CurrentCignaPolicy IP0733

Tryngolza (olezarsen) for Familial Chylomicronemia Syndrome

This policy governs prior authorization and medical necessity criteria for coverage of Tryngolza (olezarsen) as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome (FCS) under Cigna-administered plans.

Policy Summary

PayerCigna

PolicyTryngolza (olezarsen) for Familial Chylomicronemia Syndrome

Policy CodePolicy IP0733

Change TypeCriteria added/clarified (diagnostic pathway, baseline specification, scoring)

Effective Date

Next Review Date

Key ActionObtain prior authorization and document baseline fasting triglyceride ≥ 880 mg/dL (prior to triglyceride-lowering medications), diagnostic confirmation (genetic or defined clinical criteria), and specialist involvement to support approval.

SourceLink

POLICY UPDATE CHANGES

Added requirement that fasting triglyceride level ≥ 880 mg/dL be specified as at baseline prior to treatment with a triglyceride-lowering medication.

Clarified that for inconclusive molecular genetic testing, the Moulin familial chylomicronemia score ≥ 10 is the accepted scoring option.

Added explicit clinical diagnosis pathway alternative to genetic testing with defined clinical elements (fasting TG ≥ 880 mg/dL at baseline; history of recurrent acute pancreatitis or recurrent hospitalizations for severe abdominal pain; absence of secondary causes; lack of response to traditional triglyceride-lowering medications).

Added Appendices A and B containing diagnostic scoring criteria (Moulin FCS score and North American FCS score).

≥ 880 mg/dLrequired baseline fasting triglyceride for approval

≥ 18 yrsminimum patient age for FDA-approved indication

Policy Summary

PayerCigna

PolicyTryngolza (olezarsen) for Familial Chylomicronemia Syndrome

Policy CodePolicy IP0733

Change TypeCriteria added/clarified (diagnostic pathway, baseline specification, scoring)

Effective Date

Next Review Date

SourceLink

On This Page

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Coverage Criteria for Tryngolza (olezarsen)

Initial Therapy

Covered when ALL of the following are met:

FDA-Approved Indication (Initial)

ONE of
- Genetic confirmation: Molecular genetic test results demonstrate biallelic pathogenic variants in at least one gene causing familial chylomicronemia syndrome (examples: LPL, GPIHBP1, APOA5, APOC2, LMF1).
- Genetic inconclusive with score: Molecular genetic test results are inconclusive AND the patient has either a Moulin familial chylomicronemia syndrome score ≥ 10 OR a North American familial chylomicronemia syndrome score ≥ 45.
- Clinical diagnosis pathway: Patient has a clinical diagnosis based on ALL of the following: (a) history of acute pancreatitis not caused by alcohol or cholelithiasis OR history of recurrent hospitalizations for severe abdominal pain without other explainable cause; AND (b) absence of secondary hypertriglyceridemia (e.g., obesity, uncontrolled diabetes); AND (c) lack of response to traditional triglyceride-lowering medications (e.g., statins, niacin, fibrates, omega-3 fatty acids).

Initial approval duration = 1 year

Tryngolza (olezarsen) is not medically necessary for any use other than treatment of familial chylomicronemia syndrome (FCS). This exclusion includes treatment of routine hypertriglyceridemia or hypertriglyceridemia without a confirmed diagnosis of FCS. Receipt of sample product does not satisfy documentation or coverage requirements.

Use of Tryngolza for indications other than familial chylomicronemia syndrome (FCS) is considered not medically necessary. Specifically, Tryngolza is not covered for general hypertriglyceridemia in the absence of a confirmed FCS diagnosis, and other non‑FCS uses are excluded from coverage.

Coding and Key Parameters

Coding — general notemixed

N/A	No specific CPT/HCPCS/ICD-10/NDC codes listed in the document.

Baseline fasting triglyceride — threshold for approval

Required baseline fasting triglycerideFasting triglyceride level ≥ 880 mg/dL at baseline (prior to treatment with a triglyceride‑lowering medication)

Baseline definition noteBaseline refers to measurement prior to initiation of triglyceride‑lowering medications (e.g., statins, niacin, fibrates, omega‑3 fatty acids)

DocumentationLaboratory documentation of fasting triglyceride level is required

Minimum age for FDA indication

Minimum age for FDA indicationPatient must be ≥ 18 years of age

Indication age contextTryngolza is indicated as an adjunct to diet to reduce triglycerides in adults with FCS

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for Tryngolza. Initial approvals are for 1 year. Tryngolza must be prescribed by or in consultation with a physician who specializes in the condition being treated (cardiologist, endocrinologist, lipidologist, or a physician who focuses in the treatment of disorders related to severe hypertriglyceridemia). Documentation is required as noted below and must include patient-identifying information.

Initial approval duration: 1 year
Prescriber requirement: cardiologist, endocrinologist, lipidologist, or specialist in severe hypertriglyceridemia (or consultation with such a specialist)

Step Therapy

Step Therapy / Prior Medication Failure

Requirement for lack of response to traditional triglyceride-lowering medications is part of the coverage criteria when a clinical diagnosis is used. Documentation should show trials and inadequate response to therapies such as statins, niacin, fibrates, and omega-3 fatty acids before considering Tryngolza.

Step therapy requirement applies when clinical diagnosis pathway is used: documentation of lack of response to traditional triglyceride-lowering medications (e.g., statins, niacin, fibrates, omega-3 fatty acids).

Background

Familial chylomicronemia syndrome (FCS) is an ultrarare genetic cause of severe hypertriglyceridemia, estimated to affect approximately 1–10 per 1,000,000 persons in the United States. FCS is caused by biallelic pathogenic variants in genes such as LPL, GPIHBP1, APOA5, APOC2, or LMF1 and typically presents with triglyceride concentrations in the thousands, a clinical history of abdominal pain and recurrent acute pancreatitis, and findings such as eruptive xanthomas and lipemia retinalis. Tryngolza (olezarsen) is an apolipoprotein C‑III–directed antisense oligonucleotide indicated as an adjunct to a low‑fat diet to reduce triglycerides in adults with FCS.

Definitions

Familial Chylomicronemia Syndrome (FCS) — definition and genetic causes

DefinitionAn ultrarare genetic form of severe hypertriglyceridemia often presenting with triglyceride levels in the thousands and associated with pancreatitis, eruptive xanthomas, and lipemia retinalis

Genetic causesCaused by biallelic pathogenic variants in genes including LPL, GPIHBP1, APOA5, APOC2, or LMF1

PrevalenceEstimated prevalence 1–10 per 1,000,000 persons in the US

Tryngolza (olezarsen) — drug definition and approved use

Drug class and targetAn apolipoprotein C‑III (APOC3)‑directed antisense oligonucleotide

FDA‑approved useIndicated as an adjunct to a low‑fat diet to reduce triglycerides in adults with familial chylomicronemia syndrome (FCS)

Documentation Required

Required Documentation

Documentation is required for all elements noted in the coverage criteria. Acceptable records include chart notes, laboratory tests (including baseline fasting triglyceride level), molecular genetic test reports, clinical scoring results (e.g., Moulin or North American familial chylomicronemia syndrome scores), and documentation of clinical diagnosis details (history of pancreatitis, absence of secondary causes, hospitalizations). All documentation must include patient-specific identifying information.

Baseline fasting triglyceride level (≥ 880 mg/dL) — lab report required
Molecular genetic test results showing biallelic pathogenic variants (if available) — test report required
If genetic testing inconclusive: Moulin score ≥ 10 or North American score ≥ 45 — score documentation required
If clinical diagnosis used: documentation of history of acute pancreatitis or recurrent unexplained severe abdominal pain, absence of secondary hypertriglyceridemia, and lack of response to traditional triglyceride-lowering medications
Documentation that medication will be used with a low-fat diet
Prescriber specialty or consultation note