Crysvita (burosumab-twza) is considered medically necessary for patients who:
1)
Are 6 months of age or
older AND
2)
Have a diagnosis of
X-linked hypophosphatemia (XLH),which is also known as X-linked dominant
hypophosphatemic rickets or X-linked vitamin D-resistant rickets) AND
3)
Patient will discontinue
any oral phosphate or active vitamin D analog supplementation at least one week
prior to starting therapy with Crysvita AND
4)
Prescriber agrees to
measure serum phosphorous level monthly for the first three (3) months of
therapy and periodically throughout therapy, holding the dose if level above
5mg/dL AND
5)
Fasting serum phosphorous
is not within or above the normal range for age at start of therapy AND
6)
Patient does not have
severe renal impairment or end stage renal disease (ESRD), defined as eGFR <
30mL/min/1.73m2.
Crysvita is also considered medically necessary for members meeting the
following criteria:
1)
Diagnosis of
Tumor-Induced Osteomalacia (TIO) with confirmed serum FGF23 levels; AND
2)
Age > 2 years; AND
3)
Failure of a > 3
consecutive month trial or oral phosphate and vitamin D replacement therapy,
unless contraindicated or clinically significant adverse effects are
experienced; AND
4)
Current (within the last
30 days) serum phosphorus levels are one of the following (a or b):
a.
Below the reference range
for age and gender (use laboratory-specific reference ranges if available), and
member has not received oral phosphate or vitamin D replacement therapy;
b.
In normal range, but
member remains symptomatic (e.g., osteomalacia, muscle weakness, fatigue, bone
pain, fractures) despite currently receiving oral phosphate and/or vitamin D
replacement therapy;
5)
Documentation confirms
the causative tumor(s) is/are not amenable to surgical excision or resection;
6)
Crysvita is not
prescribed concurrently with oral phosphate or vitamin D replacement therapy
Reauthorization Criteria:
1)
Patient must have
diagnosis of X-linked hypophosphatemia or tumor-induced osteomalacia AND
2)
Prescriber agrees to
measure serum phosphorous throughout therapy and hold the dose if level above
5mg/dL AND
3)
Patient does not have
severe renal impairment or end stage renal disease (ESRD), defined as eGFR <
30mL/min/1.73m2.