Javygtor (sapropterin dihydrochloride) — Highmark
Phenylketonuria (PKU)
Preferred products
- generic sapropterin dihydrochloride
Initial criteria
- age ≥ 1 month
- diagnosis of PKU (ICD-10: E70.0)
- member is on a Phe-restrictive diet
- documented baseline phenylalanine (Phe) level > 6 mg/dL (360 μM/L)
- clinical documentation of member’s current weight
- dose does not exceed 20 mg/kg/day
- if request is for brand Kuvan or Javygtor, member has experienced therapeutic failure or intolerance to generic sapropterin dihydrochloride
- not used in combination with Palynziq (pegvaliase-pqpz)
Reauthorization criteria
- initial therapy has resulted in a 30% or greater decrease in blood Phe levels from baseline OR blood Phe levels within 2–6 mg/dL (120–360 μM/L)
- member is on a Phe-restrictive diet
- clinical documentation of member’s current weight
- dose does not exceed 20 mg/kg/day
- if request is for brand Kuvan or Javygtor, member has experienced therapeutic failure or intolerance to generic sapropterin dihydrochloride
- not used in combination with Palynziq (pegvaliase-pqpz)
Approval duration
initial: up to 3 months; reauthorization: up to 12 months