Product Details

Crysvita

Burosumab
30 mg/mL
Solution for Subcutaneous Injection
Single-Use Vial (Preservative-Free)

DIN/PIN/NPN

02483645

Manufacturer

Kyowa Kirin, Inc.

Formulary Listing Date

2022-08-04  

Unit Price

451.4947

Amount MOH Pays

451.4947

Coverage Status

Exceptional Access Program Product

ODB Formulary Therapeutic Classification

Therapeutic Note

NO

ATC Code

M05BX05

Interchangeable Products

NO  

LU Clinical Criteria

NO  

EAP Criteria

Therapeutic Class Reimbursement Criteria
Metabolic/Genetic Modifiers

Burosumab

  • Brand(s): Crysvita
  • Dosage Form/Strength: 10 mg/mL, 20 mg/mL, 30 mg/mL Vial
  • Effective date: December 21, 2021

Initiation Criteria: 

For the treatment of X-linked hypophosphatemia (XLH) in patients who meet all of the following criteria: 

  1. Treatment is initiated in a pediatric patient who is at least 1 year of age and in whom the epiphyseal closure has not occurred yet; AND 

  1. XLH diagnosis is confirmed by genetic documentation of phosphate-regulating endopeptidase homolog, X-linked (PHEX) gene variant in either the patient or in a directly related family member with appropriate X-linked inheritance; AND 

  1. Clinical presentation consistent with XLH diagnosis, including fasting hypophosphatemia1 and normal renal function (defined as fasting serum creatinine level below the age-adjusted upper limit of normal); AND 

  1. Radiographic evidence of rickets with a baseline2 rickets severity score (RSS) total score of 2 or greater at the time Crysvita treatment is initiated; AND 

  1. Patient is under the care of a specialist with expertise in the diagnosis and management of XLH. 

1Normal range based on age and gender as informed by the Canadian Laboratory Initiative on Pediatric Reference Intervals (CALIPER; https://caliperproject.ca/) can be used as a reference of this information. 

2Baseline RSS total score is defined as the RSS total score measured immediately prior to initiation of Crysvita therapy. 

Renewal Criteria: 

Renewals of reimbursement will be considered in patients meeting the following criteria: 

  • Patient continues to be under the care of a specialist with expertise in the diagnosis and management of XLH; AND 

  • The patient does not meet any of the discontinuation criteria while on therapy.

Patients should be assessed on an annual basis. In pediatric patients in whom epiphyseal closure has not occurred, documentation demonstrating improvement from baseline RSS total score in the first 12 months and/or maintenance of RSS total score improvement achieved in the first 12 months is to be provided at the time of renewal.

Discontinuation Criteria: 

  • In pediatrica patients in whom epiphyseal closure has not yet occurred and who met the above initiation criteria, treatment should be discontinued upon meeting any of the following circumstances:
    o     There is no demonstrated improvement in the 12-month RSS total score from baseline2 RSS total score; OR
    o     The patient’s RSS total score achieved after the first 12 months of burosumab therapy has not been maintained subsequently. 

  • In adolescentb patients in whom epiphyseal closure has occurred and who met the above initiation criteria and initiated treatment as a pediatric patient, treatment should be discontinued upon development of any of the following clinical circumstances:
    o     Hyperparathyroidism; OR
    o     Nephrocalcinosis; OR
    o     Evidence of fracture or pseudo-fracture based on radiographic assessment. 

  • In adultc patients who met the above initiation criteria and initiated treatment as a pediatric patient, treatment should be discontinued upon development of any of the following clinical circumstances:
    o     Hyperparathyroidism; OR
    o     Nephrocalcinosis; OR
    o     Evidence of fracture or pseudo-fracture based on radiographic assessment. 

2Baseline RSS total score is defined as the RSS total score measured immediately prior to initiation of Crysvita therapy. 

aPediatric refers to a patient who is aged 17 years or younger.

bAdolescent refers to a pediatric patient who is aged 13 to 17 years.

cAdult refers to a patient who is 18 years of age and older. 

Approval duration for initial requests: 1 year

Approved dosage for initial and renewal: 

Funding will be provided at a minimum dose of 10 mg up to a maximum dose of 90 mg. 

  • Children (1-17 years of age): 0.8mg/kg of body weight (rounded to the nearest 10 mg) subcutaneously every 2 weeks. 

  • Adults (18 years of age and older): 1mg/kg of body weight subcutaneously (rounded to the nearest 10 mg) every 4 weeks. 

Dose to be adjusted based on serum phosphorus levels.

EAP Drug Request Form:

Standard Form for EAP Drug Requests

Product Monograph

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