Sephience (sepiapterin oral powder) — Medica

Initial criteria

• Medication is prescribed in conjunction with a phenylalanine-restricted diet
• 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 has had a clinical response according to prescriber (e.g., cognitive and/or behavioral improvements) OR patient has achieved a ≥ 20% reduction in blood phenylalanine concentration from pretreatment baseline OR treatment with Sephience has resulted in an increase in dietary phenylalanine tolerance
• Patient is not receiving concomitant Palynziq (pegvaliase-pqpz) at a stable maintenance dose (concomitant use permitted only during Palynziq dose titration)

Approval duration

Initial: 12 weeks; Reauthorization: 1 year