Zelvysia (sapropterin dihydrochloride powder for oral solution – Aucta) — Cigna
Phenylketonuria
Initial criteria
- Medication is prescribed in conjunction with a phenylalanine-restricted diet; AND
- Medication is prescribed by or in consultation with a metabolic disease specialist (or specialist who focuses on the treatment of metabolic diseases)
Reauthorization criteria
- Patient meets ONE of the following (a, b, or c):
- a) According to the prescriber, patient has had a clinical response; OR
- b) Patient has achieved a ≥ 20% reduction in blood phenylalanine concentration from pre-treatment baseline; OR
- c) According to the prescriber, treatment with sapropterin has resulted in an increase in dietary phenylalanine tolerance; AND
- Patient is not receiving concomitant Palynziq (pegvaliase-pqpz subcutaneous injection) at a stable maintenance dose
- Note: Concomitant use with Palynziq is permitted during Palynziq dose titration.
Approval duration
initial 12 weeks; reauth 1 year