Generic Name: indacaterol glycopyrronium mometasone furoate
Brand Name: Enerzair Breezhaler
Manufacturer: Novartis Pharmaceuticals Canada Inc.
Therapeutic Area: Asthma maintenance, adults
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.
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
NOC Status at Filing: Pre NOC
Project Status: Complete
Companion Diagnostics: No
Date Recommendation Issued: November 24, 2020
Recommendation Type: Reimburse with clinical criteria and/or conditions
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 input open||March 31, 2020|
|Call for patient input closed||May 21, 2020|
- 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|