Brineura® (Cerliponase Alfa) – Commercial Medical Benefit Drug Policyopen_in_new

UnitedHealthcare covers Brineura (cerliponase alfa) to slow loss of ambulation in pediatric patients with genetically/clinically confirmed CLN2 (TPP1 deficiency) and considers use for other forms of neuronal ceroid lipofuscinosis unproven and not medically necessary. Coverage requires diagnosis by or in consultation with a CLN2‑expert neurologist, CLN2 Clinical Scoring System thresholds (initial combined motor+language 3–6 with each domain ≥1; continuation motor ≥1), prescription by/with a CLN2 expert, intraventricular administration via an intracerebroventricular catheter by experienced providers, FDA‑label dosing, and authorizations limited to 12 months.

"For continuation, patient must have motor domain score ≥1 on the CLN2 Clinical Scoring System."

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