Vijoice — Blue Cross Blue Shield of Kansas

PIK3CA-Related Overgrowth Spectrum (PROS)

Initial criteria

The patient meets ONE of the following:
A. Continuation of therapy: The patient has been treated with Vijoice within the past 90 days (starting on samples is not approvable) OR the prescriber states patient has been treated within past 90 days and is at risk if therapy is changed.
OR
B. New start criteria – ALL of the following:
1. Diagnosis of PIK3CA-Related Overgrowth Spectrum (PROS) confirmed by ALL of the following:
A. Presence of somatic PIK3CA mutation AND
B. Congenital or early childhood onset AND
C. Overgrowth sporadic and mosaic AND
D. ONE of the following:
1. At least TWO of: Overgrowth, Vascular malformations, Epidermal nevus OR
2. At least ONE of: Large isolated lymphatic malformations, Isolated macrodactyly OR overgrown splayed feet/hands/limbs, Truncal adipose overgrowth, Hemimegalencephaly (bilateral)/dysplastic megalencephaly/focal cortical dysplasia, Epidermal nevus, Seborrheic keratoses, Benign lichenoid keratoses.
2. The patient has severe manifestations of PROS that require systemic therapy AND
3. If the patient has an FDA labeled indication, ONE of the following:
A. Patient’s age is within FDA labeling for the indication (age ≥ 2 years) OR
B. There is support for use of the requested agent for the patient’s age for the requested indication AND
4. The prescriber is a specialist in PROS or has consulted with a specialist experienced in PROS AND
5. The patient does not have any FDA labeled contraindications to alpelisib.

1. The patient was previously approved for the requested agent through the plan’s prior authorization process AND
2. The patient has had clinical benefit with the requested agent AND
3. The patient has NOT had disease progression (e.g., increase in lesion number or volume) with the requested agent (medical records required) AND
4. The prescriber is a specialist in PROS or has consulted with a specialist experienced in PROS AND
5. The patient does not have any FDA labeled contraindications to alpelisib.

initial 6 months; renewal 12 months