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Galafold — Blue Cross Blue Shield of Kansas

Fabry disease with a confirmed diagnosis and an amenable galactosidase alpha (GLA) gene variant based on in vitro assay data

Initial criteria

  • ONE of the following:
  • A. The requested agent is eligible for continuation of therapy AND ONE of the following:
  • 1. The patient has been treated with the requested agent (starting on samples is not approvable) within the past 90 days OR
  • 2. The prescriber states the patient has been treated with the requested agent (starting on samples is not approvable) within the past 90 days AND is at risk if therapy is changed
  • OR
  • B. BOTH of the following:
  • 1. The patient has a diagnosis of Fabry disease AND BOTH of the following:
  • A. The diagnosis was confirmed by mutation in the galactosidase alpha (GLA) gene AND
  • B. The patient has a confirmed amenable GLA variant based on in vitro assay data (a complete list of amenable variants is available in the Galafold prescribing information, or a specific variant can be verified as amenable at http://www.galafoldamenabilitytable.com/hcp)
  • AND
  • 2. If the patient has an FDA labeled indication, then ONE of the following:
  • A. The patient’s age is within FDA labeling for the requested indication for the requested agent OR
  • B. There is support for using the requested agent for the patient’s age for the requested indication
  • AND
  • The prescriber is a specialist in the area of the patient’s diagnosis (e.g., endocrinologist, geneticist, nephrologist), or the prescriber has consulted with a specialist in the area of the patient’s diagnosis
  • AND
  • The patient will NOT be using the requested agent in combination with enzyme replacement therapy (ERT) (e.g., Elfabrio, Fabrazyme) for the requested indication
  • AND
  • The patient does NOT have any FDA labeled contraindications to the requested agent

Reauthorization criteria

  • The patient has been previously approved for the requested agent through the plan’s Prior Authorization process [Note: patients not previously approved for the requested agent will require initial evaluation review]
  • AND The patient has had clinical benefit with the requested agent
  • AND The prescriber is a specialist in the area of the patient’s diagnosis (e.g., endocrinologist, geneticist, nephrologist), or the prescriber has consulted with a specialist in the area of the patient’s diagnosis
  • AND The patient will NOT be using the requested agent in combination with enzyme replacement therapy (ERT) (e.g., Elfabrio, Fabrazyme) for the requested indication
  • AND The patient does NOT have any FDA labeled contraindications to the requested agent

Approval duration

initial 6 months; renewal 12 months