Inclisiran (Leqvio) (CPB 1004, reviewed 2026-07-14)

IMMEDIATELY: Billing team must implement mandatory precertification workflow for inclisiran (Leqvio/J1306). (1) Update billing system to require prior authorization before claim submission for all Aetna commercial plans. (2) Configure system to flag claims with ICD-10 codes E78.010, E78.011, E78.019, E75.5, E78.00, E78.2, E78.41, or diabetes/CKD codes (E08-E13, N18.1-N18.9) requiring precertification. (3) Establish precertification submission process: Route all requests to Aetna GCIT team via phone (866) 752-7021 or fax (888) 267-3277 with Statement of Medical Necessity (SMN). (4) Educate providers that prescribers MUST be cardiologist, endocrinologist, lipid specialist, or hypercholesterolemia specialist. (5) Create internal checklist to verify medical necessity requirements before submitting: documented ASCVD history OR untreated LDL-C ≥190 mg/dL, current LDL-C thresholds per diagnosis, and statin therapy history (≥3 months high/moderate-intensity OR documented contraindication/intolerance). (6) Train billing staff on three approval pathways: (a) ASCVD with LDL-C ≥70 mg/dL (or ≥55 mg/dL with multiple events/risk factors), (b) HeFH ages 12+, (c) HoFH ages 12+ with genetic confirmation. (7) Do NOT bill J1306 without approved precertification; claims will be denied. (8) For continuation therapy, ensure documentation shows LDL-C reduction achievement. Note: This policy does NOT apply to Medicare; route Medicare beneficiaries per Medicare Part B Criteria.