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Last Updated: November 5, 2019
Result type: Reports
Project Number: SF0593-000
Product Line: Reimbursement Review

Generic Name: mepolizumab

Brand Name: Nucala

Manufacturer: GlaxoSmithKline Inc.

Therapeutic Area: Asthma, severe eosinophilic

Indications: Asthma, severe eosinophilic

Manufacturer Requested Reimbursement Criteria1: Not applicable.

Submission Type: Request For Advice

Project Status: Complete

Biosimilar: No

Companion Diagnostics: No

Date Recommendation Issued: March 27, 2019

Recommendation Type: Reimburse with clinical criteria and/or conditions

  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 Milestones1

Call for patient input postedOctober 24, 2018
Patient group input closedDecember 12, 2018

- Patient input submission received from Asthma Canada and The Ontario Lung Association

Patient input summary sent for review to patient input groupsDecember 17, 2018
Patient group comments on input summary closedDecember 20, 2018

- Patient input summary feedback received

Request for Advice receivedOctober 24, 2018
Manufacturer informed of request for adviceOctober 24, 2018
Manufacturer information or comments dueNovember 07, 2018
Request for Advice initiatedOctober 29, 2018
Draft CDR Request for Advice report sent to manufacturerDecember 05, 2018
Comments from manufacturer on draft CDR Request for Advice report receivedDecember 14, 2018
Redaction requests from manufacturer on draft CDR Request for Advice report receivedDecember 21, 2018
CDR review team's comments on draft CDR Request for Advice report sent to manufacturerJanuary 04, 2019
Canadian Drug Expert Committee (CDEC) meetingJanuary 16, 2019
CDEC recommendation & redacted CDR Request for Advice report sent to manufacturer and drug plansJanuary 28, 2019
Embargo period ended and validation of redacted CDR Request for Advice report receivedFebruary 11, 2019

- Request for Clarification received from CDR Participating Drug Plans

Drug plans' request for clarification placed on CDEC agendaMarch 20, 2019
Response to request for clarification and CDEC Final Recommendation sent to sponsor and drug plansMarch 27, 2019
CDEC Final Recommendation postedMarch 29, 2019
Final CDR review report(s) postedApril 23, 2019