Palynziq (pegvaliase-pqpz) — Medica

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., dietary phenylalanine and protein restriction or prior sapropterin therapy)
• Medication is prescribed by or in consultation with a metabolic disease specialist (or specialist who focuses on metabolic diseases)

Reauthorization criteria

• Patient is age ≥ 18 years
• EITHER patient is continuing to titrate Palynziq to an effective maintenance dose, and if the patient is receiving 60 mg once daily, treatment duration at this dose has not exceeded 16 weeks
• OR patient’s blood phenylalanine concentration is ≤ 600 micromol/L OR has achieved ≥ 20% reduction from pre-treatment baseline, AND patient is not receiving concomitant sapropterin (Kuvan, Javygtor, generic)

Approval duration

1 year