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mepolizumab

Last Updated: April 23, 2019
Result type: Reports
Project Number: SF0593-000
Product Line: Common Drug Review

Generic Name: mepolizumab

Brand Name: Nucala

Manufacturer: GlaxoSmithKline Inc.

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 posted October 24, 2018
Patient group input closed December 12, 2018
Clarification:

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

Patient input summary sent for review to patient input groups December 17, 2018
Patient group comments on input summary closed December 20, 2018
Clarification:

- Patient input summary feedback received

Request for Advice received October 24, 2018
Manufacturer informed of request for advice October 24, 2018
Manufacturer information or comments due November 07, 2018
Request for Advice initiated October 29, 2018
Draft CDR Request for Advice report sent to manufacturer December 05, 2018
Comments from manufacturer on draft CDR Request for Advice report received December 14, 2018
Redaction requests from manufacturer on draft CDR Request for Advice report received December 21, 2018
CDR review team's comments on draft CDR Request for Advice report sent to manufacturer January 04, 2019
Canadian Drug Expert Committee (CDEC) meeting January 16, 2019
CDEC recommendation & redacted CDR Request for Advice report sent to manufacturer and drug plans January 28, 2019
Embargo period ended and validation of redacted CDR Request for Advice report received February 11, 2019
Clarification:

- Request for Clarification received from CDR Participating Drug Plans

Drug plans' request for clarification placed on CDEC agenda March 20, 2019
Response to request for clarification and CDEC Final Recommendation sent to applicant and drug plans March 27, 2019
CDEC Final Recommendation posted March 29, 2019
Final CDR review report(s) posted April 23, 2019