skip to content
Primary navigation


Drug - Palynziq (pegvaliase-pqpz injection) [BioMarion Pharmaceutical Inc.]

April 2019

Therapeutic area - PKU Treatment Agents

Initial approval criteria

  • Patient must be ≥ 18 years of age AND
  • Have a confirmed diagnosis of phenylketonuria AND
  • Have uncontrolled blood phenylalanine concentrations > 600 micromols/L with current therapy AND
  • In patients responsive to tetrahydrobiopterin (BH4), a failure to an adequate trial of sapropterin (Kuvan) has been demonstrated AND
  • Patient is NOT concurrently receiving sapropterin therapy AND
  • Patient has been instructed to adhere to dietary restriction of protein and phenylalanine AND
  • A covered epinephrine auto-injector and covered medical food for low-phenylalanine diet must be prescribed to the patient as substantiated in patient chart notes

Renewal criteria

  • Maintain blood phenylalanine concentration reductions of 20% below baseline measurements AND
  • Remain free from anaphylactic episodes with therapy

Quantity limits

  • Initial: 4 syringes/28 days for induction
  • Renewals: 30 syringes/30 days for titration or maintenance


MHCP Provider Call Center 651-431-2700 or 800-366-5411

back to top