Initial Evaluation
Crysvita will be approved when ALL of the following are met:
- ONE of the following:
- BOTH of the following:
- The patient has a diagnosis of X-linked hypophosphatemia (XLH) as confirmed by ONE of the following:
- Genetic testing OR
- Elevated levels of intact fibroblast growth factor 23 (FGF23) OR
- The prescriber has provided information indicating the patient has a positive family history of XLH AND
- ONE of the following:
- The patient’s epiphyseal plate has not fused OR
- The patient’s epiphyseal plate has fused AND the patient is experiencing symptoms of XLH (e.g., bone pain, fractures, limited mobility) OR
- The patient has a diagnosis of X-linked hypophosphatemia (XLH) as confirmed by ONE of the following:
- The patient has a diagnosis of tumor-induced osteomalacia (TIO) associated with phosphaturic mesenchymal tumors AND BOTH of the following:
- The requested medication is being used to treat FGF23 related hypophosphatemia AND
- The tumor cannot be curatively surgically resected or localized AND
- BOTH of the following:
- The patient is within the FDA labeled age for the requested medication for the requested indication AND
- The prescriber is a specialist in the area of the patient’s diagnosis (e.g., nephrologist, endocrinologist) or the prescriber has consulted with a specialist in the area of the patient’s diagnosis AND
- The patient does NOT have any FDA labeled contraindications to the requested medication AND
- The requested dose is within FDA labeled dosing for the requested indication
Length of Approval: 12 months
Renewal Evaluation
Crysvita will be approved when ALL of the following are met:
- The patient has been previously approved for the requested medication through the plan’s Prior Authorization criteria AND
- ONE of the following:
- The patient has a diagnosis of X-linked hypophosphatemia (XLH) OR
- The patient has a diagnosis of tumor-induced osteomalacia (TIO) associated with phosphaturic mesenchymal tumors AND
- The patient is within the FDA labeled age for the requested medication for the requested indication AND
- The patient has had clinical benefit with the requested medication (e.g., enhanced height velocity, improvement in lower extremity bowing and associated abnormalities, radiographic evidence of epiphyseal healing, improvement in bone pain, enhanced mobility, improvement in osteomalacia, improvement in fracture healing) AND
- The prescriber is a specialist in the area of the patient’s diagnosis (e.g., nephrologist, endocrinologist) or the prescriber has consulted with a specialist in the area of the patient’s diagnosis AND
- The patient does NOT have any FDA labeled contraindications to the requested medication AND
- The requested dose is within FDA labeled dosing for the requested indication
Length of Approval: 12 months
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