Sephience (sepiapterin) — Highmark

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 60 mg/kg/day
• member has experienced therapeutic failure or intolerance to plan-preferred 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 60 mg/kg/day
• not used in combination with Palynziq (pegvaliase-pqpz)

Approval duration

initial: up to 3 months; reauthorization: up to 12 months