Zelvysia — Medica

Initial criteria

• age ≥ 1 month
• the medication is prescribed in conjunction with a phenylalanine-restricted diet
• the 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 the prescriber (examples of clinical response may include cognitive and/or behavioral improvements) OR patient has achieved a ≥ 20% reduction in blood phenylalanine concentration from pre-treatment baseline OR treatment with sapropterin has resulted in an increase in dietary phenylalanine tolerance
• patient is not receiving concomitant Palynziq (pegvaliase-pqpz subcutaneous injection) at a stable maintenance dose (concomitant use with Palynziq is permitted during Palynziq dose titration)

Approval duration

initial: 12 weeks; reauthorization: 1 year