alpelisib (PROS) — Blue Cross Blue Shield of Texas

Initial criteria

• Diagnosis of PIK3CA-Related Overgrowth Spectrum (PROS) confirmed by ALL of the following: presence of somatic PIK3CA mutation (medical records required) AND congenital or early childhood onset AND overgrowth sporadic and mosaic AND 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/hands or overgrown limbs, truncal adipose overgrowth, hemimegalencephaly (bilateral)/dysplastic megalencephaly/focal cortical dysplasia, epidermal nevus, seborrheic keratoses, benign lichenoid keratoses
• Patient has severe manifestations of PROS that require systemic therapy
• If FDA labeled indication, then ONE of the following applies: patient’s age is within FDA labeling for the requested indication for the requested agent OR there is support for using the requested agent for the patient’s age for the requested indication
• Prescriber is a specialist in the area of the patient's diagnosis (e.g., experienced in PROS) or has consulted with a specialist in the area
• Patient does not have any FDA labeled contraindications to the requested agent

Reauthorization criteria

• Patient has been previously approved for the requested agent through the plan’s prior authorization process
• Patient has had clinical benefit with the requested agent
• Patient has not had disease progression (e.g., increase in lesion number or volume) with the requested agent (medical records required)
• Prescriber is a specialist in the area of the patient's diagnosis (e.g., experienced in PROS) or has consulted with a specialist in the area
• Patient does not have any FDA labeled contraindications to the requested agent

Approval duration

6–12 months