sapropterin dihydrochloride — CareFirst (Caremark)

Initial criteria

• Member is age ≥ 1 month
• Diagnosis of phenylketonuria (PKU) with baseline phenylalanine level ≥ 360 micromol/L (6 mg/dL) with dietary interventions alone
• Medication prescribed by or in consultation with a physician who specializes in the treatment of metabolic disease and/or PKU
• Submission of enzyme assay, genetic testing, or phenylalanine level results supporting diagnosis

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