Palynziq

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

Questions?

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