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CommercialPrior AuthMedium impact

Plozasiran (Redemplo) (CPB 1096)

Aetna·Cardiology, Endocrinology, Genetics +2 more·Medical Policy
Effective date
Not stated
We identified it
Sep 30, 2026
Days to comply
—

Summary

Aetna has issued a new clinical policy (CPB 1096) establishing coverage criteria for plozasiran (Redemplo), a gene-based therapy for familial chylomicronemia syndrome (FCS) in adult commercial members. The policy requires precertification for all claims, restricts prescribing to specialized providers, and mandates specific diagnostic confirmation and triglyceride thresholds before approval. Continuation of therapy requires demonstrated clinical response and concurrent dietary management.

Action Required

Action needed
IMMEDIATELY: Billing and provider relations teams must implement the following: (1) Establish precertification process for all plozasiran (Redemplo) claims by contacting Aetna GCIT team at (866) 752-7021 or fax (888) 267-3277 before claim submission; (2) Update billing software to flag any plozasiran claims and require documented precertification authorization number prior to processing; (3) Notify prescribing providers (cardiologists, endocrinologists, lipid specialists, geneticists, or FCS specialists) that plozasiran requires precertification and requires submission of Statement of Medical Necessity (SMN) form via Specialty Pharmacy Precertification process; (4) Establish internal checklist to verify all initial approval criteria are met before claim submission: confirmed FCS diagnosis (genetic testing OR NAFCS score ≥45 OR Moulin score ≥10), fasting triglycerides ≥880 mg/dL, patient on very-low-fat diet (≤20-30g total fat/day), and no concurrent olezarsen (Tryngolza) use; (5) For reauthorization requests, verify documented positive clinical response (TG reduction or reduced pancreatitis episodes) and continued dietary compliance; (6) Implement tracking mechanism to ensure no claims are submitted with concurrent billing of olezarsen, as this is a coverage exclusion. Failure to obtain precertification will result in claim denials. Document all precertification numbers in patient record for appeal purposes.

Affected Billing Codes

84478
96372
E78.3
K85.00
K85.01
K85.02
K85.10
K85.11
K85.12
K85.20
K85.21
K85.22
K85.30
K85.31
K85.32
K85.80
K85.81
K85.82
K85.90
K85.91
K85.92