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fluticasone furoate/umeclidinium/vilanterol

Last Updated: September 19, 2018
Result type: Reports
Project Number: SR0562-000
Product Line: Common Drug Review

Generic Name: fluticasone furoate umeclidinium vilanterol

Brand Name: Trelegy Ellipta

Manufacturer: GlaxoSmithKline Inc.

Indications: Chronic obstructive pulmonary disease (COPD)

Manufacturer Requested Reimbursement Criteria1: For the long-term, once daily, maintenance treatment of chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema, where the following clinical criteria are met: - Moderate to severe COPD as defined by spirometry; and - At risk of exacerbations despite a long-acting bronchodilator (LAMA or LABA); or - Symptomatic or at risk of exacerbations despite a LAMA/LABA or ICS/LABA; or - Currently on a LAMA/ICS/LABA.

Submission Type: New Combination

Project Status: Complete

Biosimilar: No

Companion Diagnostics: No

Date Recommendation Issued: August 23, 2018

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 postedJanuary 31, 2018
Patient group input closedMarch 22, 2018
Clarification:

- Patient input submission received

Patient input summary sent for review to patient input groupsApril 03, 2018
Patient group comments on input summary closedApril 10, 2018
Clarification:

- Patient input summary feedback received

Submission receivedMarch 01, 2018
Submission accepted for reviewMarch 15, 2018
Review initiatedMarch 16, 2018
Draft CDR review report(s) sent to applicantJune 04, 2018
Comments from applicant on draft CDR review report(s) receivedJune 13, 2018
Redaction requests from applicant on draft CDR review report(s) receivedJune 20, 2018
CDR review team's comments on draft CDR review report(s) sent to applicantJuly 06, 2018
Canadian Drug Expert Committee (CDEC) meetingJuly 18, 2018
CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plansAugust 01, 2018
Embargo period ended and validation of redacted CDR review report(s) receivedAugust 16, 2018
CDEC Final Recommendation issued to applicant and drug plansAugust 23, 2018
CDEC Final Recommendation postedAugust 27, 2018
Final CDR review report(s) and patient input postedSeptember 18, 2018

Tags

copd, pulmonary disease, chronic obstructive, respiratory, COPD; emphysema; Trelegy ellipta; fluticasone furoate umeclidinium vilanterol