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sebelipase alfa

Last Updated: November 27, 2018
Result type: Reports
Project Number: SR0544-000
Product Line: Common Drug Review

Generic Name: sebelipase alfa

Brand Name: Kanuma

Manufacturer: Alexion Pharmaceuticals

Indications: Lysosomal acid lipase deficiency

Submission Type: New

Project Status: Complete

Biosimilar: No

Date Recommendation Issued: September 26, 2018

Recommendation Type: Reimburse with clinical criteria and/or conditions

Fee Schedule: Schedule A

Key Milestones2

Call for patient input posted October 04, 2017
Patient group input closed November 23, 2017
Clarification:

- Patient input submission received

Patient input summary sent for review to patient input groups December 04, 2017
Patient group comments on input summary closed December 11, 2017
Clarification:

- Patient input summary feedback received

Submission received November 02, 2017
Submission accepted for review November 16, 2017
Review initiated November 17, 2017
Draft CDR review report(s) sent to applicant February 16, 2018
Comments from applicant on draft CDR review report(s) received March 02, 2018
Clarification:

- Extension request received from applicant

- Extension granted

Redaction requests from applicant on draft CDR review report(s) received March 09, 2018
CDR review team's comments on draft CDR review report(s) sent to applicant March 29, 2018
Canadian Drug Expert Committee (CDEC) meeting April 11, 2018
CDEC recommendation & redacted CDR review report(s) sent to applicant and drug plans April 25, 2018
Embargo period ended and validation of redacted CDR review report(s) received June 07, 2018
Clarification:

- Request for extension to embargo period received from the manufacturer

- Embargo extension request granted

- Reconsideration requested

Applicant's request for reconsideration placed on CDEC agenda September 19, 2018
CDEC Final Recommendation issued to applicant and drug plans September 26, 2018
CDEC Final Recommendation posted September 28, 2018
Final CDR review report(s) and patient input posted November 21, 2018