Palynziq (pegvaliase-pqpz) — CareFirst (Caremark)

Initial criteria

• Member is age ≥ 18 years
• Baseline blood phenylalanine concentration prior to initiation is > 600 micromol/L
• Prescribed by or in consultation with a physician who specializes in metabolic disease and/or phenylketonuria (PKU)

Reauthorization criteria

• Authorization of 12 months may be granted for members who have achieved a clinical response as evidenced by blood phenylalanine concentration ≤ 600 micromol/L
• Authorization of 6 months may be granted for members who have not achieved an adequate clinical response (blood phenylalanine concentration ≤ 600 micromol/L) AND meet one of the following: (1) Member has not been titrated to the maximum allowed dose of 60 mg once daily OR (2) Member has received less than 16 weeks of continuous treatment at the maximum allowed dose of 60 mg once daily

Approval duration

Initial: 6 months; Reauthorization: 6 or 12 months