Palynziq (pegvaliase-pqpz) — United Healthcare
phenylketonuria (PKU)
Initial criteria
- Diagnosis of phenylketonuria (PKU)
- AND Patient has a blood phenylalanine concentration greater than 600 micromol/L
- AND Patient is actively on a phenylalanine-restricted diet
- AND Patient is not receiving Palynziq in combination with sapropterin dihydrochloride
Reauthorization criteria
- Documentation of positive clinical response (e.g., blood phenylalanine concentration less than 600 micromol/L, 20% reduction in blood phenylalanine concentration from pretreatment baseline)
- AND Patient is actively on a phenylalanine-restricted diet
- AND Patient is not receiving Palynziq in combination with sapropterin dihydrochloride
Approval duration
12 months