CurrentUnitedHealthcarePolicy 2026 P 2391-1

Redemplo (plozasiran) prior authorization

Prior authorization and medical necessity criteria for Redemplo (plozasiran) to reduce triglycerides in adults with familial chylomicronemia syndrome (FCS); applies to UnitedHealthcare pharmacy programs and prescribers in covered populations.

Policy Summary

PayerUnitedHealthcare

PolicyRedemplo (plozasiran) prior authorization

Policy CodePolicy 2026 P 2391-1

Change TypeNew prior authorization program

Effective DateMay 1, 2026

Next Review Date

Key ActionSubmit prior authorization documenting FCS diagnosis with genetic confirmation or NAFCS Score ≥ 45, untreated fasting triglycerides ≥ 880 mg/dL, and prescriber specialty.

SourceLink

POLICY UPDATE CHANGES

New prior authorization program established for Redemplo (plozasiran).

12 monthsauthorization duration

≥880 mg/dLuntreated fasting triglyceride threshold

NAFCS ≥45alternative diagnostic criterion

P&T 02/2026therapy review date

Coverage Criteria

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Use of Redemplo (plozasiran) in combination with Tryngolza (olezarsen) is excluded. Claims or prior authorization requests that indicate concurrent use of these agents are not eligible for approval and may be denied.

Coding and Thresholds

Untreated fasting triglycerides

Untreated fasting triglycerides≥ 880 mg/dL

ContextRequired as part of initial authorization for Redemplo (plozasiran)

Measurement conditionsFasting, untreated (off triglyceride-lowering therapy) level

North American FCS (NAFCS) Score

UseAlternative diagnostic criterion to genetic confirmation for FCS

Provider Actions and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization required. Initial authorization for Redemplo (policy code) will be approved only when all listed clinical and prescriber requirements are met.

Diagnosis: Familial chylomicronemia syndrome (FCS) (monogenic chylomicronemia, type 1 hyperlipoproteinemia).
Confirmation: Genetic confirmation of FCS (e.g., homozygous, compound heterozygous, or double heterozygote for loss-of-function or inactivating mutations in genes affecting lipoprotein lipase activity including LPL, GPIHBP1, APOA5, APOC2, or LMF1) OR North American FCS (NAFCS) Score ≥ 45.
Laboratory: Untreated fasting triglycerides ≥ 880 mg/dL.
Prescriber: Must be prescribed by a Cardiologist, Endocrinologist, Gastroenterologist, or Lipid specialist (lipidologist).
Exclusion: Not to be used in combination with Tryngolza (olezarsen).

Note

Automated approval / claims‑based consideration

UnitedHealthcare may use automated, claims‑based approval or re‑authorization pathways. Prior approvals or re‑authorizations can be granted based solely on previous claim/medication history, relevant ICD‑10 diagnosis codes, and/or claim logic where programmatically enabled.

Automated approval may consider prior medication fills, existing diagnosis codes for FCS, and historical claim patterns.
Use of automated approval/re‑approval processes varies by UHC program and therapeutic class.

Documentation Required

Documentation Required for Review

Document the clinical evidence that supports the diagnosis and meets the authorization criteria.

Diagnosis documentation: Clinical record indicating FCS (monogenic chylomicronemia, type 1 hyperlipoproteinemia).
Genetic testing results OR NAFCS Score: Genetic test report confirming pathogenic mutations in relevant genes (LPL, GPIHBP1, APOA5, APOC2, LMF1) OR documentation of NAFCS Score ≥ 45.
Laboratory values: Untreated fasting triglyceride measurement showing ≥ 880 mg/dL (include date and lab result).
Prescriber specialty: Medical record showing prescriber is a Cardiologist, Endocrinologist, Gastroenterologist, or Lipid specialist.
Medication history: Prior lipid-lowering therapies and relevant medication history, if applicable.

Denial Risk

Combination therapy exclusion — denial risk

Use in combination with Tryngolza (olezarsen) is not allowed and may result in denial of the request.

If claim or prior authorization indicates concurrent use with Tryngolza (olezarsen), the request should be denied.
Ensure medication lists and recent prescriptions are reviewed for contraindicated combination.

Initial Therapy Criteria

Continuation / Reauthorization Criteria

Site of Care

Note

No site‑of‑care restrictions specified

No site‑of‑care restrictions are specified for administration of Redemplo in this policy.

Authorization will be issued for 12 months; state mandates and member benefit plans may still apply.

Background

Redemplo (plozasiran) is an apoC-III-directed siRNA indicated as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome (FCS). FCS is a rare monogenic disorder characterized by markedly elevated triglycerides and increased risk of pancreatitis; Redemplo is intended to lower triglyceride levels in this population as part of comprehensive management.

Definitions

Familial chylomicronemia syndrome (FCS)

Clinical relevanceFCS leads to markedly elevated triglycerides and increased risk of pancreatitis; Redemplo is indicated as an adjunct to diet to reduce triglycerides in adults with FCS.

Genetic confirmation examplesHomozygous, compound heterozygous, or double heterozygote loss-of-function or inactivating mutations in genes affecting LPL activity (LPL, GPIHBP1, APOA5, APOC2, LMF1).