CurrentCignaPolicy IP0733

Tryngolza (olezarsen) for Familial Chylomicronemia Syndrome

Defines Cigna's 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). Applies to prescription benefit plans administered by Cigna Companies.

Policy Summary

PayerCigna

PolicyTryngolza (olezarsen) for Familial Chylomicronemia Syndrome

Policy CodePolicy IP0733

Change TypeNew policy

Effective DateJun 15, 2025

Next Review DateN/A

Key ActionObtain prior authorization; initial approval granted for 1 year when all criteria (age ≥18, fasting triglycerides ≥880 mg/dL, required genetic evidence or alternative diagnostic criteria, low-fat diet, and specialist prescriber) are met.

SourceLink

POLICY UPDATE CHANGES

New policy created for Tryngolza (olezarsen) with effective date 06/15/2025.

≥ 880 mg/dLRequired fasting triglyceride level for eligibility

≥ 18Minimum age for approval

1 yearInitial approval duration

42.5%Triglyceride reduction vs placebo (Month 6)

IP0733

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Coverage and Medical Necessity Criteria

Initial Therapy (FDA-Approved Indication)

Approve for 1 year if the patient meets ALL of the following (A, B, C, D, and E):

Initial approval for FCS: A) Patient is ≥ 18 years of age;

Initial approval for FCS: B) Documentation is provided that patient has a fasting triglyceride level ≥ 880 mg/dL;

Initial approval for FCS

ONE of: i. Documentation is provided that molecular genetic test results demonstrate biallelic pathogenic variants in at least one gene causing familial chylomicronemia syndrome;
ONE of
- ONE of: a) Patient has a familial chylomicronemia syndrome score ≥ 10;
- ONE of: b) Patient has a North American familial chylomicronemia syndrome score ≥ 45;
- ONE of: c) Patient has a history of pancreatitis;
- ONE of: d) Patient has a history of eruptive xanthomas;
- ONE of: e) Patient has a history of lipemia retinalis;

Initial approval for FCS: D) The medication will be used concomitantly with a low-fat diet;

Initial approval for FCS: E) Medication is prescribed by a cardiologist, an endocrinologist, or a physician who focuses in the treatment of disorders related to severe hypertriglyceridemia.

Tryngolza (olezarsen) for hypertriglyceridemia without a confirmed diagnosis of familial chylomicronemia syndrome (FCS) is considered not medically necessary. Receipt of sample product does not satisfy any criteria requirements for coverage.

Any use of Tryngolza other than for familial chylomicronemia syndrome (FCS) as defined in this policy is considered not medically necessary. This includes, but is not limited to, use for general hypertriglyceridemia when FCS has not been confirmed; Tryngolza is not FDA-approved for those indications.

Clinical Thresholds and Codes

Fasting triglyceride level

Fasting triglyceride threshold>= 880 mg/dL

Context in clinical trialA fasting triglyceride level >= 880 mg/dL was required for enrollment in the Phase III trial of Tryngolza

Policy requirement for approvalDocumentation of fasting triglycerides >= 880 mg/dL is required for initial 1-year approval for FCS

Prescriber Requirements and Prior Authorization

Prior Authorization

Prior authorization required — initial approval 1 year

Prior authorization is required for Tryngolza. Initial approval is for 1 year when all criteria are met, including patient age ≥ 18 years and a documented fasting triglyceride level ≥ 880 mg/dL.

Step Therapy

Step therapy / concomitant requirements

No prior step therapy (failure of alternative agents) is specified in the policy; however, therapy must be used concomitantly with a low‑fat diet and the medication must be prescribed by or in consultation with a specialist (cardiologist, endocrinologist, or physician who focuses on severe hypertriglyceridemia).

Documentation Required

Key Definitions

FCS (Familial Chylomicronemia Syndrome)

DefinitionFamilial chylomicronemia syndrome (FCS) is an ultrarare, genetic form of severe hypertriglyceridemia

Typical severityPatients may have triglyceride levels in the thousands; untreated levels often > 885 mg/dL

Genetic causeCaused by biallelic pathogenic variants in genes such as LPL, GPIHBP1, APOA5, APOC2, or LMF1

Tryngolza (olezarsen)

Drug classAn apolipoprotein C-III (APO-CIII)-directed antisense oligonucleotide

IndicationIndicated as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome (FCS)

Clinical Background

Familial chylomicronemia syndrome (FCS) is an ultrarare, genetic cause of severe hypertriglyceridemia that places patients at risk for complications such as acute pancreatitis. Tryngolza is indicated as an adjunct to diet to reduce triglycerides in adults with FCS; the policy therefore limits coverage to that confirmed diagnosis and specifies that uses outside that indication are not medically necessary.

Document Revisions

2025-06-15Policy createdLatest

New policy created for Tryngolza (olezarsen) and made effective 06/15/2025.