Patisiran (Onpattro)

Onpattro (patisiran) is covered only for adults (≥18) to treat the polyneuropathy of hereditary transthyretin‑mediated amyloidosis with genetic confirmation of a TTR mutation; no off‑label compendial uses are approved. Approval is for 12 months and requires documentation of age, genetic test and indication, weight-based IV dosing (0.3 mg/kg q3 weeks if <100 kg; 30 mg q3 weeks if ≥100 kg), records of infusion/weight, required premedication (corticosteroid, acetaminophen, H1 and H2 blockers), daily Vitamin A supplementation, and demonstrated clinical benefit for reauthorization.

"Onpattro is administered via intravenous (IV) infusion (route of administration requirement)."

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