MedicaidPrior AuthMedium impact
Palynziq™ (pegvaliase-pqpz) Injection (Revised)
Humana·KY, SC · Pharmacy, Genetics, Pediatrics·Medicaid
Effective date
Jul 22, 2026
We identified it
Jul 22, 2026
Summary
This is a revised Palynziq (pegvaliase-pqpz) pharmacy coverage policy for Humana Medicaid plans in Kentucky and South Carolina, effective July 22, 2026. The policy establishes prior authorization requirements for this pegylated enzyme replacement therapy used to treat phenylketonuria (PKU) in adult patients with uncontrolled phenylalanine levels >600 micromol/L. Billing teams must ensure prior authorization is obtained before dispensing and verify members meet all three clinical criteria.
Action Required
By July 22, 2026: Pharmacy billing team must implement prior authorization requirements for Palynziq (pegvaliase-pqpz) in Humana Medicaid systems for Kentucky and South Carolina. Before processing any claims, verify: (1) member has confirmed PKU diagnosis with elevated phenylalanine levels, (2) provider attests to required confirmatory testing (plasma amino acid analysis with elevated Phe:Tyr ratio AND urine pterin analysis/DHPR assay OR molecular testing showing 2 PAH variants), and (3) member has documented uncontrolled baseline phenylalanine >600 micromol/L despite existing management (Kuvan, large amino acid therapy, or phenylalanine-restricted diet). Update billing software to flag Palynziq claims for prior authorization review. Educate providers and prior auth staff that Palynziq is not recommended with concomitant Kuvan therapy and requires enrollment in Palynziq REMS program. Claims submitted without documented prior authorization will be denied.