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
- 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 posted | January 31, 2018 |
| Patient group input closed | March 22, 2018 |
| Clarification: - Patient input submission received | |
| Patient input summary sent for review to patient input groups | April 03, 2018 |
| Patient group comments on input summary closed | April 10, 2018 |
| Clarification: - Patient input summary feedback received | |
| Submission received | March 01, 2018 |
| Submission accepted for review | March 15, 2018 |
| Review initiated | March 16, 2018 |
| Draft CDR review report(s) sent to applicant | June 04, 2018 |
| Comments from applicant on draft CDR review report(s) received | June 13, 2018 |
| Redaction requests from applicant on draft CDR review report(s) received | June 20, 2018 |
| CDR review team's comments on draft CDR review report(s) sent to applicant | July 06, 2018 |
| Canadian Drug Expert Committee (CDEC) meeting | July 18, 2018 |
| CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plans | August 01, 2018 |
| Embargo period ended and validation of redacted CDR review report(s) received | August 16, 2018 |
| CDEC Final Recommendation issued to applicant and drug plans | August 23, 2018 |
| CDEC Final Recommendation posted | August 27, 2018 |
| Final CDR review report(s) and patient input posted | September 18, 2018 |