ModifiedColorado Rocky Mountain Health PlansPolicy 2026 P 2364-2

Tryngolza®(olezarsen) - Prior Authorization/Medical Necessity - UnitedHealthcare Commercial Plansopen_in_new

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyTryngolza®(olezarsen) - Prior Authorization/Medical Necessity - UnitedHealthcare Commercial Plansopen_in_new

Policy CodePolicy 2026 P 2364-2

Change TypeModified (criteria clarified; exclusions added)

Effective DateMay 1, 2026

Next Review Date

Key ActionSubmit documentation demonstrating diagnosis of FCS with genetic confirmation or NAFCS score ≥ 45, untreated fasting triglycerides ≥ 880 mg/dL, prescriber specialty, and that Tryngolza will not be used with Redemplo (plozasiran).

SourceLink

POLICY UPDATE CHANGES

New program created in 2/2025 and annual review in 2/2026.

Simplified genetic confirmation criteria added.

Combination use criteria added (not used with Redemplo/plozasiran).

Updated references and annual review.

12 monthsAuthorization Duration

>= 880 mg/dLTriglyceride threshold

>= 45NAFCS Score threshold

4Required prescriber specialties

Coverage Summary

Defines initial and reauthorization coverage criteria, prescriber requirements, exclusions (concomitant use), authorization duration, and additional program rules for Tryngolza (olezarsen) for UnitedHealthcare Commercial Plans. 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). The policy sets prior authorization and medical necessity criteria for use.

Quick Facts / Thresholds

Authorization Duration12 months

Triglyceride threshold>= 880 mg/dL

NAFCS Score threshold>= 45

Required prescriber specialtiesCardiologist; Endocrinologist; Gastroenterologist; Lipid specialist (4)

Initial Therapy Criteria

Initial Authorization

Tryngolza will be approved based on all of the following criteria:

ref”:

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Continuation / Reauthorization Criteria

Authorization will be issued for 12 months.

For reauthorization, provide documentation of a positive clinical response to Tryngolza therapy (for example, reduction in triglycerides or reduction in episodes of acute pancreatitis).

Provider Actions & Authorization Requirements

Prior Authorization

Prior authorization required with clinical criteria

Submit documentation demonstrating diagnosis of FCS with genetic confirmation or NAFCS score ≥ 45, untreated fasting triglycerides ≥ 880 mg/dL, prescriber specialty, and that Tryngolza will not be used with Redemplo (plozasiran).

Documentation Required

Reauthorization clinical response documentation

Provide documentation of positive clinical response to Tryngolza (e.g., triglyceride reduction or fewer acute pancreatitis episodes) for reauthorization.

Applicable Codes

No specific billing codes listed in policymixed

No codes listed

Clinical Evidence & References

P&T Approval Date: 2/2025 and 2/2026.

Key clinical trial/publication: Stroes et al., NEJM 2024 on olezarsen and familial chylomicronemia syndrome.

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). The policy sets prior authorization and medical necessity criteria for use.

Revision History

2/2025program_created

New program created (Prior Authorization/Medical Necessity program established for Tryngolza).

2/2025criteria_simplifiedLatest

Simplified genetic confirmation criteria added (genetic examples include LPL, GPIHBP1, APOA5, APOC2, LMF1).

2/2025exclusion_addedLatest

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyTryngolza®(olezarsen) - Prior Authorization/Medical Necessity - UnitedHealthcare Commercial Plansopen_in_new

Policy CodePolicy 2026 P 2364-2

Change TypeModified (criteria clarified; exclusions added)

Effective DateMay 1, 2026

Next Review Date

SourceLink

On This Page

Familial chylomicronemia syndrome (FCS): Monogenic chylomicronemia, type 1 hyperlipoproteinemia; diagnosis may be genetically confirmed or identified via NAFCS score.

NAFCS Score: North American FCS Score; a score of ≥ 45 is used as diagnostic confirmation in this policy.

Untreated fasting triglycerides: Measured fasting triglyceride level prior to Tryngolza therapy; threshold of ≥ 880 mg/dL is required.

Documentation Required

Specialist prescriber requirement

Ensure prescriber is a cardiologist, endocrinologist, gastroenterologist, or lipid specialist (lipidologist) as required for initial and reauthorization approvals.

Cardiologist
Endocrinologist
Gastroenterologist
Lipid specialist (lipidologist)

Denial Risk

Concurrent Redemplo use exclusion

Claims will not be approved if Tryngolza is used in combination with Redemplo (plozasiran).

Billing Rule

Automated approval allowance

UnitedHealthcare may approve initial and reauthorization requests based solely on previous claim/medication history, diagnosis codes (ICD-10) and/or claim logic; automated approval may be used and supply limits may apply.

Combination use exclusion added: Tryngolza not to be used in combination with Redemplo (plozasiran).

2/2026annual_review

Annual review performed (not material); references updated through 2025.

2/2025references_updated

Updated references and clinical citations (references list includes publications through 2025).