Last Updated : September 19, 2018
Details
FilesGeneric Name:
fluticasone furoate umeclidinium vilanterol
Project Status:
Complete
Therapeutic Area:
Chronic obstructive pulmonary disease (COPD)
Manufacturer:
GlaxoSmithKline Inc.
Call for patient/clinician input open:
Brand Name:
Trelegy Ellipta
Project Line:
Reimbursement Review
Project Number:
SR0562-000
Call for patient/clinician input closed:
NOC Status at Filing:
Pre NOC
Performance Metric:
Achieved
Biosimilar:
No
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:
Initial
Fee Schedule:
Schedule A
Indications:
Chronic obstructive pulmonary disease (COPD)
Recommendation Type:
Reimburse with clinical criteria and/or conditions
Final Recommendation:
- The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of Canada's Drug Agency. Reimbursement criteria from Canada's Drug Agency 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 |
Files
Last Updated : September 19, 2018