Vijoice (alpelisib) — Medica

Initial criteria

• age ≥ 2 years
• patient has at least one severe clinical manifestation of PROS as determined by the prescriber (e.g., excessive tissue growth, blood vessel malformations, scoliosis, vascular tumors, cardiac or renal manifestations, or those who require systemic treatment)
• patient has a PIK3CA mutation confirmed by genetic testing
• medication is prescribed by or in consultation with a physician that specializes in treatment of genetic disorders

Reauthorization criteria

• patient has been established on Vijoice for at least 6 months
• patient has experienced a reduction in volume from baseline in at least one lesion as confirmed by measurement
• patient has experienced an improvement in at least one sign or symptom of PROS from baseline (e.g., pain, fatigue, vascular malformation, limb asymmetry, or disseminated intravascular coagulation)

Approval duration

initial: 6 months; reauthorization: 1 year