CurrentUnitedHealthcarePolicy 2025 P 1470-1

Tryngolza (olezarsen) prior authorization

Prior authorization policy for Tryngolza (olezarsen) as adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome (FCS); applies to UnitedHealthcare pharmacy coverage and prescribing providers.

Policy Summary

PayerUnitedHealthcare

PolicyTryngolza (olezarsen) prior authorization

Policy CodePolicy 2025 P 1470-1

Change TypeNew policy

Effective DateMay 1, 2025

Next Review Date

Key ActionObtain prior authorization with documented diagnosis of familial chylomicronemia syndrome (FCS) for initial approval.

SourceLink

POLICY UPDATE CHANGES

Policy established for Tryngolza (olezarsen) with prior authorization requirements and reauthorization rules.

12 monthsauthorization duration

2/2025P&T approval

2025-05-01effective

FCScovered diagnosis

Coverage Criteria

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inv-02: Reauthorization — Covered when ALL of the following are met

Covered when ALL of the following are met

Reauthorization for Tryngolza: Documentation of positive clinical response to Tryngolza therapy (e.g., reduction in triglycerides, reduction in episodes of acute pancreatitis).

Clinical response evidence required for continued approval

Coverage decisions for Tryngolza (olezarsen) are subject to state mandates, applicable federal regulatory requirements, and the terms of the member’s specific benefit plan. Other UnitedHealthcare policies and utilization management programs may also affect application of these criteria and any supply limits or medical necessity determinations.

Reauthorization / Continuation Criteria

inv-14: Reauthorization / Continuation — criteria and duration

Reauthorization/continuation criteria and duration

Continuation authorization: Documentation of positive clinical response required for reauthorization; authorizations are issued for 12 months.12 months

Supply limits and medical necessity may be in place; state mandates and member benefit plans may affect coverage

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization required for Tryngolza (olezarsen). Initial authorization requires a documented diagnosis of familial chylomicronemia syndrome (FCS).

Diagnosis: familial chylomicronemia syndrome (FCS) / monogenic chylomicronemia (ICD-10 codes required on request)
Program: UnitedHealthcare Pharmacy Clinical Pharmacy Programs — Prior Authorization/Notification (Program Number 2025 P 1470-1)

Step Therapy

Step therapy / Other Utilization Management

No formal step therapy is specified for Tryngolza in the coverage criteria; however, other utilization management programs and supply limits may apply. Providers should verify plan-specific programs before prescribing.

No explicit step-therapy requirement stated in the criteria
Other UM programs (e.g., supply limits, medical necessity rules) may apply and vary by therapeutic class

Documentation Required

Required Documentation

Documentation is required to support both initial and reauthorization requests. For reauthorization, documentation must demonstrate a positive clinical response to Tryngolza (for example, reduction in triglyceride levels or fewer episodes of acute pancreatitis). Keep medical records and laboratory data available for review.

Reauthorization: documentation of positive clinical response (e.g., decreased triglycerides, reduced acute pancreatitis episodes)
Initial: documentation of FCS diagnosis

Denial Risk

Denial Triggers

Lack of required documentation, diagnosis, or necessary claim/medication history may trigger denial. UnitedHealthcare may use automated approval/re-approval based on prior claims, medication history, diagnosis codes, and claim logic; ensure accurate coding and complete records to avoid inappropriate denials.

Denial triggers: missing FCS diagnosis, insufficient clinical response documentation on reauthorization, incomplete medical records
Automated rules: prior claims/medication history and diagnosis codes may be used for approval or denial

Step	Requirement / Description
1	No explicit step therapy steps are outlined in this policy. Other utilization management programs may apply (e.g., approvals based on prior claims/medication history, diagnosis codes, automated approval processes); supply limits and medical necessity may be applied.

Site of Care

Note

Site of care not specified; supply limits/medical necessity may apply

The policy does not specify a required site of care; programs may impose supply limits or medical necessity rules regardless of site.

Site of care not specified in policy.
Supply limits and medical necessity determinations may be applied by the program.

Background

Tryngolza (olezarsen) is an APOC‑III–directed antisense oligonucleotide indicated as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome (FCS). Clinical review and documentation of response (for reauthorization) or appropriate diagnostic coding (for initial authorization) may be used to adjudicate requests; supply limits and other medical necessity rules may also apply.

Definitions

Familial chylomicronemia syndrome (FCS)

DefinitionFamilial chylomicronemia syndrome (FCS) — monogenic chylomicronemia, type hyperlipoproteinemia

Indication for TryngolzaFCS: Tryngolza (olezarsen) is indicated as an adjunct to diet to reduce triglycerides in adults with FCS

Coverage requirementDiagnosis of FCS is required for initial authorization of Tryngolza

Documentation noteReauthorization requires documentation of positive clinical response (e.g., triglyceride reduction or fewer episodes of acute pancreatitis)