Pegvaliase-pqpz (Palynziq)

Covered: Pegvaliase (Palynziq) is covered to reduce blood phenylalanine in patients with PKU who have uncontrolled Phe >600 µmol/L despite dietary and/or prior pharmacologic treatment, and is not covered if these criteria or specialist involvement are not met. Key requirements: initial documentation of baseline Phe ≥600 µmol/L and prior treatments, prescription by or consultation with a metabolic disease specialist, dosing per induction (2.5 mg SC weekly) with a maximum of 40 mg SC once daily, approval up to 12 months, and reauthorization only with ≥20% Phe reduction from baseline or current Phe ≤600 µmol/L plus supporting lab/clinical documentation.

"To reduce blood phenylalanine concentrations in patients with phenylketonuria (PKU) who have uncontrolled blood phenylalanine concentrations greater than 600 micromol/L despite treatment."

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