Pharmacy Prior Authorization Criteria

Tryngolza (olezarsen sodium)

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)

Criteria

Tryngolza

Prior Authorization (Initial Authorization)

Length of Approval: 6 Month(s)

• Diagnosis of familial chylomicronemia syndrome (FCS) (type 1 hyperlipoproteinemia)
AND
• One of the following:
• Genetic confirmation of biallelic pathogenic variants in FCS-causing genes (i.e., LPL, GPIHBP1, APOA5, APOC2, or LMF1)
OR
• A North American FCS (NAFCS) Score of greater than or equal to 45 [4]
AND
• Both of the following:
• One of the following:
• Patient has tried or will receive treatment with standard of care triglyceride lowering therapy (i.e., prescription omega-3 fatty acid and a fibrate)
OR
• Patient has an intolerance to standard of care triglyceride lowering therapy (i.e., prescription omega-3 fatty acid and a fibrate)
AND
• 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
AND
• Prescribed by or in consultation with one of the following:
• Cardiologist
• Endocrinologist
• Gastroenterologist
• Lipid specialist (lipidologist)

Tryngolza

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

• Patient demonstrates positive clinical response to therapy (e.g., reduction in triglyceride levels from baseline)

P & T Revisions

2025-03-20, 2025-02-10

References

1. Tryngolza Prescribing Information. Ionis Pharmaceuticals, Inc. Carlsbad, CA 92010. December 2024.
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

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Revision History

• 2025-03-20: EHB formulary added to guideline.
• 2025-02-10: New program

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