Vijoice — Blue Cross Blue Shield of Alabama

Initial criteria

• The patient has a diagnosis of PIK3CA-Related Overgrowth Spectrum (PROS) confirmed by ALL of the following:
• • Presence of somatic PIK3CA mutation
• • Congenital or early childhood onset
• • Overgrowth sporadic and mosaic
• AND ONE of the following:
• • The patient has at least TWO of the following features: Overgrowth; Vascular malformations; Epidermal nevus
• OR
• • The patient has at least ONE of the following features: Large isolated lymphatic malformations; Isolated macrodactyly OR overgrown splayed feet/hands, overgrown limbs; Truncal adipose overgrowth; Hemimegalencephaly (bilateral)/dysplastic megalencephaly/focal cortical dysplasia; Epidermal nevus; Seborrheic keratoses; Benign lichenoid keratoses
• AND The patient has severe manifestations of PROS that require systemic therapy
• AND If the patient has an FDA labeled indication, then ONE of the following: The patient's age is within FDA labeling for the requested indication OR 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., experienced in PROS) or 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 agent
• OR The patient has been treated with the requested agent (not on samples) within the past 90 days OR the prescriber states the patient has been treated with the requested agent (not on samples) within the past 90 days and is at risk if therapy is changed

Reauthorization criteria

• The patient has been previously approved for the requested agent through the plan’s Prior Authorization process
• AND The patient has had clinical benefit with the requested agent

Approval duration

6 months