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burosumab

Last Updated: December 11, 2019
Result type: Reports
Project Number: SR0602-000
Product Line: Common Drug Review

Generic Name: burosumab

Brand Name: Crysvita

Manufacturer: Kyowa Kirin Limited

Indications: Treatment of X-Linked Hypophosphatemia

Manufacturer Requested Reimbursement Criteria1: For the treatment of X-linked hypophosphatemia (XLH) in adult and pediatric patients 1 year of age and older.

Submission Type: New

Project Status: Active

Biosimilar: No

Companion Diagnostics: No

Fee Schedule: Schedule A

  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 Milestones2

Call for patient input postedJanuary 24, 2019
Patient group input closedMarch 15, 2019
Clarification:

- Patient input submission received from Canadian Organization for Rare Disorders

Patient input summary sent for review to patient input groupsAugust 22, 2019
Patient group comments on input summary closedAugust 29, 2019
Clarification:

- Patient input summary feedback received

Submission receivedJuly 23, 2019
Submission accepted for reviewAugust 07, 2019
Review initiatedAugust 08, 2019
Draft CADTH review report(s) sent to sponsorOctober 25, 2019
Comments from sponsor on draft CADTH review report(s) receivedNovember 05, 2019
CADTH review team's comments on draft CADTH review report(s) sent to sponsorNovember 29, 2019
Canadian Drug Expert Committee (CDEC) meetingDecember 11, 2019
CDEC recommendation sent to sponsor and drug plansDecember 23, 2019
To
January 02, 2020