CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Tryngolza (olezarsen) for Familial Chylomicronemia Syndrome (FCS)

Policy governs Medicaid coverage and authorization criteria for Tryngolza (olezarsen) as adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome (FCS), including initial 6-month authorizations and reauthorization criteria, dosing, and quantity limits.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyTryngolza (olezarsen) for Familial Chylomicronemia Syndrome (FCS)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateAug 12, 2025

Next Review DateN/A

Key ActionObtain a 6-month prior authorization and document required criteria including genetic testing or NAFCS ≥60, fasting triglycerides ≥880 mg/dL, recurrent pancreatitis, exclusion of secondary causes, diet adherence, platelet count ≥100,000/mm3, and specialist prescribing or consultation.

POLICY UPDATE CHANGES

No material changes to clinical coverage or criteria for Tryngolza (olezarsen) — policy remains unchanged.

1Indication covered (FCS)

6 monthsAuthorization duration

1 pen/moQuantity limit

>=880 mg/dLTriglyceride threshold

Coverage Summary

Policy scope: Tryngolza (olezarsen) is covered as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome (FCS). Initial and reauthorization approvals are for 6 months. Quantity is limited to 1 autoinjector pen per month (80 mg once monthly). Key numeric thresholds: age ≥ 18 years, fasting triglycerides ≥ 880 mg/dL, NAFCS score ≥ 60, and platelet count ≥ 100,000 /mm3.

Policy quick facts

Indication coveredFCS (familial chylomicronemia syndrome)

Authorization duration6 months

Quantity limit1 pen per month (80 mg autoinjector)

Age threshold>= 18 years

Triglyceride threshold>= 880 mg/dL (fasting)

Platelet threshold>= 100,000 /mm3 prior to initiation

Medical Necessity Criteria

Reauthorization / Continued Treatment - Familial Chylomicronemia Syndrome (FCS)

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

ALL of the following

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

Provider Actions

Prior Authorization

Prior authorization required

A 6-month prior authorization is required for initial and continued treatment. Initial approval requires documentation of genetic confirmation of FCS (biallelic pathogenic variants in FCS-causing genes) or a NAFCS score ≥ 60, a fasting triglyceride level ≥ 880 mg/dL, a history of recurrent acute pancreatitis, exclusion of secondary causes of hypertriglyceridemia, adherence to a low‑fat diet, a pretreatment platelet count ≥ 100,000/mm3, and that the medication is prescribed by or in consultation with a lipidologist, endocrinologist, or cardiologist.

Genetic testing showing biallelic pathogenic variants in FCS-causing genes or NAFCS Score ≥ 60
Fasting triglycerides ≥ 880 mg/dL
Recurrent acute pancreatitis
Exclusion of secondary causes (e.g., alcohol, uncontrolled diabetes, medications)
Adherence to a low‑fat diet (≈20–30 g/day; ~10–15% of calories from fat)
Platelet count ≥ 100,000 /mm3 prior to initiation
Prescribed by or in consultation with a lipidologist, endocrinologist, or cardiologist

Documentation Required

Document clinical response for reauthorization

For reauthorization, document a positive clinical response to treatment (for example, reduction in triglyceride level from baseline or fewer episodes of acute pancreatitis), continued adherence to a low‑fat diet, and ongoing management by or consultation with a lipidologist, endocrinologist, or cardiologist.

Billing Rule

Quantity limit enforcement

Dispensing is limited to one 80 mg autoinjector pen per month; see the policy quantity limit for Tryngolza 80 mg single‑dose autoinjector pen.

Background, Evidence & Definitions

Background and indication details: Tryngolza (olezarsen) is indicated for adults with FCS and requires either genetic confirmation (biallelic pathogenic variants in FCS-causing genes such as LPL, GPIHBP1, APOA5, APOC2) or a high clinical score (NAFCS ≥ 60). The policy targets patients with severe hypertriglyceridemia (fasting TG ≥ 880 mg/dL), often with recurrent acute pancreatitis. Prior to initiation, secondary causes of elevated TG must be excluded, the member must be adherent to a low-fat diet, treatment should be prescribed by or in consultation with a lipidologist/endocrinologist/cardiologist, and a baseline platelet count ≥ 100,000 /mm3 is required for safety.

Source	Citation
Key trial/publication	Olezarsen, acute pancreatitis, and familial chylomicronemia syndrome. N Engl J Med. 2024;390(19):1781-1792.
Manufacturer labeling	Tryngolza [package insert], Ionis Pharmaceuticals, Inc.; 2024.
Indication statement (policy)	Tryngolza is indicated as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome (FCS).
Quantity limit (dosing info)	Tryngolza 80 mg single-dose autoinjector pen: 1 autoinjector pen per month; recommended dosage 80 mg subcutaneously once monthly.

Term	Definition
Familial Chylomicronemia Syndrome (FCS)	A rare genetic disorder caused by biallelic pathogenic variants in genes such as LPL, GPIHBP1, APOA5, APOC2 leading to severe hypertriglyceridemia and recurrent pancreatitis.
NAFCS Score	National Acute Familial Chylomicronemia Syndrome score; a clinical scoring system where a score ≥ 60 supports FCS diagnosis per policy.