Last Updated : January 22, 2021
Details
FilesGeneric 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:
- 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
Last Updated : January 22, 2021