Palynziq (pegvaliase-pqpz) — Highmark

Initial criteria

• age ≥ 18 years
• diagnosis of PKU (ICD-10: E70.0)
• baseline phenylalanine (Phe) level > 600 μmol/L
• therapeutic failure, contraindication, or intolerance to BOTH of the following: (1) dietary therapy with a Phe-restrictive diet AND (2) sapropterin dihydrochloride
• Palynziq is not used in combination with Kuvan or Javygtor (sapropterin dihydrochloride)

Reauthorization criteria

• blood Phe concentration ≤ 600 μmol/L OR
• prescriber attests additional therapy with Palynziq is needed AND one of the following: (1) member is not currently taking 60 mg/day of Palynziq OR (2) member has not had an adequate trial of 60 mg/day of Palynziq for 16 weeks

Approval duration

12 months