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burosumab

Last Updated: July 14, 2020
Result type: Reports
Project Number: SR0602-000
Product Line: Reimbursement Review

Generic Name: burosumab

Brand Name: Crysvita

Manufacturer: Kyowa Kirin Limited

Therapeutic Area: Treatment of X-Linked Hypophosphatemia

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: Initial

Project Status: Complete

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 posted January 24, 2019
Patient group input closed March 15, 2019
Clarification:

- Patient input submission received from Canadian Organization for Rare Disorders

Patient input summary sent for review to patient input groups August 22, 2019
Patient group comments on input summary closed August 29, 2019
Clarification:

- Patient input summary feedback received

Submission received July 23, 2019
Submission accepted August 07, 2019
Review initiated August 08, 2019
Draft CADTH review report(s) sent to sponsor October 25, 2019
Comments from sponsor on draft CADTH review report(s) received November 05, 2019
CADTH review team's comments on draft CADTH review report(s) sent to sponsor November 29, 2019
Canadian Drug Expert Committee (CDEC) meeting December 11, 2019
CDEC recommendation sent to sponsor and drug plans December 23, 2019
Embargo period ended February 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 agenda May 20, 2020
CDEC Final Recommendation & CADTH review report(s) issued to sponsor and drug plans May 27, 2020
CDEC Final Recommendation posted May 29, 2020
Redaction requests from sponsor on draft CADTH review report(s) received June 10, 2020
Redacted CADTH review report(s) sent to sponsor and drug plans June 12, 2020
Validation of redacted CADTH review report(s) received June 19, 2020
Final CADTH review report(s) posted July 10, 2020