J0584 — Injection, burosumab-twza 1 mg
HCPCS/CPT
Prior Authorization
No Prior Auth Required
Code is covered without prior authorization (high confidence)
Medicare Pricing
Work RVU
0.00
Facility
N/A
Non-Facility
N/A
Documentation Required
- Documentation of diagnosis: XLH or FGF23-related hypophosphatemia in TIO (clinical notes, problem list).
- For XLH initial therapy: genetic testing results (e.g., confirmed PHEX gene mutation in patient or first-degree relative) OR laboratory result showing elevated Serum FGF23 level > 30 pg/mL OR biochemical labs demonstrating: Serum phosphate < 3.0 mg/dL; Serum creatinine (SCr) below age adjusted ULN; Serum 25(OH)D ≥ 16 ng/mL.
- For TIO initial therapy: documentation that the phosphaturic mesenchymal tumor cannot be curatively resected or localized.
- Fasting serum phosphorus lab results demonstrating phosphorus is below the normal range for age (baseline).
Key Coverage Criteria
- Crysvita (burosumab) is proven for the treatment of X-linked hypophosphatemia (XLH).
- Crysvita (burosumab) is medically necessary for the treatment of XLH when the following criteria are met for initial therapy: Diagnosis of XLH, confirmed by one of the following: Genetic testing (e.g., confirmed PHEX gene mutation in patient or first-degree relative); or Elevated Serum fibroblast growth factor 23 (FGF23) level > 30 pg/mL; or All of the following biochemical findings associated with XLH: Serum phosphate < 3.0 mg/dL (0.97 mmol/L); and Serum creatinine (SCr) below age adjusted uppe [...]
- Crysvita (burosumab) is medically necessary for the treatment of XLH for continuation of therapy when the following criteria are met: Patient has previously received treatment with burosumab; and Prescribed by, or in consultation with, an endocrinologist or specialist experienced in the treatment of metabolic bone disorders; and Patient has experienced a positive clinical response to burosumab (e.g., enhanced height velocity, improvement in skeletal deformities, reduction of fractures, reduction [...]
- Crysvita (burosumab) is proven for the treatment of Fibroblast Growth Factor 23 (FGF23)-related hypophosphatemia in tumor-induced osteomalacia (TIO).
- Crysvita (burosumab) is medically necessary for the treatment of FGF23-related hypophosphatemia in TIO when the following criteria are met for initial therapy: Diagnosis of FGF23-related hypophosphatemia in TIO associated with phosphaturic mesenchymal tumors; and Disease cannot be curatively resected or localized; and Patient is age 2 years or greater; and Prescribed by, or in consultation with, an oncologist, an endocrinologist, or specialist experienced in the treatment of metabolic bone disor [...]
- Crysvita (burosumab) is medically necessary for the treatment of FGF23-related hypophosphatemia in TIO for continuation of therapy when the following criteria are met: Patient has previously received treatment with burosumab; and Prescribed by, or in consultation with, an oncologist, an endocrinologist or specialist experienced in the treatment of metabolic bone disorders; and Patient has experienced a positive clinical response to burosumab (e.g., enhanced height velocity, improvement in skelet [...]
14 Active Policies
UHC-POL-crysvita-burosumab-twza — Crysvita (Burosumab-Twza)
UHC-POL-provider-administered-drugs-soc — Provider Administered Drugs – Site of Care
UMR-POL-UMR-crysvita-burosumab-twza — Crysvita (Burosumab-Twza)
UMR-POL-UMR-provider-administered-drugs-soc — Provider Administered Drugs – Site of Care
SUREST-POL-SUREST-crysvita-burosumab-twza
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