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indacaterol /mometasone furoate

Last Updated: October 5, 2020
Result type: Reports
Project Number: SR0646-000
Product Line: Common Drug Review

Generic Name: indacaterol /mometasone furoate

Brand Name: Atectura Breezhaler

Manufacturer: Novartis Pharmaceuticals Canada Inc.

Indications: Asthma maintenance (adults, children 12 or older)

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: New

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 input openMarch 31, 2020
Call for patient input closedMay 21, 2020
Clarification:

- Patient input submission received from Asthma Canada and Lung Health Foundation

Submission receivedMay 19, 2020
Submission acceptedJune 02, 2020
Review initiatedJune 03, 2020
Draft CADTH review report(s) provided to sponsor for commentAugust 18, 2020
Deadline for sponsors commentsAugust 27, 2020
CADTH responses on draft review report(s) provided to sponsorOctober 08, 2020
Expert committee meeting (initial)October 21, 2020
Draft recommendation issuedNovember 02, 2020
To
November 04, 2020