Crysvita®
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
Questions?
MHCP Provider Call Center 651-431-2700 or 800-366-5411