October 08, 2020
Expert committee meeting (initial) October 21, 2020
Draft recommendation issued to sponsor November 03, 2020
End of embargo period November 17, 2020
Final recommendation issued to sponsor and drug plans November 24, 2020
Final recommendation posted November 26, 2020
Deadline for sponsor to submit redaction requests on draft CADTH review report(s) December 08, 2020
CADTH review report(s) posted January 22, 2021

Files

Recommendation and Reasons View PDF
Clinical Report View PDF
Pharmacoeconomic Report View PDF
Patient Group Input Submissions View PDF
Last Updated : January 22, 2021