Pharmacy Prior Authorization Criteria

Tryngolza (olezarsen sodium) - PA, NF

Indications for Prior Authorization

Tryngolza (olezarsen sodium)

• For diagnosis of Familial chylomicronemia syndrome (FCS)
  Indicated as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome (FCS)

• For diagnosis of Severe hypertriglyceridemia
  Indicated to reduce triglycerides and the risk of acute pancreatitis in adults with severe hypertriglyceridemia.

Criteria

Tryngolza 80 mg*

Prior Authorization, Non Formulary (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Familial chylomicronemia syndrome (FCS)

• Diagnosis of familial chylomicronemia syndrome (FCS) (type 1 hyperlipoproteinemia)
AND
• Submission of medical records (e.g., chart notes) confirming one of the following:
• Presence genetic confirmation of biallelic pathogenic variants in FCS-causing genes (i.e., LPL, GPIHBP1, APOA5, APOC2, or LMF1) as detected by an FDA-approved test or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA)
OR
• A North American FCS (NAFCS) Score of greater than or equal to 45 [4]
OR
• A Moulin score greater than 10
AND
• Submission of medical records (e.g., chart notes) or paid claims confirming one of the following:
• Both of the following:
• Patient has tried at least a 90-day trial of one of the following standard of care triglyceride lowering therapy:
• Prescription omega-3 fatty acid [e.g., Lovaza, Vascepa]
• Fibrate [e.g., fenofibrate, gemfibrozil]
OR
• Patient has been unable to achieve treatment goals (i.e., tiglyceride levels less than 500 mg/dL)
OR
• Patient has an intolerance to standard of care triglyceride lowering therapy (i.e., prescription omega-3 fatty acid [e.g. Lovaza, Vascepa] or a fibrate [e.g., fenofibrate, gemfibrozil])
AND
• Submission of medical records (e.g., chart notes) confirming baseline fasting triglyceride levels are greater than or equal to 880 mg/dL prior to treatment with requested drug
AND
• Requested drug will be used as adjunct to a low-fat diet (e.g., less than 5% calories from added sugars, 20% to 25% calories from total fat)
AND
• Requested drug will not be used in combination with Redemplo (plozasiran)
AND
• Prescribed by or in consultation with one of the following:
• Cardiologist
• Endocrinologist
• Gastroenterologist
• Lipid specialist (lipidologist)

Tryngolza 80 mg*

Prior Authorization, Non Formulary (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Familial chylomicronemia syndrome (FCS)

• Patient demonstrates positive clinical response to therapy (e.g., reduction in triglyceride levels from baseline)
AND
• Requested drug will not be used in combination with Redemplo (plozasiran)
AND
• Requested drug will continue to be used as adjunct to a low-fat diet (e.g., less than 5% calories from added sugars, 20% to 25% calories from total fat)

Tryngolza 50 mg*

Prior Authorization, Non Formulary (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Severe hypertriglyceridemia

• Diagnosis of severe hypertriglyceridemia
AND
• Submission of medical records (e.g., chart notes) confirming one of the following baseline fasting triglyceride levels prior to treatment with requested drug:
• Greater than or equal to 500 mg/dL and at high risk for acute pancreatitis not related to alcohol use, biliary disease, or uncontrolled diabetes
• Greater than or equal to 1000 mg/dL
AND
• Submission of medical records (e.g., chart notes) or paid claims confirming one of the following:
• Both of the following:
• Patient has tried at least a 90-day trial of one of the following standard of care triglyceride lowering therapy:
• Prescription omega-3 fatty acid [e.g., Lovaza, Vascepa]
• Fibrate [e.g., fenofibrate, gemfibrozil]
AND
• Patient has been unable to achieve treatment goals (i.e., tiglyceride levels less than 500 mg/dL)
OR
• Patient has an intolerance to standard of care triglyceride lowering therapy (i.e., prescription omega-3 fatty acid [e.g. Lovaza, Vascepa] or a fibrate [e.g., fenofibrate, gemfibrozil])
AND
• Requested drug will be used as adjunct to a low-fat diet (e.g., less than 5% calories from added sugars, 20% to 25% calories from total fat)
AND
• One of the following:
• Patient is receiving other lipid lowering (e.g., statins, ezetimibe) at the maximally tolerated dose
• Patient has a documented inability to take other lipid-lowering therapy
AND
• Prescribed by or in consultation with one of the following:
• Cardiologist
• Endocrinologist
• Gastroenterologist
• Lipid specialist (lipidologist)

Tryngolza 50 mg*

Prior Authorization, Non Formulary (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Severe hypertriglyceridemia

• Patient demonstrates positive clinical response to therapy (e.g., reduction in triglyceride levels from baseline)
AND
• One of the following:
• Patient is continuing to receive other lipid lowering therapy (e.g., statins, ezetimibe) at the maximally tolerated dose
• Patient has a documented inability to take other lipid-lowering therapy
AND
• Requested drug will continue to be used as adjunct to a low-fat diet (e.g., less than 5% calories from added sugars, 20% to 25% calories from total fat)

Tryngolza 80 mg*

Prior Authorization, Non Formulary (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Severe hypertriglyceridemia

• Diagnosis of severe hypertriglyceridemia
AND
• Submission of medical records (e.g., chart notes) confirming one of the following baseline fasting triglyceride levels prior to treatment with requested drug:
• Greater than or equal to 500 mg/dL and at high risk for acute pancreatitis not related to alcohol use, biliary disease, or uncontrolled diabetes
• Greater than or equal to 1000 mg/dL
AND
• Submission of medical records (e.g., chart notes) or paid claims confirming one of the following:
• Both of the following:
• Patient has tried at least a 90-day trial of one of the following standard of care triglyceride lowering therapy:
• Prescription omega-3 fatty acid [e.g., Lovaza, Vascepa]
• Fibrate [e.g., fenofibrate, gemfibrozil]
AND
• Patient has been unable to achieve treatment goals (i.e., tiglyceride levels less than 500 mg/dL)
OR
• Patient has an intolerance to standard of care triglyceride lowering therapy (i.e., prescription omega-3 fatty acid [e.g. Lovaza, Vascepa] or a fibrate [e.g., fenofibrate, gemfibrozil])
AND
• Requested drug will be used as adjunct to a low-fat diet (e.g., less than 5% calories from added sugars, 20% to 25% calories from total fat)
AND
• One of the following:
• Patient is receiving other lipid lowering (e.g., statins, ezetimibe) at the maximally tolerated dose
• Patient has a documented inability to take other lipid-lowering therapy
AND
• Prescribed by or in consultation with one of the following:
• Cardiologist
• Endocrinologist
• Gastroenterologist
• Lipid specialist (lipidologist)
AND
• Submission of medical records (e.g., chart notes) or paid claims confirming patient has tried Tryngolza 50 mg for at least 3 consecutive months and has failed to achieve treatment goals

Tryngolza 80 mg*

Prior Authorization, Non Formulary (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Severe hypertriglyceridemia

• Patient demonstrates positive clinical response to therapy (e.g., reduction in triglyceride levels from baseline)
AND
• One of the following:
• Patient is continuing to receive other lipid lowering therapy (e.g., statins, ezetimibe) at the maximally tolerated dose
• Patient has a documented inability to take other lipid-lowering therapy
AND
• Requested drug will continue to be used as adjunct to a low-fat diet (e.g., less than 5% calories from added sugars, 20% to 25% calories from total fat)
AND
• Submission of medical records (e.g., chart notes) or paid claims confirming patient has tried Tryngolza 50 mg for at least 3 consecutive months and has failed to achieve treatment goals

P & T Revisions

2026-07-08, 2026-07-01, 2026-06-25, 2026-06-24, 2026-01-30, 2025-03-20, 2025-02-10

References

1. Tryngolza Prescribing Information. Ionis Pharmaceuticals, Inc. Carlsbad, CA 92010. January 2025.
2. Stroes ESG, Alexander VJ, Karwatowska-Prokopczuk E, et al. Olezarsen, Acute Pancreatitis, and Familial Chylomicronemia Syndrome. N Engl J Med. 2024;390(19):1781-1792. doi:10.1056/NEJMoa2400201
3. Study Details | A Study of Olezarsen (Formerly Known as AKCEA-APOCIII-LRx) Administered to Patients With Familial Chylomicronemia Syndrome (FCS) | ClinicalTrials.gov. https://clinicaltrials.gov/study/NCT04568434. Accessed January 10, 2024.
4. Hegele RA, Ahmad Z, Ashraf A, et al. Development and validation of clinical criteria to identify familial chylomicronemia syndrome (FCS) in North America. J Clin Lipidol. Published online November 12, 2024. doi:10.1016/j.jacl.2024.09.008
5. Clinical consult with cardiologist. January 15, 2026.
6. Clinical consult with cardiologist. January 23, 2026.

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End Notes

1. Per clinical consult with a cardiologist from January 2026, Tryngolza demonstrated a consistent lowering effect on triglycerides during a 12-month treatment period [5].

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Revision History

• 2026-07-08: Update guideline
• 2026-07-01: Addition of new GPI
• 2026-06-25: Operational updates
• 2026-06-24: Addition of prospective severe hypertriglyceridemia indication and update to FCS criteria
• 2026-01-30: 2026 Annual Review. (1) Extend initial approval duration to 12 months. (2) Update to standard genetic testing language. (3) Addition of another diagnosis confirmation option. (4) Addition of examples of omega-3-fatty acids and fibrates. (5) Add criteria to ensure no combination use with Redemplo (plozasiran). (6) Updated references.
• 2025-03-20: EHB formulary added to guideline.
• 2025-02-10: New program

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