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asfotase alfa — Blue Cross Blue Shield of New Mexico

perinatal/infantile-onset hypophosphatasia (HPP)

Initial criteria

  • The patient has a diagnosis of either perinatal/infantile- OR juvenile-onset hypophosphatasia (HPP) AND ALL of the following:
  • A. The patient was <18 years of age at onset [chart notes required] AND
  • B. The patient is experiencing active disease (e.g., bone pain, fractures, gait problems) AND
  • C. The patient has/had clinical manifestations consistent with hypophosphatasia at the age of onset prior to age 18 (e.g., vitamin B6-dependent seizures, fractures, lost teeth with roots, skeletal abnormalities such as rachitic chest deformity leading to respiratory problems or bowed arms/legs, failure to thrive) [chart notes required] AND
  • D. ONE of the following [chart notes required]:
  • 1. Molecular genetic testing has confirmed mutations in the ALPL gene encoding TNSALP OR
  • 2. ALL of the following:
  • A. Radiographic imaging confirms the diagnosis of hypophosphatasia at onset prior to age 18 (e.g., infantile rickets, alveolar bone loss, craniosynostosis) AND
  • B. Reduced unfractionated serum alkaline phosphatase (ALP) activity below normal reference range for age/sex in the absence of bisphosphonate therapy AND
  • C. ONE of the following laboratory findings:
  • 1. Elevated serum pyridoxal 5'-phosphate (PLP) within one week without vitamin supplements OR
  • 2. Elevated urine phosphoethanolamine (PEA) OR
  • 3. Elevated urinary inorganic pyrophosphate (PPi)
  • 2. The prescriber is a specialist in endocrinology/genetics or has consulted with one AND
  • 3. The patient has had an ophthalmology examination and renal ultrasound at baseline before starting therapy AND
  • 4. The patient has no FDA labeled contraindications to Strensiq AND
  • 5. Requested quantity (dose) is within FDA labeled dosing based on weight OR supported for higher dose indication

Reauthorization criteria

  • The patient was previously approved for Strensiq through the plan’s prior authorization process AND
  • The patient has shown clinical improvement from baseline in ≥1 of the following [chart notes required]:
  • A. Respiratory status (e.g., level of respiratory support) OR
  • B. Growth improvement (length/height, weight, or head circumference by z-scores) OR
  • C. Radiographic improvement in skeletal manifestations (RSS, RGI-C, or fracture decrease) OR
  • D. Level of activity (motor function or ADL improvement) AND
  • The prescriber is a specialist in endocrinology/genetics or has consulted with one AND
  • The patient has been monitored for ophthalmic and renal calcifications and for vision or renal function changes AND
  • No FDA labeled contraindications AND
  • Requested quantity (dose) is within FDA labeled dosing based on weight OR support for higher dose

Approval duration

12 months