Palynziq (pegvaliase-pqpz subcutaneous injection − BioMarin) — Cigna

Phenylketonuria (PKU)

Initial criteria

Patient is age ≥ 18 years
Patient has uncontrolled blood phenylalanine concentrations > 600 micromol/L on at least one existing treatment modality (e.g., restriction of dietary phenylalanine and protein intake and prior treatment with sapropterin [Kuvan, Javygtor, generic])
Medication is prescribed by or in consultation with a metabolic disease specialist (or specialist who focuses in the treatment of metabolic diseases)

Patient is age ≥ 18 years
Patient meets ONE of the following:
a) Patient meets BOTH of the following:
(1) Patient is continuing to titrate Palynziq to an effective maintenance dose, per the prescriber; AND
(2) If the patient is receiving a dose of Palynziq 60 mg once daily, the treatment duration at this dose has not exceeded 16 weeks; OR
b) Patient meets BOTH of the following:
(1) Patient meets ONE of the following:
(a) Patient’s blood phenylalanine concentration is ≤ 600 micromol/L; OR
(b) Patient has achieved a ≥ 20% reduction in blood phenylalanine concentration from pre-treatment baseline; AND
(2) Patient is not receiving concomitant therapy with sapropterin (Kuvan, Javygtor, generic)

1 year