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burosumab

Last Updated: November 28, 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

Date Recommendation Issued: May 27, 2020

Recommendation Type: Reimburse with clinical criteria and/or conditions

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 acceptedAugust 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
Embargo period endedFebruary 11, 2020
Clarification:

- Request for extension to embargo period received from the sponsor

- Embargo extension request granted

- Reconsideration requested

Sponsor's request for reconsideration placed on CDEC agendaMay 20, 2020
CDEC Final Recommendation & CADTH review report(s) issued to sponsor and drug plansMay 27, 2020
CDEC Final Recommendation postedMay 29, 2020
Redaction requests from sponsor on draft CADTH review report(s) receivedJune 10, 2020
Redacted CADTH review report(s) sent to sponsor and drug plansJune 12, 2020
Validation of redacted CADTH review report(s) receivedJune 19, 2020
Final CADTH review report(s) posted-