Medicare AdvantagePrior AuthMedium impact
Palynziq™ (pegvaliase-pqpz) Injection (Revised)
Humana·KY, SC · Genetics, Pediatrics, Internal Medicine +1 more·Medicaid
Effective date
Jan 28, 2026
We identified it
Jun 25, 2026
Summary
Humana revised its Palynziq (pegvaliase-pqpz) prior authorization policy effective January 28, 2026, for Medicare and Medicaid (Kentucky and South Carolina). The policy maintains three strict approval criteria requiring confirmed PKU diagnosis with specific lab testing (plasma amino acid analysis and pterin/DHPR assay), plus documented uncontrolled phenylalanine levels >600 micromol/L despite existing management. All claims require prior authorization with approvals granted in plan year durations for both initial and renewal requests.
Action Required
By January 28, 2026: Billing team must implement the revised Palynziq prior authorization requirements in the billing system. Prior to submitting claims, ensure providers have documented: (1) confirmed PKU diagnosis with elevated phenylalanine levels; (2) prior confirmatory testing results including plasma amino acid analysis and urine pterin or DHPR assay; and (3) baseline phenylalanine levels >600 micromol/L on existing management (Kuvan, large amino acid therapy, or phenylalanine-restricted diet). Update pre-authorization request templates to mandate all three criteria. Flag claims as requiring prior authorization before submission to Humana. For Kentucky and South Carolina Medicaid members and Medicare Advantage members: verify patient meets all three criteria before claim submission. Communicate with providers that Palynziq cannot be used concomitantly with Kuvan and that premedication protocols and anaphylaxis risk mitigation (including auto-injectable epinephrine prescribing and Black Box Warning compliance) are mandatory. Failure to obtain prior authorization will result in claim denials. Route all Palynziq requests through the Palynziq REMS program.