Generic Name:
Project Status:
Therapeutic Area:
Treatment of X-Linked Hypophosphatemia
Kyowa Kirin Canada, Inc.
Call for patient/clinician input open:
Brand Name:
Project Line:
Reimbursement Review
Project Number:
Call for patient/clinician input closed:
Manufacturer Requested Reimbursement Criteria1:
In addition to the criteria currently recommended by CADTH in the pediatric population of XLH patients (May 2020), the sponsor is requesting the following criteria for adult patients living with XLH: In alignment with consensus guidelines (Haffner et al., 2019) and the submitted clinical evidence, the sponsor is requesting that burosumab be recommended for reimbursement in adult patients with XLH who meet the following criteria: a clinical presentation consistent with XLH, including: fasting hypophosphatemia, and normal renal function (defined as fasting serum creatinine below the age-adjusted upper limit of normal), and a confirmed PHEX gene variant in either the patient or in a directly related family member with appropriate X-linked inheritance and persistent bone and/or joint pain due to XLH, and/or osteomalacia that limits daily activities, and/or pseudofractures or osteomalacia-related fractures, and insufficient response or refractory to conventional therapy or if patients experience complications related to conventional therapy.
Submission Type:
Fee Schedule:
For the treatment of X-linked hypophosphataemia (XLH) in adult patients.
Anticipated Date:
  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.