Palynziq — Medical Mutual

Initial criteria

• Patient is age ≥ 18 years
• Patient has uncontrolled blood phenylalanine concentration > 600 micromol/L
• Patient has trialed and failed, or has a contraindication to sapropterin (Kuvan, generic)
• Palynziq is prescribed by or in consultation with a metabolic diseases specialist or a provider who specializes in the treatment of PKU and other metabolic diseases
• An epinephrine auto-injector has been prescribed
• Palynziq will not be used concurrently with Kuvan
• Site of care medical necessity is met

Reauthorization criteria

• Patient has had a response to Palynziq therapy evidenced by a 20% reduction in blood phenylalanine levels from baseline OR blood phenylalanine concentration ≤ 600 micromol/L
• Site of care medical necessity is met

Approval duration

1 year initial, 1 year reauth