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Drug - Crysvita® (burosumab-twza) [Ultragenix Pharmaceutical Inc.]

December 2018

Therapeutic area - Fibroblast Growth Factor 23 (FGF23) Inhibitors, mab (C7J)

Initial approval criteria

  • Patient is at least 1 year of age AND
  • Patient has not received oral phosphate and/or active vitamin D analogs within 1 week prior to the start of therapy AND
  • Must be prescribed by, or in consultation with, a nephrologist or endocrinologist AND
  • Patient must have a diagnosis of X-linked Hypophosphatemia (XLH) confirmed by at least one of the following:
    • Serum fibroblast growth factor-23 (FGF23) level > 30 pg/mL OR
    • Phosphate regulating gene with homology to endopeptidases located on the X chromosome (PHEX-gene) mutations in the patient AND
  • Patient has a reduced tubular resorption of phosphate corrected for glomerular filtration rate (TmP/GFR) AND
  • Baseline fasting serum phosphorus level with current hypophosphatemia, defined as a phosphate level below the lower limit of the laboratory normal reference range AND
  • Patient does not have severe renal impairment, defined as a glomerular filtration rate (GFR) of < 30 mL/min
  • Initial approval is for 6 months

Renewal criteria

  • Patient continues to meet the criteria identified in section the initial approval section AND
  • Absence of unacceptable toxicity from the drug AND
  • Current serum phosphorus level is not above the upper limit of the laboratory normal reference range AND
  • Disease response as indicated by increased serum phosphorus levels, a reduction in serum total alkaline phosphatase activity, improvement in symptoms (e.g., skeletal pain, linear growth), and/or improvement in radiographic imaging of rickets/osteomalacia
  • Renewal approval is for 12 months

Quantity limits

  • Pediatrics (1 to less than 18 years of age): 90 mg every 14 days
  • Adults (18 years of age and older): 90 mg every 28 days

Billing Information

  • Crysvita must be billed as a medical claim


MHCP Provider Call Center 651-431-2700 or 800-366-5411

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