CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Tryngolza (olezarsen) — Coverage Criteria for Familial Chylomicronemia Syndrome

Covers medical necessity criteria, dosing, and authorization limits for Tryngolza (olezarsen) as adjunct therapy to diet to reduce triglycerides in adults with familial chylomicronemia syndrome (FCS); applies to prescribers and prior authorization reviewers.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyTryngolza (olezarsen) — Coverage Criteria for Familial Chylomicronemia Syndrome

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization for 6 months with documentation of confirmed FCS, fasting triglycerides ≥ 880 mg/dL, prior therapy failure, specialist involvement, platelet count >100,000/mm³, and diet adherence.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

80 mgrecommended monthly dose

1 pen/moquantity limit

≥ 880triglyceride threshold

>100kplatelet requirement

6 moinitial auth

Coverage Criteria for Tryngolza (olezarsen)

Initial Therapy

Authorization of 6 months may be granted when ALL of the following are met:

Initial Authorization for FCS: 1. Member is 18 years of age or older; 2. Documentation that member has a confirmed diagnosis of FCS by one of: (a) genetic testing showing biallelic pathogenic variants in FCS-causing genes (e.g., LPL, GPIHBP1, APOA5, APOC2, LMF1, GPD1), (b) National Acute Familial Chylomicronemia Syndrome (NAFCS) Score ≥ 60, or (c) recurrent acute pancreatitis; 3. Documentation that member has a fasting triglyceride level ≥ 880 mg/dL (10 mmol/L); 4. Documentation that member is refractory to standard triglyceride-lowering therapies (e.g., statins, fibrates, or other lipid-lowering medications); 5. Secondary factors that increase triglycerides have been excluded (e.g., high alcohol intake, uncontrolled diabetes, medications, and medical conditions known to increase TG); 6. Member is adherent to and will continue with a low-fat diet (e.g., ≤ 20 to 30 grams of total fat per day, 10% to 15% of calories per day of fat); 7. The medication is prescribed by or in consultation with a lipidologist, endocrinologist, or cardiologist; 8. Platelet count > 100,000/mm³ prior to treatment initiation; 9. Coverage will not be provided for a diagnosis of multifactorial chylomicronemia (MCS).

All conditions must be met

Continuation Therapy

Authorization of 6 months may be granted for continued treatment when ALL of the following are met:

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyTryngolza (olezarsen) — Coverage Criteria for Familial Chylomicronemia Syndrome

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

SourceLink

On This Page

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Reauthorization for FCS: 1. Documentation supporting a positive clinical response with the requested medication (e.g., reduction in fasting triglyceride level from baseline, reduction in episodes of acute pancreatitis); 2. The member continues to be adherent to a low-fat diet (e.g., ≤ 20 to 30 grams of total fat per day, 10% to 15% of calories per day of fat); 3. The member continues to be managed by or in consultation with a lipidologist, endocrinologist, or cardiologist.

All conditions must be met for reauthorization

Coverage will not be provided for a diagnosis of multifactorial chylomicronemia (MCS).

Key Laboratory and Dosing Parameters

inv-04: Fasting triglyceride level — threshold for initiation

Fasting triglyceride threshold for initiation≥ 880 mg/dL (10 mmol/L)

Context for measurementFasting triglyceride level must be documented prior to initiation as part of initial authorization criteria for FCS

Related authorization durationMeets criteria for a 6-month initial authorization when combined with other required criteria

inv-05: Baseline platelet count — required minimum platelet count

Minimum baseline platelet countPlatelet count > 100,000/mm³

Timing of testPlatelet count must be obtained prior to treatment initiation

Role in authorizationRequired element of initial authorization for Tryngolza in FCS

Provider Requirements and Prior Authorization Instructions

Prior Authorization

Prior Authorization Required

An authorization of up to 6 months may be granted for initial and reauthorization requests when all clinical criteria are met. Prior authorization is required for Tryngolza (or the requested triglyceride-lowering medication) for treatment of confirmed Familial Chylomicronemia Syndrome (FCS).

Authorization duration: 6 months (initial and reauthorization)
Prior authorization required before drug initiation

Denial Risk

Denial Risk: Multifactorial Chylomicronemia (MCS)

Coverage will be denied if the member has a diagnosis of multifactorial chylomicronemia syndrome (MCS). Ensure the diagnosis is FCS (monogenic) rather than MCS (multifactorial) before submitting an authorization request.

Do not approve coverage for ICD-10 diagnoses consistent with MCS
Denial risk if documentation supports multifactorial etiology rather than confirmed FCS

Documentation Required

Documentation Required: Confirmed FCS Diagnosis

Documented confirmation of FCS must be provided with the prior authorization request. Acceptable documentation includes one of the following: genetic testing showing biallelic pathogenic variants in FCS-associated genes (e.g., LPL, GPIHBP1, APOA5, APOC2, LMF1, GPD1); a National Acute Familial Chylomicronemia Syndrome (NAFCS) score ≥ 60; or a history of recurrent acute pancreatitis consistent with FCS.

Acceptable evidence: genetic testing result, NAFCS score ≥ 60, or recurrent acute pancreatitis history
Include relevant lab reports, genetic test reports, and clinical notes with the request

Prior Authorization

Provider Actions: Prior Therapy and Baseline Documentation

The member must be refractory to standard triglyceride-lowering therapies prior to approval. Provide documentation of prior trials and inadequate response (or intolerance) to agents such as statins, fibrates, or other lipid-lowering medications. Also include baseline fasting triglyceride ≥ 880 mg/dL and exclusion of secondary causes (e.g., uncontrolled diabetes, high alcohol intake, medications) and evidence of adherence to a low-fat diet.

Document prior therapy trials (statins, fibrates, others) and rationale for inadequate response or intolerance
Required labs: fasting triglycerides ≥ 880 mg/dL prior to initiation
Exclude secondary causes and document low-fat diet adherence (≤20–30 g fat/day)

Definitions and Diagnostic Criteria

inv-11: Confirmed diagnosis of FCS — genetic criteria, NAFCS score, or histologic confirmation

Genetic confirmationBiallelic pathogenic variants in FCS-causing genes (e.g., LPL, GPIHBP1, APOA5, APOC2, LMF1, GPD1)

NAFCS scoreNational Acute Familial Chylomicronemia Syndrome (NAFCS) Score ≥ 60

Clinical/histologic confirmationHistory of recurrent acute pancreatitis can be used as confirmation

Background

Familial chylomicronemia syndrome (FCS) is an inherited disorder characterized by very high triglyceride levels and risk of recurrent acute pancreatitis. Management includes strict adherence to a low-fat diet and use of standard triglyceride‑lowering therapies; Tryngolza (olezarsen) is considered as adjunct therapy to diet for adults with confirmed FCS who meet eligibility criteria. A confirmed diagnosis may be established by biallelic pathogenic variants in known FCS genes (e.g., LPL, GPIHBP1, APOA5, APOC2, LMF1, GPD1), a NAFCS Score ≥ 60, or a history of recurrent acute pancreatitis.