Javygtor — CareFirst (Caremark)

Initial criteria

• Member is age ≥ 1 month
• Member has been diagnosed with phenylketonuria (PKU)
• Baseline phenylalanine level ≥ 360 micromol/L (6 mg/dL) with dietary interventions alone
• Palynziq will be discontinued after appropriate overlap if patient currently receiving Palynziq for PKU

Reauthorization criteria

• Achieve or maintain ≥ 30% decrease in phenylalanine levels from baseline OR
• Phenylalanine levels < 360 micromol/L (6 mg/dL) OR
• Demonstrate improvement in neuropsychiatric symptoms
• Kuvan should not be used concomitantly with Palynziq

Approval duration

Initial: 60 days; Reauthorization: 6 months