CurrentUnitedHealthcarePolicy N/A

Tryngolza (olezarsen) prior authorization

Defines UnitedHealthcare prior authorization and reauthorization requirements for Tryngolza (olezarsen) for treatment of familial chylomicronemia syndrome (FCS) in adults.

Policy Summary

PayerUnitedHealthcare

PolicyTryngolza (olezarsen) prior authorization

Policy CodePolicy N/A

Change TypeNew prior authorization program

Effective DateMay 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization documenting a confirmed diagnosis of familial chylomicronemia syndrome (FCS) for initial approval and evidence of clinical response for reauthorization.

SourceLink

POLICY UPDATE CHANGES

New prior authorization program for Tryngolza (olezarsen) established.

P&T 02/2025approval date

12 moauthorization duration

FCSindication limited to

Coverage Criteria for Tryngolza (olezarsen)

inv-01: Initial Therapy — Covered when ALL of the following are met:

Covered when ALL of the following are met:

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

Covered when ALL of the following are met:

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

Reauthorization requires evidence of benefit

Coverage for Tryngolza (olezarsen) may be affected by external requirements beyond the clinical criteria in this policy. State mandates, applicable federal regulatory requirements, and the member’s specific benefit plan coverage can limit or modify eligibility and approval. Additionally, other UnitedHealthcare policies and utilization management programs may apply and alter coverage decisions.

This policy does not exhaustively define every situation in which Tryngolza may be considered not covered. Medical necessity determinations, programmatic supply limits, and automated claim or medication-history based rules can result in a request being denied or not approved under a member’s plan. UnitedHealthcare may also approve or deny requests based solely on prior claim/medication history, diagnosis codes, and claim-logic where applicable.

Reauthorization / Continuation Criteria

inv-14: Reauthorization — Reauthorization requires evidence of clinical benefit.

Reauthorization requires evidence of clinical benefit.

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

Authorization renewed for 12 months if criteria met

Provider Actions, Documentation, and Denial Risks

Prior Authorization

Prior Authorization Required

Prior authorization required. Initial approval requires a confirmed diagnosis of familial chylomicronemia syndrome (FCS) (i.e., monogenic chylomicronemia, type 1 hyperlipoproteinemia). Authorization will be issued for 12 months. State mandates may apply; federal regulatory requirements and the member-specific benefit plan coverage may also impact coverage criteria.

Initial approval: confirmed diagnosis of FCS (monogenic chylomicronemia, type 1 hyperlipoproteinemia)
Authorization duration: 12 months
State and federal mandates and member-specific benefit plan may affect coverage

Documentation Required

Reauthorization Documentation Required

For reauthorization, documentation must show a positive clinical response to Tryngolza (for example, reduction in triglyceride levels or fewer episodes of acute pancreatitis). UnitedHealthcare may use prior claims/medication history, diagnosis codes (ICD-10), and/or claim logic to approve initial or reauthorization requests where applicable.

Reauthorization requirement: documented positive clinical response (e.g., ↓ triglycerides, ↓ acute pancreatitis episodes)
Automated approval pathways may be used based on claims/medication history and diagnosis codes

Step Therapy

No step therapy or required prior failures to other therapies are specified in this document.

Denial Risk

Potential Denial Drivers

Requests may be denied if the member-specific benefit plan, federal regulatory requirements, state mandates, other utilization management programs, or supply limits and medical necessity criteria are not met. UnitedHealthcare may also deny requests that do not include required documentation of benefit or that fall outside automated approval processes.

Denial drivers: missing or insufficient documentation of clinical response for reauthorization
Denial drivers: member plan exclusions, federal/state regulatory constraints, other utilization management programs
Denial drivers: supply limits or unmet medical necessity criteria

Background on Tryngolza (olezarsen)

Tryngolza (olezarsen) is an apolipoprotein C-III (APOC3)-directed antisense oligonucleotide indicated as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome (FCS), also known as monogenic chylomicronemia or type 1 hyperlipoproteinemia. The policy limits coverage to this specific indication and frames prior authorization requirements around a confirmed diagnosis of FCS for initial approval and documentation of clinical benefit for reauthorization. Authorizations are issued for 12 months when criteria are met.

Step	Requirement
0	No step therapy requirements specified in this policy.

Policy Summary

PayerUnitedHealthcare

PolicyTryngolza (olezarsen) prior authorization

Policy CodePolicy N/A

Change TypeNew prior authorization program

Effective DateMay 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization documenting a confirmed diagnosis of familial chylomicronemia syndrome (FCS) for initial approval and evidence of clinical response for reauthorization.

SourceLink

On This Page

OpenPayer

Tryngolza (olezarsen) prior authorization

Coverage Criteria for Tryngolza (olezarsen)

Initial Authorization Criteria

Reauthorization / Continuation Criteria

Coding and Clinical Response Indicators

Provider Actions, Documentation, and Denial Risks

Definitions

Background on Tryngolza (olezarsen)

Step Therapy Requirements

Site of Care