CurrentAnthemPolicy CC-0294

Redemplo (plozasiran) — Coverage Criteria for Familial Chylomicronemia Syndrome

Clinical criteria, coding, and utilization management for Redemplo (plozasiran) as adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome (FCS); applies to medical benefit prior authorization and continuation review.

Policy Summary

PayerAnthem

PolicyRedemplo (plozasiran) — Coverage Criteria for FCS

Policy CodePolicy CC-0294

Change TypeNew clinical criteria and coding added

Effective DateN/A

Next Review DateDec 8, 2025

Key ActionSubmit prior authorization demonstrating patient is ≥18 years with FCS (genetic confirmation or clinical criteria), a recent fasting triglyceride ≥500 mg/dL, and plan to use Redemplo with a very low‑fat diet.

SourceLink

POLICY UPDATE CHANGES

New clinical criteria and quantity limit for Redemplo.

Added HCPCS NOC C9399, J3490 and ICD-10-CM E78.3 for Redemplo.

25 mg/0.5 mLproduct strength

1 syringequantity limit per fill

every 3 monthsdosing interval

6 monthsinitial approval

1 yearcontinuation approval

TG ≥500 mg/dLlaboratory threshold

Coverage Criteria for Redemplo (plozasiran)

Initial Therapy

Covered when ALL of the following are met

Age: Individual is 18 years of age or older

Diagnosis: Individual has a diagnosis of familial chylomicronemia syndrome

Diagnostic confirmation: Diagnosis demonstrated by either: (A) homozygous, compound heterozygous or double heterozygous loss-of-function mutation in LPL, APOC2, APOA5, GPIHBP1 or LMF1 OR (B) history of elevated fasting triglycerides (>= 1,000 mg/dL on three occasions) PLUS one qualifying clinical finding (absent/low postheparin lipoprotein lipase activity <20% of normal; recurrent acute pancreatitis not due to alcohol or cholelithiasis; recurrent hospitalizations for severe unexplained abdominal pain; childhood pancreatitis; family history of hypertriglyceridemia-induced pancreatitis)

Reference Watts 2025

Policy Summary

PayerAnthem

PolicyRedemplo (plozasiran) — Coverage Criteria for FCS

Policy CodePolicy CC-0294

Change TypeNew clinical criteria and coding added

Effective DateN/A

Next Review DateDec 8, 2025

SourceLink

On This Page

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Continuation Therapy

Covered when ALL of the following are met

Diagnosis: Individual has a diagnosis of familial chylomicronemia syndrome

Reference Watts 2025

Efficacy: Documentation of a clinically significant reduction in fasting triglyceride level with Redemplo (plozasiran) therapyclinically significant reduction (per reviewer)

Dietary therapy: Continued use in combination with a very low-fat diet (less than 20 grams per day of fat)< 20 g/day

Coding — HCPCS and Diagnosis Codes

HCPCSHCPCS

C9399	Unclassified drugs or biologicals [when specified as Redemplo (plozasiran)]
J3490	Unclassified drugs [when specified as Redemplo (plozasiran)]

ICD-10 DiagnosisICD-10

E78.3

Hyperchylomicronemia

Recent fasting triglyceride — eligibility threshold

Recent fasting triglyceride>= 500 mg/dL (measured within 90 days)

Timing windowLaboratory result must be from within the 90 days prior to request

Reference guidelineGrundy 2018 cited as supporting reference in policy

Historic fasting triglyceride for FCS definition

Historic fasting triglyceride criterion>= 1,000 mg/dL on three occasions

Role in diagnosisCan be used as part of diagnostic confirmation for FCS when paired with one qualifying clinical finding

Supporting detailsListed in initial diagnostic criteria (Watts 2025) for FCS definition

Provider Actions, Authorization, and Documentation

Prior Authorization

Prior Authorization and Quantity Limit

Prior authorization is required for Redemplo (plozasiran). Quantity limit: 25 mg/0.5 mL — 1 syringe every 3 months. Age and diagnosis limits: request must be for an individual age ≥18 with a diagnosis of familial chylomicronemia syndrome (FCS). Dosing/quantity and combination restrictions: Redemplo is administered subcutaneously once every three months and must not be used in combination with Tryngolza (olezarsen).

Prior authorization required
Quantity limit: 25 mg/0.5 mL — 1 syringe every 3 months
Indicated for adults (≥18 years) with FCS
Do not use in combination with Tryngolza (olezarsen)

Step Therapy

No step therapy is specified for Redemplo. Note: conventional triglyceride‑lowering drugs are generally ineffective in individuals with familial chylomicronemia syndrome (FCS); therefore, prior use of other triglyceride-lowering agents is not required before approval.

No step therapy required
Conventional triglyceride-lowering drugs generally ineffective in FCS

Documentation Required

Required Documentation for Initial Approval

For initial approval, submit documentation confirming age, diagnosis, genetics or clinical evidence, recent triglyceride level, and concurrent dietary management. Required documentation includes:

Proof of age ≥18 years
Documentation of FCS demonstrated by either: (A) genetic testing showing homozygous, compound heterozygous, or double heterozygous loss-of-function mutation in LPL, APOC2, APOA5, GPIHBP1, or LMF1; OR (B) clinical history of fasting triglycerides ≥1,000 mg/dL on three occasions PLUS one of: absent/low postheparin LPL activity (<20% of normal), recurrent pancreatitis not due to alcohol/cholelithiasis, recurrent hospitalizations for severe abdominal pain without other cause, childhood pancreatitis, or family history of hypertriglyceridemia‑induced pancreatitis
Recent (within 90 days) fasting triglyceride level ≥500 mg/dL
Plan for use in combination with a very low‑fat diet (≤20 g/day of fat)

Documentation Required

Required Documentation for Continuation

For continuation/renewal, submit documentation of ongoing diagnosis confirmation and clinical benefit, plus adherence to dietary recommendations. Required documentation includes:

Ongoing diagnosis of FCS with supporting genetic test results OR prior clinical evidence as listed for initial approval
Evidence of clinically significant reduction in fasting triglyceride level on Redemplo therapy
Documentation of continued use in combination with a very low‑fat diet (≤20 g/day of fat)
Information demonstrating adherence to prescribed dosing schedule (injections every 3 months)

Denial Risk

Denial Triggers

Denial may occur if the medical criteria are not met or if Redemplo is used in combination with Tryngolza (olezarsen). Ensure all required diagnostic and laboratory documentation is provided to avoid denial.

Denial triggers: clinical criteria not met
Denial trigger: concomitant use with Tryngolza (olezarsen)

Definitions

Familial chylomicronemia syndrome (FCS)

DefinitionFamilial chylomicronemia syndrome (FCS) is a rare genetic disorder caused by pathogenic loss-of-function mutations in lipoprotein lipase (LPL) or cofactors (APOC2, APOA5, GPIHBP1, LMF1) leading to impaired catabolism of chylomicrons, extreme hypertriglyceridemia, and recurrent pancreatitis.

Genetic causesPathogenic mutations in LPL or its cofactors: APOC2, APOA5, GPIHBP1, LMF1 (homozygous, compound heterozygous, or double heterozygous loss-of-function genotypes)

Clinical phenotypeVery severe hypertriglyceridemia with risk of recurrent acute pancreatitis; dietary fat restriction (<= 20 g/day) is a core management strategy; conventional triglyceride-lowering drugs are generally ineffective.

Alternate diagnostic pathwayCan be diagnosed by history of fasting triglycerides >=1,000 mg/dL on three occasions plus a qualifying clinical finding (e.g., absent/low postheparin LPL activity, recurrent pancreatitis, childhood pancreatitis, family history of hypertriglyceridemia-induced pancreatitis).

OpenPayer

Redemplo (plozasiran) — Coverage Criteria for Familial Chylomicronemia Syndrome

Coverage Criteria for Redemplo (plozasiran)

Coding — HCPCS and Diagnosis Codes

Provider Actions, Authorization, and Documentation

Background on Redemplo

Definitions