Pegvaliase-pqpz (Palynziq®)

Covered: Pegvaliase (Palynziq) for adults (≥18) with PKU and documented blood phenylalanine ≥600 µmol/L despite prior treatments, prescribed by or in consultation with a metabolic disease specialist; concomitant use with sapropterin (Kuvan) is not permitted for reauthorization. Key requirements: baseline Phe ≥600 µmol/L and documentation of prior inadequate control, induction dosing 2.5 mg SC once weekly ×4 weeks with maximum 40 mg SC daily, approval limited to 12 months, and reauthorization requires either ≥20% reduction from baseline or current Phe ≤600 µmol/L (and no concurrent sapropterin).

"Must be prescribed by or in consultation with a metabolic disease specialist."

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