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alpelisib (PROS) — Blue Cross Blue Shield of Illinois

PIK3CA-Related Overgrowth Spectrum (PROS)

Initial criteria

  • ALL of the following:
  • 1. Diagnosis of PIK3CA-Related Overgrowth Spectrum (PROS) confirmed by ALL of:
  • A. Presence of somatic PIK3CA mutation [medical records required] AND
  • B. Congenital or early childhood onset AND
  • C. Overgrowth is sporadic and mosaic AND
  • D. ONE of the following:
  • 1. Patient has at least TWO of the following features: Overgrowth; Vascular malformations; Epidermal nevus OR
  • 2. Patient has at least ONE of the following features: Large isolated lymphatic malformations; Isolated macrodactyly or overgrown/splayed feet or hands or overgrown limbs; Truncal adipose overgrowth; Hemimegalencephaly (bilateral)/dysplastic megalencephaly/focal cortical dysplasia; Epidermal nevus; Seborrheic keratoses; Benign lichenoid keratoses AND
  • 2. Patient has severe manifestations of PROS that require systemic therapy AND
  • 3. If the patient has an FDA labeled indication, then ONE of the following:
  • A. Patient 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
  • 4. Prescriber is a specialist in the area of patient's diagnosis (e.g., experienced in PROS), or has consulted with such a specialist AND
  • 5. Patient does NOT have any FDA labeled contraindications to the requested agent

Reauthorization criteria

  • ALL of the following:
  • 1. Patient has been previously approved for the requested agent through the plan’s Prior Authorization process AND
  • 2. Patient has had clinical benefit with the requested agent AND
  • 3. Patient has NOT had disease progression (e.g., increase in lesion number or volume) with the requested agent [medical records required] AND
  • 4. Prescriber is a specialist in the area of the patient's diagnosis (e.g., experienced in PROS), or has consulted with such a specialist AND
  • 5. Patient does NOT have any FDA labeled contraindications to the requested agent

Approval duration

BCBSIL: 12 months; Others: 6 months initial / 12 months renewal