Pegvaliase-pqpz (Palynziq)

Covered: Palynziq (pegvaliase‑pqpz) is covered for adult PKU patients to lower blood phenylalanine when baseline Phe ≥600 µmol/L despite existing management and must be prescribed by or in consultation with a metabolic disease specialist (pediatric/off‑label uses are not supported). Key requirements: 12‑month approvals with documentation of baseline and follow‑up Phe and strict stepwise titration (start 2.5 mg SC weekly → titrate to 20 mg SC daily; increase to 40 mg SC daily only after ≥24 weeks on 20 mg), renewal requires ≥20% Phe reduction from baseline or Phe ≤600 µmol/L, and discontinue if response criteria are not met after 16 weeks at 40 mg daily.

"Palynziq is indicated to reduce blood phenylalanine concentrations in adult patients with phenylketonuria (PKU) who have uncontrolled blood phenylalanine concentrations greater than 600 micromol/L ..."

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