Sephience (sepiapterin oral powder - PTC Therapeutics) — Cigna

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 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
• According to the prescriber, treatment with Sephience 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 (concomitant use with Palynziq is permitted during Palynziq dose titration)

Approval duration

initial: 12 weeks; reauth: 1 year