fluticasone furoate/vilanterol

Details

Generic Name:
fluticasone furoate/vilanterol
Project Status:
Withdrawn
Therapeutic Area:
Asthma
Manufacturer:
GlaxoSmithKline Inc.
Call for patient/clinician input open:
Brand Name:
Breo Ellipta
Project Line:
Reimbursement Review
Project Number:
SR0568-000
Call for patient/clinician input closed:
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Breo Ellipta should be reimbursed preferentially to Advair to maximize asthma control in patients aged 18 years and older with reversible obstructive airways disease.
Submission Type:
Resubmission
Fee Schedule:
Schedule B
Indications:
Asthma
Date NOC Issued:
  1. 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 postedApril 04, 2018
Patient group input closedMay 24, 2018
Clarification:

- No patient input submission received

Submission receivedMay 02, 2018
Submission acceptedMay 16, 2018
Review initiatedMay 17, 2018
Draft CADTH review report(s) sent to sponsorAugust 01, 2018
Comments from sponsor on draft CADTH review report(s) receivedAugust 13, 2018
Redaction requests from sponsor on draft CADTH review report(s) receivedAugust 15, 2018
Clarification:

- Voluntarily withdrawn by the manufacturer on 2018-08-14