CRYSVITA (burosumab-twza)

CRYSVITA (burosumab-twza)

OFFICE ADMINISTRATION

Indications for Prior Authorization:

• Treatment of X-linked hypophosphatemia (XLH) in adult and pediatric patients 1 year of age and older

Patients must meet the following criteria for the indication(s) above:

• Patient is 1 year of age or older, AND
• Diagnosis of X-linked hypophosphatemia (XLH), AND
• Prescribed by or in consultation with an endocrinologist or nephrologist, AND
• Patient has a baseline serum phosphorus level below normal range for age, AND
• Patient has a baseline tubular reabsorption of phosphate corrected for glomerular filtration rate that was below the normal range for age and gender, AND
• Patient will not use oral phosphate and active Vitamin D analogs, AND
• Patient does not have severe renal impairment or end stage renal disease

Dosing:

• Pediatric XLH:
  • Starting dose: 0.8 mg/kg of body weight rounded to the nearest 10 mg, administered every 2 weeks. Minimum dose 10 mg up to a maximum dose of 90 mg.
  • Do not adjust Crysvita more frequently than every 4 weeks.
  • Dose may be increased up to approximately 2 mg/kg (maximum 90 mg), administered every 2 weeks to achieve normal serum phosphorus
• Adult XLH:
  • Dose regimen: 1 mg/kg body weight rounded to the nearest 10 mg up to a maximum dose of 90 mg administered every 4 weeks

Approval:

• 1 year