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indacaterol /mometasone furoate

Last Updated: January 20, 2021
Result type: Reports
Project Number: SR0646-000
Product Line: Reimbursement Review

Generic Name: indacaterol /mometasone furoate

Brand Name: Atectura Breezhaler

Manufacturer: Novartis Pharmaceuticals Canada Inc.

Therapeutic Area: Asthma maintenance (adults, children 12 or older)

Indications: Indicated as a once-daily maintenance treatment of asthma in adults and adolescents 12 years of age and older with reversible obstructive airways disease. Atectura Breezhaler should be prescribed for patients not adequately controlled on a long-term asthma control medication, such as ICS or whose disease severity clearly warrants treatment with both a LABA and an ICS.

Manufacturer Requested Reimbursement Criteria1: Indicated as a once-daily maintenance treatment of asthma in adults and adolescents 12 years of age and older with reversible obstructive airways disease. Atectura Breezhaler should be prescribed for patients not adequately controlled on a long-term asthma control medication, such as ICS or whose disease severity clearly warrants treatment with both a LABA and an ICS.

Submission Type: Initial

NOC Status at Filing: Post 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

  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 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 20, 2021