Vijoice — Blue Cross Blue Shield of Montana

Initial criteria

• The patient has a diagnosis of PIK3CA-Related Overgrowth Spectrum (PROS) confirmed by ALL of the following: A. Presence of somatic PIK3CA mutation [medical records required] AND B. Congenital or early childhood onset AND C. Overgrowth sporadic and mosaic AND D. ONE of the following: 1. The patient has at least TWO of the following features: A. Overgrowth B. Vascular malformations C. Epidermal nevus OR 2. The patient has at least ONE of the following features: A. Large isolated lymphatic malformations B. Isolated macrodactyly OR overgrown splayed feet/hands, overgrown limbs C. Truncal adipose overgrowth D. Hemimegalencephaly (bilateral)/dysplastic megalencephaly/focal cortical dysplasia E. Epidermal nevus F. Seborrheic keratoses G. Benign lichenoid keratoses
• The patient has severe manifestations of PROS that requires systemic therapy
• 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
• The prescriber is a specialist in the area of patient's diagnosis (e.g., experienced in PROS), or the prescriber has consulted with a specialist in the area of the patient's diagnosis
• The patient does NOT have any FDA labeled contraindications to the requested agent
• For Ohio residents in Fully Insured or HIM Shop (SG) plans: A. The patient does NOT have any FDA labeled contraindications to the requested agent AND B. ONE of the following: 1. The patient has another FDA labeled indication for the requested agent and route of administration OR 2. The patient has another indication that is supported in compendia for the requested agent and route of administration OR 3. The prescriber has submitted TWO peer-reviewed journal articles supporting the proposed use(s) as generally safe and effective

Reauthorization criteria

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

Approval duration

6 months for initial (all other plans), 12 months renewal; 12 months for BCBSIL