Criteria
Coverage is subject to the specific terms of the member's benefit plan.
The use of burosumab (Crysvita) may be considered medically necessary when
ALL
of the following criteria are met:
X-linked Hypophosphatemia (XLH)
-
The requested medication must be prescribed by, or in consult with, nephrologist, endocrinologist, geneticist, or specialist experienced in the treatment of metabolic bone disorders;
and
-
The diagnosis has been confirmed by one of the following:
-
Family history of XLH, low serum phosphate, and increased alkaline phosphatase (ALP);
or
-
Genetic testing confirming a pathogenic mutation of the phosphate regulating gene with homology to endopeptidases on the X chromosome (PHEX gene);
or
-
Serum fibroblast growth factor-23 (FGF23) level > 30 pg/mL;
and
-
If the member is 18 years or older, one of the following must be met:
-
The member's epiphyseal plate has not fused;
or
- The member has bone fractures; or
- The member has had a 3-month trial of conventional treatment with oral phosphate supplementation combined with active vitamin D (e.g., calcitriol), as evidenced by paid claims or pharmacy printouts, and continues to have significant musculoskeletal pain and limited mobility.
Initial Authorization: 12 months (one-time six (6)-month approval for adult with planned orthopedic surgical procedure)
Reauthorization Criteria
Continuation of therapy with burosumab (Crysvita) may be considered medically necessary when the following is met:
-
Documentation must be submitted demonstrating that the member has demonstrated a disease stability or beneficial response to therapy from baseline as shown by one or more of the following:
-
Normalization of phosphate levels as defined by laboratory;
or
-
Normalization of bone-specific alkaline phosphatase activity;
or
- Normalization of tubular resorption of phosphate corrected for glomerular filtration rate (TmP/GFR).
Tumor-Induced Osteomalacia
-
Documentation to confirm the diagnosis must be submitted, as evidenced by the following:
- The diagnosis has been confirmed by a serum fibroblast growth factor-23 (FGF23) level > 30 pg/mL with unresectable phosphaturic mesenchymal tumor
Reauthorization Criteria
Continuation of therapy with burosumab (Crysvita) may be considered medically necessary when the following is met:
- The individual has received a therapeutic response as evidenced by normalization of serum phosphate levels, improved ambulation, healing of bone fractures, or reduced pain
The use of burosumab (Crysvita) for all other indications not listed in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness cannot be established by the available published peer-reviewed literature.
Procedure Code
