PALYNZIQ (pegvaliase-pqpz)

PALYNZIQ (pegvaliase-pqpz)

OFFICE ADMINISTERED (FIRST DOSE) 

SELF ADMINISTERED (SUBSEQUENT DOSES)

Indications for Prior Authorization:

• To reduce blood phenylalanine concentrations in adult patients with phenylketonuria (PKU) who have uncontrolled blood phenylalanine concentrations greater than 600 imcromol/L on existing management

Patients must meet the following criteria for the indication(s) above:

• Initial therapy:
  • Patient has uncontrolled blood phenylalanine concentrations greater than 600 mincromol/L on at least one existing treatment modality (e.g., restriction of dietary phenylalanine and protein intake, prior treatment with Kuvan®), AND
  • The medication is prescribed by or in consultation with a metabolic disease specialist (or a specialist who focuses in the treatment of metabolic diseases)
• Continuing therapy:
  • The patient's blood phenylalaine concentration is less than or equal to 600 micromol/L, OR
  • The patient has achieved at least a 20% reduction in blood phenylalanine concentration from pre-treatment baseline (i.e., blood phenylalanine concentration before starting Palynziq therapy)
• Discontinue Palynziq in patients who have not achieved a response (at least a 20% reduction in blood phenylalanine concentration from pre-treatment baseline OR a blood phenylalaine concentration less than or equal to 600 micromol/L) after 16 weeks of continuous treatment with the maximum dosage of 40 mg once daily

Dosing:

• The recommended initial induction dosage for Palynziq is 2.5mg subcutaneously once weekly for 4 weeks.  Administer the initial dose under the supervision of a healthcare provider.
• Titrate the Palynziq dosage in a step-wise manner, based on tolerability, over at least 5 weeks, to achieve a dosage of 20 mg subcutaneously once daily
• Maximum dose is 40 mg once daily

Approval:

• Initial: 6 months
• Continuation: 1 year